Clinical Endocrinology News

When Andrea Austin, MD, an emergency medicine specialist, left the military in 2020, she knew the adjustment to civilian life and practice might be difficult. To help smooth the transition, she reached out to a physician mentor who also had a professional coaching certificate. After a conversation, Dr. Austin signed up for 6 months of career coaching. 

It was time well spent, according to Dr. Austin, who today is a coach herself. “It was really the first time I had the ability to choose what I wanted to do, and that required a mindset shift,” she explains. “A big part of coaching is helping physicians discover their agency so that they can make the best career choices.” 

courtesy Dr. Andrea Austin

Physicians have long lacked the coaching resources typically made available to corporate executives. But that’s changing. In today’s high-pressure environment, where doctors are burning out at a rapid pace, coaching can sometimes be an avenue to staying in the field, especially if that coach is a fellow physician who understands what you’re facing. 

With a physician shortage that the Association of American Medical Colleges expects to hit 86,000 in the next decade or so, coaching could be a stone worth turning over. A 2024 report in JAMA Network Open found that coaching provided by physician peers led to a significant reduction in interpersonal disengagement and burnout. 

“What I think is exciting about coaching is that it allows you to better understand yourself and know your strengths and weaknesses,” said Dr. Austin. “It might seem simple, but many ‘soft skills’ aren’t considered mainstream in medicine. Coaching allows us to understand them and ourselves better.” 
 

Why Are Doctors Using Coaches?

Although it’s hard to put a number on how many physicians are turning to coaches, the number of coaches available for doctors is growing rapidly. The American Medical Women’s Association maintains a database of physician coaches. According to deputy director Jodi Godfrey, MS, RDN, the number of members who have added coaching to their skill set has tripled in the past 4 years. “Many cite burnout as the reason they sought coaching support, and then they decided to go on to get certified in coaching.”

courtesy Michael Hanlon

The pandemic is one reason physician coaching has grown, said Elizabeth Esparaz, MD, an ophthalmologist and physician coach. “Since the pandemic, the word ‘burnout’ is thrown around a good deal.” And the causes are clear. “Doctors are facing longer hours, they must make split-second decisions, they’re multitasking, and they have less support staff.”

Among her coaching clients, Dr. Austin has noticed other common struggles: fears of litigation, time scarcity with patients, declining reimbursement that hasn’t kept up with inflation, and loss of autonomy because of the corporatization of healthcare. 

Coaching, Dr. Esparaz believes, can be an antidote to many of these issues. “Coaches help doctors see their strengths and find better ways of applying them,” she said. “We help them move forward, and also see their blind spots.”
 

Clarity, Goals, and Making the Right Choices

Physician coaching comes in a variety of flavors — some one on one, and others in the form of group sessions. All, however, serve the purpose of helping physicians gain career clarity. “Sometimes clients realize their job may not be working for them, but that there are things they can do to change that without having to leave the field,” said Jattu Senesie, MD, a former ob.gyn. who is now a physician coach. 

Dr. Esparaz works with doctors to establish SMART goals: specific, measurable, attainable, realistic, and time based. She gave the example of learning how to set boundaries. “If a physician is asked to create a presentation for work, I encourage them to ask for compensation or administrative time before committing to unpaid tasks.”

Another big issue: charting. It’s increasingly burdensome, and many doctors find it encroaching on their home lives. “If we can identify a problem like that, we can come up with a strategy for mitigating it,” Dr. Esparaz said. This might include setting a goal of getting 80% of charting completed immediately after the patient encounter on the busiest clinic day of the week. The client tests the experiment and then revisits it with the coach to discuss what worked and what didn’t, refining the process until it has freed up the physician’s home life. 

courtesy Dr. Jattu Senesie

The younger generation of doctors often struggles with career choices, too, because it’s the first time they are without structure, said Dr. Senesie. There’s med school and residency, which puts a framework around every move a doctor makes. But once they become attending physicians, the choices are endless. “Coaching can help them find a new structure and systems that will allow them to thrive.”

Although mentoring has been a well-embraced concept for decades, it “hits a wall,” at some point in terms of what it can offer, Dr. Austin said. That’s where coaching can take over. “There’s a point where a mentor cannot help someone self-actualize. As a coach, you don’t need to know everything about a doctor’s life, but you can help them learn to ask themselves the right questions to solve problems.”
 

Should You Stay or Should You Go?

Dr. Austin’s approach begins with the premise that healthcare today is challenging and dysfunctional — but doctors still have agency. She has worked with clients on the verge of leaving the field and helped them find their way back. 

“They have a light bulb moment and open up to the idea that they have much to give still,” she said. “We take an inventory to help them better communicate their needs and make changes, and I help them connect to their values. Sometimes that exercise allows them to reframe their current work environment.” 

Not every doctor who goes through coaching remains in the field. But “that’s the exception, not the rule,” Dr. Austin said. And that’s okay. “If that’s the outcome, coaching probably helped them get to that point faster, and with an informed decision.” 

Dr. Senesie has been coaching for about a decade, and in that time, she’s seen a shift that goes beyond figuring out career goals. “Doctors are more aware of the need for well-being today. The pandemic made it impossible to ignore what doesn’t work for us. When I work with clients, we look for ways to make the job more tenable.” 

According to Dr. Senesie, younger doctors are looking for that balance at the outset. “They want to be physicians, but they also want a life,” she said. “It’s a challenge for them because in addition to that mindset, they’re also coming out with more debt than older generations. They want out from underneath that.”
 

When It’s Time to Find a Physician Coach

Wondering whether coaching is right for you? Consider these symptoms:

• You need help setting boundaries at work.
• You feel like you’re sacrificing your own well-being for your job.
• You’re using maladaptive strategies to cope with the stress at work.
• You’ve reached a point where you are considering leaving the field.

If you’re interested in finding a physician coach, there are several places to begin your search, word of mouth being one of them. “Conferences and social media can also expose you to coaches,” suggested Dr. Esparaz. There are different methods and approaches to coaching. So, as you research, “make sure the coach you choose has techniques and a framework that fit what you’re after.” 

Dr. Austin warned that it is an unregulated industry, so buyer beware. To ensure you’re getting an accredited physician coach, look for people who have obtained an International Coach Federation (ICF) accreditation. These coaches will hold an associate certified coach credential, which requires at least 60 hours of coaching-specific training approved by the ICF, in addition to other assessments and education. 

Ensure that the coach you choose is within your budget. “There are some people charging astronomical rates out there,” Dr. Austin said. “If you’re burned out or struggling, it can be easy to reach for your credit card.”

Dr. Austin also cautioned doctors seeking a coach to avoid promises that sound too good to be true. Some coaching can have a gaslighting quality to it, she warned, “suggesting it can allow you to endure any environment.” But positive self-talk alone won’t cure an abusive or discriminatory situation. “If a client describes a toxic work environment,” the coach has an “ethical imperative” to help that person protect themselves. 
 

A Side Gig or a New Career Path

After Dr. Austin’s experience with her coach, she made the choice to continue as an emergency physician part-time while starting her own coaching business. “It’s important for me personally to keep in touch with what’s happening on the ground, but I have no judgment for anyone who chooses to leave clinical practice to become a coach.”

When Dr. Senesie looks back on her own struggles as a clinician, she recognizes the state of burnout she was in 10 years ago. “I knew there was an issue, but I didn’t have the mindset to find a way to make it work,” she said. “I left the field when I was at my depths of burnout, which is generally not the best way to go about it.” 

Guidance might have allowed her to take into account other avenues and helped her remain in the field, said Dr. Senesie. She has since learned that “there are many ways to practice medicine, and the way we’ve gone about it traditionally has worked for some, but not necessarily for everyone.” 

There may be more possibilities than you think. By helping you assess your path and make meaningful changes, a physician coach might be the key to remaining in the field you love.

A version of this article first appeared on Medscape.com.

When Andrea Austin, MD, an emergency medicine specialist, left the military in 2020, she knew the adjustment to civilian life and practice might be difficult. To help smooth the transition, she reached out to a physician mentor who also had a professional coaching certificate. After a conversation, Dr. Austin signed up for 6 months of career coaching. 

It was time well spent, according to Dr. Austin, who today is a coach herself. “It was really the first time I had the ability to choose what I wanted to do, and that required a mindset shift,” she explains. “A big part of coaching is helping physicians discover their agency so that they can make the best career choices.” 

courtesy Dr. Andrea Austin

Physicians have long lacked the coaching resources typically made available to corporate executives. But that’s changing. In today’s high-pressure environment, where doctors are burning out at a rapid pace, coaching can sometimes be an avenue to staying in the field, especially if that coach is a fellow physician who understands what you’re facing. 

With a physician shortage that the Association of American Medical Colleges expects to hit 86,000 in the next decade or so, coaching could be a stone worth turning over. A 2024 report in JAMA Network Open found that coaching provided by physician peers led to a significant reduction in interpersonal disengagement and burnout. 

“What I think is exciting about coaching is that it allows you to better understand yourself and know your strengths and weaknesses,” said Dr. Austin. “It might seem simple, but many ‘soft skills’ aren’t considered mainstream in medicine. Coaching allows us to understand them and ourselves better.” 
 

Why Are Doctors Using Coaches?

Although it’s hard to put a number on how many physicians are turning to coaches, the number of coaches available for doctors is growing rapidly. The American Medical Women’s Association maintains a database of physician coaches. According to deputy director Jodi Godfrey, MS, RDN, the number of members who have added coaching to their skill set has tripled in the past 4 years. “Many cite burnout as the reason they sought coaching support, and then they decided to go on to get certified in coaching.”

courtesy Michael Hanlon

The pandemic is one reason physician coaching has grown, said Elizabeth Esparaz, MD, an ophthalmologist and physician coach. “Since the pandemic, the word ‘burnout’ is thrown around a good deal.” And the causes are clear. “Doctors are facing longer hours, they must make split-second decisions, they’re multitasking, and they have less support staff.”

Among her coaching clients, Dr. Austin has noticed other common struggles: fears of litigation, time scarcity with patients, declining reimbursement that hasn’t kept up with inflation, and loss of autonomy because of the corporatization of healthcare. 

Coaching, Dr. Esparaz believes, can be an antidote to many of these issues. “Coaches help doctors see their strengths and find better ways of applying them,” she said. “We help them move forward, and also see their blind spots.”
 

Clarity, Goals, and Making the Right Choices

Physician coaching comes in a variety of flavors — some one on one, and others in the form of group sessions. All, however, serve the purpose of helping physicians gain career clarity. “Sometimes clients realize their job may not be working for them, but that there are things they can do to change that without having to leave the field,” said Jattu Senesie, MD, a former ob.gyn. who is now a physician coach. 

Dr. Esparaz works with doctors to establish SMART goals: specific, measurable, attainable, realistic, and time based. She gave the example of learning how to set boundaries. “If a physician is asked to create a presentation for work, I encourage them to ask for compensation or administrative time before committing to unpaid tasks.”

Another big issue: charting. It’s increasingly burdensome, and many doctors find it encroaching on their home lives. “If we can identify a problem like that, we can come up with a strategy for mitigating it,” Dr. Esparaz said. This might include setting a goal of getting 80% of charting completed immediately after the patient encounter on the busiest clinic day of the week. The client tests the experiment and then revisits it with the coach to discuss what worked and what didn’t, refining the process until it has freed up the physician’s home life. 

courtesy Dr. Jattu Senesie

The younger generation of doctors often struggles with career choices, too, because it’s the first time they are without structure, said Dr. Senesie. There’s med school and residency, which puts a framework around every move a doctor makes. But once they become attending physicians, the choices are endless. “Coaching can help them find a new structure and systems that will allow them to thrive.”

Although mentoring has been a well-embraced concept for decades, it “hits a wall,” at some point in terms of what it can offer, Dr. Austin said. That’s where coaching can take over. “There’s a point where a mentor cannot help someone self-actualize. As a coach, you don’t need to know everything about a doctor’s life, but you can help them learn to ask themselves the right questions to solve problems.”
 

Should You Stay or Should You Go?

Dr. Austin’s approach begins with the premise that healthcare today is challenging and dysfunctional — but doctors still have agency. She has worked with clients on the verge of leaving the field and helped them find their way back. 

“They have a light bulb moment and open up to the idea that they have much to give still,” she said. “We take an inventory to help them better communicate their needs and make changes, and I help them connect to their values. Sometimes that exercise allows them to reframe their current work environment.” 

Not every doctor who goes through coaching remains in the field. But “that’s the exception, not the rule,” Dr. Austin said. And that’s okay. “If that’s the outcome, coaching probably helped them get to that point faster, and with an informed decision.” 

Dr. Senesie has been coaching for about a decade, and in that time, she’s seen a shift that goes beyond figuring out career goals. “Doctors are more aware of the need for well-being today. The pandemic made it impossible to ignore what doesn’t work for us. When I work with clients, we look for ways to make the job more tenable.” 

According to Dr. Senesie, younger doctors are looking for that balance at the outset. “They want to be physicians, but they also want a life,” she said. “It’s a challenge for them because in addition to that mindset, they’re also coming out with more debt than older generations. They want out from underneath that.”
 

When It’s Time to Find a Physician Coach

Wondering whether coaching is right for you? Consider these symptoms:

• You need help setting boundaries at work.
• You feel like you’re sacrificing your own well-being for your job.
• You’re using maladaptive strategies to cope with the stress at work.
• You’ve reached a point where you are considering leaving the field.

If you’re interested in finding a physician coach, there are several places to begin your search, word of mouth being one of them. “Conferences and social media can also expose you to coaches,” suggested Dr. Esparaz. There are different methods and approaches to coaching. So, as you research, “make sure the coach you choose has techniques and a framework that fit what you’re after.” 

Dr. Austin warned that it is an unregulated industry, so buyer beware. To ensure you’re getting an accredited physician coach, look for people who have obtained an International Coach Federation (ICF) accreditation. These coaches will hold an associate certified coach credential, which requires at least 60 hours of coaching-specific training approved by the ICF, in addition to other assessments and education. 

Ensure that the coach you choose is within your budget. “There are some people charging astronomical rates out there,” Dr. Austin said. “If you’re burned out or struggling, it can be easy to reach for your credit card.”

Dr. Austin also cautioned doctors seeking a coach to avoid promises that sound too good to be true. Some coaching can have a gaslighting quality to it, she warned, “suggesting it can allow you to endure any environment.” But positive self-talk alone won’t cure an abusive or discriminatory situation. “If a client describes a toxic work environment,” the coach has an “ethical imperative” to help that person protect themselves. 
 

A Side Gig or a New Career Path

After Dr. Austin’s experience with her coach, she made the choice to continue as an emergency physician part-time while starting her own coaching business. “It’s important for me personally to keep in touch with what’s happening on the ground, but I have no judgment for anyone who chooses to leave clinical practice to become a coach.”

When Dr. Senesie looks back on her own struggles as a clinician, she recognizes the state of burnout she was in 10 years ago. “I knew there was an issue, but I didn’t have the mindset to find a way to make it work,” she said. “I left the field when I was at my depths of burnout, which is generally not the best way to go about it.” 

Guidance might have allowed her to take into account other avenues and helped her remain in the field, said Dr. Senesie. She has since learned that “there are many ways to practice medicine, and the way we’ve gone about it traditionally has worked for some, but not necessarily for everyone.” 

There may be more possibilities than you think. By helping you assess your path and make meaningful changes, a physician coach might be the key to remaining in the field you love.

A version of this article first appeared on Medscape.com.

When Andrea Austin, MD, an emergency medicine specialist, left the military in 2020, she knew the adjustment to civilian life and practice might be difficult. To help smooth the transition, she reached out to a physician mentor who also had a professional coaching certificate. After a conversation, Dr. Austin signed up for 6 months of career coaching. 

It was time well spent, according to Dr. Austin, who today is a coach herself. “It was really the first time I had the ability to choose what I wanted to do, and that required a mindset shift,” she explains. “A big part of coaching is helping physicians discover their agency so that they can make the best career choices.” 

courtesy Dr. Andrea Austin

Physicians have long lacked the coaching resources typically made available to corporate executives. But that’s changing. In today’s high-pressure environment, where doctors are burning out at a rapid pace, coaching can sometimes be an avenue to staying in the field, especially if that coach is a fellow physician who understands what you’re facing. 

With a physician shortage that the Association of American Medical Colleges expects to hit 86,000 in the next decade or so, coaching could be a stone worth turning over. A 2024 report in JAMA Network Open found that coaching provided by physician peers led to a significant reduction in interpersonal disengagement and burnout. 

“What I think is exciting about coaching is that it allows you to better understand yourself and know your strengths and weaknesses,” said Dr. Austin. “It might seem simple, but many ‘soft skills’ aren’t considered mainstream in medicine. Coaching allows us to understand them and ourselves better.” 
 

Why Are Doctors Using Coaches?

Although it’s hard to put a number on how many physicians are turning to coaches, the number of coaches available for doctors is growing rapidly. The American Medical Women’s Association maintains a database of physician coaches. According to deputy director Jodi Godfrey, MS, RDN, the number of members who have added coaching to their skill set has tripled in the past 4 years. “Many cite burnout as the reason they sought coaching support, and then they decided to go on to get certified in coaching.”

courtesy Michael Hanlon

The pandemic is one reason physician coaching has grown, said Elizabeth Esparaz, MD, an ophthalmologist and physician coach. “Since the pandemic, the word ‘burnout’ is thrown around a good deal.” And the causes are clear. “Doctors are facing longer hours, they must make split-second decisions, they’re multitasking, and they have less support staff.”

Among her coaching clients, Dr. Austin has noticed other common struggles: fears of litigation, time scarcity with patients, declining reimbursement that hasn’t kept up with inflation, and loss of autonomy because of the corporatization of healthcare. 

Coaching, Dr. Esparaz believes, can be an antidote to many of these issues. “Coaches help doctors see their strengths and find better ways of applying them,” she said. “We help them move forward, and also see their blind spots.”
 

Clarity, Goals, and Making the Right Choices

Physician coaching comes in a variety of flavors — some one on one, and others in the form of group sessions. All, however, serve the purpose of helping physicians gain career clarity. “Sometimes clients realize their job may not be working for them, but that there are things they can do to change that without having to leave the field,” said Jattu Senesie, MD, a former ob.gyn. who is now a physician coach. 

Dr. Esparaz works with doctors to establish SMART goals: specific, measurable, attainable, realistic, and time based. She gave the example of learning how to set boundaries. “If a physician is asked to create a presentation for work, I encourage them to ask for compensation or administrative time before committing to unpaid tasks.”

Another big issue: charting. It’s increasingly burdensome, and many doctors find it encroaching on their home lives. “If we can identify a problem like that, we can come up with a strategy for mitigating it,” Dr. Esparaz said. This might include setting a goal of getting 80% of charting completed immediately after the patient encounter on the busiest clinic day of the week. The client tests the experiment and then revisits it with the coach to discuss what worked and what didn’t, refining the process until it has freed up the physician’s home life. 

courtesy Dr. Jattu Senesie

The younger generation of doctors often struggles with career choices, too, because it’s the first time they are without structure, said Dr. Senesie. There’s med school and residency, which puts a framework around every move a doctor makes. But once they become attending physicians, the choices are endless. “Coaching can help them find a new structure and systems that will allow them to thrive.”

Although mentoring has been a well-embraced concept for decades, it “hits a wall,” at some point in terms of what it can offer, Dr. Austin said. That’s where coaching can take over. “There’s a point where a mentor cannot help someone self-actualize. As a coach, you don’t need to know everything about a doctor’s life, but you can help them learn to ask themselves the right questions to solve problems.”
 

Should You Stay or Should You Go?

Dr. Austin’s approach begins with the premise that healthcare today is challenging and dysfunctional — but doctors still have agency. She has worked with clients on the verge of leaving the field and helped them find their way back. 

