Clinical Endocrinology News

Results from a preliminary clinical trial demonstrated the obesity drug, tirzepatide, effectively treated obstructive sleep apnea (OSA), according to information sent to investors of the pharmaceutical company, Eli Lilly.

Indiana-based Eli Lilly sells tirzepatide under the brand name Zepbound, which was approved by the FDA in November to treat overweight and obesity. Tirzepatide is also marketed under the name Mounjaro to treat diabetes, and it’s among the same class of drugs as other well-known weight loss and diabetes drugs like Ozempic and Wegovy.

The newly announced results came from a pair of studies that followed people with moderate to severe OSA who also had obesity. People in the study took tirzepatide, which is given by injection, for one year. One study evaluated people who were using CPAP during sleep, and another study included people who didn’t use the device. People in both studies taking tirzepatide had significant reductions in sleep events and also lost about 20% of body weight. About 70% of people in the studies were men.

The findings have not yet been published in a peer-reviewed medical journal, and the preliminary results were announced by Eli Lilly because of reporting requirements related to information that could affect stock prices. The company indicated that detailed results will be presented at a conference of the American Diabetes Association in June and will be submitted to a peer-reviewed journal for consideration of publication. The company also plans to submit the information to the FDA for approval consideration mid-year, the investor news release stated.

People in the study taking tirzepatide on average experienced 63% fewer instances of reduced oxygen due to breathing changes, or events when breathing entirely stopped, Eli Lilly reported.

A sleep expert from Washington University in St. Louis told The New York Times the initial findings were extremely positive and noted that tirzepatide works to treat the underlying cause of sleep apnea, rather than current treatments that just address symptoms.

Tirzepatide “is a great alternative for people who are obese and can’t use CPAP or are on CPAP and want to improve the effect,” Eric Landsness, MD, PhD, told The New York Times. 

Eli Lilly indicated the most commonly reported adverse events in the studies were diarrhea, nausea, vomiting, and constipation.

An estimated 39 million people have OSA and about 33 million people use CPAP machines, according to The National Council on Aging. The condition has been increasingly diagnosed in recent years and becomes more likely to affect people as they get older.

A version of this article appeared on WebMD.com.

Results from a preliminary clinical trial demonstrated the obesity drug, tirzepatide, effectively treated obstructive sleep apnea (OSA), according to information sent to investors of the pharmaceutical company, Eli Lilly.

Indiana-based Eli Lilly sells tirzepatide under the brand name Zepbound, which was approved by the FDA in November to treat overweight and obesity. Tirzepatide is also marketed under the name Mounjaro to treat diabetes, and it’s among the same class of drugs as other well-known weight loss and diabetes drugs like Ozempic and Wegovy.

The newly announced results came from a pair of studies that followed people with moderate to severe OSA who also had obesity. People in the study took tirzepatide, which is given by injection, for one year. One study evaluated people who were using CPAP during sleep, and another study included people who didn’t use the device. People in both studies taking tirzepatide had significant reductions in sleep events and also lost about 20% of body weight. About 70% of people in the studies were men.

The findings have not yet been published in a peer-reviewed medical journal, and the preliminary results were announced by Eli Lilly because of reporting requirements related to information that could affect stock prices. The company indicated that detailed results will be presented at a conference of the American Diabetes Association in June and will be submitted to a peer-reviewed journal for consideration of publication. The company also plans to submit the information to the FDA for approval consideration mid-year, the investor news release stated.

People in the study taking tirzepatide on average experienced 63% fewer instances of reduced oxygen due to breathing changes, or events when breathing entirely stopped, Eli Lilly reported.

A sleep expert from Washington University in St. Louis told The New York Times the initial findings were extremely positive and noted that tirzepatide works to treat the underlying cause of sleep apnea, rather than current treatments that just address symptoms.

Tirzepatide “is a great alternative for people who are obese and can’t use CPAP or are on CPAP and want to improve the effect,” Eric Landsness, MD, PhD, told The New York Times. 

Eli Lilly indicated the most commonly reported adverse events in the studies were diarrhea, nausea, vomiting, and constipation.

An estimated 39 million people have OSA and about 33 million people use CPAP machines, according to The National Council on Aging. The condition has been increasingly diagnosed in recent years and becomes more likely to affect people as they get older.

A version of this article appeared on WebMD.com.

Results from a preliminary clinical trial demonstrated the obesity drug, tirzepatide, effectively treated obstructive sleep apnea (OSA), according to information sent to investors of the pharmaceutical company, Eli Lilly.

Indiana-based Eli Lilly sells tirzepatide under the brand name Zepbound, which was approved by the FDA in November to treat overweight and obesity. Tirzepatide is also marketed under the name Mounjaro to treat diabetes, and it’s among the same class of drugs as other well-known weight loss and diabetes drugs like Ozempic and Wegovy.

The newly announced results came from a pair of studies that followed people with moderate to severe OSA who also had obesity. People in the study took tirzepatide, which is given by injection, for one year. One study evaluated people who were using CPAP during sleep, and another study included people who didn’t use the device. People in both studies taking tirzepatide had significant reductions in sleep events and also lost about 20% of body weight. About 70% of people in the studies were men.

The findings have not yet been published in a peer-reviewed medical journal, and the preliminary results were announced by Eli Lilly because of reporting requirements related to information that could affect stock prices. The company indicated that detailed results will be presented at a conference of the American Diabetes Association in June and will be submitted to a peer-reviewed journal for consideration of publication. The company also plans to submit the information to the FDA for approval consideration mid-year, the investor news release stated.

People in the study taking tirzepatide on average experienced 63% fewer instances of reduced oxygen due to breathing changes, or events when breathing entirely stopped, Eli Lilly reported.

A sleep expert from Washington University in St. Louis told The New York Times the initial findings were extremely positive and noted that tirzepatide works to treat the underlying cause of sleep apnea, rather than current treatments that just address symptoms.

Tirzepatide “is a great alternative for people who are obese and can’t use CPAP or are on CPAP and want to improve the effect,” Eric Landsness, MD, PhD, told The New York Times. 

Eli Lilly indicated the most commonly reported adverse events in the studies were diarrhea, nausea, vomiting, and constipation.

An estimated 39 million people have OSA and about 33 million people use CPAP machines, according to The National Council on Aging. The condition has been increasingly diagnosed in recent years and becomes more likely to affect people as they get older.

A version of this article appeared on WebMD.com.

Here’s a new direction for smartphones in healthcare. 

Researchers from the National Institute of Standards and Technology (NIST), Boulder, Colorado, say a smartphone compass could be used to analyze biomarkers in body fluids — blood, sweat, urine, or saliva — to monitor or diagnose disease.

“We’re just at this point demonstrating this new way of sensing that we hope [will be] very accessible and very portable,” said Gary Zabow, PhD, a group leader in the applied physics division at NIST who supervised the research. 

In a proof-of-concept study, the researchers measured glucose levels in sangria, pinot grigio, and champagne. The detection limit reached micromolar concentrations — on par with or better than some widely used glucose sensors, such as continuous glucose monitors. They also accurately measured the pH levels of coffee, orange juice, and root beer.

More tests are needed to confirm the method works in biological fluids, so it could be a while before it’s available for clinical or commercial use. 

Still, the prospect is “exciting,” said Aydogan Ozcan, PhD, a bioengineering professor at the University of California, Los Angeles, who was not involved in the study. “It might enable new capabilities for advanced sensing applications in field settings or even at home.”

The advance builds on growing research using smartphones to put powerful medical devices in patients’ hands. A new AI-powered app can use a smartphone camera to detect skin cancer, while other apps administer cognitive tests to detect dementia. Smartphone cameras can even be harnessed for “advanced optical microscopes and sensors to the level where we could even see and detect individual DNA molecules with inexpensive optical attachments,” Dr. Ozcan said. More than six billion people worldwide own a smartphone.

The compass inside smartphones is a magnetometer — it measures magnetic fields. Normally it detects the earth’s magnetic fields, but it can also detect small, nearby magnets and changes in those magnets’ positions. 

The researchers embedded a small magnet inside a strip of “smart hydrogel — a piece of material that expands or contracts” when immersed in a solution, said Dr. Zabow.

As the hydrogel gets bigger or smaller, it moves the magnet, Dr. Zabow explained. For example, if the hydrogel is designed to expand when the solution is acidic or contract when it’s basic, it can move the magnet closer or farther from the phone’s magnetometer, providing an indicator of pH. For glucose, the hydrogel expands or contracts depending on the concentration of sugar in the liquid.

With some calibration and coding to translate that reading into a number, “you can effectively read out glucose or pH,” Dr. Zabow said.

Only a small strip of hydrogel is needed, “like a pH test strip that you use for a pool,” said first study author Mark Ferris, PhD, a postdoctoral researcher at NIST. 

Like a pool pH test strip, this test is meant to be “easy to use, and at that kind of price,” Dr. Ferris said. “It’s supposed to be something that’s cheap and disposable.” Each pH hydrogel strip is about 3 cents, and glucose strips are 16 cents, Dr. Ferris estimated. In bulk, those prices could go down.

Next the team plans to test the strips with biological fluids. But complex fluids like blood could pose a challenge, as other molecules present could react with the strip and affect the results. “It may be that you need to tweak the chemistry of the hydrogel to make sure it is really specific to one biomolecule and there is no interference from other biomolecules,” Dr. Zabow said.

The technique could be adapted to detect other biomarkers or molecules, the researchers said. It could also be used to check for chemical contaminants in tap, lake, or stream water. 
 

A version of this article appeared on Medscape.com.

Here’s a new direction for smartphones in healthcare. 

Researchers from the National Institute of Standards and Technology (NIST), Boulder, Colorado, say a smartphone compass could be used to analyze biomarkers in body fluids — blood, sweat, urine, or saliva — to monitor or diagnose disease.

“We’re just at this point demonstrating this new way of sensing that we hope [will be] very accessible and very portable,” said Gary Zabow, PhD, a group leader in the applied physics division at NIST who supervised the research. 

In a proof-of-concept study, the researchers measured glucose levels in sangria, pinot grigio, and champagne. The detection limit reached micromolar concentrations — on par with or better than some widely used glucose sensors, such as continuous glucose monitors. They also accurately measured the pH levels of coffee, orange juice, and root beer.

More tests are needed to confirm the method works in biological fluids, so it could be a while before it’s available for clinical or commercial use. 

Still, the prospect is “exciting,” said Aydogan Ozcan, PhD, a bioengineering professor at the University of California, Los Angeles, who was not involved in the study. “It might enable new capabilities for advanced sensing applications in field settings or even at home.”

The advance builds on growing research using smartphones to put powerful medical devices in patients’ hands. A new AI-powered app can use a smartphone camera to detect skin cancer, while other apps administer cognitive tests to detect dementia. Smartphone cameras can even be harnessed for “advanced optical microscopes and sensors to the level where we could even see and detect individual DNA molecules with inexpensive optical attachments,” Dr. Ozcan said. More than six billion people worldwide own a smartphone.

The compass inside smartphones is a magnetometer — it measures magnetic fields. Normally it detects the earth’s magnetic fields, but it can also detect small, nearby magnets and changes in those magnets’ positions. 

The researchers embedded a small magnet inside a strip of “smart hydrogel — a piece of material that expands or contracts” when immersed in a solution, said Dr. Zabow.

As the hydrogel gets bigger or smaller, it moves the magnet, Dr. Zabow explained. For example, if the hydrogel is designed to expand when the solution is acidic or contract when it’s basic, it can move the magnet closer or farther from the phone’s magnetometer, providing an indicator of pH. For glucose, the hydrogel expands or contracts depending on the concentration of sugar in the liquid.

With some calibration and coding to translate that reading into a number, “you can effectively read out glucose or pH,” Dr. Zabow said.

Only a small strip of hydrogel is needed, “like a pH test strip that you use for a pool,” said first study author Mark Ferris, PhD, a postdoctoral researcher at NIST. 

Like a pool pH test strip, this test is meant to be “easy to use, and at that kind of price,” Dr. Ferris said. “It’s supposed to be something that’s cheap and disposable.” Each pH hydrogel strip is about 3 cents, and glucose strips are 16 cents, Dr. Ferris estimated. In bulk, those prices could go down.

Next the team plans to test the strips with biological fluids. But complex fluids like blood could pose a challenge, as other molecules present could react with the strip and affect the results. “It may be that you need to tweak the chemistry of the hydrogel to make sure it is really specific to one biomolecule and there is no interference from other biomolecules,” Dr. Zabow said.

The technique could be adapted to detect other biomarkers or molecules, the researchers said. It could also be used to check for chemical contaminants in tap, lake, or stream water. 
 

A version of this article appeared on Medscape.com.

Here’s a new direction for smartphones in healthcare. 

Researchers from the National Institute of Standards and Technology (NIST), Boulder, Colorado, say a smartphone compass could be used to analyze biomarkers in body fluids — blood, sweat, urine, or saliva — to monitor or diagnose disease.

“We’re just at this point demonstrating this new way of sensing that we hope [will be] very accessible and very portable,” said Gary Zabow, PhD, a group leader in the applied physics division at NIST who supervised the research. 

In a proof-of-concept study, the researchers measured glucose levels in sangria, pinot grigio, and champagne. The detection limit reached micromolar concentrations — on par with or better than some widely used glucose sensors, such as continuous glucose monitors. They also accurately measured the pH levels of coffee, orange juice, and root beer.

More tests are needed to confirm the method works in biological fluids, so it could be a while before it’s available for clinical or commercial use. 

Still, the prospect is “exciting,” said Aydogan Ozcan, PhD, a bioengineering professor at the University of California, Los Angeles, who was not involved in the study. “It might enable new capabilities for advanced sensing applications in field settings or even at home.”

The advance builds on growing research using smartphones to put powerful medical devices in patients’ hands. A new AI-powered app can use a smartphone camera to detect skin cancer, while other apps administer cognitive tests to detect dementia. Smartphone cameras can even be harnessed for “advanced optical microscopes and sensors to the level where we could even see and detect individual DNA molecules with inexpensive optical attachments,” Dr. Ozcan said. More than six billion people worldwide own a smartphone.

The compass inside smartphones is a magnetometer — it measures magnetic fields. Normally it detects the earth’s magnetic fields, but it can also detect small, nearby magnets and changes in those magnets’ positions. 

The researchers embedded a small magnet inside a strip of “smart hydrogel — a piece of material that expands or contracts” when immersed in a solution, said Dr. Zabow.

As the hydrogel gets bigger or smaller, it moves the magnet, Dr. Zabow explained. For example, if the hydrogel is designed to expand when the solution is acidic or contract when it’s basic, it can move the magnet closer or farther from the phone’s magnetometer, providing an indicator of pH. For glucose, the hydrogel expands or contracts depending on the concentration of sugar in the liquid.

With some calibration and coding to translate that reading into a number, “you can effectively read out glucose or pH,” Dr. Zabow said.

Only a small strip of hydrogel is needed, “like a pH test strip that you use for a pool,” said first study author Mark Ferris, PhD, a postdoctoral researcher at NIST. 

Like a pool pH test strip, this test is meant to be “easy to use, and at that kind of price,” Dr. Ferris said. “It’s supposed to be something that’s cheap and disposable.” Each pH hydrogel strip is about 3 cents, and glucose strips are 16 cents, Dr. Ferris estimated. In bulk, those prices could go down.

Next the team plans to test the strips with biological fluids. But complex fluids like blood could pose a challenge, as other molecules present could react with the strip and affect the results. “It may be that you need to tweak the chemistry of the hydrogel to make sure it is really specific to one biomolecule and there is no interference from other biomolecules,” Dr. Zabow said.

The technique could be adapted to detect other biomarkers or molecules, the researchers said. It could also be used to check for chemical contaminants in tap, lake, or stream water. 
 

A version of this article appeared on Medscape.com.

The photo of the patient’s foot, sent from his campsite, included a cheeky note: “I remember you telling me that getting in trouble doing something was better than getting in trouble doing nothing. This lets me get out there and know that I have feedback.”

The “this” was the patient’s “foot selfie,” an approach that allows patients at a risk for diabetic foot ulcers (DFUs) to snap a picture and send it to their healthcare providers for evaluation.

This particular patient had an extensive history of previous wounds. Some had essentially kept him house-bound in the past, as he was afraid to get another one.

This time, however, he got an all-clear to keep on camping, “and we scheduled him in on the following Tuesday [for follow-up],” said the camper’s physician David G. Armstrong, DPM, MD, PhD, professor of surgery and neurological surgery, USC Keck School of Medicine, Los Angeles.

Dr. Armstrong is one of the researchers evaluating the concept of foot selfies. It’s a welcome advance, he and others said, and has been shown to help heal wounds and reverse pre-ulcer lesions. Research on foot selfies continues, but much more is needed to solve the issue of DFUs, diabetic foot infections (DFIs), and the high rates of reinfection, experts know.

Worldwide, about 18.6 million people have a DFU each year, including 1.6 million in the United States. About 50%-60% of ulcers become infected, with 20% of moderate to severe infections requiring amputation of the limb. The 5-year mortality rate for DFUs is 30%, but it climbs to 70% after amputation. While about 40% of ulcers heal within 12 weeks, 42% recur at the 1-year mark, setting up a vicious and costly cycle. Healthcare costs for patients with diabetes and DFUs are five times as high as costs for patients with diabetes but no DFUs. The per capita cost to treat a DFU in America is $17,500.

While the statistics paint a grim picture, progress is being made on several fronts:

• US Food and Drug Administration (FDA) guidance on the development of drugs for DFUs, under evaluation, is forthcoming.
• New treatments are under study.
• A multidisciplinary team approach is known to improve outcomes.

Anatomy of a DFU

When neuropathy develops in those with diabetes, they no longer have what Dr. Armstrong calls the “gift” of pain perception. “They can wear a hole in their foot like you and I wear a hole in our sock or shoe,” he said. “That hole is called a diabetic foot ulcer.”

A DFU is an open wound on the foot, often occurring when bleeding develops beneath a callus and then the callus wears away. Deeper tissues of the foot are then exposed.

About half of the DFUs get infected, hence the FDA guidance, said Dr. Armstrong, who is also founding president of the American Limb Preservation Society, which aims to eliminate preventable amputations within the next generation. Every 20 seconds, Dr. Armstrong said, someone in the world loses a leg due to diabetes.
 

FDA Guidance on Drug Development for DFIs

In October, the FDA issued draft guidance for industry to articulate the design of clinical trials for developing antibacterial drugs to treat DFIs without concomitant bone and joint involvement. Comments closed on December 18. Among the points in the guidance, which is nonbinding, are to include DFIs of varying depths and extent in phase 3 trials and ideally to include only those patients who have not had prior antibacterial treatment for the current DFI.

According to an FDA spokesperson, “The agency is working to finalize the guidance. However, a timeline for its release has not yet been established.”

The good news about the upcoming FDA guidance, Dr. Armstrong said, is that the agency has realized the importance of treating the infections. Fully one third of direct costs of care for diabetes are spent on the lower extremities, he said. Keeping patients out of the hospital, uninfected, and “keeping legs on bodies” are all important goals, he said.

Pharmaceutical firms need to understand that “you aren’t dealing with a normal ulcer,” said Andrew J.M. Boulton, MD, professor of medicine at the University of Manchester and physician consultant at the Manchester Royal Infirmary, Manchester, England, and a visiting professor at the University of Miami. For research, “the most important thing is to take account of off-loading the ulcers,” he said. “Most ulcers will heal if put in a boot.”

Dr. Boulton, like Dr. Armstrong, a long-time expert in the field, contended that pharma has not understood this concept and has wasted millions over the last three decades doing studies that were poorly designed and controlled.
 

Treatments: Current, Under Study

Currently, DFIs are treated with antimicrobial therapy, without or without debridement, along with a clinical assessment for ischemia. If ischemia is found, care progresses to wound care and off-loading devices, such as healing sandals. Clinicians then assess the likelihood of improved outcomes with revascularization based on operative risks and distribution of lower extremity artery disease and proceed depending on the likelihood. If osteomyelitis testing shows it is present, providers proceed to wound debridement, limb-sparing amputation, and prolonged antimicrobials, as needed.

More options are needed, Dr. Armstrong said.

Among the many approaches under study:

• DFUs can be accurately detected by applying artificial intelligence to the “foot selfie” images taken by patients on smartphones, research by Dr.  and  has found.
• After a phase 3 study of  for DFUs originally intending to enroll 300 subjects was discontinued because of slow patient recruitment, an interim analysis was conducted on 44 participants. It showed a positive trend toward wound closure in the group receiving the injected gene therapy, VM202 (ENGENSIS), in their calf muscles. VM202 is a plasmid DNA-encoding human hepatocyte growth factor. While those in both the intervention and placebo groups showed wound-closing effects at month 6, in 23 patients with neuro-ischemic ulcers, the percentage of those reaching complete closure of the DFU was significantly higher in the treated group at months 3, 4, and 5 (P = .0391, .0391, and .0361, respectively). After excluding two outliers, the difference in months 3-6 became more significant (P = .03).
• An closed more DFUs than standard care after 12 weeks — 70% vs 34% (P = .00032). Of the 100 participants randomized, 50 per group, 42% of the treatment group and 56% of the control group experienced adverse events, with eight withdrawn due to serious adverse events (such as osteomyelitis).
• A closed more refractory DFUs over a 16-week study than standard sharp debridement, with 65% of water-treated ulcers healed but just 42% of the standard care group (P = .021, unadjusted).
• Researchers from UC Davis and VA Northern California Healthcare are evaluating timolol, a beta adrenergic receptor blocker already approved for topical administration for glaucoma, as a way to heal chronic DFUs faster. After demonstrating that the medication worked in animal models, researchers then launched a study to use it off-label for DFUs. While data are still being analyzed, researcher Roslyn (Rivkah) Isseroff, MD, of UC Davis and VA, said that data so far demonstrate that the timolol reduced transepidermal water loss in the healed wounds, and that is linked with a decrease in re-ulceration.

The Power of a Team

Multidisciplinary approaches to treatment are effective in reducing amputation, with one review of 33 studies finding the approach worked to decrease amputation in 94% of them. “The American Limb Preservation Society (ALPS) lists 30 programs,” said Dr. Armstrong, the founding president of the organization. “There may be as many as 100.”

Team compositions vary but usually include at least one medical specialty clinician, such as infectious disease, primary care, or endocrinology, and two or more specialty clinicians, such as vascular, podiatric, orthopedic, or plastic surgery. A shoe specialist is needed to prescribe and manage footwear. Other important team members include nutrition experts and behavioral health professionals to deal with associated depression.

Johns Hopkins’ Multidisciplinary Diabetic Foot and Wound Service launched in 2012 and includes vascular surgeons, surgical podiatrists, endocrinologists, wound care nurses, advanced practice staff, board-certified wound care specialists, orthopedic surgeons, infection disease experts, physical therapists, and certified orthotists.

“This interdisciplinary care model has been repeatedly validated by research as superior for limb salvage and wound healing,” said Nestoras Mathioudakis, MD, codirector of the service. “For instance, endocrinologists and diabetes educators are crucial for managing uncontrolled diabetes — a key factor in infection and delayed wound healing. Similarly, vascular surgeons play a vital role in addressing peripheral arterial disease to improve blood flow to the affected area.”

“Diabetic foot ulcers might require prolonged periods of specialized care, including meticulous wound management and off-loading, overseen by surgical podiatrists and wound care experts,” he said. “In cases where infection is present, particularly with multidrug resistant organisms or when standard antibiotics are contraindicated, the insight of an infectious disease specialist is invaluable.”

While the makeup of teams varies from location to location, he said “the hallmark of effective teams is their ability to comprehensively manage glycemic control, foot wounds, vascular disease, and infections.”

The power of teams, Dr. Armstrong said, is very much evident after his weekly “foot selfie rounds” conducted Mondays at 7 AM, with an “all feet on deck” approach. “Not a week goes by when we don’t stop a hospitalization,” he said of the team evaluating the photos, due to detecting issues early, while still in the manageable state.

Teams can trump technology, Dr. Armstrong said. A team of just a primary care doctor and a podiatrist can make a significant reduction in amputations, he said, just by a “Knock your socks off” approach. He reminds primary care doctors that observing the feet of their patients with diabetes can go a long way to reducing DFUs and the hospitalizations and amputations that can result.