“They have a light bulb moment and open up to the idea that they have much to give still,” she said. “We take an inventory to help them better communicate their needs and make changes, and I help them connect to their values. Sometimes that exercise allows them to reframe their current work environment.” 

Not every doctor who goes through coaching remains in the field. But “that’s the exception, not the rule,” Dr. Austin said. And that’s okay. “If that’s the outcome, coaching probably helped them get to that point faster, and with an informed decision.” 

Dr. Senesie has been coaching for about a decade, and in that time, she’s seen a shift that goes beyond figuring out career goals. “Doctors are more aware of the need for well-being today. The pandemic made it impossible to ignore what doesn’t work for us. When I work with clients, we look for ways to make the job more tenable.” 

According to Dr. Senesie, younger doctors are looking for that balance at the outset. “They want to be physicians, but they also want a life,” she said. “It’s a challenge for them because in addition to that mindset, they’re also coming out with more debt than older generations. They want out from underneath that.”
 

When It’s Time to Find a Physician Coach

Wondering whether coaching is right for you? Consider these symptoms:

• You need help setting boundaries at work.
• You feel like you’re sacrificing your own well-being for your job.
• You’re using maladaptive strategies to cope with the stress at work.
• You’ve reached a point where you are considering leaving the field.

If you’re interested in finding a physician coach, there are several places to begin your search, word of mouth being one of them. “Conferences and social media can also expose you to coaches,” suggested Dr. Esparaz. There are different methods and approaches to coaching. So, as you research, “make sure the coach you choose has techniques and a framework that fit what you’re after.” 

Dr. Austin warned that it is an unregulated industry, so buyer beware. To ensure you’re getting an accredited physician coach, look for people who have obtained an International Coach Federation (ICF) accreditation. These coaches will hold an associate certified coach credential, which requires at least 60 hours of coaching-specific training approved by the ICF, in addition to other assessments and education. 

Ensure that the coach you choose is within your budget. “There are some people charging astronomical rates out there,” Dr. Austin said. “If you’re burned out or struggling, it can be easy to reach for your credit card.”

Dr. Austin also cautioned doctors seeking a coach to avoid promises that sound too good to be true. Some coaching can have a gaslighting quality to it, she warned, “suggesting it can allow you to endure any environment.” But positive self-talk alone won’t cure an abusive or discriminatory situation. “If a client describes a toxic work environment,” the coach has an “ethical imperative” to help that person protect themselves. 
 

A Side Gig or a New Career Path

After Dr. Austin’s experience with her coach, she made the choice to continue as an emergency physician part-time while starting her own coaching business. “It’s important for me personally to keep in touch with what’s happening on the ground, but I have no judgment for anyone who chooses to leave clinical practice to become a coach.”

When Dr. Senesie looks back on her own struggles as a clinician, she recognizes the state of burnout she was in 10 years ago. “I knew there was an issue, but I didn’t have the mindset to find a way to make it work,” she said. “I left the field when I was at my depths of burnout, which is generally not the best way to go about it.” 

Guidance might have allowed her to take into account other avenues and helped her remain in the field, said Dr. Senesie. She has since learned that “there are many ways to practice medicine, and the way we’ve gone about it traditionally has worked for some, but not necessarily for everyone.” 

There may be more possibilities than you think. By helping you assess your path and make meaningful changes, a physician coach might be the key to remaining in the field you love.

A version of this article first appeared on Medscape.com.

A multi-institutional partnership has funded six new research projects aimed at developing novel insulin analogs that more closely mimic the action of a healthy pancreas. 

The Type 1 Diabetes Grand Challenge comprises Diabetes UK, JDRF (now called “Breakthrough T1D” in the United States), and the Steve Morgan Foundation. It will provide a total of £50 million (about $64 million in US dollars) for type 1 diabetes research, including £15 million (~$19 million) for six separate projects on novel insulins to be conducted at universities in the United States, Australia, and China. Four will aim to develop glucose-responsive “smart” insulins, another one ultrafast-acting insulin, and the sixth a product combining insulin and glucagon. 

“Even with the currently available modern insulins, people living with type 1 diabetes put lots of effort into managing their diabetes every day to find a good balance between acceptable glycemic control on the one hand and avoiding hypoglycemia on the other. The funded six new research projects address major shortcomings in insulin therapy,” Tim Heise, MD, vice-chair of the project’s Novel Insulins Scientific Advisory Panel, said in a statement from the Steve Morgan Foundation. 

All six projects are currently in the preclinical stage, Dr. Heise said, noting that “the idea behind the funding program is to help the most promising research initiatives to reach the clinical stage.”

Glucose-responsive, or so-called “smart,” insulins are considered the holy grail because they would become active only to prevent hyperglycemia and remain dormant otherwise, thereby not causing hypoglycemia as current insulin analogs can. The idea isn’t new. In 2010, there was excitement in the type 1 diabetes community when the pharmaceutical company Merck acquired a smaller company called SmartCells that had been working on a “smart insulin” for several years. But nothing came of that. 

“The challenges then and today are pretty similar. In particular, it is quite difficult to find a glucose-sensing moiety that is safe, reacts sufficiently to relatively small changes in the human body in both falling and increasing glucose, and can be produced in large quantities,” Dr. Heise, lead scientist and co-founder of the diabetes contract research organization Profil, based in Neuss, Germany, told this news organization.

Several papers since have reported proof-of-concept in rodents, but there are no published data thus far in humans. However, in recent years the major insulin manufacturers Novo Nordisk and Eli Lilly have acquired smaller companies with the aim of smart insulin development. 

It will still take some time, Dr. Heise said. “The challenges are well understood, although difficult to overcome. There has been quite some progress in the development of glucose-sensing moieties including, but not limited to, nanotechnological approaches.”

Applications for the newly funded projects “were thoroughly reviewed by a large panel of scientists with different areas of expertise. At the end, there was agreement in the review panel that these projects deserved further investigation, although considering their early stage, there still is a substantial risk of failure for all these projects,” he said. 

The development path might be a bit more straightforward for the other two projects. Ultra–fast-acting insulin is needed because the action of the current ones, Novo Nordisk’s Fiasp and Eli Lilly and Company’s Lyumjev, is still delayed, potentially leading to postmeal hyperglycemia if administered after or immediately prior to eating. “A truly rapid short-acting insulin might make it finally possible to progress from hybrid to fully closed loop systems, allowing a technological ‘cure’ for people with diabetes,” Dr. Heise said in the statement. 

And a protein combining insulin with glucagon could help minimize the risk for hypoglycemia, which still exists for current insulin analogs and remains “one of the major concerns associated with insulin therapy today,” he noted. 

Dr. Heise told this news organization that compared with “smart” insulin, development of the other two products “might be a bit faster if they succeed. But none of these approaches will make it to market in the next 5 years, and if one entered clinic within the next 2 years, that would be a huge success.” Nonetheless, “these research projects, if successful, might do no less than heralding a new era in insulin therapy.”

Dr. Heise is an employee of Profil, which has worked with a large number of the major diabetes industry manufacturers.

A version of this article first appeared on Medscape.com.

A multi-institutional partnership has funded six new research projects aimed at developing novel insulin analogs that more closely mimic the action of a healthy pancreas. 

The Type 1 Diabetes Grand Challenge comprises Diabetes UK, JDRF (now called “Breakthrough T1D” in the United States), and the Steve Morgan Foundation. It will provide a total of £50 million (about $64 million in US dollars) for type 1 diabetes research, including £15 million (~$19 million) for six separate projects on novel insulins to be conducted at universities in the United States, Australia, and China. Four will aim to develop glucose-responsive “smart” insulins, another one ultrafast-acting insulin, and the sixth a product combining insulin and glucagon. 

“Even with the currently available modern insulins, people living with type 1 diabetes put lots of effort into managing their diabetes every day to find a good balance between acceptable glycemic control on the one hand and avoiding hypoglycemia on the other. The funded six new research projects address major shortcomings in insulin therapy,” Tim Heise, MD, vice-chair of the project’s Novel Insulins Scientific Advisory Panel, said in a statement from the Steve Morgan Foundation. 

All six projects are currently in the preclinical stage, Dr. Heise said, noting that “the idea behind the funding program is to help the most promising research initiatives to reach the clinical stage.”

Glucose-responsive, or so-called “smart,” insulins are considered the holy grail because they would become active only to prevent hyperglycemia and remain dormant otherwise, thereby not causing hypoglycemia as current insulin analogs can. The idea isn’t new. In 2010, there was excitement in the type 1 diabetes community when the pharmaceutical company Merck acquired a smaller company called SmartCells that had been working on a “smart insulin” for several years. But nothing came of that. 

“The challenges then and today are pretty similar. In particular, it is quite difficult to find a glucose-sensing moiety that is safe, reacts sufficiently to relatively small changes in the human body in both falling and increasing glucose, and can be produced in large quantities,” Dr. Heise, lead scientist and co-founder of the diabetes contract research organization Profil, based in Neuss, Germany, told this news organization.

Several papers since have reported proof-of-concept in rodents, but there are no published data thus far in humans. However, in recent years the major insulin manufacturers Novo Nordisk and Eli Lilly have acquired smaller companies with the aim of smart insulin development. 

It will still take some time, Dr. Heise said. “The challenges are well understood, although difficult to overcome. There has been quite some progress in the development of glucose-sensing moieties including, but not limited to, nanotechnological approaches.”

Applications for the newly funded projects “were thoroughly reviewed by a large panel of scientists with different areas of expertise. At the end, there was agreement in the review panel that these projects deserved further investigation, although considering their early stage, there still is a substantial risk of failure for all these projects,” he said. 

The development path might be a bit more straightforward for the other two projects. Ultra–fast-acting insulin is needed because the action of the current ones, Novo Nordisk’s Fiasp and Eli Lilly and Company’s Lyumjev, is still delayed, potentially leading to postmeal hyperglycemia if administered after or immediately prior to eating. “A truly rapid short-acting insulin might make it finally possible to progress from hybrid to fully closed loop systems, allowing a technological ‘cure’ for people with diabetes,” Dr. Heise said in the statement. 

And a protein combining insulin with glucagon could help minimize the risk for hypoglycemia, which still exists for current insulin analogs and remains “one of the major concerns associated with insulin therapy today,” he noted. 

Dr. Heise told this news organization that compared with “smart” insulin, development of the other two products “might be a bit faster if they succeed. But none of these approaches will make it to market in the next 5 years, and if one entered clinic within the next 2 years, that would be a huge success.” Nonetheless, “these research projects, if successful, might do no less than heralding a new era in insulin therapy.”

Dr. Heise is an employee of Profil, which has worked with a large number of the major diabetes industry manufacturers.

A version of this article first appeared on Medscape.com.

A multi-institutional partnership has funded six new research projects aimed at developing novel insulin analogs that more closely mimic the action of a healthy pancreas. 

The Type 1 Diabetes Grand Challenge comprises Diabetes UK, JDRF (now called “Breakthrough T1D” in the United States), and the Steve Morgan Foundation. It will provide a total of £50 million (about $64 million in US dollars) for type 1 diabetes research, including £15 million (~$19 million) for six separate projects on novel insulins to be conducted at universities in the United States, Australia, and China. Four will aim to develop glucose-responsive “smart” insulins, another one ultrafast-acting insulin, and the sixth a product combining insulin and glucagon. 

“Even with the currently available modern insulins, people living with type 1 diabetes put lots of effort into managing their diabetes every day to find a good balance between acceptable glycemic control on the one hand and avoiding hypoglycemia on the other. The funded six new research projects address major shortcomings in insulin therapy,” Tim Heise, MD, vice-chair of the project’s Novel Insulins Scientific Advisory Panel, said in a statement from the Steve Morgan Foundation. 

All six projects are currently in the preclinical stage, Dr. Heise said, noting that “the idea behind the funding program is to help the most promising research initiatives to reach the clinical stage.”

Glucose-responsive, or so-called “smart,” insulins are considered the holy grail because they would become active only to prevent hyperglycemia and remain dormant otherwise, thereby not causing hypoglycemia as current insulin analogs can. The idea isn’t new. In 2010, there was excitement in the type 1 diabetes community when the pharmaceutical company Merck acquired a smaller company called SmartCells that had been working on a “smart insulin” for several years. But nothing came of that. 

“The challenges then and today are pretty similar. In particular, it is quite difficult to find a glucose-sensing moiety that is safe, reacts sufficiently to relatively small changes in the human body in both falling and increasing glucose, and can be produced in large quantities,” Dr. Heise, lead scientist and co-founder of the diabetes contract research organization Profil, based in Neuss, Germany, told this news organization.

Several papers since have reported proof-of-concept in rodents, but there are no published data thus far in humans. However, in recent years the major insulin manufacturers Novo Nordisk and Eli Lilly have acquired smaller companies with the aim of smart insulin development. 

It will still take some time, Dr. Heise said. “The challenges are well understood, although difficult to overcome. There has been quite some progress in the development of glucose-sensing moieties including, but not limited to, nanotechnological approaches.”

Applications for the newly funded projects “were thoroughly reviewed by a large panel of scientists with different areas of expertise. At the end, there was agreement in the review panel that these projects deserved further investigation, although considering their early stage, there still is a substantial risk of failure for all these projects,” he said. 

The development path might be a bit more straightforward for the other two projects. Ultra–fast-acting insulin is needed because the action of the current ones, Novo Nordisk’s Fiasp and Eli Lilly and Company’s Lyumjev, is still delayed, potentially leading to postmeal hyperglycemia if administered after or immediately prior to eating. “A truly rapid short-acting insulin might make it finally possible to progress from hybrid to fully closed loop systems, allowing a technological ‘cure’ for people with diabetes,” Dr. Heise said in the statement. 

And a protein combining insulin with glucagon could help minimize the risk for hypoglycemia, which still exists for current insulin analogs and remains “one of the major concerns associated with insulin therapy today,” he noted. 

Dr. Heise told this news organization that compared with “smart” insulin, development of the other two products “might be a bit faster if they succeed. But none of these approaches will make it to market in the next 5 years, and if one entered clinic within the next 2 years, that would be a huge success.” Nonetheless, “these research projects, if successful, might do no less than heralding a new era in insulin therapy.”

Dr. Heise is an employee of Profil, which has worked with a large number of the major diabetes industry manufacturers.

A version of this article first appeared on Medscape.com.

A patient who developed atrial fibrillation resulting from the failure to adjust the levothyroxine dose after rapid, significant weight loss while on the antiobesity drug tirzepatide (Zepbound) serves as a key reminder in managing patients experiencing rapid weight loss, either from antiobesity medications or any other means: Patients taking medications with weight-based dosing need to have their doses closely monitored.

“Failing to monitor and adjust dosing of these [and other] medications during a period of rapid weight loss may lead to supratherapeutic — even toxic — levels, as was seen in this [case],” underscore the authors of an editorial regarding the Teachable Moment case, published in JAMA Internal Medicine.

Toxicities from excessive doses can have a range of detrimental effects. In terms of thyroid medicine, the failure to adjust levothyroxine treatment for hypothyroidism in cases of rapid weight loss can lead to thyrotoxicosis, and in older patients in particular, a resulting thyrotropin level < 0.1 mIU/L is associated with as much as a threefold increased risk for atrial fibrillation, as observed in the report. 
 

Case Demonstrates Risks

The case involved a 62-year-old man with obesity, hypothyroidism, and type 1 diabetes who presented to the emergency department with palpitations, excessive sweating, confusion, fever, and hand tremors. Upon being diagnosed with atrial fibrillation, the patient was immediately treated. 

His medical history revealed the underlying culprit: Six months earlier, the patient had started treatment with the gastric inhibitory polypeptide (GIP)/glucagon-like peptide (GLP) 1 dual agonist tirzepatide. As is typical with the drug, the patient’s weight quickly plummeted, dropping from a starting body mass index of 44.4 down to 31.2 after 6 months and a decrease in body weight from 132 kg to 93 kg (a loss of 39 kg [approximately 86 lb]).

Despite the substantial change in body weight, his initial dose of 200 µg of levothyroxine, received for hypothyroidism, was not adjusted.

When he was prescribed tirzepatide, 2.5 mg weekly, for obesity, the patient had been recommended to increase the dose every 4 weeks as tolerated and, importantly, to have a follow-up visit in a month. But because he lived in different states seasonally, the follow-up never occurred.

Upon his emergency department visit, the patient’s thyrotropin level had dropped from 1.9 mIU/L at the first visit 6 months earlier to 0.001 mIU/L (well within the atrial fibrillation risk range), and his free thyroxine level (fT4) was 7.26 ng/ dL — substantially outside of the normal range of about 0.9-1.7 ng/dL for adults. 

“The patient had 4-times higher fT4 levels of the upper limit,” first author Kagan E. Karakus, MD, of the Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora, told this news organization. “That is why he had experienced the adverse event of atrial fibrillation.”
 

Thyrotoxicosis Symptoms Can Be ‘Insidious,’ Levothyroxine Should Be Monitored

Although tirzepatide has not been approved by the US Food and Drug Administration for the treatment of type 1 diabetes, obesity is on the rise among patients with this disorder and recent research has shown a more than 10% reduction in body weight in 6 months and significant reductions in A1c with various doses. 

Of note, in the current case, although the patient’s levothyroxine dose was not adjusted, his insulin dose was gradually self-decreased during his tirzepatide treatment to prevent hypoglycemia.

“If insulin treatment is excessive in diabetes, it causes hypoglycemia, [and] people with type 1 diabetes will recognize the signs of hypoglycemia related to excessive insulin earlier,” Dr. Karakus said.

If symptoms appear, patients can reduce their insulin doses on their own; however, the symptoms of thyrotoxicosis caused by excessive levothyroxine can be more insidious compared with hypoglycemia, he explained. 

“Although patients can change their insulin doses, they cannot change the levothyroxine doses since it requires a blood test [thyroid-stimulating hormone; TSH] and a new prescription of the new dose.”

The key lesson is that “following levothyroxine treatment initiation or dose adjustment, 4-6 weeks is the optimal duration to recheck [the] thyrotropin level and adjust the dose as needed,” Dr. Karakus said.
 

Key Medications to Monitor

Other common outpatient medications that should be closely monitored in patients experiencing rapid weight loss, by any method, range from anticoagulants, anticonvulsants, and antituberculosis drugs to antibiotics and antifungals, the authors note.

Of note, medications with a narrow therapeutic index include phenytoin, warfarin, lithium carbonate, digoxin theophylline, tacrolimus, valproic acid, carbamazepine, and cyclosporine.

The failure to make necessary dose adjustments “is seen more often since the newer antiobesity drugs reduce a great amount of weight within months, almost as rapidly as bariatric surgery,” Dr. Karakus said.

“It is very important for physicians to be aware of the weight-based medications and narrow therapeutic index medications since their doses should be adjusted carefully, especially during weight loss,” he added.

Furthermore, “the patient should also know that weight reduction medication may cause adverse effects like nausea, vomiting and also may affect metabolism of other medications such that some medication doses should be adjusted regularly.”

In the editorial published with the study, Tyrone A. Johnson, MD, of the Department of Medicine, University of California, San Francisco, and colleagues note that the need for close monitoring is particularly important with older patients, who, in addition to having a higher likelihood of comorbidities, commonly have polypharmacy that could increase the potential for adverse effects.

Another key area concern is the emergence of direct-to-consumer avenues for GLP-1/GIP agonists for the many who either cannot afford or do not have access to the drugs, providing further opportunities for treatment without appropriate clinical oversight, they add.

Overall, the case “highlights the potential dangers underlying under-supervised prescribing of GLP-1/GIP receptor agonists and affirms the need for strong partnerships between patients and their clinicians during their use,” they wrote. 

“These medications are best used in collaboration with continuity care teams, in context of a patient’s entire health, and in comprehensive risk-benefit assessment throughout the entire duration of treatment.”
 