Dr. Mathioudakis and Dr. Isseroff reported no disclosures. Dr. Boulton consults for Urgo Medical, Nevro Corporation, and AOT, Inc. Dr. Armstrong reported receiving consulting fees from Podimetrics; Molnlycke; Cardiovascular Systems, Inc.; Endo Pharmaceuticals; and Averitas Pharma (GRT US).

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

The photo of the patient’s foot, sent from his campsite, included a cheeky note: “I remember you telling me that getting in trouble doing something was better than getting in trouble doing nothing. This lets me get out there and know that I have feedback.”

The “this” was the patient’s “foot selfie,” an approach that allows patients at a risk for diabetic foot ulcers (DFUs) to snap a picture and send it to their healthcare providers for evaluation.

This particular patient had an extensive history of previous wounds. Some had essentially kept him house-bound in the past, as he was afraid to get another one.

This time, however, he got an all-clear to keep on camping, “and we scheduled him in on the following Tuesday [for follow-up],” said the camper’s physician David G. Armstrong, DPM, MD, PhD, professor of surgery and neurological surgery, USC Keck School of Medicine, Los Angeles.

Dr. Armstrong is one of the researchers evaluating the concept of foot selfies. It’s a welcome advance, he and others said, and has been shown to help heal wounds and reverse pre-ulcer lesions. Research on foot selfies continues, but much more is needed to solve the issue of DFUs, diabetic foot infections (DFIs), and the high rates of reinfection, experts know.

Worldwide, about 18.6 million people have a DFU each year, including 1.6 million in the United States. About 50%-60% of ulcers become infected, with 20% of moderate to severe infections requiring amputation of the limb. The 5-year mortality rate for DFUs is 30%, but it climbs to 70% after amputation. While about 40% of ulcers heal within 12 weeks, 42% recur at the 1-year mark, setting up a vicious and costly cycle. Healthcare costs for patients with diabetes and DFUs are five times as high as costs for patients with diabetes but no DFUs. The per capita cost to treat a DFU in America is $17,500.

While the statistics paint a grim picture, progress is being made on several fronts:

• US Food and Drug Administration (FDA) guidance on the development of drugs for DFUs, under evaluation, is forthcoming.
• New treatments are under study.
• A multidisciplinary team approach is known to improve outcomes.

Anatomy of a DFU

When neuropathy develops in those with diabetes, they no longer have what Dr. Armstrong calls the “gift” of pain perception. “They can wear a hole in their foot like you and I wear a hole in our sock or shoe,” he said. “That hole is called a diabetic foot ulcer.”

A DFU is an open wound on the foot, often occurring when bleeding develops beneath a callus and then the callus wears away. Deeper tissues of the foot are then exposed.

About half of the DFUs get infected, hence the FDA guidance, said Dr. Armstrong, who is also founding president of the American Limb Preservation Society, which aims to eliminate preventable amputations within the next generation. Every 20 seconds, Dr. Armstrong said, someone in the world loses a leg due to diabetes.
 

FDA Guidance on Drug Development for DFIs

In October, the FDA issued draft guidance for industry to articulate the design of clinical trials for developing antibacterial drugs to treat DFIs without concomitant bone and joint involvement. Comments closed on December 18. Among the points in the guidance, which is nonbinding, are to include DFIs of varying depths and extent in phase 3 trials and ideally to include only those patients who have not had prior antibacterial treatment for the current DFI.

According to an FDA spokesperson, “The agency is working to finalize the guidance. However, a timeline for its release has not yet been established.”

The good news about the upcoming FDA guidance, Dr. Armstrong said, is that the agency has realized the importance of treating the infections. Fully one third of direct costs of care for diabetes are spent on the lower extremities, he said. Keeping patients out of the hospital, uninfected, and “keeping legs on bodies” are all important goals, he said.

Pharmaceutical firms need to understand that “you aren’t dealing with a normal ulcer,” said Andrew J.M. Boulton, MD, professor of medicine at the University of Manchester and physician consultant at the Manchester Royal Infirmary, Manchester, England, and a visiting professor at the University of Miami. For research, “the most important thing is to take account of off-loading the ulcers,” he said. “Most ulcers will heal if put in a boot.”

Dr. Boulton, like Dr. Armstrong, a long-time expert in the field, contended that pharma has not understood this concept and has wasted millions over the last three decades doing studies that were poorly designed and controlled.
 

Treatments: Current, Under Study

Currently, DFIs are treated with antimicrobial therapy, without or without debridement, along with a clinical assessment for ischemia. If ischemia is found, care progresses to wound care and off-loading devices, such as healing sandals. Clinicians then assess the likelihood of improved outcomes with revascularization based on operative risks and distribution of lower extremity artery disease and proceed depending on the likelihood. If osteomyelitis testing shows it is present, providers proceed to wound debridement, limb-sparing amputation, and prolonged antimicrobials, as needed.

More options are needed, Dr. Armstrong said.

Among the many approaches under study:

• DFUs can be accurately detected by applying artificial intelligence to the “foot selfie” images taken by patients on smartphones, research by Dr.  and  has found.
• After a phase 3 study of  for DFUs originally intending to enroll 300 subjects was discontinued because of slow patient recruitment, an interim analysis was conducted on 44 participants. It showed a positive trend toward wound closure in the group receiving the injected gene therapy, VM202 (ENGENSIS), in their calf muscles. VM202 is a plasmid DNA-encoding human hepatocyte growth factor. While those in both the intervention and placebo groups showed wound-closing effects at month 6, in 23 patients with neuro-ischemic ulcers, the percentage of those reaching complete closure of the DFU was significantly higher in the treated group at months 3, 4, and 5 (P = .0391, .0391, and .0361, respectively). After excluding two outliers, the difference in months 3-6 became more significant (P = .03).
• An closed more DFUs than standard care after 12 weeks — 70% vs 34% (P = .00032). Of the 100 participants randomized, 50 per group, 42% of the treatment group and 56% of the control group experienced adverse events, with eight withdrawn due to serious adverse events (such as osteomyelitis).
• A closed more refractory DFUs over a 16-week study than standard sharp debridement, with 65% of water-treated ulcers healed but just 42% of the standard care group (P = .021, unadjusted).
• Researchers from UC Davis and VA Northern California Healthcare are evaluating timolol, a beta adrenergic receptor blocker already approved for topical administration for glaucoma, as a way to heal chronic DFUs faster. After demonstrating that the medication worked in animal models, researchers then launched a study to use it off-label for DFUs. While data are still being analyzed, researcher Roslyn (Rivkah) Isseroff, MD, of UC Davis and VA, said that data so far demonstrate that the timolol reduced transepidermal water loss in the healed wounds, and that is linked with a decrease in re-ulceration.

The Power of a Team

Multidisciplinary approaches to treatment are effective in reducing amputation, with one review of 33 studies finding the approach worked to decrease amputation in 94% of them. “The American Limb Preservation Society (ALPS) lists 30 programs,” said Dr. Armstrong, the founding president of the organization. “There may be as many as 100.”

Team compositions vary but usually include at least one medical specialty clinician, such as infectious disease, primary care, or endocrinology, and two or more specialty clinicians, such as vascular, podiatric, orthopedic, or plastic surgery. A shoe specialist is needed to prescribe and manage footwear. Other important team members include nutrition experts and behavioral health professionals to deal with associated depression.

Johns Hopkins’ Multidisciplinary Diabetic Foot and Wound Service launched in 2012 and includes vascular surgeons, surgical podiatrists, endocrinologists, wound care nurses, advanced practice staff, board-certified wound care specialists, orthopedic surgeons, infection disease experts, physical therapists, and certified orthotists.

“This interdisciplinary care model has been repeatedly validated by research as superior for limb salvage and wound healing,” said Nestoras Mathioudakis, MD, codirector of the service. “For instance, endocrinologists and diabetes educators are crucial for managing uncontrolled diabetes — a key factor in infection and delayed wound healing. Similarly, vascular surgeons play a vital role in addressing peripheral arterial disease to improve blood flow to the affected area.”

“Diabetic foot ulcers might require prolonged periods of specialized care, including meticulous wound management and off-loading, overseen by surgical podiatrists and wound care experts,” he said. “In cases where infection is present, particularly with multidrug resistant organisms or when standard antibiotics are contraindicated, the insight of an infectious disease specialist is invaluable.”

While the makeup of teams varies from location to location, he said “the hallmark of effective teams is their ability to comprehensively manage glycemic control, foot wounds, vascular disease, and infections.”

The power of teams, Dr. Armstrong said, is very much evident after his weekly “foot selfie rounds” conducted Mondays at 7 AM, with an “all feet on deck” approach. “Not a week goes by when we don’t stop a hospitalization,” he said of the team evaluating the photos, due to detecting issues early, while still in the manageable state.

Teams can trump technology, Dr. Armstrong said. A team of just a primary care doctor and a podiatrist can make a significant reduction in amputations, he said, just by a “Knock your socks off” approach. He reminds primary care doctors that observing the feet of their patients with diabetes can go a long way to reducing DFUs and the hospitalizations and amputations that can result.

Dr. Mathioudakis and Dr. Isseroff reported no disclosures. Dr. Boulton consults for Urgo Medical, Nevro Corporation, and AOT, Inc. Dr. Armstrong reported receiving consulting fees from Podimetrics; Molnlycke; Cardiovascular Systems, Inc.; Endo Pharmaceuticals; and Averitas Pharma (GRT US).

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

The photo of the patient’s foot, sent from his campsite, included a cheeky note: “I remember you telling me that getting in trouble doing something was better than getting in trouble doing nothing. This lets me get out there and know that I have feedback.”

The “this” was the patient’s “foot selfie,” an approach that allows patients at a risk for diabetic foot ulcers (DFUs) to snap a picture and send it to their healthcare providers for evaluation.

This particular patient had an extensive history of previous wounds. Some had essentially kept him house-bound in the past, as he was afraid to get another one.

This time, however, he got an all-clear to keep on camping, “and we scheduled him in on the following Tuesday [for follow-up],” said the camper’s physician David G. Armstrong, DPM, MD, PhD, professor of surgery and neurological surgery, USC Keck School of Medicine, Los Angeles.

Dr. Armstrong is one of the researchers evaluating the concept of foot selfies. It’s a welcome advance, he and others said, and has been shown to help heal wounds and reverse pre-ulcer lesions. Research on foot selfies continues, but much more is needed to solve the issue of DFUs, diabetic foot infections (DFIs), and the high rates of reinfection, experts know.

Worldwide, about 18.6 million people have a DFU each year, including 1.6 million in the United States. About 50%-60% of ulcers become infected, with 20% of moderate to severe infections requiring amputation of the limb. The 5-year mortality rate for DFUs is 30%, but it climbs to 70% after amputation. While about 40% of ulcers heal within 12 weeks, 42% recur at the 1-year mark, setting up a vicious and costly cycle. Healthcare costs for patients with diabetes and DFUs are five times as high as costs for patients with diabetes but no DFUs. The per capita cost to treat a DFU in America is $17,500.

While the statistics paint a grim picture, progress is being made on several fronts:

• US Food and Drug Administration (FDA) guidance on the development of drugs for DFUs, under evaluation, is forthcoming.
• New treatments are under study.
• A multidisciplinary team approach is known to improve outcomes.

Anatomy of a DFU

When neuropathy develops in those with diabetes, they no longer have what Dr. Armstrong calls the “gift” of pain perception. “They can wear a hole in their foot like you and I wear a hole in our sock or shoe,” he said. “That hole is called a diabetic foot ulcer.”

A DFU is an open wound on the foot, often occurring when bleeding develops beneath a callus and then the callus wears away. Deeper tissues of the foot are then exposed.

About half of the DFUs get infected, hence the FDA guidance, said Dr. Armstrong, who is also founding president of the American Limb Preservation Society, which aims to eliminate preventable amputations within the next generation. Every 20 seconds, Dr. Armstrong said, someone in the world loses a leg due to diabetes.
 

FDA Guidance on Drug Development for DFIs

In October, the FDA issued draft guidance for industry to articulate the design of clinical trials for developing antibacterial drugs to treat DFIs without concomitant bone and joint involvement. Comments closed on December 18. Among the points in the guidance, which is nonbinding, are to include DFIs of varying depths and extent in phase 3 trials and ideally to include only those patients who have not had prior antibacterial treatment for the current DFI.

According to an FDA spokesperson, “The agency is working to finalize the guidance. However, a timeline for its release has not yet been established.”

The good news about the upcoming FDA guidance, Dr. Armstrong said, is that the agency has realized the importance of treating the infections. Fully one third of direct costs of care for diabetes are spent on the lower extremities, he said. Keeping patients out of the hospital, uninfected, and “keeping legs on bodies” are all important goals, he said.

Pharmaceutical firms need to understand that “you aren’t dealing with a normal ulcer,” said Andrew J.M. Boulton, MD, professor of medicine at the University of Manchester and physician consultant at the Manchester Royal Infirmary, Manchester, England, and a visiting professor at the University of Miami. For research, “the most important thing is to take account of off-loading the ulcers,” he said. “Most ulcers will heal if put in a boot.”

Dr. Boulton, like Dr. Armstrong, a long-time expert in the field, contended that pharma has not understood this concept and has wasted millions over the last three decades doing studies that were poorly designed and controlled.
 

Treatments: Current, Under Study

Currently, DFIs are treated with antimicrobial therapy, without or without debridement, along with a clinical assessment for ischemia. If ischemia is found, care progresses to wound care and off-loading devices, such as healing sandals. Clinicians then assess the likelihood of improved outcomes with revascularization based on operative risks and distribution of lower extremity artery disease and proceed depending on the likelihood. If osteomyelitis testing shows it is present, providers proceed to wound debridement, limb-sparing amputation, and prolonged antimicrobials, as needed.

More options are needed, Dr. Armstrong said.

Among the many approaches under study:

• DFUs can be accurately detected by applying artificial intelligence to the “foot selfie” images taken by patients on smartphones, research by Dr.  and  has found.
• After a phase 3 study of  for DFUs originally intending to enroll 300 subjects was discontinued because of slow patient recruitment, an interim analysis was conducted on 44 participants. It showed a positive trend toward wound closure in the group receiving the injected gene therapy, VM202 (ENGENSIS), in their calf muscles. VM202 is a plasmid DNA-encoding human hepatocyte growth factor. While those in both the intervention and placebo groups showed wound-closing effects at month 6, in 23 patients with neuro-ischemic ulcers, the percentage of those reaching complete closure of the DFU was significantly higher in the treated group at months 3, 4, and 5 (P = .0391, .0391, and .0361, respectively). After excluding two outliers, the difference in months 3-6 became more significant (P = .03).
• An closed more DFUs than standard care after 12 weeks — 70% vs 34% (P = .00032). Of the 100 participants randomized, 50 per group, 42% of the treatment group and 56% of the control group experienced adverse events, with eight withdrawn due to serious adverse events (such as osteomyelitis).
• A closed more refractory DFUs over a 16-week study than standard sharp debridement, with 65% of water-treated ulcers healed but just 42% of the standard care group (P = .021, unadjusted).
• Researchers from UC Davis and VA Northern California Healthcare are evaluating timolol, a beta adrenergic receptor blocker already approved for topical administration for glaucoma, as a way to heal chronic DFUs faster. After demonstrating that the medication worked in animal models, researchers then launched a study to use it off-label for DFUs. While data are still being analyzed, researcher Roslyn (Rivkah) Isseroff, MD, of UC Davis and VA, said that data so far demonstrate that the timolol reduced transepidermal water loss in the healed wounds, and that is linked with a decrease in re-ulceration.

The Power of a Team

Multidisciplinary approaches to treatment are effective in reducing amputation, with one review of 33 studies finding the approach worked to decrease amputation in 94% of them. “The American Limb Preservation Society (ALPS) lists 30 programs,” said Dr. Armstrong, the founding president of the organization. “There may be as many as 100.”

Team compositions vary but usually include at least one medical specialty clinician, such as infectious disease, primary care, or endocrinology, and two or more specialty clinicians, such as vascular, podiatric, orthopedic, or plastic surgery. A shoe specialist is needed to prescribe and manage footwear. Other important team members include nutrition experts and behavioral health professionals to deal with associated depression.

Johns Hopkins’ Multidisciplinary Diabetic Foot and Wound Service launched in 2012 and includes vascular surgeons, surgical podiatrists, endocrinologists, wound care nurses, advanced practice staff, board-certified wound care specialists, orthopedic surgeons, infection disease experts, physical therapists, and certified orthotists.

“This interdisciplinary care model has been repeatedly validated by research as superior for limb salvage and wound healing,” said Nestoras Mathioudakis, MD, codirector of the service. “For instance, endocrinologists and diabetes educators are crucial for managing uncontrolled diabetes — a key factor in infection and delayed wound healing. Similarly, vascular surgeons play a vital role in addressing peripheral arterial disease to improve blood flow to the affected area.”

“Diabetic foot ulcers might require prolonged periods of specialized care, including meticulous wound management and off-loading, overseen by surgical podiatrists and wound care experts,” he said. “In cases where infection is present, particularly with multidrug resistant organisms or when standard antibiotics are contraindicated, the insight of an infectious disease specialist is invaluable.”

While the makeup of teams varies from location to location, he said “the hallmark of effective teams is their ability to comprehensively manage glycemic control, foot wounds, vascular disease, and infections.”

The power of teams, Dr. Armstrong said, is very much evident after his weekly “foot selfie rounds” conducted Mondays at 7 AM, with an “all feet on deck” approach. “Not a week goes by when we don’t stop a hospitalization,” he said of the team evaluating the photos, due to detecting issues early, while still in the manageable state.

Teams can trump technology, Dr. Armstrong said. A team of just a primary care doctor and a podiatrist can make a significant reduction in amputations, he said, just by a “Knock your socks off” approach. He reminds primary care doctors that observing the feet of their patients with diabetes can go a long way to reducing DFUs and the hospitalizations and amputations that can result.

Dr. Mathioudakis and Dr. Isseroff reported no disclosures. Dr. Boulton consults for Urgo Medical, Nevro Corporation, and AOT, Inc. Dr. Armstrong reported receiving consulting fees from Podimetrics; Molnlycke; Cardiovascular Systems, Inc.; Endo Pharmaceuticals; and Averitas Pharma (GRT US).

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

TOPLINE:

Less than 7 hours of sleep per night is common in individuals with type 1 diabetes (T1D) but is tied to poor cardiometabolic health, particularly in adolescents.

METHODOLOGY:

• Sleep is recognized as an important factor in diabetes assessment and treatment by the 2023 American Diabetes Association’s Standards of Medical Care in Diabetes, but it is unclear whether sleep may improve health outcomes across the lifespan in patients with T1D.
• This secondary analysis of the BCQR-T1D crossover trial investigated the link between sleep and cardiometabolic health in 42 adults (age, 19-60 years) and 42 adolescents (age, 12-18 years) with T1D.
• Participants had T1D duration greater than 9 months and received bromocriptine quick-release (BCQR) therapy or placebo for 4 weeks and then switched between the treatments in a separate 4-week period.
• They underwent laboratory testing and anthropometric measurements. Also, continuous glucose monitoring data were collected for a week during each treatment phase along with an accompanying insulin dosing diary.
• Participants were required to wear an actigraphy monitor on the wrist of their nondominant hand for 7 days during each treatment phase to estimate sleep duration.

TAKEAWAY:

• Most adolescents (62%) and adults (74%) with T1D reported less than 7 hours of sleep at baseline.
• Participants with insufficient sleep versus those without insufficient sleep (< 7 vs > 7 hours) had a larger waist circumference and higher mean body mass index, systolic blood pressure, and pulse pressure, as well as lower estimated insulin sensitivity and brachial artery distensibility (P < .05 for all).
• When stratified by age, only adolescents with T1D with insufficient sleep had significant differences in most health outcomes by sleep duration status, except that adults with less than 7 hours of sleep had higher pulse pressure than those with more than 7 hours of sleep.
• Compared with placebo, BCQR slightly improved sleeping parameters in adolescents by delaying their time of waking up and prolonging their time in bed.

IN PRACTICE:

“Sleep may be an important and novel target for improving health in individuals with T1D, particularly when initiated in adolescence or early in diabetes,” the authors wrote.

SOURCE:

Stacey L. Simon, PhD, and Janet K. Snell-Bergeon, PhD, University of Colorado Anschutz Medical Campus, Aurora, led this study, which was published online in Diabetes, Obesity and Metabolism.

LIMITATIONS:

The study lacked polysomnography or melatonin assessment to quantify circadian rhythms and subjective sleep quality ratings. It also had no objective measurement of the timing of the daily pills of BCQR, which, when taken in the morning, are hypothesized to reset the circadian rhythm for hypothalamic dopamine and serotonin. The recommended sleep duration of 8 hours for adolescents was not used as the cutoff value due to too few participants who qualified. Also, this study›s findings may be affected by the fact that participants were recruited throughout the year, while adolescents show different sleeping patterns during the academic year compared with school breaks.

DISCLOSURES:

This work was supported by a JDRF grant. Two authors declared receiving equipment, honoraria for lectures, and support for conference travel, which were all unrelated to this study.

A version of this article appeared on Medscape.com.

TOPLINE:

Less than 7 hours of sleep per night is common in individuals with type 1 diabetes (T1D) but is tied to poor cardiometabolic health, particularly in adolescents.

METHODOLOGY:

• Sleep is recognized as an important factor in diabetes assessment and treatment by the 2023 American Diabetes Association’s Standards of Medical Care in Diabetes, but it is unclear whether sleep may improve health outcomes across the lifespan in patients with T1D.
• This secondary analysis of the BCQR-T1D crossover trial investigated the link between sleep and cardiometabolic health in 42 adults (age, 19-60 years) and 42 adolescents (age, 12-18 years) with T1D.
• Participants had T1D duration greater than 9 months and received bromocriptine quick-release (BCQR) therapy or placebo for 4 weeks and then switched between the treatments in a separate 4-week period.
• They underwent laboratory testing and anthropometric measurements. Also, continuous glucose monitoring data were collected for a week during each treatment phase along with an accompanying insulin dosing diary.
• Participants were required to wear an actigraphy monitor on the wrist of their nondominant hand for 7 days during each treatment phase to estimate sleep duration.

TAKEAWAY:

• Most adolescents (62%) and adults (74%) with T1D reported less than 7 hours of sleep at baseline.
• Participants with insufficient sleep versus those without insufficient sleep (< 7 vs > 7 hours) had a larger waist circumference and higher mean body mass index, systolic blood pressure, and pulse pressure, as well as lower estimated insulin sensitivity and brachial artery distensibility (P < .05 for all).
• When stratified by age, only adolescents with T1D with insufficient sleep had significant differences in most health outcomes by sleep duration status, except that adults with less than 7 hours of sleep had higher pulse pressure than those with more than 7 hours of sleep.
• Compared with placebo, BCQR slightly improved sleeping parameters in adolescents by delaying their time of waking up and prolonging their time in bed.

IN PRACTICE:

“Sleep may be an important and novel target for improving health in individuals with T1D, particularly when initiated in adolescence or early in diabetes,” the authors wrote.

SOURCE:

Stacey L. Simon, PhD, and Janet K. Snell-Bergeon, PhD, University of Colorado Anschutz Medical Campus, Aurora, led this study, which was published online in Diabetes, Obesity and Metabolism.

LIMITATIONS:

The study lacked polysomnography or melatonin assessment to quantify circadian rhythms and subjective sleep quality ratings. It also had no objective measurement of the timing of the daily pills of BCQR, which, when taken in the morning, are hypothesized to reset the circadian rhythm for hypothalamic dopamine and serotonin. The recommended sleep duration of 8 hours for adolescents was not used as the cutoff value due to too few participants who qualified. Also, this study›s findings may be affected by the fact that participants were recruited throughout the year, while adolescents show different sleeping patterns during the academic year compared with school breaks.

DISCLOSURES:

This work was supported by a JDRF grant. Two authors declared receiving equipment, honoraria for lectures, and support for conference travel, which were all unrelated to this study.

A version of this article appeared on Medscape.com.

TOPLINE:

Less than 7 hours of sleep per night is common in individuals with type 1 diabetes (T1D) but is tied to poor cardiometabolic health, particularly in adolescents.