A Caveat: Subclinical Levothyroxine Dosing

Commenting on the study, Matthew Ettleson, MD, a clinical instructor of medicine in the Section of Endocrinology, Diabetes, & Metabolism, University of Chicago, noted the important caveat that patients with hypothyroidism are commonly on subclinical doses, with varying dose adjustment needs.

“The patient in the case was clearly on a replacement level dose. However, many patients are on low doses of levothyroxine (75 µg or lower) for subclinical hypothyroidism, and, in general, I think the risks are lower with patients with subclinical hypothyroidism on lower doses of levothyroxine,” he told this news organization.

Because of that, “frequent TSH monitoring may be excessive in this population,” he said. “I would hesitate to empirically lower the dose with weight loss, unless it was clear that the patient was unlikely to follow up.

“Checking TSH at a more frequent interval and adjusting the dose accordingly should be adequate to prevent situations like this case.”

Dr. Karakus, Dr. Ettleson, and the editorial authors had no relevant disclosures to report.
 

A version of this article appeared on Medscape.com.

A patient who developed atrial fibrillation resulting from the failure to adjust the levothyroxine dose after rapid, significant weight loss while on the antiobesity drug tirzepatide (Zepbound) serves as a key reminder in managing patients experiencing rapid weight loss, either from antiobesity medications or any other means: Patients taking medications with weight-based dosing need to have their doses closely monitored.

“Failing to monitor and adjust dosing of these [and other] medications during a period of rapid weight loss may lead to supratherapeutic — even toxic — levels, as was seen in this [case],” underscore the authors of an editorial regarding the Teachable Moment case, published in JAMA Internal Medicine.

Toxicities from excessive doses can have a range of detrimental effects. In terms of thyroid medicine, the failure to adjust levothyroxine treatment for hypothyroidism in cases of rapid weight loss can lead to thyrotoxicosis, and in older patients in particular, a resulting thyrotropin level < 0.1 mIU/L is associated with as much as a threefold increased risk for atrial fibrillation, as observed in the report. 
 

Case Demonstrates Risks

The case involved a 62-year-old man with obesity, hypothyroidism, and type 1 diabetes who presented to the emergency department with palpitations, excessive sweating, confusion, fever, and hand tremors. Upon being diagnosed with atrial fibrillation, the patient was immediately treated. 

His medical history revealed the underlying culprit: Six months earlier, the patient had started treatment with the gastric inhibitory polypeptide (GIP)/glucagon-like peptide (GLP) 1 dual agonist tirzepatide. As is typical with the drug, the patient’s weight quickly plummeted, dropping from a starting body mass index of 44.4 down to 31.2 after 6 months and a decrease in body weight from 132 kg to 93 kg (a loss of 39 kg [approximately 86 lb]).

Despite the substantial change in body weight, his initial dose of 200 µg of levothyroxine, received for hypothyroidism, was not adjusted.

When he was prescribed tirzepatide, 2.5 mg weekly, for obesity, the patient had been recommended to increase the dose every 4 weeks as tolerated and, importantly, to have a follow-up visit in a month. But because he lived in different states seasonally, the follow-up never occurred.

Upon his emergency department visit, the patient’s thyrotropin level had dropped from 1.9 mIU/L at the first visit 6 months earlier to 0.001 mIU/L (well within the atrial fibrillation risk range), and his free thyroxine level (fT4) was 7.26 ng/ dL — substantially outside of the normal range of about 0.9-1.7 ng/dL for adults. 

“The patient had 4-times higher fT4 levels of the upper limit,” first author Kagan E. Karakus, MD, of the Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora, told this news organization. “That is why he had experienced the adverse event of atrial fibrillation.”
 

Thyrotoxicosis Symptoms Can Be ‘Insidious,’ Levothyroxine Should Be Monitored

Although tirzepatide has not been approved by the US Food and Drug Administration for the treatment of type 1 diabetes, obesity is on the rise among patients with this disorder and recent research has shown a more than 10% reduction in body weight in 6 months and significant reductions in A1c with various doses. 

Of note, in the current case, although the patient’s levothyroxine dose was not adjusted, his insulin dose was gradually self-decreased during his tirzepatide treatment to prevent hypoglycemia.

“If insulin treatment is excessive in diabetes, it causes hypoglycemia, [and] people with type 1 diabetes will recognize the signs of hypoglycemia related to excessive insulin earlier,” Dr. Karakus said.

If symptoms appear, patients can reduce their insulin doses on their own; however, the symptoms of thyrotoxicosis caused by excessive levothyroxine can be more insidious compared with hypoglycemia, he explained. 

“Although patients can change their insulin doses, they cannot change the levothyroxine doses since it requires a blood test [thyroid-stimulating hormone; TSH] and a new prescription of the new dose.”

The key lesson is that “following levothyroxine treatment initiation or dose adjustment, 4-6 weeks is the optimal duration to recheck [the] thyrotropin level and adjust the dose as needed,” Dr. Karakus said.
 

Key Medications to Monitor

Other common outpatient medications that should be closely monitored in patients experiencing rapid weight loss, by any method, range from anticoagulants, anticonvulsants, and antituberculosis drugs to antibiotics and antifungals, the authors note.

Of note, medications with a narrow therapeutic index include phenytoin, warfarin, lithium carbonate, digoxin theophylline, tacrolimus, valproic acid, carbamazepine, and cyclosporine.

The failure to make necessary dose adjustments “is seen more often since the newer antiobesity drugs reduce a great amount of weight within months, almost as rapidly as bariatric surgery,” Dr. Karakus said.

“It is very important for physicians to be aware of the weight-based medications and narrow therapeutic index medications since their doses should be adjusted carefully, especially during weight loss,” he added.

Furthermore, “the patient should also know that weight reduction medication may cause adverse effects like nausea, vomiting and also may affect metabolism of other medications such that some medication doses should be adjusted regularly.”

In the editorial published with the study, Tyrone A. Johnson, MD, of the Department of Medicine, University of California, San Francisco, and colleagues note that the need for close monitoring is particularly important with older patients, who, in addition to having a higher likelihood of comorbidities, commonly have polypharmacy that could increase the potential for adverse effects.

Another key area concern is the emergence of direct-to-consumer avenues for GLP-1/GIP agonists for the many who either cannot afford or do not have access to the drugs, providing further opportunities for treatment without appropriate clinical oversight, they add.

Overall, the case “highlights the potential dangers underlying under-supervised prescribing of GLP-1/GIP receptor agonists and affirms the need for strong partnerships between patients and their clinicians during their use,” they wrote. 

“These medications are best used in collaboration with continuity care teams, in context of a patient’s entire health, and in comprehensive risk-benefit assessment throughout the entire duration of treatment.”
 

A Caveat: Subclinical Levothyroxine Dosing

Commenting on the study, Matthew Ettleson, MD, a clinical instructor of medicine in the Section of Endocrinology, Diabetes, & Metabolism, University of Chicago, noted the important caveat that patients with hypothyroidism are commonly on subclinical doses, with varying dose adjustment needs.

“The patient in the case was clearly on a replacement level dose. However, many patients are on low doses of levothyroxine (75 µg or lower) for subclinical hypothyroidism, and, in general, I think the risks are lower with patients with subclinical hypothyroidism on lower doses of levothyroxine,” he told this news organization.

Because of that, “frequent TSH monitoring may be excessive in this population,” he said. “I would hesitate to empirically lower the dose with weight loss, unless it was clear that the patient was unlikely to follow up.

“Checking TSH at a more frequent interval and adjusting the dose accordingly should be adequate to prevent situations like this case.”

Dr. Karakus, Dr. Ettleson, and the editorial authors had no relevant disclosures to report.
 

A version of this article appeared on Medscape.com.

A patient who developed atrial fibrillation resulting from the failure to adjust the levothyroxine dose after rapid, significant weight loss while on the antiobesity drug tirzepatide (Zepbound) serves as a key reminder in managing patients experiencing rapid weight loss, either from antiobesity medications or any other means: Patients taking medications with weight-based dosing need to have their doses closely monitored.

“Failing to monitor and adjust dosing of these [and other] medications during a period of rapid weight loss may lead to supratherapeutic — even toxic — levels, as was seen in this [case],” underscore the authors of an editorial regarding the Teachable Moment case, published in JAMA Internal Medicine.

Toxicities from excessive doses can have a range of detrimental effects. In terms of thyroid medicine, the failure to adjust levothyroxine treatment for hypothyroidism in cases of rapid weight loss can lead to thyrotoxicosis, and in older patients in particular, a resulting thyrotropin level < 0.1 mIU/L is associated with as much as a threefold increased risk for atrial fibrillation, as observed in the report. 
 

Case Demonstrates Risks

The case involved a 62-year-old man with obesity, hypothyroidism, and type 1 diabetes who presented to the emergency department with palpitations, excessive sweating, confusion, fever, and hand tremors. Upon being diagnosed with atrial fibrillation, the patient was immediately treated. 

His medical history revealed the underlying culprit: Six months earlier, the patient had started treatment with the gastric inhibitory polypeptide (GIP)/glucagon-like peptide (GLP) 1 dual agonist tirzepatide. As is typical with the drug, the patient’s weight quickly plummeted, dropping from a starting body mass index of 44.4 down to 31.2 after 6 months and a decrease in body weight from 132 kg to 93 kg (a loss of 39 kg [approximately 86 lb]).

Despite the substantial change in body weight, his initial dose of 200 µg of levothyroxine, received for hypothyroidism, was not adjusted.

When he was prescribed tirzepatide, 2.5 mg weekly, for obesity, the patient had been recommended to increase the dose every 4 weeks as tolerated and, importantly, to have a follow-up visit in a month. But because he lived in different states seasonally, the follow-up never occurred.

Upon his emergency department visit, the patient’s thyrotropin level had dropped from 1.9 mIU/L at the first visit 6 months earlier to 0.001 mIU/L (well within the atrial fibrillation risk range), and his free thyroxine level (fT4) was 7.26 ng/ dL — substantially outside of the normal range of about 0.9-1.7 ng/dL for adults. 

“The patient had 4-times higher fT4 levels of the upper limit,” first author Kagan E. Karakus, MD, of the Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora, told this news organization. “That is why he had experienced the adverse event of atrial fibrillation.”
 

Thyrotoxicosis Symptoms Can Be ‘Insidious,’ Levothyroxine Should Be Monitored

Although tirzepatide has not been approved by the US Food and Drug Administration for the treatment of type 1 diabetes, obesity is on the rise among patients with this disorder and recent research has shown a more than 10% reduction in body weight in 6 months and significant reductions in A1c with various doses. 

Of note, in the current case, although the patient’s levothyroxine dose was not adjusted, his insulin dose was gradually self-decreased during his tirzepatide treatment to prevent hypoglycemia.

“If insulin treatment is excessive in diabetes, it causes hypoglycemia, [and] people with type 1 diabetes will recognize the signs of hypoglycemia related to excessive insulin earlier,” Dr. Karakus said.

If symptoms appear, patients can reduce their insulin doses on their own; however, the symptoms of thyrotoxicosis caused by excessive levothyroxine can be more insidious compared with hypoglycemia, he explained. 

“Although patients can change their insulin doses, they cannot change the levothyroxine doses since it requires a blood test [thyroid-stimulating hormone; TSH] and a new prescription of the new dose.”

The key lesson is that “following levothyroxine treatment initiation or dose adjustment, 4-6 weeks is the optimal duration to recheck [the] thyrotropin level and adjust the dose as needed,” Dr. Karakus said.
 

Key Medications to Monitor

Other common outpatient medications that should be closely monitored in patients experiencing rapid weight loss, by any method, range from anticoagulants, anticonvulsants, and antituberculosis drugs to antibiotics and antifungals, the authors note.

Of note, medications with a narrow therapeutic index include phenytoin, warfarin, lithium carbonate, digoxin theophylline, tacrolimus, valproic acid, carbamazepine, and cyclosporine.

The failure to make necessary dose adjustments “is seen more often since the newer antiobesity drugs reduce a great amount of weight within months, almost as rapidly as bariatric surgery,” Dr. Karakus said.

“It is very important for physicians to be aware of the weight-based medications and narrow therapeutic index medications since their doses should be adjusted carefully, especially during weight loss,” he added.

Furthermore, “the patient should also know that weight reduction medication may cause adverse effects like nausea, vomiting and also may affect metabolism of other medications such that some medication doses should be adjusted regularly.”

In the editorial published with the study, Tyrone A. Johnson, MD, of the Department of Medicine, University of California, San Francisco, and colleagues note that the need for close monitoring is particularly important with older patients, who, in addition to having a higher likelihood of comorbidities, commonly have polypharmacy that could increase the potential for adverse effects.

Another key area concern is the emergence of direct-to-consumer avenues for GLP-1/GIP agonists for the many who either cannot afford or do not have access to the drugs, providing further opportunities for treatment without appropriate clinical oversight, they add.

Overall, the case “highlights the potential dangers underlying under-supervised prescribing of GLP-1/GIP receptor agonists and affirms the need for strong partnerships between patients and their clinicians during their use,” they wrote. 

“These medications are best used in collaboration with continuity care teams, in context of a patient’s entire health, and in comprehensive risk-benefit assessment throughout the entire duration of treatment.”
 

A Caveat: Subclinical Levothyroxine Dosing

Commenting on the study, Matthew Ettleson, MD, a clinical instructor of medicine in the Section of Endocrinology, Diabetes, & Metabolism, University of Chicago, noted the important caveat that patients with hypothyroidism are commonly on subclinical doses, with varying dose adjustment needs.

“The patient in the case was clearly on a replacement level dose. However, many patients are on low doses of levothyroxine (75 µg or lower) for subclinical hypothyroidism, and, in general, I think the risks are lower with patients with subclinical hypothyroidism on lower doses of levothyroxine,” he told this news organization.

Because of that, “frequent TSH monitoring may be excessive in this population,” he said. “I would hesitate to empirically lower the dose with weight loss, unless it was clear that the patient was unlikely to follow up.

“Checking TSH at a more frequent interval and adjusting the dose accordingly should be adequate to prevent situations like this case.”

Dr. Karakus, Dr. Ettleson, and the editorial authors had no relevant disclosures to report.
 

A version of this article appeared on Medscape.com.

Dry fasting, the practice of going without food and water, has enthusiastic advocates on TikTok, X, YouTube, and other social media platforms. Devotees claim a wide range of health effects, but medical professionals advise caution to ensure that the practice does more good than harm, especially for individuals with diabetes. 

Purported benefits and risks vary, depending on who is following the regimen and how long they abstain from food and water. Advocates on social media assert that dry fasting makes “intuition skyrocket” and puts autophagy on “overdrive.” Although such statements may rev up followers, there is little evidence to support these and many other dry-fasting claims. In fact, several physicians warned about unintended consequences.

“I had one patient who followed this fasting method often, and over time she developed kidney stones that led to a severe infection,” said Deena Adimoolam, MD, an endocrinologist in private practice in New York City and New Jersey. “Lack of both water and food can fuel hunger and increase the likelihood of overeating or binge eating once the fast is completed, which does not lead to weight loss. Untreated dehydration can lead to loss of consciousness.”

“For individuals with type 2 diabetes, dehydration can exacerbate hyperglycemia and increase the risk of complications such as diabetic ketoacidosis (DKA),” said Abeer Bader, lead clinical nutrition specialist at the Massachusetts General Hospital Weight Center in Boston. “Research also consistently shows that adequate hydration is crucial for maintaining physical and cognitive performance.”

Dry fasting also can lead to electrolyte imbalances, and the risk is higher for those with diabetes due to potential underlying kidney issues, Ms. Bader noted. “Prolonged dry fasting can result in nutrient deficiencies. For individuals with diabetes, maintaining adequate nutrition is crucial to manage blood sugar levels and overall health. The lack of both food and water can exacerbate deficiencies.”

Joanne Bruno, MD, an endocrinologist at NYU Langone Health, added, “Certain medications used for the management of type 2 diabetes, such as SGLT2 inhibitors, can cause dehydration. It is critical that patients stay well hydrated while on these medications to avoid serious side effects such as euglycemic DKA.”
 

What Exactly Is Dry Fasting?

Defining dry fasting, like any kind of fasting, has remained a challenge, according to authors of the first international consensus on fasting terminology, published on July 25 in Cell Metabolism. The clinical terminology “has remained heterogeneous and often confusing, with similar terms being used to define different fasting regimens ... reflecting the manifold contexts in which fasting is practiced.”

Indeed, dry fasting was among the most discussed terms by the consensus panel and went through several rounds before the panelists came to agreement. A few experts were critical of the practice, whereas those familiar with religious fasting traditions, such as during Ramadan, were clear about the importance of including this term in the consensus process.

“The dissent was resolved by the clarification that this form of fasting has historical and geographical extensions and that the present consensus process did not aim at evaluating therapeutic effectiveness or safety for any term defined,” the authors wrote.

The panel concluded that dry fasting is not the same as total or complete fasting because the latter can include water (such as water-only fasting). Their final definition of dry fasting is ‘’a fasting regimen during which a voluntary abstinence from all foods and beverages, including water, is practiced for a certain period of time.’’

Different types of fasting regimens, such as intermittent fasting, may include dry fasting, in which case it is referred to as “intermittent dry fasting.” This is defined in the consensus as intermittent fasting regimens that involve abstaining from food and fluid intake during the fasting interval, which typically lasts 9-20 hours. 

Most dry fasts, including religious ones, are maintained for a specific interval and are followed by a refeeding period. These fasts are not starvation, defined as no food or water intake for days.
 

What the Evidence Says

All that said, dry fasting by any other name remains dry fasting. “Abundant” evidence from animal studies suggests the potential of various types of fasting for disease prevention and treatment in humans, noted the authors of the consensus report, Along with the risks described above, small studies have explored short-term effects in people, all of which have yet to be established by larger and longer-term studies.

In a recent small study, researchers at Baylor College of Medicine, Houston, Texas, reported that dawn-to-dusk dry fasting for 30 days reduced levels of inflammatory cytokines in the 13 participants with a high body mass index. Earlier work by the group showed that dawn-to-dusk dry fasting for 30 days induced “anti-atherosclerotic, anti-inflammatory, and anti-tumorigenic proteome” in peripheral blood mononuclear cells of 14 individuals with metabolic syndrome (The researchers declined to comment for this article.)

Importantly, the health effects can vary among individuals for unknown reasons, found a recent cross-sectional study of fasting blood glucose (FBG) changes in 181 patients with type 2 diabetes during Ramadan intermittent fasting (RIF), which involves dry fasting during daylight hours for 1 month. The researchers classified participants into three groups: reduced average FBG levels (44%), no change in FBG levels (24%), and increased FBG levels (32%). The authors wrote that further studies are needed to identify factors associated with the differences and to identify “those who are great candidates for RIF.”

In contrast to some of the concerns expressed by clinicians, an exploratory study of daytime dry fasting among 34 healthy Baha’i volunteers in Germany concluded that the 19-day regimen “is safe, has no negative effects on hydration, can improve fat metabolism and can cause transient phase shifts of circadian rhythms.” The authors acknowledge that a larger number and more diverse participants are needed to validate the findings and assess the impact on long-term health.
 

What to Advise Patients

For patients who want to fast as part of their weight loss regimen or to help manage diabetes, clinicians can consider suggesting “alternate ways of eating that might achieve similar goals,” Ms. Bader said. One is intermittent fasting without dry fasting: the 16:8 method (16 hours of fasting, 8 hours of eating) or the 5:2 method (normal eating for 5 days, reduced calorie intake for 2 days), which can support improved insulin sensitivity and metabolic health.

Caloric restriction can also work if the patient maintains a balanced diet that includes all essential nutrients, she said. A low-carbohydrate diet that focuses on limiting carbohydrate intake while increasing consumption of lean proteins and healthy fats has been shown to lower blood sugar levels and improve insulin sensitivity.