METHODOLOGY:

• Sleep is recognized as an important factor in diabetes assessment and treatment by the 2023 American Diabetes Association’s Standards of Medical Care in Diabetes, but it is unclear whether sleep may improve health outcomes across the lifespan in patients with T1D.
• This secondary analysis of the BCQR-T1D crossover trial investigated the link between sleep and cardiometabolic health in 42 adults (age, 19-60 years) and 42 adolescents (age, 12-18 years) with T1D.
• Participants had T1D duration greater than 9 months and received bromocriptine quick-release (BCQR) therapy or placebo for 4 weeks and then switched between the treatments in a separate 4-week period.
• They underwent laboratory testing and anthropometric measurements. Also, continuous glucose monitoring data were collected for a week during each treatment phase along with an accompanying insulin dosing diary.
• Participants were required to wear an actigraphy monitor on the wrist of their nondominant hand for 7 days during each treatment phase to estimate sleep duration.

TAKEAWAY:

• Most adolescents (62%) and adults (74%) with T1D reported less than 7 hours of sleep at baseline.
• Participants with insufficient sleep versus those without insufficient sleep (< 7 vs > 7 hours) had a larger waist circumference and higher mean body mass index, systolic blood pressure, and pulse pressure, as well as lower estimated insulin sensitivity and brachial artery distensibility (P < .05 for all).
• When stratified by age, only adolescents with T1D with insufficient sleep had significant differences in most health outcomes by sleep duration status, except that adults with less than 7 hours of sleep had higher pulse pressure than those with more than 7 hours of sleep.
• Compared with placebo, BCQR slightly improved sleeping parameters in adolescents by delaying their time of waking up and prolonging their time in bed.

IN PRACTICE:

“Sleep may be an important and novel target for improving health in individuals with T1D, particularly when initiated in adolescence or early in diabetes,” the authors wrote.

SOURCE:

Stacey L. Simon, PhD, and Janet K. Snell-Bergeon, PhD, University of Colorado Anschutz Medical Campus, Aurora, led this study, which was published online in Diabetes, Obesity and Metabolism.

LIMITATIONS:

The study lacked polysomnography or melatonin assessment to quantify circadian rhythms and subjective sleep quality ratings. It also had no objective measurement of the timing of the daily pills of BCQR, which, when taken in the morning, are hypothesized to reset the circadian rhythm for hypothalamic dopamine and serotonin. The recommended sleep duration of 8 hours for adolescents was not used as the cutoff value due to too few participants who qualified. Also, this study›s findings may be affected by the fact that participants were recruited throughout the year, while adolescents show different sleeping patterns during the academic year compared with school breaks.

DISCLOSURES:

This work was supported by a JDRF grant. Two authors declared receiving equipment, honoraria for lectures, and support for conference travel, which were all unrelated to this study.

A version of this article appeared on Medscape.com.

Physician practice ownership by corporations, including health insurers, private equity firms, and large pharmacy chains, reached 30.1% as of January for the first time surpassing ownership by hospitals and health systems (28.4%), according to a new report.

As a result, about three in five physician practices are now owned by nonphysicians.

In early 2020, corporations owned just about 17% of US medical practices, while hospitals and health systems owned about 25%, according to the report released Thursday by nonprofit Physician Advocacy Institute (PAI). But corporate ownership of medical groups surged during the pandemic.

These trends raise questions about how best to protect patients and physicians in a changing employment landscape, said Kelly Kenney, PAI’s chief executive officer, in a statement.

“Corporate entities are assuming control of physician practices and changing the face of medicine in the United States with little to no scrutiny from regulators,” Ms. Kenney said.

The research, conducted by consulting group Avalere for PAI, used the IQVIA OneKey database that contains physician and practice location information on hospital and health system ownership.

By 2022-2023, there was a 7.3% increase in the percentage of practices owned by hospitals and 5.9% increase in the percentage of physicians employed by these organizations, PAI said. In the same time frame, there was an 11% increase in the percentage of practices owned by corporations and a 3.0% increase in the percentage of physicians employed by these entities.

“Physicians have an ethical responsibility to their patients’ health,” Ms. Kenney said. “Corporate entities have a fiduciary responsibility to their shareholders and are motivated to put profits first…these interests can conflict with providing the best medical care to patients.”
 

Federal Scrutiny Increases

However, both federal and state regulators are paying more attention to what happens to patients and physicians when corporations acquire practices.

“Given recent trends, we are concerned that some transactions may generate profits for those firms at the expense of patients’ health, workers’ safety, quality of care, and affordable healthcare for patients and taxpayers,” said the Federal Trade Commission (FTC) and the Justice (DOJ) and Health and Human Services (HHS) departments.

This statement appears in those agencies’ joint request for information (RFI) announced in March. An RFI is a tool that federal agencies can use to gauge the level of both support and opposition they would face if they were to try to change policies. Public comments are due May 6.

Corporations and advocacy groups often submit detailed comments outlining reasons why the federal government should or should not act on an issue. But individuals also can make their case in this forum.

The FTC, DOJ, and HHS are looking broadly at consolidation in healthcare, but they also spell out potential concerns related to acquisition of physician practices.

For example, they asked clinicians and support staff to provide feedback about whether acquisitions lead to changes in:

• Take-home pay
• Staffing levels
• Workplace safety
• Compensation model (eg, from fixed salary to volume based)
• Policies regarding patient referrals
• Mix of patients
• The volume of patients
• The way providers practice medicine (eg, incentives, prescribing decisions, forced protocols, restrictions on time spent with patients, or mandatory coding practices)
• Administrative or managerial organization (eg, transition to a management services organization).

A version of this article appeared on Medscape.com.

Physician practice ownership by corporations, including health insurers, private equity firms, and large pharmacy chains, reached 30.1% as of January for the first time surpassing ownership by hospitals and health systems (28.4%), according to a new report.

As a result, about three in five physician practices are now owned by nonphysicians.

In early 2020, corporations owned just about 17% of US medical practices, while hospitals and health systems owned about 25%, according to the report released Thursday by nonprofit Physician Advocacy Institute (PAI). But corporate ownership of medical groups surged during the pandemic.

These trends raise questions about how best to protect patients and physicians in a changing employment landscape, said Kelly Kenney, PAI’s chief executive officer, in a statement.

“Corporate entities are assuming control of physician practices and changing the face of medicine in the United States with little to no scrutiny from regulators,” Ms. Kenney said.

The research, conducted by consulting group Avalere for PAI, used the IQVIA OneKey database that contains physician and practice location information on hospital and health system ownership.

By 2022-2023, there was a 7.3% increase in the percentage of practices owned by hospitals and 5.9% increase in the percentage of physicians employed by these organizations, PAI said. In the same time frame, there was an 11% increase in the percentage of practices owned by corporations and a 3.0% increase in the percentage of physicians employed by these entities.

“Physicians have an ethical responsibility to their patients’ health,” Ms. Kenney said. “Corporate entities have a fiduciary responsibility to their shareholders and are motivated to put profits first…these interests can conflict with providing the best medical care to patients.”
 

Federal Scrutiny Increases

However, both federal and state regulators are paying more attention to what happens to patients and physicians when corporations acquire practices.

“Given recent trends, we are concerned that some transactions may generate profits for those firms at the expense of patients’ health, workers’ safety, quality of care, and affordable healthcare for patients and taxpayers,” said the Federal Trade Commission (FTC) and the Justice (DOJ) and Health and Human Services (HHS) departments.

This statement appears in those agencies’ joint request for information (RFI) announced in March. An RFI is a tool that federal agencies can use to gauge the level of both support and opposition they would face if they were to try to change policies. Public comments are due May 6.

Corporations and advocacy groups often submit detailed comments outlining reasons why the federal government should or should not act on an issue. But individuals also can make their case in this forum.

The FTC, DOJ, and HHS are looking broadly at consolidation in healthcare, but they also spell out potential concerns related to acquisition of physician practices.

For example, they asked clinicians and support staff to provide feedback about whether acquisitions lead to changes in:

• Take-home pay
• Staffing levels
• Workplace safety
• Compensation model (eg, from fixed salary to volume based)
• Policies regarding patient referrals
• Mix of patients
• The volume of patients
• The way providers practice medicine (eg, incentives, prescribing decisions, forced protocols, restrictions on time spent with patients, or mandatory coding practices)
• Administrative or managerial organization (eg, transition to a management services organization).

A version of this article appeared on Medscape.com.

Physician practice ownership by corporations, including health insurers, private equity firms, and large pharmacy chains, reached 30.1% as of January for the first time surpassing ownership by hospitals and health systems (28.4%), according to a new report.

As a result, about three in five physician practices are now owned by nonphysicians.

In early 2020, corporations owned just about 17% of US medical practices, while hospitals and health systems owned about 25%, according to the report released Thursday by nonprofit Physician Advocacy Institute (PAI). But corporate ownership of medical groups surged during the pandemic.

These trends raise questions about how best to protect patients and physicians in a changing employment landscape, said Kelly Kenney, PAI’s chief executive officer, in a statement.

“Corporate entities are assuming control of physician practices and changing the face of medicine in the United States with little to no scrutiny from regulators,” Ms. Kenney said.

The research, conducted by consulting group Avalere for PAI, used the IQVIA OneKey database that contains physician and practice location information on hospital and health system ownership.

By 2022-2023, there was a 7.3% increase in the percentage of practices owned by hospitals and 5.9% increase in the percentage of physicians employed by these organizations, PAI said. In the same time frame, there was an 11% increase in the percentage of practices owned by corporations and a 3.0% increase in the percentage of physicians employed by these entities.

“Physicians have an ethical responsibility to their patients’ health,” Ms. Kenney said. “Corporate entities have a fiduciary responsibility to their shareholders and are motivated to put profits first…these interests can conflict with providing the best medical care to patients.”
 

Federal Scrutiny Increases

However, both federal and state regulators are paying more attention to what happens to patients and physicians when corporations acquire practices.

“Given recent trends, we are concerned that some transactions may generate profits for those firms at the expense of patients’ health, workers’ safety, quality of care, and affordable healthcare for patients and taxpayers,” said the Federal Trade Commission (FTC) and the Justice (DOJ) and Health and Human Services (HHS) departments.

This statement appears in those agencies’ joint request for information (RFI) announced in March. An RFI is a tool that federal agencies can use to gauge the level of both support and opposition they would face if they were to try to change policies. Public comments are due May 6.

Corporations and advocacy groups often submit detailed comments outlining reasons why the federal government should or should not act on an issue. But individuals also can make their case in this forum.

The FTC, DOJ, and HHS are looking broadly at consolidation in healthcare, but they also spell out potential concerns related to acquisition of physician practices.

For example, they asked clinicians and support staff to provide feedback about whether acquisitions lead to changes in:

• Take-home pay
• Staffing levels
• Workplace safety
• Compensation model (eg, from fixed salary to volume based)
• Policies regarding patient referrals
• Mix of patients
• The volume of patients
• The way providers practice medicine (eg, incentives, prescribing decisions, forced protocols, restrictions on time spent with patients, or mandatory coding practices)
• Administrative or managerial organization (eg, transition to a management services organization).

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity.

When I was doing my nephrology training, I had an attending who would write notes that were, well, kind of funny. I remember one time we were seeing a patient whose first name was “Lucky.” He dryly opened his section of the consult note as follows: “This is a 56-year-old woman with an ironic name who presents with acute renal failure.”

As an exhausted renal fellow, I appreciated the bit of color amid the ongoing series of tragedies that was the consult service. But let’s be clear — writing like this in the medical record is not a good idea. It wasn’t a good idea then, when any record might end up disclosed during a malpractice suit, and it’s really not a good idea now, when patients have ready and automated access to all the notes we write about them.

And yet, worse language than that of my attending appears in hospital notes all the time; there is research about this. Specifically, I’m talking about language that does not have high clinical utility but telegraphs the biases of the person writing the note. This is known as “stigmatizing language” and it can be overt or subtle.

For example, a physician wrote “I listed several fictitious medication names and she reported she was taking them.”

This casts suspicions about the patient’s credibility, as does the more subtle statement, “he claims nicotine patches don’t work for him.” Stigmatizing language may cast the patient in a difficult light, like this note: “she persevered on the fact that ... ‘you wouldn’t understand.’ ”

This stuff creeps into our medical notes because doctors are human, not AI — at least not yet — and our frustrations and biases are real. But could those frustrations and biases lead to medical errors? Even deaths? Stay with me.

We are going to start by defining a very sick patient population: those admitted to the hospital and who, within 48 hours, have either been transferred to the intensive care unit or died. Because of the severity of illness in this population we’ve just defined, figuring out whether a diagnostic or other error was made would be extremely high yield; these can mean the difference between life and death.

In a letter appearing in JAMA Internal Medicine, researchers examined a group of more than 2300 patients just like this from 29 hospitals, scouring the medical records for evidence of these types of errors.

Nearly one in four (23.2%) had at least one diagnostic error, which could include a missed physical exam finding, failure to ask a key question on history taking, inadequate testing, and so on.

Understanding why we make these errors is clearly critical to improving care for these patients. The researchers hypothesized that stigmatizing language might lead to errors like this. For example, by demonstrating that you don’t find a patient credible, you may ignore statements that would help make a better diagnosis.

Just over 5% of these patients had evidence of stigmatizing language in their medical notes. Like earlier studies, this language was more common if the patient was Black or had unstable housing.

Critically, stigmatizing language was more likely to be found among those who had diagnostic errors — a rate of 8.2% vs 4.1%. After adjustment for factors like race, the presence of stigmatizing language was associated with roughly a doubling of the risk for diagnostic errors.

Now, I’m all for eliminating stigmatizing language from our medical notes. And, given the increased transparency of all medical notes these days, I expect that we’ll see less of this over time. But of course, the fact that a physician doesn’t write something that disparages the patient does not necessarily mean that they don’t retain that bias. That said, those comments have an effect on all the other team members who care for that patient as well; it sets a tone and can entrench an individual’s bias more broadly. We should strive to eliminate our biases when it comes to caring for patients. But perhaps the second best thing is to work to keep those biases to ourselves.
 

Dr. Wilson is associate professor of medicine and public health and director of the Clinical and Translational Research Accelerator at Yale University, New Haven, Conn. He has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity.

When I was doing my nephrology training, I had an attending who would write notes that were, well, kind of funny. I remember one time we were seeing a patient whose first name was “Lucky.” He dryly opened his section of the consult note as follows: “This is a 56-year-old woman with an ironic name who presents with acute renal failure.”

As an exhausted renal fellow, I appreciated the bit of color amid the ongoing series of tragedies that was the consult service. But let’s be clear — writing like this in the medical record is not a good idea. It wasn’t a good idea then, when any record might end up disclosed during a malpractice suit, and it’s really not a good idea now, when patients have ready and automated access to all the notes we write about them.

And yet, worse language than that of my attending appears in hospital notes all the time; there is research about this. Specifically, I’m talking about language that does not have high clinical utility but telegraphs the biases of the person writing the note. This is known as “stigmatizing language” and it can be overt or subtle.

For example, a physician wrote “I listed several fictitious medication names and she reported she was taking them.”

This casts suspicions about the patient’s credibility, as does the more subtle statement, “he claims nicotine patches don’t work for him.” Stigmatizing language may cast the patient in a difficult light, like this note: “she persevered on the fact that ... ‘you wouldn’t understand.’ ”

This stuff creeps into our medical notes because doctors are human, not AI — at least not yet — and our frustrations and biases are real. But could those frustrations and biases lead to medical errors? Even deaths? Stay with me.

We are going to start by defining a very sick patient population: those admitted to the hospital and who, within 48 hours, have either been transferred to the intensive care unit or died. Because of the severity of illness in this population we’ve just defined, figuring out whether a diagnostic or other error was made would be extremely high yield; these can mean the difference between life and death.

In a letter appearing in JAMA Internal Medicine, researchers examined a group of more than 2300 patients just like this from 29 hospitals, scouring the medical records for evidence of these types of errors.

Nearly one in four (23.2%) had at least one diagnostic error, which could include a missed physical exam finding, failure to ask a key question on history taking, inadequate testing, and so on.

Understanding why we make these errors is clearly critical to improving care for these patients. The researchers hypothesized that stigmatizing language might lead to errors like this. For example, by demonstrating that you don’t find a patient credible, you may ignore statements that would help make a better diagnosis.

Just over 5% of these patients had evidence of stigmatizing language in their medical notes. Like earlier studies, this language was more common if the patient was Black or had unstable housing.

Critically, stigmatizing language was more likely to be found among those who had diagnostic errors — a rate of 8.2% vs 4.1%. After adjustment for factors like race, the presence of stigmatizing language was associated with roughly a doubling of the risk for diagnostic errors.

Now, I’m all for eliminating stigmatizing language from our medical notes. And, given the increased transparency of all medical notes these days, I expect that we’ll see less of this over time. But of course, the fact that a physician doesn’t write something that disparages the patient does not necessarily mean that they don’t retain that bias. That said, those comments have an effect on all the other team members who care for that patient as well; it sets a tone and can entrench an individual’s bias more broadly. We should strive to eliminate our biases when it comes to caring for patients. But perhaps the second best thing is to work to keep those biases to ourselves.
 

Dr. Wilson is associate professor of medicine and public health and director of the Clinical and Translational Research Accelerator at Yale University, New Haven, Conn. He has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity.

When I was doing my nephrology training, I had an attending who would write notes that were, well, kind of funny. I remember one time we were seeing a patient whose first name was “Lucky.” He dryly opened his section of the consult note as follows: “This is a 56-year-old woman with an ironic name who presents with acute renal failure.”

As an exhausted renal fellow, I appreciated the bit of color amid the ongoing series of tragedies that was the consult service. But let’s be clear — writing like this in the medical record is not a good idea. It wasn’t a good idea then, when any record might end up disclosed during a malpractice suit, and it’s really not a good idea now, when patients have ready and automated access to all the notes we write about them.

And yet, worse language than that of my attending appears in hospital notes all the time; there is research about this. Specifically, I’m talking about language that does not have high clinical utility but telegraphs the biases of the person writing the note. This is known as “stigmatizing language” and it can be overt or subtle.

For example, a physician wrote “I listed several fictitious medication names and she reported she was taking them.”

This casts suspicions about the patient’s credibility, as does the more subtle statement, “he claims nicotine patches don’t work for him.” Stigmatizing language may cast the patient in a difficult light, like this note: “she persevered on the fact that ... ‘you wouldn’t understand.’ ”

This stuff creeps into our medical notes because doctors are human, not AI — at least not yet — and our frustrations and biases are real. But could those frustrations and biases lead to medical errors? Even deaths? Stay with me.

We are going to start by defining a very sick patient population: those admitted to the hospital and who, within 48 hours, have either been transferred to the intensive care unit or died. Because of the severity of illness in this population we’ve just defined, figuring out whether a diagnostic or other error was made would be extremely high yield; these can mean the difference between life and death.

In a letter appearing in JAMA Internal Medicine, researchers examined a group of more than 2300 patients just like this from 29 hospitals, scouring the medical records for evidence of these types of errors.

Nearly one in four (23.2%) had at least one diagnostic error, which could include a missed physical exam finding, failure to ask a key question on history taking, inadequate testing, and so on.

Understanding why we make these errors is clearly critical to improving care for these patients. The researchers hypothesized that stigmatizing language might lead to errors like this. For example, by demonstrating that you don’t find a patient credible, you may ignore statements that would help make a better diagnosis.

Just over 5% of these patients had evidence of stigmatizing language in their medical notes. Like earlier studies, this language was more common if the patient was Black or had unstable housing.

Critically, stigmatizing language was more likely to be found among those who had diagnostic errors — a rate of 8.2% vs 4.1%. After adjustment for factors like race, the presence of stigmatizing language was associated with roughly a doubling of the risk for diagnostic errors.

Now, I’m all for eliminating stigmatizing language from our medical notes. And, given the increased transparency of all medical notes these days, I expect that we’ll see less of this over time. But of course, the fact that a physician doesn’t write something that disparages the patient does not necessarily mean that they don’t retain that bias. That said, those comments have an effect on all the other team members who care for that patient as well; it sets a tone and can entrench an individual’s bias more broadly. We should strive to eliminate our biases when it comes to caring for patients. But perhaps the second best thing is to work to keep those biases to ourselves.
 

Dr. Wilson is associate professor of medicine and public health and director of the Clinical and Translational Research Accelerator at Yale University, New Haven, Conn. He has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

TOPLINE:

Biscuits reformulated with the sweeteners and sweetness enhancers (S&SEs) neotame and stevia rebaudioside M (StRebM) yield appetite responses similar to those of sucrose-sweetened ones but decrease post-meal insulin and glucose levels in adults with overweight or obesity.

METHODOLOGY:

• In 2023, the World Health Organization issued a conditional recommendation that S&SE should not be used for weight control, apparently due to a lack of evidence for a clear benefit and weak evidence linking S&SE intake with excess weight and poorer health outcomes.
• This randomized crossover trial, conducted in England and France between 2021 and 2022, evaluated the acute (1 day) and repeated (daily for 2 weeks) effects of S&SEs vs sucrose in solid food on appetite and endocrine responses in adults with overweight or obesity.
• Overall, 53 adults (33 women, 20 men; aged 18-60 years) with overweight or obesity consumed biscuits with fruit filling containing either sucrose or reformulated with the S&SEs StRebM or neotame, daily for three 2-week intervention periods separated by a washout period of 14-21 days.
• Participants were required to fast for 12 hours before attending a laboratory session at the beginning (day 1) and end (day 14) of each consumption period.
• The primary endpoint was the composite appetite score, while secondary endpoints included food preferences, postprandial glucose and insulin response, and other satiety-related peptides, such as ghrelin, glucagon-like peptide 1, and pancreatic polypeptide.

TAKEAWAY:

• The composite appetite scores were comparable between the sucrose, StRebM, and neotame groups, with lower appetite suppression observed on day 14 than on day 1 for all three formulations.
• Neotame (P < .001) and StRebM (P < .001) lowered postprandial insulin levels compared with sucrose, while glucose levels saw a decline only with StRebM (and not with neotame) compared with sucrose (P < .05).
• The S&SEs had no effect on satiety levels, as any acute or repeated exposures to StRebM or neotame vs sucrose did not affect the ghrelin and glucagon-like peptide-1 responses.
• Gastrointestinal issues were more frequently reported in the neotame and StRebM groups than in the sucrose group.

IN PRACTICE:

“There is no detrimental impact of replacing sugar with S&SE in these endpoints,” the authors wrote. “Additionally, glucose and insulin responses were blunted after acute and repeated consumption of S&SE-reformulated biscuits, which may confer a benefit for blood glucose control, for example, in individuals at risk of developing type 2 diabetes.”

SOURCE:

This study was led by Catherine Gibbons, School of Psychology, Faculty of Medicine and Health, University of Leeds, England. It was published online in eBioMedicine.

LIMITATIONS:

The reformulated products required the addition of polyol bulking agents (8% maltitol and 8% sorbitol) to match the biscuits in sensory qualities as closely as possible. Gastrointestinal symptoms (initial bloating and flatulence) in the neotame and StRebM formulations may be due to the polyols, classed as low-digestible carbohydrates.

DISCLOSURES:

This study received funding from a European Union Horizon 2020 program, SWEET (Sweeteners and sweetness enhancers: Impact on health, obesity, safety, and sustainability). The authors reported receiving funding and honoraria from the food and beverage industry and trade groups from various entities.

A version of this article appeared on Medscape.com.

TOPLINE:

Biscuits reformulated with the sweeteners and sweetness enhancers (S&SEs) neotame and stevia rebaudioside M (StRebM) yield appetite responses similar to those of sucrose-sweetened ones but decrease post-meal insulin and glucose levels in adults with overweight or obesity.

METHODOLOGY:

• In 2023, the World Health Organization issued a conditional recommendation that S&SE should not be used for weight control, apparently due to a lack of evidence for a clear benefit and weak evidence linking S&SE intake with excess weight and poorer health outcomes.
• This randomized crossover trial, conducted in England and France between 2021 and 2022, evaluated the acute (1 day) and repeated (daily for 2 weeks) effects of S&SEs vs sucrose in solid food on appetite and endocrine responses in adults with overweight or obesity.
• Overall, 53 adults (33 women, 20 men; aged 18-60 years) with overweight or obesity consumed biscuits with fruit filling containing either sucrose or reformulated with the S&SEs StRebM or neotame, daily for three 2-week intervention periods separated by a washout period of 14-21 days.
• Participants were required to fast for 12 hours before attending a laboratory session at the beginning (day 1) and end (day 14) of each consumption period.
• The primary endpoint was the composite appetite score, while secondary endpoints included food preferences, postprandial glucose and insulin response, and other satiety-related peptides, such as ghrelin, glucagon-like peptide 1, and pancreatic polypeptide.