Other healthy strategies for patients include the Mediterranean diet, which emphasizes whole grains, fruits, vegetables, nuts, seeds, olive oil, and lean proteins such as fish, or a similar plant-based diet with less animal protein. Ms. Bader advises cultivating mindful eating, which involves paying attention to hunger and fullness cues, making thoughtful food choices, and focusing on being present during meals.

“Each of these dietary strategies offers potential benefits for managing type 2 diabetes and improving overall health,” Ms. Bader said. “I have not had any patients who have tried dry fasting specifically. However, I have encountered scenarios where individuals abstained from food and beverages due to religious practices. In those cases, we focused on ensuring that they maintained proper hydration and balanced nutrition during their eating periods to manage their diabetes effectively and prevent complications.”

Overall, Dr. Adimoolam suggests that clinicians help patients find a weight-loss plan that works best for them based on understanding the calories in the foods they like and don’t like. For fasting regimens, patients can be encouraged to choose one with fluids when possible, as well as intervals of time to fast and eat that work best for their lifestyle.

Ms. Bader, Dr. Bruno, and Dr. Adimoolam report no relevant conflicts.
 

A version of this article appeared on Medscape.com.

Dry fasting, the practice of going without food and water, has enthusiastic advocates on TikTok, X, YouTube, and other social media platforms. Devotees claim a wide range of health effects, but medical professionals advise caution to ensure that the practice does more good than harm, especially for individuals with diabetes. 

Purported benefits and risks vary, depending on who is following the regimen and how long they abstain from food and water. Advocates on social media assert that dry fasting makes “intuition skyrocket” and puts autophagy on “overdrive.” Although such statements may rev up followers, there is little evidence to support these and many other dry-fasting claims. In fact, several physicians warned about unintended consequences.

“I had one patient who followed this fasting method often, and over time she developed kidney stones that led to a severe infection,” said Deena Adimoolam, MD, an endocrinologist in private practice in New York City and New Jersey. “Lack of both water and food can fuel hunger and increase the likelihood of overeating or binge eating once the fast is completed, which does not lead to weight loss. Untreated dehydration can lead to loss of consciousness.”

“For individuals with type 2 diabetes, dehydration can exacerbate hyperglycemia and increase the risk of complications such as diabetic ketoacidosis (DKA),” said Abeer Bader, lead clinical nutrition specialist at the Massachusetts General Hospital Weight Center in Boston. “Research also consistently shows that adequate hydration is crucial for maintaining physical and cognitive performance.”

Dry fasting also can lead to electrolyte imbalances, and the risk is higher for those with diabetes due to potential underlying kidney issues, Ms. Bader noted. “Prolonged dry fasting can result in nutrient deficiencies. For individuals with diabetes, maintaining adequate nutrition is crucial to manage blood sugar levels and overall health. The lack of both food and water can exacerbate deficiencies.”

Joanne Bruno, MD, an endocrinologist at NYU Langone Health, added, “Certain medications used for the management of type 2 diabetes, such as SGLT2 inhibitors, can cause dehydration. It is critical that patients stay well hydrated while on these medications to avoid serious side effects such as euglycemic DKA.”
 

What Exactly Is Dry Fasting?

Defining dry fasting, like any kind of fasting, has remained a challenge, according to authors of the first international consensus on fasting terminology, published on July 25 in Cell Metabolism. The clinical terminology “has remained heterogeneous and often confusing, with similar terms being used to define different fasting regimens ... reflecting the manifold contexts in which fasting is practiced.”

Indeed, dry fasting was among the most discussed terms by the consensus panel and went through several rounds before the panelists came to agreement. A few experts were critical of the practice, whereas those familiar with religious fasting traditions, such as during Ramadan, were clear about the importance of including this term in the consensus process.

“The dissent was resolved by the clarification that this form of fasting has historical and geographical extensions and that the present consensus process did not aim at evaluating therapeutic effectiveness or safety for any term defined,” the authors wrote.

The panel concluded that dry fasting is not the same as total or complete fasting because the latter can include water (such as water-only fasting). Their final definition of dry fasting is ‘’a fasting regimen during which a voluntary abstinence from all foods and beverages, including water, is practiced for a certain period of time.’’

Different types of fasting regimens, such as intermittent fasting, may include dry fasting, in which case it is referred to as “intermittent dry fasting.” This is defined in the consensus as intermittent fasting regimens that involve abstaining from food and fluid intake during the fasting interval, which typically lasts 9-20 hours. 

Most dry fasts, including religious ones, are maintained for a specific interval and are followed by a refeeding period. These fasts are not starvation, defined as no food or water intake for days.
 

What the Evidence Says

All that said, dry fasting by any other name remains dry fasting. “Abundant” evidence from animal studies suggests the potential of various types of fasting for disease prevention and treatment in humans, noted the authors of the consensus report, Along with the risks described above, small studies have explored short-term effects in people, all of which have yet to be established by larger and longer-term studies.

In a recent small study, researchers at Baylor College of Medicine, Houston, Texas, reported that dawn-to-dusk dry fasting for 30 days reduced levels of inflammatory cytokines in the 13 participants with a high body mass index. Earlier work by the group showed that dawn-to-dusk dry fasting for 30 days induced “anti-atherosclerotic, anti-inflammatory, and anti-tumorigenic proteome” in peripheral blood mononuclear cells of 14 individuals with metabolic syndrome (The researchers declined to comment for this article.)

Importantly, the health effects can vary among individuals for unknown reasons, found a recent cross-sectional study of fasting blood glucose (FBG) changes in 181 patients with type 2 diabetes during Ramadan intermittent fasting (RIF), which involves dry fasting during daylight hours for 1 month. The researchers classified participants into three groups: reduced average FBG levels (44%), no change in FBG levels (24%), and increased FBG levels (32%). The authors wrote that further studies are needed to identify factors associated with the differences and to identify “those who are great candidates for RIF.”

In contrast to some of the concerns expressed by clinicians, an exploratory study of daytime dry fasting among 34 healthy Baha’i volunteers in Germany concluded that the 19-day regimen “is safe, has no negative effects on hydration, can improve fat metabolism and can cause transient phase shifts of circadian rhythms.” The authors acknowledge that a larger number and more diverse participants are needed to validate the findings and assess the impact on long-term health.
 

What to Advise Patients

For patients who want to fast as part of their weight loss regimen or to help manage diabetes, clinicians can consider suggesting “alternate ways of eating that might achieve similar goals,” Ms. Bader said. One is intermittent fasting without dry fasting: the 16:8 method (16 hours of fasting, 8 hours of eating) or the 5:2 method (normal eating for 5 days, reduced calorie intake for 2 days), which can support improved insulin sensitivity and metabolic health.

Caloric restriction can also work if the patient maintains a balanced diet that includes all essential nutrients, she said. A low-carbohydrate diet that focuses on limiting carbohydrate intake while increasing consumption of lean proteins and healthy fats has been shown to lower blood sugar levels and improve insulin sensitivity.

Other healthy strategies for patients include the Mediterranean diet, which emphasizes whole grains, fruits, vegetables, nuts, seeds, olive oil, and lean proteins such as fish, or a similar plant-based diet with less animal protein. Ms. Bader advises cultivating mindful eating, which involves paying attention to hunger and fullness cues, making thoughtful food choices, and focusing on being present during meals.

“Each of these dietary strategies offers potential benefits for managing type 2 diabetes and improving overall health,” Ms. Bader said. “I have not had any patients who have tried dry fasting specifically. However, I have encountered scenarios where individuals abstained from food and beverages due to religious practices. In those cases, we focused on ensuring that they maintained proper hydration and balanced nutrition during their eating periods to manage their diabetes effectively and prevent complications.”

Overall, Dr. Adimoolam suggests that clinicians help patients find a weight-loss plan that works best for them based on understanding the calories in the foods they like and don’t like. For fasting regimens, patients can be encouraged to choose one with fluids when possible, as well as intervals of time to fast and eat that work best for their lifestyle.

Ms. Bader, Dr. Bruno, and Dr. Adimoolam report no relevant conflicts.
 

A version of this article appeared on Medscape.com.

Dry fasting, the practice of going without food and water, has enthusiastic advocates on TikTok, X, YouTube, and other social media platforms. Devotees claim a wide range of health effects, but medical professionals advise caution to ensure that the practice does more good than harm, especially for individuals with diabetes. 

Purported benefits and risks vary, depending on who is following the regimen and how long they abstain from food and water. Advocates on social media assert that dry fasting makes “intuition skyrocket” and puts autophagy on “overdrive.” Although such statements may rev up followers, there is little evidence to support these and many other dry-fasting claims. In fact, several physicians warned about unintended consequences.

“I had one patient who followed this fasting method often, and over time she developed kidney stones that led to a severe infection,” said Deena Adimoolam, MD, an endocrinologist in private practice in New York City and New Jersey. “Lack of both water and food can fuel hunger and increase the likelihood of overeating or binge eating once the fast is completed, which does not lead to weight loss. Untreated dehydration can lead to loss of consciousness.”

“For individuals with type 2 diabetes, dehydration can exacerbate hyperglycemia and increase the risk of complications such as diabetic ketoacidosis (DKA),” said Abeer Bader, lead clinical nutrition specialist at the Massachusetts General Hospital Weight Center in Boston. “Research also consistently shows that adequate hydration is crucial for maintaining physical and cognitive performance.”

Dry fasting also can lead to electrolyte imbalances, and the risk is higher for those with diabetes due to potential underlying kidney issues, Ms. Bader noted. “Prolonged dry fasting can result in nutrient deficiencies. For individuals with diabetes, maintaining adequate nutrition is crucial to manage blood sugar levels and overall health. The lack of both food and water can exacerbate deficiencies.”

Joanne Bruno, MD, an endocrinologist at NYU Langone Health, added, “Certain medications used for the management of type 2 diabetes, such as SGLT2 inhibitors, can cause dehydration. It is critical that patients stay well hydrated while on these medications to avoid serious side effects such as euglycemic DKA.”
 

What Exactly Is Dry Fasting?

Defining dry fasting, like any kind of fasting, has remained a challenge, according to authors of the first international consensus on fasting terminology, published on July 25 in Cell Metabolism. The clinical terminology “has remained heterogeneous and often confusing, with similar terms being used to define different fasting regimens ... reflecting the manifold contexts in which fasting is practiced.”

Indeed, dry fasting was among the most discussed terms by the consensus panel and went through several rounds before the panelists came to agreement. A few experts were critical of the practice, whereas those familiar with religious fasting traditions, such as during Ramadan, were clear about the importance of including this term in the consensus process.

“The dissent was resolved by the clarification that this form of fasting has historical and geographical extensions and that the present consensus process did not aim at evaluating therapeutic effectiveness or safety for any term defined,” the authors wrote.

The panel concluded that dry fasting is not the same as total or complete fasting because the latter can include water (such as water-only fasting). Their final definition of dry fasting is ‘’a fasting regimen during which a voluntary abstinence from all foods and beverages, including water, is practiced for a certain period of time.’’

Different types of fasting regimens, such as intermittent fasting, may include dry fasting, in which case it is referred to as “intermittent dry fasting.” This is defined in the consensus as intermittent fasting regimens that involve abstaining from food and fluid intake during the fasting interval, which typically lasts 9-20 hours. 

Most dry fasts, including religious ones, are maintained for a specific interval and are followed by a refeeding period. These fasts are not starvation, defined as no food or water intake for days.
 

What the Evidence Says

All that said, dry fasting by any other name remains dry fasting. “Abundant” evidence from animal studies suggests the potential of various types of fasting for disease prevention and treatment in humans, noted the authors of the consensus report, Along with the risks described above, small studies have explored short-term effects in people, all of which have yet to be established by larger and longer-term studies.

In a recent small study, researchers at Baylor College of Medicine, Houston, Texas, reported that dawn-to-dusk dry fasting for 30 days reduced levels of inflammatory cytokines in the 13 participants with a high body mass index. Earlier work by the group showed that dawn-to-dusk dry fasting for 30 days induced “anti-atherosclerotic, anti-inflammatory, and anti-tumorigenic proteome” in peripheral blood mononuclear cells of 14 individuals with metabolic syndrome (The researchers declined to comment for this article.)

Importantly, the health effects can vary among individuals for unknown reasons, found a recent cross-sectional study of fasting blood glucose (FBG) changes in 181 patients with type 2 diabetes during Ramadan intermittent fasting (RIF), which involves dry fasting during daylight hours for 1 month. The researchers classified participants into three groups: reduced average FBG levels (44%), no change in FBG levels (24%), and increased FBG levels (32%). The authors wrote that further studies are needed to identify factors associated with the differences and to identify “those who are great candidates for RIF.”

In contrast to some of the concerns expressed by clinicians, an exploratory study of daytime dry fasting among 34 healthy Baha’i volunteers in Germany concluded that the 19-day regimen “is safe, has no negative effects on hydration, can improve fat metabolism and can cause transient phase shifts of circadian rhythms.” The authors acknowledge that a larger number and more diverse participants are needed to validate the findings and assess the impact on long-term health.
 

What to Advise Patients

For patients who want to fast as part of their weight loss regimen or to help manage diabetes, clinicians can consider suggesting “alternate ways of eating that might achieve similar goals,” Ms. Bader said. One is intermittent fasting without dry fasting: the 16:8 method (16 hours of fasting, 8 hours of eating) or the 5:2 method (normal eating for 5 days, reduced calorie intake for 2 days), which can support improved insulin sensitivity and metabolic health.

Caloric restriction can also work if the patient maintains a balanced diet that includes all essential nutrients, she said. A low-carbohydrate diet that focuses on limiting carbohydrate intake while increasing consumption of lean proteins and healthy fats has been shown to lower blood sugar levels and improve insulin sensitivity.

Other healthy strategies for patients include the Mediterranean diet, which emphasizes whole grains, fruits, vegetables, nuts, seeds, olive oil, and lean proteins such as fish, or a similar plant-based diet with less animal protein. Ms. Bader advises cultivating mindful eating, which involves paying attention to hunger and fullness cues, making thoughtful food choices, and focusing on being present during meals.

“Each of these dietary strategies offers potential benefits for managing type 2 diabetes and improving overall health,” Ms. Bader said. “I have not had any patients who have tried dry fasting specifically. However, I have encountered scenarios where individuals abstained from food and beverages due to religious practices. In those cases, we focused on ensuring that they maintained proper hydration and balanced nutrition during their eating periods to manage their diabetes effectively and prevent complications.”

Overall, Dr. Adimoolam suggests that clinicians help patients find a weight-loss plan that works best for them based on understanding the calories in the foods they like and don’t like. For fasting regimens, patients can be encouraged to choose one with fluids when possible, as well as intervals of time to fast and eat that work best for their lifestyle.

Ms. Bader, Dr. Bruno, and Dr. Adimoolam report no relevant conflicts.
 

A version of this article appeared on Medscape.com.

Rising consolidation among pharmacy benefit managers (PBMs) allows the companies to profit at the expense of patients and independent pharmacists. That’s the conclusion of a recent Federal Trade Commission (FTC) report on interim findings from the agency’s ongoing investigation of PBMs. 

Lawmakers are increasingly scrutinizing the industry amid growing concern among physicians and consumers about how PBMs exploit their market dominance. The top six PBMs managed 94% of US drug claims in 2023, with the majority handled by the industry’s three giants: CVS Caremark, Cigna’s Express Scripts, and United Healthcare’s OptumRx.

PBMs manage prescription drug benefits for health insurers, Medicare Part D drug plans, and large employers. They act as middlemen between health insurers and pharmacies, developing formularies of covered drugs and promising savings from the discounts and rebates they negotiate with drugmakers.

The FTC’s interim report found that the giant PBMs often exercise significant control over what drugs are available and at what price and which pharmacies patients can use to access their prescribed medications. Consumers suffer as a result, the report concluded.

Madelaine A. Feldman, MD, vice president for advocacy and government affairs for the Coalition of State Rheumatology Organizations, shared her perspective on the FTC report in an email Q&A with this news organization. She is affiliated with The Rheumatology Group, based in Metairie, Louisiana. 

Dr. Feldman has long tracked the PBM industry and appeared as a witness before influential government panels, including the House Energy and Commerce Committee. She has highlighted for lawmakers the challenges physicians face in helping patients get needed medicines. 

For example, she shared cases of PBMs steering patients toward the more expensive of three widely used rheumatoid arthritis medicines that have a similar mechanism of action, the Janus kinase (JAK) inhibitors, Dr. Feldman said. 

One of the drugs cost roughly half of the other two — about $30,000 per year vs $65,000-$70,000. Yet only the two expensive drugs were included in the PBM formulary. As a result, the cheapest drug holds only a sliver of market share; the remainder is dominated by the two expensive products, she told the House Oversight and Accountability Committee in 2021.

This Q&A has been edited for length and clarity.

What would you want federal and state policymakers to do in response to the FTC’s report?

I think Congress needs to clearly delineate the differences between anticompetitive pharmacy issues, drug pricing issues, and their effect on formulary construction issues.

Lawmakers should demand more transparency and consider legislation that would remove perverse incentives that prompt PBMs to choose higher priced drugs for their formularies. 

That may require other regulatory or legislative actions to ensure lower prices (not higher kickbacks) are incentivized. Ultimately, in order to gain true competition within the health insurance business, these oligopolies of multiple businesses need to be broken up. Anything less seems to be nibbling around the edges and allows the Big Three to continue their “whack-a mole” in circumventing piecemeal regulatory and legislative policies.

You’ve followed PBM practices closely for many years. Was there anything in this interim FTC report that surprised you?

Though not surprised, I am glad that it was released because it had been a year in investigation and there were many requests for some type of substantive report. 

Two things that are missing that I feel are paramount are investigating how the three big PBMs are causing physical harm to patients as a result of the profit component in formulary construction and the profound financial impact of hidden PBM profit centers in self-insured employer health plans.

What we have seen over the years is the result of the perverse incentives for the PBMs to prefer the most profitable medications on their formularies. 

They use utilization management tools such as step therapy, nonmedical switching, and exclusions to maintain their formularies’ profitability. These tools have been shown to delay and deny the proper care of patients, resulting in not just monetary but physical harm as well. 

I would think the physical harm done to patients in manipulating the formularies should be addressed in this report as well and, in fact, may be the most important aspect of consumer protection of this issue.

In terms of the FTC’s mission to not “unduly burden” legitimate business, I would like to see the sector of self-insured employers addressed. 

The report details how PBMs steer prescriptions to their affiliated pharmacies. The FTC says that can push smaller pharmacies out of the market, ultimately leading to higher costs and lower quality services for people. What’s your perspective? 

Having more community pharmacies is better than having less. We are seeing more “pharmacy deserts” in rural areas as a result of many community pharmacies having to close.

The FTC voted 4-1 to allow staff to issue the interim report, with Commissioner Melissa Holyoak voting no. And some FTC commissioners seem divided on the usefulness of the report. Why?

Commissioner Holyoak states the “the Report leaves us without a better understanding of the competition concerns surrounding PBMs or how consumers are impacted by PBM practices.” 

I do agree with her that the harm to patients’ medical status was not even addressed as far as I could tell in this report. There are multiple news articles and reports on the harms inflicted upon patients by the UM tools that drive the construction of ever changing formularies, all based on contracting with manufacturers that result in the highest profit for the PBM.

Holyoak also states, “Among other critical conclusions, the Report does not address the seemingly contradictory conclusions in the 2005 Report that PBMs, including vertically owned PBMs, generated cost savings for consumers.” 

That may be true, but in 2005, the rise of PBMs was just beginning and the huge vertical and horizontal integration had yet to begin. Also, 2005 was still in the beginning of the biologic drug deluge, which did create competition to get on the formulary. Since then, PBMs have done nothing to control the rise in prices but instead, apparently have used the competition to get higher price concessions from manufacturers based on a percentage of the list price to line their pockets.

Commissioner Ferguson agreed with releasing the report but he had many issues with this report including the lack of PBM response. 