TAKEAWAY:

• The composite appetite scores were comparable between the sucrose, StRebM, and neotame groups, with lower appetite suppression observed on day 14 than on day 1 for all three formulations.
• Neotame (P < .001) and StRebM (P < .001) lowered postprandial insulin levels compared with sucrose, while glucose levels saw a decline only with StRebM (and not with neotame) compared with sucrose (P < .05).
• The S&SEs had no effect on satiety levels, as any acute or repeated exposures to StRebM or neotame vs sucrose did not affect the ghrelin and glucagon-like peptide-1 responses.
• Gastrointestinal issues were more frequently reported in the neotame and StRebM groups than in the sucrose group.

IN PRACTICE:

“There is no detrimental impact of replacing sugar with S&SE in these endpoints,” the authors wrote. “Additionally, glucose and insulin responses were blunted after acute and repeated consumption of S&SE-reformulated biscuits, which may confer a benefit for blood glucose control, for example, in individuals at risk of developing type 2 diabetes.”

SOURCE:

This study was led by Catherine Gibbons, School of Psychology, Faculty of Medicine and Health, University of Leeds, England. It was published online in eBioMedicine.

LIMITATIONS:

The reformulated products required the addition of polyol bulking agents (8% maltitol and 8% sorbitol) to match the biscuits in sensory qualities as closely as possible. Gastrointestinal symptoms (initial bloating and flatulence) in the neotame and StRebM formulations may be due to the polyols, classed as low-digestible carbohydrates.

DISCLOSURES:

This study received funding from a European Union Horizon 2020 program, SWEET (Sweeteners and sweetness enhancers: Impact on health, obesity, safety, and sustainability). The authors reported receiving funding and honoraria from the food and beverage industry and trade groups from various entities.

A version of this article appeared on Medscape.com.

TOPLINE:

Biscuits reformulated with the sweeteners and sweetness enhancers (S&SEs) neotame and stevia rebaudioside M (StRebM) yield appetite responses similar to those of sucrose-sweetened ones but decrease post-meal insulin and glucose levels in adults with overweight or obesity.

METHODOLOGY:

• In 2023, the World Health Organization issued a conditional recommendation that S&SE should not be used for weight control, apparently due to a lack of evidence for a clear benefit and weak evidence linking S&SE intake with excess weight and poorer health outcomes.
• This randomized crossover trial, conducted in England and France between 2021 and 2022, evaluated the acute (1 day) and repeated (daily for 2 weeks) effects of S&SEs vs sucrose in solid food on appetite and endocrine responses in adults with overweight or obesity.
• Overall, 53 adults (33 women, 20 men; aged 18-60 years) with overweight or obesity consumed biscuits with fruit filling containing either sucrose or reformulated with the S&SEs StRebM or neotame, daily for three 2-week intervention periods separated by a washout period of 14-21 days.
• Participants were required to fast for 12 hours before attending a laboratory session at the beginning (day 1) and end (day 14) of each consumption period.
• The primary endpoint was the composite appetite score, while secondary endpoints included food preferences, postprandial glucose and insulin response, and other satiety-related peptides, such as ghrelin, glucagon-like peptide 1, and pancreatic polypeptide.

TAKEAWAY:

• The composite appetite scores were comparable between the sucrose, StRebM, and neotame groups, with lower appetite suppression observed on day 14 than on day 1 for all three formulations.
• Neotame (P < .001) and StRebM (P < .001) lowered postprandial insulin levels compared with sucrose, while glucose levels saw a decline only with StRebM (and not with neotame) compared with sucrose (P < .05).
• The S&SEs had no effect on satiety levels, as any acute or repeated exposures to StRebM or neotame vs sucrose did not affect the ghrelin and glucagon-like peptide-1 responses.
• Gastrointestinal issues were more frequently reported in the neotame and StRebM groups than in the sucrose group.

IN PRACTICE:

“There is no detrimental impact of replacing sugar with S&SE in these endpoints,” the authors wrote. “Additionally, glucose and insulin responses were blunted after acute and repeated consumption of S&SE-reformulated biscuits, which may confer a benefit for blood glucose control, for example, in individuals at risk of developing type 2 diabetes.”

SOURCE:

This study was led by Catherine Gibbons, School of Psychology, Faculty of Medicine and Health, University of Leeds, England. It was published online in eBioMedicine.

LIMITATIONS:

The reformulated products required the addition of polyol bulking agents (8% maltitol and 8% sorbitol) to match the biscuits in sensory qualities as closely as possible. Gastrointestinal symptoms (initial bloating and flatulence) in the neotame and StRebM formulations may be due to the polyols, classed as low-digestible carbohydrates.

DISCLOSURES:

This study received funding from a European Union Horizon 2020 program, SWEET (Sweeteners and sweetness enhancers: Impact on health, obesity, safety, and sustainability). The authors reported receiving funding and honoraria from the food and beverage industry and trade groups from various entities.

A version of this article appeared on Medscape.com.

The appeal of working from home is undeniable. It comes with no daily commute, casual dress, and the ability to manage work-life balance more effectively.

Telemedicine is often the first thing that comes to mind when physicians think about remote medical practice. In its traditional sense, telemedicine entails live video consults, replicating the in-person experience as closely as possible, minus the hands-on component. However, this format is just one of many types of virtual care presenting opportunities to practice medicine from home.

The scope and volume of such opportunities are expanding due to technology, regulatory shifts at the state and federal levels favoring remote healthcare, and a wider move toward remote work. Virtual practice options for physicians range from full-time employment to flexible part-time positions that can be used to earn supplementary income.

Just a few of those virtual options are:

Remote Patient Monitoring

Remote patient monitoring uses technology for tracking patient health data, applicable in real-time or asynchronously, through devices ranging from specialized monitors to consumer wearables. Data are securely transmitted to healthcare providers, enabling them to guide or make treatment choices remotely. This method has proven particularly valuable in managing chronic diseases where continuous monitoring can significantly affect outcomes.

Like standard telemedicine, remote patient monitoring offers flexibility, autonomy, and the ability to work from home. It is picking up steam across the healthcare industry, especially in critical care, surgery, post-acute care, and primary care, so there are opportunities for physicians across a variety of specialties.

Online Medication Management and Text-Based Consults

Gathering necessary information for patient care decisions often doesn’t require a direct, face-to-face visit in person or by telemedicine. Clinical data can be efficiently collected through online forms, HIPAA-compliant messaging, medical record reviews, and information gathered by staff.

An approach that uses all these sources enables effective medication management for stable chronic conditions (such as hypertension), as well as straightforward but simple acute issues (such as urinary tract infections). It also is useful for quick follow-ups with patients after starting new treatments, to address questions between visits, and to give them educational material.

Some medical practices and virtual healthcare corporations have made online medication management and text-based consults the center of their business model. Part-time positions with platforms that offer this type of care let physicians fit consultations into their schedule as time permits, without committing to scheduled appointments.

eConsults

Electronic consultations, or eConsults, facilitate collaboration among healthcare professionals about complex cases without direct patient interaction.

These services operate via online platforms that support asynchronous communication and often bypass the need for a traditional referral. Typically, a primary care provider submits a query that is then assigned to a specialist. Next, the specialist reviews the information and offers recommendations for the patient’s care plan.

Major eConsult platforms such as AristaMD and RubiconMD contract with healthcare systems and medical practices. Physicians can easily join the specialist panels of these companies and complete assigned consultations from their homes or offices, paid on a per-consult basis. They should check their employment contracts to make sure such independent contract work is allowed.

Phone-Only On-Call Positions

On-call rotations for after-hour care bring with them challenges in staffing and scheduling vacations. These challenges have helped trigger as-needed or per diem on-call roles, in which a physician provides recommendations and orders over the phone without needing to visit an office or a hospital.

Examples of workplaces that employ phone-only on-call physicians include smaller jails, mental health facilities, dialysis centers, long-term care facilities, and sporting groups or events needing back-up for on-site nurses or emergency medical technicians.

While these positions can sometimes be challenging for a physician to find, they are out there. They can be a fantastic option to earn additional income through low-stress clinical work performed from home.

Supervision of Nurse Practitioners (NPs) and Physician Assistants (PAs)

In states that mandate such physician oversight, it often be conducted remotely — depending on that state’s rules, the practice type, and the scope of services being provided. This remote option introduces part-time opportunities for physicians to oversee NPs and PAs without being in the medical office. Essentially, the doctor needs to be available for phone or email consultations, complete chart reviews, and meet regularly with the provider.

Remote supervision roles are available across various types of healthcare organizations and medical practices. There also are opportunities with insurers, many of which have established NP-run, in-home member assessment programs that require remote supervision by a doctor.

Remote Medical Directorships

Medical directors are a key part of the clinician team in a wide variety of healthcare settings requiring clinical protocol oversight, regulatory compliance, and guidance for other clinicians making treatment decisions. Many directorships do not require direct patient contact and therefore are conducive to remote work, given technologies such as electronic health record and secure messaging systems.

Organizations such as emergency medical service agencies, hospice services, med spas, blood and plasma donation centers, home health agencies, and substance use disorder treatment programs increasingly rely on remote medical directorships to meet legal requirements and accreditation standards.

Although these positions are often viewed as “nonclinical,” they carry significant clinical responsibilities. Examples are developing and reviewing treatment protocols, ensuring adherence to healthcare regulations, and sometimes intervening in complex patient cases or when adverse outcomes occur.

Keeping a Role in Patient Welfare

Clearly, working from home as a physician doesn’t have to mean taking on a nonclinical job. Beyond the options already mentioned, there are numerous others — for example, working as a medical monitor for clinical trials, in utilization management for insurance companies, or in conducting independent medical exams for insurance claims. While these roles don’t involve direct patient treatment, they require similar skills and affect the quality of care.

If such remote opportunities aren’t currently available in your workplace, consider approaching your management about trying them. You can make an effective argument that remote practice alternatives bring value to the organization through expanded patient care capabilities and potential cost savings.

Physicians who are experiencing burnout, seeking a career change, or interested in earning extra income should consider exploring more of the unconventional ways that they can practice medicine.

A version of this article appeared on Medscape.com.

The appeal of working from home is undeniable. It comes with no daily commute, casual dress, and the ability to manage work-life balance more effectively.

Telemedicine is often the first thing that comes to mind when physicians think about remote medical practice. In its traditional sense, telemedicine entails live video consults, replicating the in-person experience as closely as possible, minus the hands-on component. However, this format is just one of many types of virtual care presenting opportunities to practice medicine from home.

The scope and volume of such opportunities are expanding due to technology, regulatory shifts at the state and federal levels favoring remote healthcare, and a wider move toward remote work. Virtual practice options for physicians range from full-time employment to flexible part-time positions that can be used to earn supplementary income.

Just a few of those virtual options are:

Remote Patient Monitoring

Remote patient monitoring uses technology for tracking patient health data, applicable in real-time or asynchronously, through devices ranging from specialized monitors to consumer wearables. Data are securely transmitted to healthcare providers, enabling them to guide or make treatment choices remotely. This method has proven particularly valuable in managing chronic diseases where continuous monitoring can significantly affect outcomes.

Like standard telemedicine, remote patient monitoring offers flexibility, autonomy, and the ability to work from home. It is picking up steam across the healthcare industry, especially in critical care, surgery, post-acute care, and primary care, so there are opportunities for physicians across a variety of specialties.

Online Medication Management and Text-Based Consults

Gathering necessary information for patient care decisions often doesn’t require a direct, face-to-face visit in person or by telemedicine. Clinical data can be efficiently collected through online forms, HIPAA-compliant messaging, medical record reviews, and information gathered by staff.