I do agree with him that the FTC should have used some type of “force” to get the information they needed from the PBMs. The Big Three are known for obfuscation and delaying providing information to legislative and regulatory agencies.
 

A version of this article appeared on Medscape.com.

Rising consolidation among pharmacy benefit managers (PBMs) allows the companies to profit at the expense of patients and independent pharmacists. That’s the conclusion of a recent Federal Trade Commission (FTC) report on interim findings from the agency’s ongoing investigation of PBMs. 

Lawmakers are increasingly scrutinizing the industry amid growing concern among physicians and consumers about how PBMs exploit their market dominance. The top six PBMs managed 94% of US drug claims in 2023, with the majority handled by the industry’s three giants: CVS Caremark, Cigna’s Express Scripts, and United Healthcare’s OptumRx.

PBMs manage prescription drug benefits for health insurers, Medicare Part D drug plans, and large employers. They act as middlemen between health insurers and pharmacies, developing formularies of covered drugs and promising savings from the discounts and rebates they negotiate with drugmakers.

The FTC’s interim report found that the giant PBMs often exercise significant control over what drugs are available and at what price and which pharmacies patients can use to access their prescribed medications. Consumers suffer as a result, the report concluded.

Madelaine A. Feldman, MD, vice president for advocacy and government affairs for the Coalition of State Rheumatology Organizations, shared her perspective on the FTC report in an email Q&A with this news organization. She is affiliated with The Rheumatology Group, based in Metairie, Louisiana. 

Dr. Feldman has long tracked the PBM industry and appeared as a witness before influential government panels, including the House Energy and Commerce Committee. She has highlighted for lawmakers the challenges physicians face in helping patients get needed medicines. 

For example, she shared cases of PBMs steering patients toward the more expensive of three widely used rheumatoid arthritis medicines that have a similar mechanism of action, the Janus kinase (JAK) inhibitors, Dr. Feldman said. 

One of the drugs cost roughly half of the other two — about $30,000 per year vs $65,000-$70,000. Yet only the two expensive drugs were included in the PBM formulary. As a result, the cheapest drug holds only a sliver of market share; the remainder is dominated by the two expensive products, she told the House Oversight and Accountability Committee in 2021.

This Q&A has been edited for length and clarity.

What would you want federal and state policymakers to do in response to the FTC’s report?

I think Congress needs to clearly delineate the differences between anticompetitive pharmacy issues, drug pricing issues, and their effect on formulary construction issues.

Lawmakers should demand more transparency and consider legislation that would remove perverse incentives that prompt PBMs to choose higher priced drugs for their formularies. 

That may require other regulatory or legislative actions to ensure lower prices (not higher kickbacks) are incentivized. Ultimately, in order to gain true competition within the health insurance business, these oligopolies of multiple businesses need to be broken up. Anything less seems to be nibbling around the edges and allows the Big Three to continue their “whack-a mole” in circumventing piecemeal regulatory and legislative policies.

You’ve followed PBM practices closely for many years. Was there anything in this interim FTC report that surprised you?

Though not surprised, I am glad that it was released because it had been a year in investigation and there were many requests for some type of substantive report. 

Two things that are missing that I feel are paramount are investigating how the three big PBMs are causing physical harm to patients as a result of the profit component in formulary construction and the profound financial impact of hidden PBM profit centers in self-insured employer health plans.

What we have seen over the years is the result of the perverse incentives for the PBMs to prefer the most profitable medications on their formularies. 

They use utilization management tools such as step therapy, nonmedical switching, and exclusions to maintain their formularies’ profitability. These tools have been shown to delay and deny the proper care of patients, resulting in not just monetary but physical harm as well. 

I would think the physical harm done to patients in manipulating the formularies should be addressed in this report as well and, in fact, may be the most important aspect of consumer protection of this issue.

In terms of the FTC’s mission to not “unduly burden” legitimate business, I would like to see the sector of self-insured employers addressed. 

The report details how PBMs steer prescriptions to their affiliated pharmacies. The FTC says that can push smaller pharmacies out of the market, ultimately leading to higher costs and lower quality services for people. What’s your perspective? 

Having more community pharmacies is better than having less. We are seeing more “pharmacy deserts” in rural areas as a result of many community pharmacies having to close.

The FTC voted 4-1 to allow staff to issue the interim report, with Commissioner Melissa Holyoak voting no. And some FTC commissioners seem divided on the usefulness of the report. Why?

Commissioner Holyoak states the “the Report leaves us without a better understanding of the competition concerns surrounding PBMs or how consumers are impacted by PBM practices.” 

I do agree with her that the harm to patients’ medical status was not even addressed as far as I could tell in this report. There are multiple news articles and reports on the harms inflicted upon patients by the UM tools that drive the construction of ever changing formularies, all based on contracting with manufacturers that result in the highest profit for the PBM.

Holyoak also states, “Among other critical conclusions, the Report does not address the seemingly contradictory conclusions in the 2005 Report that PBMs, including vertically owned PBMs, generated cost savings for consumers.” 

That may be true, but in 2005, the rise of PBMs was just beginning and the huge vertical and horizontal integration had yet to begin. Also, 2005 was still in the beginning of the biologic drug deluge, which did create competition to get on the formulary. Since then, PBMs have done nothing to control the rise in prices but instead, apparently have used the competition to get higher price concessions from manufacturers based on a percentage of the list price to line their pockets.

Commissioner Ferguson agreed with releasing the report but he had many issues with this report including the lack of PBM response. 

I do agree with him that the FTC should have used some type of “force” to get the information they needed from the PBMs. The Big Three are known for obfuscation and delaying providing information to legislative and regulatory agencies.
 

A version of this article appeared on Medscape.com.

Rising consolidation among pharmacy benefit managers (PBMs) allows the companies to profit at the expense of patients and independent pharmacists. That’s the conclusion of a recent Federal Trade Commission (FTC) report on interim findings from the agency’s ongoing investigation of PBMs. 

Lawmakers are increasingly scrutinizing the industry amid growing concern among physicians and consumers about how PBMs exploit their market dominance. The top six PBMs managed 94% of US drug claims in 2023, with the majority handled by the industry’s three giants: CVS Caremark, Cigna’s Express Scripts, and United Healthcare’s OptumRx.

PBMs manage prescription drug benefits for health insurers, Medicare Part D drug plans, and large employers. They act as middlemen between health insurers and pharmacies, developing formularies of covered drugs and promising savings from the discounts and rebates they negotiate with drugmakers.

The FTC’s interim report found that the giant PBMs often exercise significant control over what drugs are available and at what price and which pharmacies patients can use to access their prescribed medications. Consumers suffer as a result, the report concluded.

Madelaine A. Feldman, MD, vice president for advocacy and government affairs for the Coalition of State Rheumatology Organizations, shared her perspective on the FTC report in an email Q&A with this news organization. She is affiliated with The Rheumatology Group, based in Metairie, Louisiana. 

Dr. Feldman has long tracked the PBM industry and appeared as a witness before influential government panels, including the House Energy and Commerce Committee. She has highlighted for lawmakers the challenges physicians face in helping patients get needed medicines. 

For example, she shared cases of PBMs steering patients toward the more expensive of three widely used rheumatoid arthritis medicines that have a similar mechanism of action, the Janus kinase (JAK) inhibitors, Dr. Feldman said. 

One of the drugs cost roughly half of the other two — about $30,000 per year vs $65,000-$70,000. Yet only the two expensive drugs were included in the PBM formulary. As a result, the cheapest drug holds only a sliver of market share; the remainder is dominated by the two expensive products, she told the House Oversight and Accountability Committee in 2021.

This Q&A has been edited for length and clarity.

What would you want federal and state policymakers to do in response to the FTC’s report?

I think Congress needs to clearly delineate the differences between anticompetitive pharmacy issues, drug pricing issues, and their effect on formulary construction issues.

Lawmakers should demand more transparency and consider legislation that would remove perverse incentives that prompt PBMs to choose higher priced drugs for their formularies. 

That may require other regulatory or legislative actions to ensure lower prices (not higher kickbacks) are incentivized. Ultimately, in order to gain true competition within the health insurance business, these oligopolies of multiple businesses need to be broken up. Anything less seems to be nibbling around the edges and allows the Big Three to continue their “whack-a mole” in circumventing piecemeal regulatory and legislative policies.

You’ve followed PBM practices closely for many years. Was there anything in this interim FTC report that surprised you?

Though not surprised, I am glad that it was released because it had been a year in investigation and there were many requests for some type of substantive report. 

Two things that are missing that I feel are paramount are investigating how the three big PBMs are causing physical harm to patients as a result of the profit component in formulary construction and the profound financial impact of hidden PBM profit centers in self-insured employer health plans.

What we have seen over the years is the result of the perverse incentives for the PBMs to prefer the most profitable medications on their formularies. 

They use utilization management tools such as step therapy, nonmedical switching, and exclusions to maintain their formularies’ profitability. These tools have been shown to delay and deny the proper care of patients, resulting in not just monetary but physical harm as well. 

I would think the physical harm done to patients in manipulating the formularies should be addressed in this report as well and, in fact, may be the most important aspect of consumer protection of this issue.

In terms of the FTC’s mission to not “unduly burden” legitimate business, I would like to see the sector of self-insured employers addressed. 

The report details how PBMs steer prescriptions to their affiliated pharmacies. The FTC says that can push smaller pharmacies out of the market, ultimately leading to higher costs and lower quality services for people. What’s your perspective? 

Having more community pharmacies is better than having less. We are seeing more “pharmacy deserts” in rural areas as a result of many community pharmacies having to close.

The FTC voted 4-1 to allow staff to issue the interim report, with Commissioner Melissa Holyoak voting no. And some FTC commissioners seem divided on the usefulness of the report. Why?

Commissioner Holyoak states the “the Report leaves us without a better understanding of the competition concerns surrounding PBMs or how consumers are impacted by PBM practices.” 

I do agree with her that the harm to patients’ medical status was not even addressed as far as I could tell in this report. There are multiple news articles and reports on the harms inflicted upon patients by the UM tools that drive the construction of ever changing formularies, all based on contracting with manufacturers that result in the highest profit for the PBM.

Holyoak also states, “Among other critical conclusions, the Report does not address the seemingly contradictory conclusions in the 2005 Report that PBMs, including vertically owned PBMs, generated cost savings for consumers.” 

That may be true, but in 2005, the rise of PBMs was just beginning and the huge vertical and horizontal integration had yet to begin. Also, 2005 was still in the beginning of the biologic drug deluge, which did create competition to get on the formulary. Since then, PBMs have done nothing to control the rise in prices but instead, apparently have used the competition to get higher price concessions from manufacturers based on a percentage of the list price to line their pockets.

Commissioner Ferguson agreed with releasing the report but he had many issues with this report including the lack of PBM response. 

I do agree with him that the FTC should have used some type of “force” to get the information they needed from the PBMs. The Big Three are known for obfuscation and delaying providing information to legislative and regulatory agencies.
 

A version of this article appeared on Medscape.com.

Consider this: If you’re taking your children to the beach, how do you protect them from drowning? You don’t tell them, “Don’t go into the ocean.” You teach them how to swim; you give them floaties; and you accompany them in the water and go in only when a lifeguard is present. In other words, you give them all the tools to protect themselves because you know they will go into the ocean anyway. 

Patients are diving into the ocean. Patients with obesity, who know that a treatment for their disease exists but is inaccessible, are diving into the ocean. Unfortunately, they are diving in without floaties or a lifeguard, and well-meaning bystanders are simply telling them to not go. 

Compounded peptides are an ocean of alternative therapies. Even though compounding pharmacists need specialized training, facilities and equipment need to be properly certified, and final dosage forms need extensive testing, pharmacies are not equal when it comes to sterile compounding. Regulatory agencies such as the US Food and Drug Administration (FDA) have expressed caution around compounded semaglutide. Professional societies such as the Obesity Medicine Association (OMA) advise against compounded peptides because they lack clinical trials that prove their safety and efficacy. Ask any individual doctor and you are likely to receive a range of opinions. 

As an endocrinologist specializing in obesity, I practice evidence-based medicine as much as possible. However, I also recognize how today’s dysfunctional medical system compels patients to dive into that ocean in search of an alternative solution. 

Doctors can’t be lifeguards, but we can at least empower patients who want to decide for themselves whether the risk of compounded peptides is worth it. 

With the help of pharmacists, compounding pharmacists, researchers, and clinicians, here is a checklist for patients who seek compounded semaglutide or tirzepatide: 

• Check the state licensing board website to see if there have been any complaints or disciplinary actions made against the pharmacy facility. These government-maintained websites vary in searchability and user-friendliness, but you are specifically looking for whether the FDA ever issued a 483 form.
• Ask for the pharmacy’s state board inspection report. There should be at least one of these reports, issued at the pharmacy’s founding, and there may be more depending on individual state regulations on frequencies of inspections.
• Ask if the compounding pharmacy is accredited by the Pharmacy Compounding Accreditation Board (PCAB). Accreditation is an extra optional step that some compounding pharmacies take to be legitimized by a third party.
• Ask if the pharmacy follows Current Good Manufacturing Practice (CGMP). CGMP is not required of 503a pharmacies, which are pharmacies that provide semaglutide or tirzepatide directly to patients, but following CGMP means an extra level of quality assurance. The bare minimum for anyone doing sterile compounding in the United States is to meet the standards found in the US Pharmacopeia, chapter <797>, Sterile Compounding.
• Ask your compounding pharmacy where they source the medication’s active pharmaceutical ingredient (API).
• Find out if this supplier is registered with the FDA by searching here or here.
• Confirm that semaglutide base, not semaglutide salt, is used in the compounding process.
• Request a certificate of analysis (COA) of the active pharmaceutical ingredient, which should be semaglutide base. This shows you whether the medication has impurities or byproducts due to its manufacturing process.
• Ask if they have third-party confirmation of potency, stability, and sterility testing of the final product.

In generating this guidance, I’m not endorsing compounded peptides, and in fact, I recognize that there is nothing keeping small-time compounding pharmacies from skirting some of these quality measures, falsifying records, and flying under the radar. However, I hope this checklist serves as a starting point for education and risk mitigation. If a compounder is unwilling or unable to answer these questions, consider it a red flag and look elsewhere. 

In an ideal world, the state regulators or the FDA would proactively supervise instead of reactively monitor; trusted compounding pharmacies would be systematically activated to ease medication shortages; and patients with obesity would have access to safe and efficacious treatments for their disease. Until then, we as providers can acknowledge the disappointments of our healthcare system while still developing realistic and individualized solutions that prioritize patient care and safety. 
 

Dr. Tchang is assistant professor, Clinical Medicine, Division of Endocrinology, Diabetes, and Metabolism, Weill Cornell Medicine, and a physician, Department of Medicine, Iris Cantor Women’s Health Center, Comprehensive Weight Control Center, New York. She is an adviser for Novo Nordisk, which manufactures Wegovy, and an adviser for Ro, a telehealth company that offers compounded semaglutide, and serves or has served as a director, officer, partner, employee, advisor, consultant, or trustee for Gelesis and Novo Nordisk.

A version of this article first appeared on Medscape.com.

Consider this: If you’re taking your children to the beach, how do you protect them from drowning? You don’t tell them, “Don’t go into the ocean.” You teach them how to swim; you give them floaties; and you accompany them in the water and go in only when a lifeguard is present. In other words, you give them all the tools to protect themselves because you know they will go into the ocean anyway. 

Patients are diving into the ocean. Patients with obesity, who know that a treatment for their disease exists but is inaccessible, are diving into the ocean. Unfortunately, they are diving in without floaties or a lifeguard, and well-meaning bystanders are simply telling them to not go. 

Compounded peptides are an ocean of alternative therapies. Even though compounding pharmacists need specialized training, facilities and equipment need to be properly certified, and final dosage forms need extensive testing, pharmacies are not equal when it comes to sterile compounding. Regulatory agencies such as the US Food and Drug Administration (FDA) have expressed caution around compounded semaglutide. Professional societies such as the Obesity Medicine Association (OMA) advise against compounded peptides because they lack clinical trials that prove their safety and efficacy. Ask any individual doctor and you are likely to receive a range of opinions. 

As an endocrinologist specializing in obesity, I practice evidence-based medicine as much as possible. However, I also recognize how today’s dysfunctional medical system compels patients to dive into that ocean in search of an alternative solution. 

Doctors can’t be lifeguards, but we can at least empower patients who want to decide for themselves whether the risk of compounded peptides is worth it. 

With the help of pharmacists, compounding pharmacists, researchers, and clinicians, here is a checklist for patients who seek compounded semaglutide or tirzepatide: 

• Check the state licensing board website to see if there have been any complaints or disciplinary actions made against the pharmacy facility. These government-maintained websites vary in searchability and user-friendliness, but you are specifically looking for whether the FDA ever issued a 483 form.
• Ask for the pharmacy’s state board inspection report. There should be at least one of these reports, issued at the pharmacy’s founding, and there may be more depending on individual state regulations on frequencies of inspections.
• Ask if the compounding pharmacy is accredited by the Pharmacy Compounding Accreditation Board (PCAB). Accreditation is an extra optional step that some compounding pharmacies take to be legitimized by a third party.
• Ask if the pharmacy follows Current Good Manufacturing Practice (CGMP). CGMP is not required of 503a pharmacies, which are pharmacies that provide semaglutide or tirzepatide directly to patients, but following CGMP means an extra level of quality assurance. The bare minimum for anyone doing sterile compounding in the United States is to meet the standards found in the US Pharmacopeia, chapter <797>, Sterile Compounding.
• Ask your compounding pharmacy where they source the medication’s active pharmaceutical ingredient (API).
• Find out if this supplier is registered with the FDA by searching here or here.
• Confirm that semaglutide base, not semaglutide salt, is used in the compounding process.
• Request a certificate of analysis (COA) of the active pharmaceutical ingredient, which should be semaglutide base. This shows you whether the medication has impurities or byproducts due to its manufacturing process.
• Ask if they have third-party confirmation of potency, stability, and sterility testing of the final product.

In generating this guidance, I’m not endorsing compounded peptides, and in fact, I recognize that there is nothing keeping small-time compounding pharmacies from skirting some of these quality measures, falsifying records, and flying under the radar. However, I hope this checklist serves as a starting point for education and risk mitigation. If a compounder is unwilling or unable to answer these questions, consider it a red flag and look elsewhere. 

In an ideal world, the state regulators or the FDA would proactively supervise instead of reactively monitor; trusted compounding pharmacies would be systematically activated to ease medication shortages; and patients with obesity would have access to safe and efficacious treatments for their disease. Until then, we as providers can acknowledge the disappointments of our healthcare system while still developing realistic and individualized solutions that prioritize patient care and safety. 
 

Dr. Tchang is assistant professor, Clinical Medicine, Division of Endocrinology, Diabetes, and Metabolism, Weill Cornell Medicine, and a physician, Department of Medicine, Iris Cantor Women’s Health Center, Comprehensive Weight Control Center, New York. She is an adviser for Novo Nordisk, which manufactures Wegovy, and an adviser for Ro, a telehealth company that offers compounded semaglutide, and serves or has served as a director, officer, partner, employee, advisor, consultant, or trustee for Gelesis and Novo Nordisk.

A version of this article first appeared on Medscape.com.

Consider this: If you’re taking your children to the beach, how do you protect them from drowning? You don’t tell them, “Don’t go into the ocean.” You teach them how to swim; you give them floaties; and you accompany them in the water and go in only when a lifeguard is present. In other words, you give them all the tools to protect themselves because you know they will go into the ocean anyway. 

Patients are diving into the ocean. Patients with obesity, who know that a treatment for their disease exists but is inaccessible, are diving into the ocean. Unfortunately, they are diving in without floaties or a lifeguard, and well-meaning bystanders are simply telling them to not go. 

Compounded peptides are an ocean of alternative therapies. Even though compounding pharmacists need specialized training, facilities and equipment need to be properly certified, and final dosage forms need extensive testing, pharmacies are not equal when it comes to sterile compounding. Regulatory agencies such as the US Food and Drug Administration (FDA) have expressed caution around compounded semaglutide. Professional societies such as the Obesity Medicine Association (OMA) advise against compounded peptides because they lack clinical trials that prove their safety and efficacy. Ask any individual doctor and you are likely to receive a range of opinions. 

As an endocrinologist specializing in obesity, I practice evidence-based medicine as much as possible. However, I also recognize how today’s dysfunctional medical system compels patients to dive into that ocean in search of an alternative solution. 

Doctors can’t be lifeguards, but we can at least empower patients who want to decide for themselves whether the risk of compounded peptides is worth it. 

With the help of pharmacists, compounding pharmacists, researchers, and clinicians, here is a checklist for patients who seek compounded semaglutide or tirzepatide: 

• Check the state licensing board website to see if there have been any complaints or disciplinary actions made against the pharmacy facility. These government-maintained websites vary in searchability and user-friendliness, but you are specifically looking for whether the FDA ever issued a 483 form.
• Ask for the pharmacy’s state board inspection report. There should be at least one of these reports, issued at the pharmacy’s founding, and there may be more depending on individual state regulations on frequencies of inspections.
• Ask if the compounding pharmacy is accredited by the Pharmacy Compounding Accreditation Board (PCAB). Accreditation is an extra optional step that some compounding pharmacies take to be legitimized by a third party.
• Ask if the pharmacy follows Current Good Manufacturing Practice (CGMP). CGMP is not required of 503a pharmacies, which are pharmacies that provide semaglutide or tirzepatide directly to patients, but following CGMP means an extra level of quality assurance. The bare minimum for anyone doing sterile compounding in the United States is to meet the standards found in the US Pharmacopeia, chapter <797>, Sterile Compounding.
• Ask your compounding pharmacy where they source the medication’s active pharmaceutical ingredient (API).
• Find out if this supplier is registered with the FDA by searching here or here.
• Confirm that semaglutide base, not semaglutide salt, is used in the compounding process.
• Request a certificate of analysis (COA) of the active pharmaceutical ingredient, which should be semaglutide base. This shows you whether the medication has impurities or byproducts due to its manufacturing process.
• Ask if they have third-party confirmation of potency, stability, and sterility testing of the final product.

In generating this guidance, I’m not endorsing compounded peptides, and in fact, I recognize that there is nothing keeping small-time compounding pharmacies from skirting some of these quality measures, falsifying records, and flying under the radar. However, I hope this checklist serves as a starting point for education and risk mitigation. If a compounder is unwilling or unable to answer these questions, consider it a red flag and look elsewhere. 

In an ideal world, the state regulators or the FDA would proactively supervise instead of reactively monitor; trusted compounding pharmacies would be systematically activated to ease medication shortages; and patients with obesity would have access to safe and efficacious treatments for their disease. Until then, we as providers can acknowledge the disappointments of our healthcare system while still developing realistic and individualized solutions that prioritize patient care and safety. 
 

Dr. Tchang is assistant professor, Clinical Medicine, Division of Endocrinology, Diabetes, and Metabolism, Weill Cornell Medicine, and a physician, Department of Medicine, Iris Cantor Women’s Health Center, Comprehensive Weight Control Center, New York. She is an adviser for Novo Nordisk, which manufactures Wegovy, and an adviser for Ro, a telehealth company that offers compounded semaglutide, and serves or has served as a director, officer, partner, employee, advisor, consultant, or trustee for Gelesis and Novo Nordisk.

A version of this article first appeared on Medscape.com.

Poorer physical function, not poorer bone mineral density (BMD), could be the principal reason for the increased fracture risk in older women with type 2 diabetes (T2D), according to a Swedish prospective observational study in JAMA Network Open.

The study was conducted in more than 3000 Swedish women by Mattias Lorentzon, MD, a professor of geriatric medicine at Gothenburg University, and chief physician at the Osteoporosis Clinic at Sahlgrenska University Hospital in Mölndal, and colleagues.

Study Details

A fractures study was performed in the Gothenburg area from March 2013 to May 2016 with follow-up of incident fracture data completed in March 2023. Data were collected from questionnaires and through examination of anthropometrics, physical function, and bone measurements using dual-energy x-ray absorptiometry and high-resolution peripheral computed tomography. A subsample underwent bone microindentation to assess BMSi.

Among the cohort’s 3008 women, ages 75-80 (mean, 77.8), 294 patients with T2D were compared with 2714 same-age unaffected women.

During a median follow-up of 7.3 years, 1071 incident fractures, 853 major osteoporotic fractures, and 232 hip fractures occurred. In models adjusted for age, BMI, clinical risk factors, and femoral neck BMD, T2D was associated with an increased risk of any fracture: hazard ratio (HR), 1.26; (95% CI, 1.04-1.54), and major osteoporotic fracture (HR, 1.25; 95% CI, 1.00-1.56).

Most fractures were due to falls, with the most common affected sites being the forearm, upper arm, spine, and hip, Dr. Lorentzon said.

Among the findings:

• In bone microarchitecture, women with T2D had higher BMD at all sites: total hip, 4.4% higher; femoral neck, 4.9% higher; and lumbar spine, 5.2% higher.
• At the tibia, the T2D group had 7.4% greater cortical area and 1.3% greater density, as well as 8.7% higher trabecular bone volume fraction.

“Our findings regarding BMD are consistent with previous publications showing higher BMD in individuals with T2D compared with those without diabetes,” Dr. Lorentzon said. A 2012 meta-analysis, for example, showed higher BMD levels in T2D patients. “Some smaller studies, however, have found worse bone microstructure and lower bone material strength in contrast to the results from our study,” Dr. Lorentzon said.

• There was no difference in BMSi, with a mean of 78 in both groups.
• The T2D group had lower performance on all physical function tests: a 9.7% lower grip strength, 9.9% slower gait speed, and 13.9% slower timed up-and-go time than women without diabetes.

“We found all parameters regarding physical function, such as muscle strength, balance, and performance, were much worse in women with diabetes than in those without,” Dr. Lorentzon said. “Dizziness could also be a contributor to the increased risk of falls, but this factor was not investigated in our study.”

Commenting on the study but not involved in it, Anthony J. Pick, MD, an endocrinologist at Northwestern Medicine Lake Forest Hospital in Lake Forest, Illinois, said sarcopenia is a common and often under-recognized problem in older adults and is especially prevalent in T2D, obesity, and heart failure. “I believe that ‘exercise is medicine’ is a key concept for metabolic and osteoporosis patients — and wellness and longevity in general — and I certainly hope studies like this drive awareness of the importance of engaging in strengthening exercises.”

Poorer physical function, not poorer bone mineral density (BMD), could be the principal reason for the increased fracture risk in older women with type 2 diabetes (T2D), according to a Swedish prospective observational study in JAMA Network Open.

The study was conducted in more than 3000 Swedish women by Mattias Lorentzon, MD, a professor of geriatric medicine at Gothenburg University, and chief physician at the Osteoporosis Clinic at Sahlgrenska University Hospital in Mölndal, and colleagues.

Study Details

A fractures study was performed in the Gothenburg area from March 2013 to May 2016 with follow-up of incident fracture data completed in March 2023. Data were collected from questionnaires and through examination of anthropometrics, physical function, and bone measurements using dual-energy x-ray absorptiometry and high-resolution peripheral computed tomography. A subsample underwent bone microindentation to assess BMSi.

Among the cohort’s 3008 women, ages 75-80 (mean, 77.8), 294 patients with T2D were compared with 2714 same-age unaffected women.

During a median follow-up of 7.3 years, 1071 incident fractures, 853 major osteoporotic fractures, and 232 hip fractures occurred. In models adjusted for age, BMI, clinical risk factors, and femoral neck BMD, T2D was associated with an increased risk of any fracture: hazard ratio (HR), 1.26; (95% CI, 1.04-1.54), and major osteoporotic fracture (HR, 1.25; 95% CI, 1.00-1.56).

Most fractures were due to falls, with the most common affected sites being the forearm, upper arm, spine, and hip, Dr. Lorentzon said.

Among the findings:

• In bone microarchitecture, women with T2D had higher BMD at all sites: total hip, 4.4% higher; femoral neck, 4.9% higher; and lumbar spine, 5.2% higher.
• At the tibia, the T2D group had 7.4% greater cortical area and 1.3% greater density, as well as 8.7% higher trabecular bone volume fraction.

“Our findings regarding BMD are consistent with previous publications showing higher BMD in individuals with T2D compared with those without diabetes,” Dr. Lorentzon said. A 2012 meta-analysis, for example, showed higher BMD levels in T2D patients. “Some smaller studies, however, have found worse bone microstructure and lower bone material strength in contrast to the results from our study,” Dr. Lorentzon said.

• There was no difference in BMSi, with a mean of 78 in both groups.
• The T2D group had lower performance on all physical function tests: a 9.7% lower grip strength, 9.9% slower gait speed, and 13.9% slower timed up-and-go time than women without diabetes.

“We found all parameters regarding physical function, such as muscle strength, balance, and performance, were much worse in women with diabetes than in those without,” Dr. Lorentzon said. “Dizziness could also be a contributor to the increased risk of falls, but this factor was not investigated in our study.”

Commenting on the study but not involved in it, Anthony J. Pick, MD, an endocrinologist at Northwestern Medicine Lake Forest Hospital in Lake Forest, Illinois, said sarcopenia is a common and often under-recognized problem in older adults and is especially prevalent in T2D, obesity, and heart failure. “I believe that ‘exercise is medicine’ is a key concept for metabolic and osteoporosis patients — and wellness and longevity in general — and I certainly hope studies like this drive awareness of the importance of engaging in strengthening exercises.”

Poorer physical function, not poorer bone mineral density (BMD), could be the principal reason for the increased fracture risk in older women with type 2 diabetes (T2D), according to a Swedish prospective observational study in JAMA Network Open.

The study was conducted in more than 3000 Swedish women by Mattias Lorentzon, MD, a professor of geriatric medicine at Gothenburg University, and chief physician at the Osteoporosis Clinic at Sahlgrenska University Hospital in Mölndal, and colleagues.

Study Details

A fractures study was performed in the Gothenburg area from March 2013 to May 2016 with follow-up of incident fracture data completed in March 2023. Data were collected from questionnaires and through examination of anthropometrics, physical function, and bone measurements using dual-energy x-ray absorptiometry and high-resolution peripheral computed tomography. A subsample underwent bone microindentation to assess BMSi.

Among the cohort’s 3008 women, ages 75-80 (mean, 77.8), 294 patients with T2D were compared with 2714 same-age unaffected women.

During a median follow-up of 7.3 years, 1071 incident fractures, 853 major osteoporotic fractures, and 232 hip fractures occurred. In models adjusted for age, BMI, clinical risk factors, and femoral neck BMD, T2D was associated with an increased risk of any fracture: hazard ratio (HR), 1.26; (95% CI, 1.04-1.54), and major osteoporotic fracture (HR, 1.25; 95% CI, 1.00-1.56).

Most fractures were due to falls, with the most common affected sites being the forearm, upper arm, spine, and hip, Dr. Lorentzon said.

Among the findings:

• In bone microarchitecture, women with T2D had higher BMD at all sites: total hip, 4.4% higher; femoral neck, 4.9% higher; and lumbar spine, 5.2% higher.
• At the tibia, the T2D group had 7.4% greater cortical area and 1.3% greater density, as well as 8.7% higher trabecular bone volume fraction.

“Our findings regarding BMD are consistent with previous publications showing higher BMD in individuals with T2D compared with those without diabetes,” Dr. Lorentzon said. A 2012 meta-analysis, for example, showed higher BMD levels in T2D patients. “Some smaller studies, however, have found worse bone microstructure and lower bone material strength in contrast to the results from our study,” Dr. Lorentzon said.

• There was no difference in BMSi, with a mean of 78 in both groups.
• The T2D group had lower performance on all physical function tests: a 9.7% lower grip strength, 9.9% slower gait speed, and 13.9% slower timed up-and-go time than women without diabetes.

“We found all parameters regarding physical function, such as muscle strength, balance, and performance, were much worse in women with diabetes than in those without,” Dr. Lorentzon said. “Dizziness could also be a contributor to the increased risk of falls, but this factor was not investigated in our study.”

Commenting on the study but not involved in it, Anthony J. Pick, MD, an endocrinologist at Northwestern Medicine Lake Forest Hospital in Lake Forest, Illinois, said sarcopenia is a common and often under-recognized problem in older adults and is especially prevalent in T2D, obesity, and heart failure. “I believe that ‘exercise is medicine’ is a key concept for metabolic and osteoporosis patients — and wellness and longevity in general — and I certainly hope studies like this drive awareness of the importance of engaging in strengthening exercises.”

ORLANDO, FLORIDA — As increasing data show benefit for continuous glucose monitoring (CGM) devices beyond just insulin-treated diabetes, efforts are being made to optimize the use of CGM in primary care settings.

Currently, Medicare and most private insurers cover CGM for people with diabetes who use insulin, regardless of the type of diabetes or the type of insulin, and for those with a history of severe hypoglycemia. Data are increasingly showing benefit for people who don’t use insulin. As of now, with the exception of some state Medicaid beneficiaries, the majority must pay out of pocket.

Such use is expected to grow with the upcoming availability of two new over-the-counter CGMs, Dexcom’s Stelo and Abbott’s Libre Rio, both made for people with diabetes who don’t use insulin. (Abbott will also launch the Lingo, a wellness CGM for people without diabetes.)

This means that CGM will become increasingly prevalent in primary care, where there is currently a great deal of variability in the capacity to manage and use the data generated by the devices to improve diabetes management, experts said during an oral abstract session at the recent American Diabetes Association (ADA) 84th Scientific Sessions and in interviews with this news organization.

“It’s picking up steam, and there’s a lot more visibility of CGM in primary care and a lot more people prescribing it,” Thomas W. Martens, MD, medical director of the International Diabetes Center at HealthPartners Institute, Minneapolis, told this news organization. He noted that the recent switch in many cases of CGM from billing as durable medical equipment to pharmacy has made prescribing easier, while television advertising has increased demand.

But still unclear, he noted, is how the CGM data are being used. “The question is, are prescriptions just being sent out and people using it like a finger-stick blood glucose monitor, or is primary care really using the data to move diabetes forward? I think that’s where a lot of the work on dissemination and implementation is going. How do we really make this a useful tool for optimizing diabetes care?”
 

Informing Food Choice, Treatment Intensification

At the ADA meeting, Dr. Martens presented topline data from a randomized multicenter controlled trial funded by Abbott, examining the effect of CGM use on guiding food choices and other behaviors in 72 adults with type 2 diabetes who were not using insulin but who were using other glucose-lowering medications.

At 3 months, with no medication changes, there was a significant overall 26% reduction in time spent above 180 mg/dL (P < .0001), which didn›t differ significantly between those randomized to CGM alone or in conjunction with a food logging app. Both groups also experienced a significant 1.1% reduction in A1c (P < .0001) and about a 4-lb weight loss (P = .014 for CGM alone, P = .0032 for CGM + app).

“The win for people not on insulin is you can see the impact of food choices really quickly with a CGM ... and then perhaps modify that to improve postprandial hyperglycemia,” Dr. Martens said.

And for the clinician, “not everybody with type 2 diabetes not on insulin can get where they need to be just by changing their diets. The CGM is a pretty good tool for knowing when you need to advance therapy.”
 

Diabetes Care and Education Specialists (DCESs) Assist CGM Use

Another speaker at the ADA meeting, Sean M. Oser, MD, director of the Practice Innovation Program and associated director of the Primary Care Diabetes Lab at the University of Colorado Anschutz Medical Campus, Aurora, Colorado, noted that 90% of adults with type 2 diabetes and 50% with type 1 diabetes receive their diabetes care in primary care settings.

“CGM is increasingly becoming standard of care in diabetes ... But [primary care providers] remain relatively untrained about CGM ... What I’m concerned about is the disparity disparities in who has access and who does not. We really need to bring our primary care colleagues along,” he said.

Dr. Oser described tools he and his wife, Tamara K. Oser, MD, professor in the Department of Family Medicine at the same institution, developed in conjunction with the American Academy of Family Physicians (AAFP), including the Transformation in Practice series (TIPS).

The PREPARE 4 CGM study examined the use of three different strategies for incorporating CGM into primary care settings: Either use of AAFP TIPS alone, TIPS plus practice facilitation services by coaches who assist the practice in implementing new workflows, or referral to a virtual CGM initiation service (virCIS) with a virtual CGM workshop that Dr. Oser and Dr. Oser also developed.

Of the 76 Colorado primary care practices participating (out of 60 planned), the 46 who chose AAFP TIPS were randomized to either the AAFP TIPS alone or to TIPS + practice facilitation. The other 30 chose virCIS with the onetime CGM basics webinar. The fact that more practices than anticipated were recruited for the study suggests that “primary care interest in CGM is very high. They want to learn,” Dr. Oser noted.

Of the 51 practice characteristics investigated, only one, the presence of a DCES, in the practice, was significantly associated with the choice of CGM implementation strategy. Of the 16 practices with access to a DCES, all of them chose self-initiation with CGM using TIPS. But of the 60 practices without a DCES, half chose the virCIS.

“We know that 36% of primary care practices have access to a DCES within the clinic, part-time or full-time, and that’s not enough, I would argue,” Dr. Oser said.

Indeed, Dr. Martens told this news organization that those professionals, formerly called “diabetes educators,” often aren’t available in primary care settings, especially in rural areas. “Unfortunately, they are not well reimbursed. A lot of care systems don’t employ as many as they ideally should because it tends not to be a moneymaker ... Something’s got to change with reimbursement for the cognitive aspects of diabetes management.”

Dr. Oser said his team’s next steps include completion of the virCIS operations, analysis of the effectiveness of the three implantation strategies in practice- and patient-level outcomes, a cost analysis of the three strategies, and further development of toolkits to assist in these efforts.

“One of our goals is to keep people at their primary care home, where they want to be ... Diabetes knows no borders. People should have access wherever they are,” Dr. Oser concluded in his ADA talk.
 

What Predicts Primary Care CGM Prescribing?

Further clues about effective strategies to improve CGM prescribing in primary care were provided in a study presented by Jovan Milosavljevic, MD, a second-year endocrinology fellow at the Fleischer Institute for Diabetes and Metabolism, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York.

He began by noting that there are currently 61.5 million diabetes visits annually in primary care compared with 32.0 million in specialty care and that there is a shortage of endocrinologists in the face of the rising number of people diagnosed with diabetes. “Primary care will continue to be the only point of care for most people with diabetes. So, standard-of-care treatment such as CGM must enter routine primary care practice to impact population-level health outcomes.”

Electronic health record data were examined for 39,710 patients with type 2 diabetes seen at 13 primary care sites affiliated with Montefiore Medical Center, a large safety net hospital in New York, where CGM is widely covered by public insurance. Between July 31, 2020, and July 31, 2023, a total of 3503, or just 8.8%, were prescribed CGM by a primary care provider.

Those with CGM prescribed were younger than those without (59.7 vs 62.7 years), about 40% of both groups were Hispanic or Black, and a majority were English-speaking: 84.5% of those prescribed CGM spoke English, while only 13.1% spoke Spanish. Over half (59.1%) of those prescribed CGM had commercial insurance, while only 11.2% had Medicaid and 29.7% had Medicare.

More patients with CGM prescribed had providers with more than 10 years in practice: 72.5% vs 64.5% with no CGM.

Not surprisingly, those with CGM prescribed were more likely on insulin — 21% using just basal and 35% on multiple daily injections. Those prescribed CGM had higher A1c levels before CGM prescription: 9.2% vs 7.2% for those not prescribed CGM.

No racial or ethnic bias was found in the relationships between CGM use and insulin use, provider experience, engagement with care, and A1c. However, there were differences by age, sex, and spoken language.

For example, the Hispanic group aged 65 years and older was less likely than those younger to be prescribed CGM, but this wasn’t seen in other ethnic groups. In fact, older White people were slightly more likely to have CGM prescribed. Spanish-speaking patients were about 43% less likely to have CGM prescribed than were English-speaking patients.

These findings suggest a dual approach might work best for improving CGM prescribing in primary care. “We can leverage the knowledge that some of these factors are independent of bias and promote clinical and evidence-based guidelines for CGM. Additionally, we should focus on physicians in training,” Dr. Milosavljevic said.

At the same time, “we need to tackle systemic inequity in prescription processes,” with measures such as improving prescription workflows, supporting prior authorization, and using patient hands-on support for older adults and Spanish-speaking individuals, he said.

In a message to this news organization, Tamara K. Oser, MD, wrote, “Disparities in CGM and other diabetes technology are prevalent and multifactorial. In addition to insurance barriers, implicit bias also plays a large role. Shared decision-making should always be used when deciding to prescribe diabetes technologies.”

The PREPARE 4 CGM study is evaluating willingness to pay for CGM, she noted.

“Even patients without insurance might want to purchase one sensor every few months to empower them to learn more about how food and exercise affect their glucose or to help assess the need for [adjusting] diabetes medications. It is an exciting time for people living with diabetes. Primary care, endocrinology, device manufacturers, and insurers should all do their part to assure increased access to these evidence-based technologies.”

Dr. Martens’ employer has received funds on his behalf for research and speaking support from Dexcom, Abbott Diabetes Care, Medtronic, Insulet, Tandem, Sanofi, Eli Lilly and Company, and Novo Nordisk, and for consulting from Sanofi and Eli Lilly and Company. He is employed by the nonprofit HealthPartners Institute dba International Diabetes Center and received no personal income from these activities.

The Osers have received advisory board consulting fees (through the University of Colorado) from Dexcom, Medscape Medical News, Ascensia, and Blue Circle Health and research grants (through the University of Colorado) from National Institute of Nursing Research, National Institute of Diabetes and Digestive and Kidney Diseases, the Helmsley Charitable Trust, Abbott Diabetes, Dexcom, and Insulet. They do not own stocks in any device or pharmaceutical company.

Dr. Milosavljevic’s work was supported by the National Institutes of Health/National Center for Advancing Translational Science and Einstein-Montefiore Clinical and Translational Science Awards. He had no further disclosures.
 

A version of this article first appeared on Medscape.com.

ORLANDO, FLORIDA — As increasing data show benefit for continuous glucose monitoring (CGM) devices beyond just insulin-treated diabetes, efforts are being made to optimize the use of CGM in primary care settings.

Currently, Medicare and most private insurers cover CGM for people with diabetes who use insulin, regardless of the type of diabetes or the type of insulin, and for those with a history of severe hypoglycemia. Data are increasingly showing benefit for people who don’t use insulin. As of now, with the exception of some state Medicaid beneficiaries, the majority must pay out of pocket.

Such use is expected to grow with the upcoming availability of two new over-the-counter CGMs, Dexcom’s Stelo and Abbott’s Libre Rio, both made for people with diabetes who don’t use insulin. (Abbott will also launch the Lingo, a wellness CGM for people without diabetes.)

This means that CGM will become increasingly prevalent in primary care, where there is currently a great deal of variability in the capacity to manage and use the data generated by the devices to improve diabetes management, experts said during an oral abstract session at the recent American Diabetes Association (ADA) 84th Scientific Sessions and in interviews with this news organization.

“It’s picking up steam, and there’s a lot more visibility of CGM in primary care and a lot more people prescribing it,” Thomas W. Martens, MD, medical director of the International Diabetes Center at HealthPartners Institute, Minneapolis, told this news organization. He noted that the recent switch in many cases of CGM from billing as durable medical equipment to pharmacy has made prescribing easier, while television advertising has increased demand.

But still unclear, he noted, is how the CGM data are being used. “The question is, are prescriptions just being sent out and people using it like a finger-stick blood glucose monitor, or is primary care really using the data to move diabetes forward? I think that’s where a lot of the work on dissemination and implementation is going. How do we really make this a useful tool for optimizing diabetes care?”
 

Informing Food Choice, Treatment Intensification

At the ADA meeting, Dr. Martens presented topline data from a randomized multicenter controlled trial funded by Abbott, examining the effect of CGM use on guiding food choices and other behaviors in 72 adults with type 2 diabetes who were not using insulin but who were using other glucose-lowering medications.

At 3 months, with no medication changes, there was a significant overall 26% reduction in time spent above 180 mg/dL (P < .0001), which didn›t differ significantly between those randomized to CGM alone or in conjunction with a food logging app. Both groups also experienced a significant 1.1% reduction in A1c (P < .0001) and about a 4-lb weight loss (P = .014 for CGM alone, P = .0032 for CGM + app).

“The win for people not on insulin is you can see the impact of food choices really quickly with a CGM ... and then perhaps modify that to improve postprandial hyperglycemia,” Dr. Martens said.

And for the clinician, “not everybody with type 2 diabetes not on insulin can get where they need to be just by changing their diets. The CGM is a pretty good tool for knowing when you need to advance therapy.”
 

Diabetes Care and Education Specialists (DCESs) Assist CGM Use

Another speaker at the ADA meeting, Sean M. Oser, MD, director of the Practice Innovation Program and associated director of the Primary Care Diabetes Lab at the University of Colorado Anschutz Medical Campus, Aurora, Colorado, noted that 90% of adults with type 2 diabetes and 50% with type 1 diabetes receive their diabetes care in primary care settings.

“CGM is increasingly becoming standard of care in diabetes ... But [primary care providers] remain relatively untrained about CGM ... What I’m concerned about is the disparity disparities in who has access and who does not. We really need to bring our primary care colleagues along,” he said.

Dr. Oser described tools he and his wife, Tamara K. Oser, MD, professor in the Department of Family Medicine at the same institution, developed in conjunction with the American Academy of Family Physicians (AAFP), including the Transformation in Practice series (TIPS).

The PREPARE 4 CGM study examined the use of three different strategies for incorporating CGM into primary care settings: Either use of AAFP TIPS alone, TIPS plus practice facilitation services by coaches who assist the practice in implementing new workflows, or referral to a virtual CGM initiation service (virCIS) with a virtual CGM workshop that Dr. Oser and Dr. Oser also developed.

Of the 76 Colorado primary care practices participating (out of 60 planned), the 46 who chose AAFP TIPS were randomized to either the AAFP TIPS alone or to TIPS + practice facilitation. The other 30 chose virCIS with the onetime CGM basics webinar. The fact that more practices than anticipated were recruited for the study suggests that “primary care interest in CGM is very high. They want to learn,” Dr. Oser noted.

Of the 51 practice characteristics investigated, only one, the presence of a DCES, in the practice, was significantly associated with the choice of CGM implementation strategy. Of the 16 practices with access to a DCES, all of them chose self-initiation with CGM using TIPS. But of the 60 practices without a DCES, half chose the virCIS.

“We know that 36% of primary care practices have access to a DCES within the clinic, part-time or full-time, and that’s not enough, I would argue,” Dr. Oser said.

Indeed, Dr. Martens told this news organization that those professionals, formerly called “diabetes educators,” often aren’t available in primary care settings, especially in rural areas. “Unfortunately, they are not well reimbursed. A lot of care systems don’t employ as many as they ideally should because it tends not to be a moneymaker ... Something’s got to change with reimbursement for the cognitive aspects of diabetes management.”

Dr. Oser said his team’s next steps include completion of the virCIS operations, analysis of the effectiveness of the three implantation strategies in practice- and patient-level outcomes, a cost analysis of the three strategies, and further development of toolkits to assist in these efforts.

“One of our goals is to keep people at their primary care home, where they want to be ... Diabetes knows no borders. People should have access wherever they are,” Dr. Oser concluded in his ADA talk.
 

What Predicts Primary Care CGM Prescribing?

Further clues about effective strategies to improve CGM prescribing in primary care were provided in a study presented by Jovan Milosavljevic, MD, a second-year endocrinology fellow at the Fleischer Institute for Diabetes and Metabolism, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York.

He began by noting that there are currently 61.5 million diabetes visits annually in primary care compared with 32.0 million in specialty care and that there is a shortage of endocrinologists in the face of the rising number of people diagnosed with diabetes. “Primary care will continue to be the only point of care for most people with diabetes. So, standard-of-care treatment such as CGM must enter routine primary care practice to impact population-level health outcomes.”

Electronic health record data were examined for 39,710 patients with type 2 diabetes seen at 13 primary care sites affiliated with Montefiore Medical Center, a large safety net hospital in New York, where CGM is widely covered by public insurance. Between July 31, 2020, and July 31, 2023, a total of 3503, or just 8.8%, were prescribed CGM by a primary care provider.

Those with CGM prescribed were younger than those without (59.7 vs 62.7 years), about 40% of both groups were Hispanic or Black, and a majority were English-speaking: 84.5% of those prescribed CGM spoke English, while only 13.1% spoke Spanish. Over half (59.1%) of those prescribed CGM had commercial insurance, while only 11.2% had Medicaid and 29.7% had Medicare.

More patients with CGM prescribed had providers with more than 10 years in practice: 72.5% vs 64.5% with no CGM.

Not surprisingly, those with CGM prescribed were more likely on insulin — 21% using just basal and 35% on multiple daily injections. Those prescribed CGM had higher A1c levels before CGM prescription: 9.2% vs 7.2% for those not prescribed CGM.

No racial or ethnic bias was found in the relationships between CGM use and insulin use, provider experience, engagement with care, and A1c. However, there were differences by age, sex, and spoken language.

For example, the Hispanic group aged 65 years and older was less likely than those younger to be prescribed CGM, but this wasn’t seen in other ethnic groups. In fact, older White people were slightly more likely to have CGM prescribed. Spanish-speaking patients were about 43% less likely to have CGM prescribed than were English-speaking patients.

These findings suggest a dual approach might work best for improving CGM prescribing in primary care. “We can leverage the knowledge that some of these factors are independent of bias and promote clinical and evidence-based guidelines for CGM. Additionally, we should focus on physicians in training,” Dr. Milosavljevic said.

At the same time, “we need to tackle systemic inequity in prescription processes,” with measures such as improving prescription workflows, supporting prior authorization, and using patient hands-on support for older adults and Spanish-speaking individuals, he said.

In a message to this news organization, Tamara K. Oser, MD, wrote, “Disparities in CGM and other diabetes technology are prevalent and multifactorial. In addition to insurance barriers, implicit bias also plays a large role. Shared decision-making should always be used when deciding to prescribe diabetes technologies.”

The PREPARE 4 CGM study is evaluating willingness to pay for CGM, she noted.

“Even patients without insurance might want to purchase one sensor every few months to empower them to learn more about how food and exercise affect their glucose or to help assess the need for [adjusting] diabetes medications. It is an exciting time for people living with diabetes. Primary care, endocrinology, device manufacturers, and insurers should all do their part to assure increased access to these evidence-based technologies.”

Dr. Martens’ employer has received funds on his behalf for research and speaking support from Dexcom, Abbott Diabetes Care, Medtronic, Insulet, Tandem, Sanofi, Eli Lilly and Company, and Novo Nordisk, and for consulting from Sanofi and Eli Lilly and Company. He is employed by the nonprofit HealthPartners Institute dba International Diabetes Center and received no personal income from these activities.

The Osers have received advisory board consulting fees (through the University of Colorado) from Dexcom, Medscape Medical News, Ascensia, and Blue Circle Health and research grants (through the University of Colorado) from National Institute of Nursing Research, National Institute of Diabetes and Digestive and Kidney Diseases, the Helmsley Charitable Trust, Abbott Diabetes, Dexcom, and Insulet. They do not own stocks in any device or pharmaceutical company.

Dr. Milosavljevic’s work was supported by the National Institutes of Health/National Center for Advancing Translational Science and Einstein-Montefiore Clinical and Translational Science Awards. He had no further disclosures.
 

A version of this article first appeared on Medscape.com.

ORLANDO, FLORIDA — As increasing data show benefit for continuous glucose monitoring (CGM) devices beyond just insulin-treated diabetes, efforts are being made to optimize the use of CGM in primary care settings.

Currently, Medicare and most private insurers cover CGM for people with diabetes who use insulin, regardless of the type of diabetes or the type of insulin, and for those with a history of severe hypoglycemia. Data are increasingly showing benefit for people who don’t use insulin. As of now, with the exception of some state Medicaid beneficiaries, the majority must pay out of pocket.

Such use is expected to grow with the upcoming availability of two new over-the-counter CGMs, Dexcom’s Stelo and Abbott’s Libre Rio, both made for people with diabetes who don’t use insulin. (Abbott will also launch the Lingo, a wellness CGM for people without diabetes.)

This means that CGM will become increasingly prevalent in primary care, where there is currently a great deal of variability in the capacity to manage and use the data generated by the devices to improve diabetes management, experts said during an oral abstract session at the recent American Diabetes Association (ADA) 84th Scientific Sessions and in interviews with this news organization.

“It’s picking up steam, and there’s a lot more visibility of CGM in primary care and a lot more people prescribing it,” Thomas W. Martens, MD, medical director of the International Diabetes Center at HealthPartners Institute, Minneapolis, told this news organization. He noted that the recent switch in many cases of CGM from billing as durable medical equipment to pharmacy has made prescribing easier, while television advertising has increased demand.

But still unclear, he noted, is how the CGM data are being used. “The question is, are prescriptions just being sent out and people using it like a finger-stick blood glucose monitor, or is primary care really using the data to move diabetes forward? I think that’s where a lot of the work on dissemination and implementation is going. How do we really make this a useful tool for optimizing diabetes care?”
 

Informing Food Choice, Treatment Intensification

At the ADA meeting, Dr. Martens presented topline data from a randomized multicenter controlled trial funded by Abbott, examining the effect of CGM use on guiding food choices and other behaviors in 72 adults with type 2 diabetes who were not using insulin but who were using other glucose-lowering medications.

At 3 months, with no medication changes, there was a significant overall 26% reduction in time spent above 180 mg/dL (P < .0001), which didn›t differ significantly between those randomized to CGM alone or in conjunction with a food logging app. Both groups also experienced a significant 1.1% reduction in A1c (P < .0001) and about a 4-lb weight loss (P = .014 for CGM alone, P = .0032 for CGM + app).

“The win for people not on insulin is you can see the impact of food choices really quickly with a CGM ... and then perhaps modify that to improve postprandial hyperglycemia,” Dr. Martens said.

And for the clinician, “not everybody with type 2 diabetes not on insulin can get where they need to be just by changing their diets. The CGM is a pretty good tool for knowing when you need to advance therapy.”
 

Diabetes Care and Education Specialists (DCESs) Assist CGM Use

Another speaker at the ADA meeting, Sean M. Oser, MD, director of the Practice Innovation Program and associated director of the Primary Care Diabetes Lab at the University of Colorado Anschutz Medical Campus, Aurora, Colorado, noted that 90% of adults with type 2 diabetes and 50% with type 1 diabetes receive their diabetes care in primary care settings.

“CGM is increasingly becoming standard of care in diabetes ... But [primary care providers] remain relatively untrained about CGM ... What I’m concerned about is the disparity disparities in who has access and who does not. We really need to bring our primary care colleagues along,” he said.

Dr. Oser described tools he and his wife, Tamara K. Oser, MD, professor in the Department of Family Medicine at the same institution, developed in conjunction with the American Academy of Family Physicians (AAFP), including the Transformation in Practice series (TIPS).

The PREPARE 4 CGM study examined the use of three different strategies for incorporating CGM into primary care settings: Either use of AAFP TIPS alone, TIPS plus practice facilitation services by coaches who assist the practice in implementing new workflows, or referral to a virtual CGM initiation service (virCIS) with a virtual CGM workshop that Dr. Oser and Dr. Oser also developed.

Of the 76 Colorado primary care practices participating (out of 60 planned), the 46 who chose AAFP TIPS were randomized to either the AAFP TIPS alone or to TIPS + practice facilitation. The other 30 chose virCIS with the onetime CGM basics webinar. The fact that more practices than anticipated were recruited for the study suggests that “primary care interest in CGM is very high. They want to learn,” Dr. Oser noted.

Of the 51 practice characteristics investigated, only one, the presence of a DCES, in the practice, was significantly associated with the choice of CGM implementation strategy. Of the 16 practices with access to a DCES, all of them chose self-initiation with CGM using TIPS. But of the 60 practices without a DCES, half chose the virCIS.

“We know that 36% of primary care practices have access to a DCES within the clinic, part-time or full-time, and that’s not enough, I would argue,” Dr. Oser said.

Indeed, Dr. Martens told this news organization that those professionals, formerly called “diabetes educators,” often aren’t available in primary care settings, especially in rural areas. “Unfortunately, they are not well reimbursed. A lot of care systems don’t employ as many as they ideally should because it tends not to be a moneymaker ... Something’s got to change with reimbursement for the cognitive aspects of diabetes management.”

Dr. Oser said his team’s next steps include completion of the virCIS operations, analysis of the effectiveness of the three implantation strategies in practice- and patient-level outcomes, a cost analysis of the three strategies, and further development of toolkits to assist in these efforts.

“One of our goals is to keep people at their primary care home, where they want to be ... Diabetes knows no borders. People should have access wherever they are,” Dr. Oser concluded in his ADA talk.
 

What Predicts Primary Care CGM Prescribing?

Further clues about effective strategies to improve CGM prescribing in primary care were provided in a study presented by Jovan Milosavljevic, MD, a second-year endocrinology fellow at the Fleischer Institute for Diabetes and Metabolism, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York.

He began by noting that there are currently 61.5 million diabetes visits annually in primary care compared with 32.0 million in specialty care and that there is a shortage of endocrinologists in the face of the rising number of people diagnosed with diabetes. “Primary care will continue to be the only point of care for most people with diabetes. So, standard-of-care treatment such as CGM must enter routine primary care practice to impact population-level health outcomes.”

Electronic health record data were examined for 39,710 patients with type 2 diabetes seen at 13 primary care sites affiliated with Montefiore Medical Center, a large safety net hospital in New York, where CGM is widely covered by public insurance. Between July 31, 2020, and July 31, 2023, a total of 3503, or just 8.8%, were prescribed CGM by a primary care provider.

Those with CGM prescribed were younger than those without (59.7 vs 62.7 years), about 40% of both groups were Hispanic or Black, and a majority were English-speaking: 84.5% of those prescribed CGM spoke English, while only 13.1% spoke Spanish. Over half (59.1%) of those prescribed CGM had commercial insurance, while only 11.2% had Medicaid and 29.7% had Medicare.

More patients with CGM prescribed had providers with more than 10 years in practice: 72.5% vs 64.5% with no CGM.

Not surprisingly, those with CGM prescribed were more likely on insulin — 21% using just basal and 35% on multiple daily injections. Those prescribed CGM had higher A1c levels before CGM prescription: 9.2% vs 7.2% for those not prescribed CGM.

No racial or ethnic bias was found in the relationships between CGM use and insulin use, provider experience, engagement with care, and A1c. However, there were differences by age, sex, and spoken language.

For example, the Hispanic group aged 65 years and older was less likely than those younger to be prescribed CGM, but this wasn’t seen in other ethnic groups. In fact, older White people were slightly more likely to have CGM prescribed. Spanish-speaking patients were about 43% less likely to have CGM prescribed than were English-speaking patients.

These findings suggest a dual approach might work best for improving CGM prescribing in primary care. “We can leverage the knowledge that some of these factors are independent of bias and promote clinical and evidence-based guidelines for CGM. Additionally, we should focus on physicians in training,” Dr. Milosavljevic said.

At the same time, “we need to tackle systemic inequity in prescription processes,” with measures such as improving prescription workflows, supporting prior authorization, and using patient hands-on support for older adults and Spanish-speaking individuals, he said.

In a message to this news organization, Tamara K. Oser, MD, wrote, “Disparities in CGM and other diabetes technology are prevalent and multifactorial. In addition to insurance barriers, implicit bias also plays a large role. Shared decision-making should always be used when deciding to prescribe diabetes technologies.”

The PREPARE 4 CGM study is evaluating willingness to pay for CGM, she noted.

“Even patients without insurance might want to purchase one sensor every few months to empower them to learn more about how food and exercise affect their glucose or to help assess the need for [adjusting] diabetes medications. It is an exciting time for people living with diabetes. Primary care, endocrinology, device manufacturers, and insurers should all do their part to assure increased access to these evidence-based technologies.”

Dr. Martens’ employer has received funds on his behalf for research and speaking support from Dexcom, Abbott Diabetes Care, Medtronic, Insulet, Tandem, Sanofi, Eli Lilly and Company, and Novo Nordisk, and for consulting from Sanofi and Eli Lilly and Company. He is employed by the nonprofit HealthPartners Institute dba International Diabetes Center and received no personal income from these activities.

The Osers have received advisory board consulting fees (through the University of Colorado) from Dexcom, Medscape Medical News, Ascensia, and Blue Circle Health and research grants (through the University of Colorado) from National Institute of Nursing Research, National Institute of Diabetes and Digestive and Kidney Diseases, the Helmsley Charitable Trust, Abbott Diabetes, Dexcom, and Insulet. They do not own stocks in any device or pharmaceutical company.

Dr. Milosavljevic’s work was supported by the National Institutes of Health/National Center for Advancing Translational Science and Einstein-Montefiore Clinical and Translational Science Awards. He had no further disclosures.
 

A version of this article first appeared on Medscape.com.

Gary* is a 60-year-old race car driver with a history of insulin resistance, elevated cholesterol, and severe reflux. His wife sent him to me when his snoring became so loud and “violent” that she could no longer sleep in the same bedroom. 

She was desperate to help him lose weight in a sustained fashion. All his previous efforts were short-lived due to his self-described pizza and burger addiction. At 5 ft 9 in and 180 lb, his body mass index (BMI) was approximately 26.5 (normal is 18.5-24.9). 

On exam, his arms and legs were relatively thin, but he had a hard, protuberant belly. Given his body habits, comorbidities, and family history of early heart disease, I was worried that his weight would eventually become life-threatening. Solely on the basis of BMI criteria, however, he is not considered to be at high risk. 

This begs the question, are we relying too much on BMI and ignoring central adiposity (ie, belly fat) and comorbid conditions when identifying at-risk patients?

The European Association for the Study of Obesity (EASO) argues exactly this point in its new guidelines published in July 2024. Titled “A New Framework for the Diagnosis, Staging, and Management of Obesity in Adults,” the guidelines assert that obesity should be redefined as a chronic and relapsing adiposity-based disease which may start off as asymptomatic but often becomes life-threatening. 

The guidelines further argue that BMI does not appropriately predict cardiometabolic risk in patients with BMI < 35. Instead, in such patients we should incorporate the use of waist-to-height ratios to reflect the potentially deleterious presence of increased visceral fat. It expands the definition of high-risk patients to include those with BMI > 25 and a waist-to-height ratio > 0.5.

It also suggests that DEXA (dual-energy x-ray absorptiometry) or bioimpedance testing be used when BMI results are ambiguous. The European guidelines recommend considering screening more routinely for eating disorders (with psychometric testing) and depression. The guidelines highlight the importance of long-term goals and of physical activity, nutrition, and psychological support in addition to pharmaceutical treatments.

On the basis of these new guidelines, I attempted to start Gary on Wegovy (semaglutide) along with sending him to a health coach, dietitian, and trainer. Unfortunately, despite documenting a waist-to-height ratio of > 0.6 and elevated fat percentage of just over 30% using bioimpedance, my prior authorization and appeal were summarily rejected by his insurance provider. 

In the United States, pharmacotherapy is typically approved for patients with a BMI of 27 or higher with a comorbidity (like high blood pressure or elevated cholesterol levels) or a BMI over 30. This clearly highlights the need for updated criteria for weight loss medication. Thank goodness for compounded semaglutide to fill this void until the medical world catches up with the EASO guidelines. 

Now on compounded semaglutide, Gary has lost 15 lb. His once rounded belly is nearly flat, and he has a normal waist-to-height ratio. While his dietary choices still leave something to be desired, his portion sizes are much smaller. His snoring has improved considerably. His most recent bioimpedance testing showed a reduced fat percentage of just under 25%.

*Patient’s name has been changed 

Caroline Messer, MD, is Clinical Assistant Professor, Mount Sinai School of Medicine, and Associate Professor, Hofstra School of Medicine, both in New York. She has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Gary* is a 60-year-old race car driver with a history of insulin resistance, elevated cholesterol, and severe reflux. His wife sent him to me when his snoring became so loud and “violent” that she could no longer sleep in the same bedroom. 

She was desperate to help him lose weight in a sustained fashion. All his previous efforts were short-lived due to his self-described pizza and burger addiction. At 5 ft 9 in and 180 lb, his body mass index (BMI) was approximately 26.5 (normal is 18.5-24.9). 

On exam, his arms and legs were relatively thin, but he had a hard, protuberant belly. Given his body habits, comorbidities, and family history of early heart disease, I was worried that his weight would eventually become life-threatening. Solely on the basis of BMI criteria, however, he is not considered to be at high risk. 

This begs the question, are we relying too much on BMI and ignoring central adiposity (ie, belly fat) and comorbid conditions when identifying at-risk patients?

The European Association for the Study of Obesity (EASO) argues exactly this point in its new guidelines published in July 2024. Titled “A New Framework for the Diagnosis, Staging, and Management of Obesity in Adults,” the guidelines assert that obesity should be redefined as a chronic and relapsing adiposity-based disease which may start off as asymptomatic but often becomes life-threatening. 

The guidelines further argue that BMI does not appropriately predict cardiometabolic risk in patients with BMI < 35. Instead, in such patients we should incorporate the use of waist-to-height ratios to reflect the potentially deleterious presence of increased visceral fat. It expands the definition of high-risk patients to include those with BMI > 25 and a waist-to-height ratio > 0.5.

It also suggests that DEXA (dual-energy x-ray absorptiometry) or bioimpedance testing be used when BMI results are ambiguous. The European guidelines recommend considering screening more routinely for eating disorders (with psychometric testing) and depression. The guidelines highlight the importance of long-term goals and of physical activity, nutrition, and psychological support in addition to pharmaceutical treatments.

On the basis of these new guidelines, I attempted to start Gary on Wegovy (semaglutide) along with sending him to a health coach, dietitian, and trainer. Unfortunately, despite documenting a waist-to-height ratio of > 0.6 and elevated fat percentage of just over 30% using bioimpedance, my prior authorization and appeal were summarily rejected by his insurance provider. 

In the United States, pharmacotherapy is typically approved for patients with a BMI of 27 or higher with a comorbidity (like high blood pressure or elevated cholesterol levels) or a BMI over 30. This clearly highlights the need for updated criteria for weight loss medication. Thank goodness for compounded semaglutide to fill this void until the medical world catches up with the EASO guidelines. 

Now on compounded semaglutide, Gary has lost 15 lb. His once rounded belly is nearly flat, and he has a normal waist-to-height ratio. While his dietary choices still leave something to be desired, his portion sizes are much smaller. His snoring has improved considerably. His most recent bioimpedance testing showed a reduced fat percentage of just under 25%.

*Patient’s name has been changed 

Caroline Messer, MD, is Clinical Assistant Professor, Mount Sinai School of Medicine, and Associate Professor, Hofstra School of Medicine, both in New York. She has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Gary* is a 60-year-old race car driver with a history of insulin resistance, elevated cholesterol, and severe reflux. His wife sent him to me when his snoring became so loud and “violent” that she could no longer sleep in the same bedroom. 

She was desperate to help him lose weight in a sustained fashion. All his previous efforts were short-lived due to his self-described pizza and burger addiction. At 5 ft 9 in and 180 lb, his body mass index (BMI) was approximately 26.5 (normal is 18.5-24.9). 

On exam, his arms and legs were relatively thin, but he had a hard, protuberant belly. Given his body habits, comorbidities, and family history of early heart disease, I was worried that his weight would eventually become life-threatening. Solely on the basis of BMI criteria, however, he is not considered to be at high risk. 

This begs the question, are we relying too much on BMI and ignoring central adiposity (ie, belly fat) and comorbid conditions when identifying at-risk patients?

The European Association for the Study of Obesity (EASO) argues exactly this point in its new guidelines published in July 2024. Titled “A New Framework for the Diagnosis, Staging, and Management of Obesity in Adults,” the guidelines assert that obesity should be redefined as a chronic and relapsing adiposity-based disease which may start off as asymptomatic but often becomes life-threatening. 

The guidelines further argue that BMI does not appropriately predict cardiometabolic risk in patients with BMI < 35. Instead, in such patients we should incorporate the use of waist-to-height ratios to reflect the potentially deleterious presence of increased visceral fat. It expands the definition of high-risk patients to include those with BMI > 25 and a waist-to-height ratio > 0.5.

It also suggests that DEXA (dual-energy x-ray absorptiometry) or bioimpedance testing be used when BMI results are ambiguous. The European guidelines recommend considering screening more routinely for eating disorders (with psychometric testing) and depression. The guidelines highlight the importance of long-term goals and of physical activity, nutrition, and psychological support in addition to pharmaceutical treatments.

On the basis of these new guidelines, I attempted to start Gary on Wegovy (semaglutide) along with sending him to a health coach, dietitian, and trainer. Unfortunately, despite documenting a waist-to-height ratio of > 0.6 and elevated fat percentage of just over 30% using bioimpedance, my prior authorization and appeal were summarily rejected by his insurance provider. 

In the United States, pharmacotherapy is typically approved for patients with a BMI of 27 or higher with a comorbidity (like high blood pressure or elevated cholesterol levels) or a BMI over 30. This clearly highlights the need for updated criteria for weight loss medication. Thank goodness for compounded semaglutide to fill this void until the medical world catches up with the EASO guidelines. 

Now on compounded semaglutide, Gary has lost 15 lb. His once rounded belly is nearly flat, and he has a normal waist-to-height ratio. While his dietary choices still leave something to be desired, his portion sizes are much smaller. His snoring has improved considerably. His most recent bioimpedance testing showed a reduced fat percentage of just under 25%.

*Patient’s name has been changed 

Caroline Messer, MD, is Clinical Assistant Professor, Mount Sinai School of Medicine, and Associate Professor, Hofstra School of Medicine, both in New York. She has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

TOPLINE:

In patients with type 2 diabetes (T2D), eating more ultraprocessed food (UPF) increased the overall risk for microvascular complications and for diabetic kidney disease in particular. The risk was partly mediated by biomarkers related to body weight, lipid metabolism, and inflammation.

METHODOLOGY:

• A higher intake of UPF increases the risk for T2D and other metabolic morbidities; but whether this leads to an increased risk for diabetic microvascular complications remains largely unexplored.
• Researchers evaluated the association between the intake of UPF and the risk for diabetic microvascular complications in a prospective cohort of 5685 participants with T2D (mean age, 59.7 years; 63.8% men) from the UK Biobank.
• Dietary information of participants was collected with a web-based 24-hour dietary recall tool that recorded the frequency of consumption of 206 foods and 32 beverages.
• Researchers found five patterns that accounted for one third of UPF intake variation by estimated weight (not calories): Bread and spreads; cereal with liquids; high dairy and low cured meat; sugary beverages and snacks; and mixed beverages and savory snacks.
• The outcomes included the risk for overall microvascular complications; for diabetic retinopathy, diabetic neuropathy, and diabetic kidney disease; and for biomarkers related to microvascular complications.

TAKEAWAY:

• During a median follow-up duration of 12.7 years, 1243 composite microvascular complications were reported, including 599 diabetic retinopathy, 237 diabetic neuropathy, and 662 diabetic kidney disease events.
• Each 10% increase in the proportion of UPF consumption increased the risk for composite microvascular complications by 8% (hazard ratio [HR], 1.08; 95% CI, 1.03-1.13) and diabetic kidney disease by 13% (HR 1.13; 95% CI, 1.06-1.20). No significant UPF intake association was found with diabetic retinopathy or diabetic neuropathy.
• In the biomarker mediation analysis, body mass index, triglycerides, and C-reactive protein collectively explained 22% (P < .001) and 15.8% (P < .001) of the associations of UPF consumption with composite microvascular complications and diabetic kidney disease, respectively.
• The food pattern rich in sugary beverages and snacks increased the risk for diabetic kidney disease, whereas the pattern rich in mixed beverages and savory snacks increased the risk for composite microvascular complications and diabetic retinopathy.

IN PRACTICE:

“In view of microvascular complications, our findings further support adhering to the recommendations outlined in the American Diabetes Association’s 2022 guidelines, which advocate for the preference of whole foods over highly processed ones,” the authors wrote.

SOURCE:

The study was led by Yue Li, MBBS, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. It was published online in The American Journal of Clinical Nutrition.

LIMITATIONS:

The dietary recall used in the UK Biobank was not specifically designed to collect dietary data according to the Nova food categories used in the study, which may have led to misclassifications. Data on usual dietary intake may not have been captured accurately, as all participants did not provide multiple dietary recalls. Individuals with T2D who completed dietary assessments were more likely to have a higher socioeconomic status and healthier lifestyle than those not filling the assessment, which could have resulted in an underrepresentation of high UPF consumers.

DISCLOSURES:

Some authors received funding from the National Natural Science Foundation of China, the National Key Research and Development Program of China, and other government sources. None of the authors declared any competing interests.
 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

In patients with type 2 diabetes (T2D), eating more ultraprocessed food (UPF) increased the overall risk for microvascular complications and for diabetic kidney disease in particular. The risk was partly mediated by biomarkers related to body weight, lipid metabolism, and inflammation.

METHODOLOGY:

• A higher intake of UPF increases the risk for T2D and other metabolic morbidities; but whether this leads to an increased risk for diabetic microvascular complications remains largely unexplored.
• Researchers evaluated the association between the intake of UPF and the risk for diabetic microvascular complications in a prospective cohort of 5685 participants with T2D (mean age, 59.7 years; 63.8% men) from the UK Biobank.
• Dietary information of participants was collected with a web-based 24-hour dietary recall tool that recorded the frequency of consumption of 206 foods and 32 beverages.
• Researchers found five patterns that accounted for one third of UPF intake variation by estimated weight (not calories): Bread and spreads; cereal with liquids; high dairy and low cured meat; sugary beverages and snacks; and mixed beverages and savory snacks.
• The outcomes included the risk for overall microvascular complications; for diabetic retinopathy, diabetic neuropathy, and diabetic kidney disease; and for biomarkers related to microvascular complications.

TAKEAWAY:

• During a median follow-up duration of 12.7 years, 1243 composite microvascular complications were reported, including 599 diabetic retinopathy, 237 diabetic neuropathy, and 662 diabetic kidney disease events.
• Each 10% increase in the proportion of UPF consumption increased the risk for composite microvascular complications by 8% (hazard ratio [HR], 1.08; 95% CI, 1.03-1.13) and diabetic kidney disease by 13% (HR 1.13; 95% CI, 1.06-1.20). No significant UPF intake association was found with diabetic retinopathy or diabetic neuropathy.
• In the biomarker mediation analysis, body mass index, triglycerides, and C-reactive protein collectively explained 22% (P < .001) and 15.8% (P < .001) of the associations of UPF consumption with composite microvascular complications and diabetic kidney disease, respectively.
• The food pattern rich in sugary beverages and snacks increased the risk for diabetic kidney disease, whereas the pattern rich in mixed beverages and savory snacks increased the risk for composite microvascular complications and diabetic retinopathy.

IN PRACTICE:

“In view of microvascular complications, our findings further support adhering to the recommendations outlined in the American Diabetes Association’s 2022 guidelines, which advocate for the preference of whole foods over highly processed ones,” the authors wrote.

SOURCE:

The study was led by Yue Li, MBBS, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. It was published online in The American Journal of Clinical Nutrition.

LIMITATIONS:

The dietary recall used in the UK Biobank was not specifically designed to collect dietary data according to the Nova food categories used in the study, which may have led to misclassifications. Data on usual dietary intake may not have been captured accurately, as all participants did not provide multiple dietary recalls. Individuals with T2D who completed dietary assessments were more likely to have a higher socioeconomic status and healthier lifestyle than those not filling the assessment, which could have resulted in an underrepresentation of high UPF consumers.

DISCLOSURES:

Some authors received funding from the National Natural Science Foundation of China, the National Key Research and Development Program of China, and other government sources. None of the authors declared any competing interests.
 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

In patients with type 2 diabetes (T2D), eating more ultraprocessed food (UPF) increased the overall risk for microvascular complications and for diabetic kidney disease in particular. The risk was partly mediated by biomarkers related to body weight, lipid metabolism, and inflammation.

METHODOLOGY:

• A higher intake of UPF increases the risk for T2D and other metabolic morbidities; but whether this leads to an increased risk for diabetic microvascular complications remains largely unexplored.
• Researchers evaluated the association between the intake of UPF and the risk for diabetic microvascular complications in a prospective cohort of 5685 participants with T2D (mean age, 59.7 years; 63.8% men) from the UK Biobank.
• Dietary information of participants was collected with a web-based 24-hour dietary recall tool that recorded the frequency of consumption of 206 foods and 32 beverages.
• Researchers found five patterns that accounted for one third of UPF intake variation by estimated weight (not calories): Bread and spreads; cereal with liquids; high dairy and low cured meat; sugary beverages and snacks; and mixed beverages and savory snacks.
• The outcomes included the risk for overall microvascular complications; for diabetic retinopathy, diabetic neuropathy, and diabetic kidney disease; and for biomarkers related to microvascular complications.

TAKEAWAY:

• During a median follow-up duration of 12.7 years, 1243 composite microvascular complications were reported, including 599 diabetic retinopathy, 237 diabetic neuropathy, and 662 diabetic kidney disease events.
• Each 10% increase in the proportion of UPF consumption increased the risk for composite microvascular complications by 8% (hazard ratio [HR], 1.08; 95% CI, 1.03-1.13) and diabetic kidney disease by 13% (HR 1.13; 95% CI, 1.06-1.20). No significant UPF intake association was found with diabetic retinopathy or diabetic neuropathy.
• In the biomarker mediation analysis, body mass index, triglycerides, and C-reactive protein collectively explained 22% (P < .001) and 15.8% (P < .001) of the associations of UPF consumption with composite microvascular complications and diabetic kidney disease, respectively.
• The food pattern rich in sugary beverages and snacks increased the risk for diabetic kidney disease, whereas the pattern rich in mixed beverages and savory snacks increased the risk for composite microvascular complications and diabetic retinopathy.

IN PRACTICE:

“In view of microvascular complications, our findings further support adhering to the recommendations outlined in the American Diabetes Association’s 2022 guidelines, which advocate for the preference of whole foods over highly processed ones,” the authors wrote.

SOURCE:

The study was led by Yue Li, MBBS, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. It was published online in The American Journal of Clinical Nutrition.

LIMITATIONS:

The dietary recall used in the UK Biobank was not specifically designed to collect dietary data according to the Nova food categories used in the study, which may have led to misclassifications. Data on usual dietary intake may not have been captured accurately, as all participants did not provide multiple dietary recalls. Individuals with T2D who completed dietary assessments were more likely to have a higher socioeconomic status and healthier lifestyle than those not filling the assessment, which could have resulted in an underrepresentation of high UPF consumers.

DISCLOSURES:

Some authors received funding from the National Natural Science Foundation of China, the National Key Research and Development Program of China, and other government sources. None of the authors declared any competing interests.
 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.