An approach that uses all these sources enables effective medication management for stable chronic conditions (such as hypertension), as well as straightforward but simple acute issues (such as urinary tract infections). It also is useful for quick follow-ups with patients after starting new treatments, to address questions between visits, and to give them educational material.

Some medical practices and virtual healthcare corporations have made online medication management and text-based consults the center of their business model. Part-time positions with platforms that offer this type of care let physicians fit consultations into their schedule as time permits, without committing to scheduled appointments.

eConsults

Electronic consultations, or eConsults, facilitate collaboration among healthcare professionals about complex cases without direct patient interaction.

These services operate via online platforms that support asynchronous communication and often bypass the need for a traditional referral. Typically, a primary care provider submits a query that is then assigned to a specialist. Next, the specialist reviews the information and offers recommendations for the patient’s care plan.

Major eConsult platforms such as AristaMD and RubiconMD contract with healthcare systems and medical practices. Physicians can easily join the specialist panels of these companies and complete assigned consultations from their homes or offices, paid on a per-consult basis. They should check their employment contracts to make sure such independent contract work is allowed.

Phone-Only On-Call Positions

On-call rotations for after-hour care bring with them challenges in staffing and scheduling vacations. These challenges have helped trigger as-needed or per diem on-call roles, in which a physician provides recommendations and orders over the phone without needing to visit an office or a hospital.

Examples of workplaces that employ phone-only on-call physicians include smaller jails, mental health facilities, dialysis centers, long-term care facilities, and sporting groups or events needing back-up for on-site nurses or emergency medical technicians.

While these positions can sometimes be challenging for a physician to find, they are out there. They can be a fantastic option to earn additional income through low-stress clinical work performed from home.

Supervision of Nurse Practitioners (NPs) and Physician Assistants (PAs)

In states that mandate such physician oversight, it often be conducted remotely — depending on that state’s rules, the practice type, and the scope of services being provided. This remote option introduces part-time opportunities for physicians to oversee NPs and PAs without being in the medical office. Essentially, the doctor needs to be available for phone or email consultations, complete chart reviews, and meet regularly with the provider.

Remote supervision roles are available across various types of healthcare organizations and medical practices. There also are opportunities with insurers, many of which have established NP-run, in-home member assessment programs that require remote supervision by a doctor.

Remote Medical Directorships

Medical directors are a key part of the clinician team in a wide variety of healthcare settings requiring clinical protocol oversight, regulatory compliance, and guidance for other clinicians making treatment decisions. Many directorships do not require direct patient contact and therefore are conducive to remote work, given technologies such as electronic health record and secure messaging systems.

Organizations such as emergency medical service agencies, hospice services, med spas, blood and plasma donation centers, home health agencies, and substance use disorder treatment programs increasingly rely on remote medical directorships to meet legal requirements and accreditation standards.

Although these positions are often viewed as “nonclinical,” they carry significant clinical responsibilities. Examples are developing and reviewing treatment protocols, ensuring adherence to healthcare regulations, and sometimes intervening in complex patient cases or when adverse outcomes occur.

Keeping a Role in Patient Welfare

Clearly, working from home as a physician doesn’t have to mean taking on a nonclinical job. Beyond the options already mentioned, there are numerous others — for example, working as a medical monitor for clinical trials, in utilization management for insurance companies, or in conducting independent medical exams for insurance claims. While these roles don’t involve direct patient treatment, they require similar skills and affect the quality of care.

If such remote opportunities aren’t currently available in your workplace, consider approaching your management about trying them. You can make an effective argument that remote practice alternatives bring value to the organization through expanded patient care capabilities and potential cost savings.

Physicians who are experiencing burnout, seeking a career change, or interested in earning extra income should consider exploring more of the unconventional ways that they can practice medicine.

A version of this article appeared on Medscape.com.

The appeal of working from home is undeniable. It comes with no daily commute, casual dress, and the ability to manage work-life balance more effectively.

Telemedicine is often the first thing that comes to mind when physicians think about remote medical practice. In its traditional sense, telemedicine entails live video consults, replicating the in-person experience as closely as possible, minus the hands-on component. However, this format is just one of many types of virtual care presenting opportunities to practice medicine from home.

The scope and volume of such opportunities are expanding due to technology, regulatory shifts at the state and federal levels favoring remote healthcare, and a wider move toward remote work. Virtual practice options for physicians range from full-time employment to flexible part-time positions that can be used to earn supplementary income.

Just a few of those virtual options are:

Remote Patient Monitoring

Remote patient monitoring uses technology for tracking patient health data, applicable in real-time or asynchronously, through devices ranging from specialized monitors to consumer wearables. Data are securely transmitted to healthcare providers, enabling them to guide or make treatment choices remotely. This method has proven particularly valuable in managing chronic diseases where continuous monitoring can significantly affect outcomes.

Like standard telemedicine, remote patient monitoring offers flexibility, autonomy, and the ability to work from home. It is picking up steam across the healthcare industry, especially in critical care, surgery, post-acute care, and primary care, so there are opportunities for physicians across a variety of specialties.

Online Medication Management and Text-Based Consults

Gathering necessary information for patient care decisions often doesn’t require a direct, face-to-face visit in person or by telemedicine. Clinical data can be efficiently collected through online forms, HIPAA-compliant messaging, medical record reviews, and information gathered by staff.

An approach that uses all these sources enables effective medication management for stable chronic conditions (such as hypertension), as well as straightforward but simple acute issues (such as urinary tract infections). It also is useful for quick follow-ups with patients after starting new treatments, to address questions between visits, and to give them educational material.

Some medical practices and virtual healthcare corporations have made online medication management and text-based consults the center of their business model. Part-time positions with platforms that offer this type of care let physicians fit consultations into their schedule as time permits, without committing to scheduled appointments.

eConsults

Electronic consultations, or eConsults, facilitate collaboration among healthcare professionals about complex cases without direct patient interaction.

These services operate via online platforms that support asynchronous communication and often bypass the need for a traditional referral. Typically, a primary care provider submits a query that is then assigned to a specialist. Next, the specialist reviews the information and offers recommendations for the patient’s care plan.

Major eConsult platforms such as AristaMD and RubiconMD contract with healthcare systems and medical practices. Physicians can easily join the specialist panels of these companies and complete assigned consultations from their homes or offices, paid on a per-consult basis. They should check their employment contracts to make sure such independent contract work is allowed.

Phone-Only On-Call Positions

On-call rotations for after-hour care bring with them challenges in staffing and scheduling vacations. These challenges have helped trigger as-needed or per diem on-call roles, in which a physician provides recommendations and orders over the phone without needing to visit an office or a hospital.

Examples of workplaces that employ phone-only on-call physicians include smaller jails, mental health facilities, dialysis centers, long-term care facilities, and sporting groups or events needing back-up for on-site nurses or emergency medical technicians.

While these positions can sometimes be challenging for a physician to find, they are out there. They can be a fantastic option to earn additional income through low-stress clinical work performed from home.

Supervision of Nurse Practitioners (NPs) and Physician Assistants (PAs)

In states that mandate such physician oversight, it often be conducted remotely — depending on that state’s rules, the practice type, and the scope of services being provided. This remote option introduces part-time opportunities for physicians to oversee NPs and PAs without being in the medical office. Essentially, the doctor needs to be available for phone or email consultations, complete chart reviews, and meet regularly with the provider.

Remote supervision roles are available across various types of healthcare organizations and medical practices. There also are opportunities with insurers, many of which have established NP-run, in-home member assessment programs that require remote supervision by a doctor.

Remote Medical Directorships

Medical directors are a key part of the clinician team in a wide variety of healthcare settings requiring clinical protocol oversight, regulatory compliance, and guidance for other clinicians making treatment decisions. Many directorships do not require direct patient contact and therefore are conducive to remote work, given technologies such as electronic health record and secure messaging systems.

Organizations such as emergency medical service agencies, hospice services, med spas, blood and plasma donation centers, home health agencies, and substance use disorder treatment programs increasingly rely on remote medical directorships to meet legal requirements and accreditation standards.

Although these positions are often viewed as “nonclinical,” they carry significant clinical responsibilities. Examples are developing and reviewing treatment protocols, ensuring adherence to healthcare regulations, and sometimes intervening in complex patient cases or when adverse outcomes occur.

Keeping a Role in Patient Welfare

Clearly, working from home as a physician doesn’t have to mean taking on a nonclinical job. Beyond the options already mentioned, there are numerous others — for example, working as a medical monitor for clinical trials, in utilization management for insurance companies, or in conducting independent medical exams for insurance claims. While these roles don’t involve direct patient treatment, they require similar skills and affect the quality of care.

If such remote opportunities aren’t currently available in your workplace, consider approaching your management about trying them. You can make an effective argument that remote practice alternatives bring value to the organization through expanded patient care capabilities and potential cost savings.

Physicians who are experiencing burnout, seeking a career change, or interested in earning extra income should consider exploring more of the unconventional ways that they can practice medicine.

A version of this article appeared on Medscape.com.

TOPLINE:

A low-fat vegan diet — high in fiber and carbohydrates and moderate in protein — reduces insulin requirement, increases insulin sensitivity, and improves glycemic control in individuals with type 1 diabetes (T1D) compared with a conventional portion-controlled diet.

METHODOLOGY:

• The effects of a low-fat vegan diet (without carbohydrate or portion restriction) were compared with those of a conventional portion-controlled, carbohydrate-controlled diet in 58 patients with T1D (age, ≥ 18 years) who had been receiving stable insulin treatment for the past 3 months.
• Participants were randomly assigned to receive either the vegan diet (n = 29), comprising vegetables, grains, legumes, and fruits, or the portion-controlled diet (n = 29), which reduced daily energy intake by 500-1000 kcal/d in participants with overweight while maintaining a stable carbohydrate intake.
• The primary clinical outcomes were insulin requirement (total daily dose of insulin), insulin sensitivity, and glycemic control (A1c).
• Other assessments included the blood, lipid profile, blood urea nitrogen, blood urea nitrogen-to-creatinine ratio, and body weight.

TAKEAWAY:

• The study was completed by 18 participants in the vegan-diet group and 17 in the portion-controlled group.
• In the vegan group, the total daily dose of insulin decreased by 12.1 units/d (P = .007) and insulin sensitivity increased by 6.6 g of carbohydrate per unit of insulin on average (P = .002), with no significant changes in the portion-controlled diet group.
• Participants on the vegan diet had lower levels of total and low-density lipoprotein cholesterol and blood urea nitrogen and a lower blood urea nitrogen-to-creatinine ratio (P for all < .001), whereas both vegan and portion-controlled groups had lower A1c levels.
• Body weight decreased by 5.2 kg (P < .001) in the vegan group; there were no significant changes in the portion-controlled group.
• For every 1-kg weight loss, there was a 2.16-unit decrease in the insulin total daily dose and a 0.9-unit increase in insulin sensitivity.

IN PRACTICE:

“This study provides substantial support for a low-fat vegan diet that is high in fiber and carbohydrates, low in fat, and moderate in protein” and suggests the potential therapeutic use of this diet in type 1 diabetes management, the authors wrote.

SOURCE:

The study led by Hana Kahleova, MD, PhD, Physicians Committee for Responsible Medicine, Washington, was published in Clinical Diabetes.

LIMITATIONS:

Dietary intake was recorded on the basis of self-reported data. A higher attrition rate was observed due to meal and blood glucose monitoring. The findings may have limited generalizability as the study participants comprised those seeking help for T1D.

DISCLOSURES:

The study was supported by the Physicians Committee for Responsible Medicine and a grant from the Institute for Technology in Healthcare. Some authors reported receiving compensation, being cofounders of a coaching program, writing books, providing nutrition coaching, giving lectures, or receiving royalties and honoraria from various sources.

A version of this article appeared on Medscape.com.

TOPLINE:

A low-fat vegan diet — high in fiber and carbohydrates and moderate in protein — reduces insulin requirement, increases insulin sensitivity, and improves glycemic control in individuals with type 1 diabetes (T1D) compared with a conventional portion-controlled diet.

METHODOLOGY:

• The effects of a low-fat vegan diet (without carbohydrate or portion restriction) were compared with those of a conventional portion-controlled, carbohydrate-controlled diet in 58 patients with T1D (age, ≥ 18 years) who had been receiving stable insulin treatment for the past 3 months.
• Participants were randomly assigned to receive either the vegan diet (n = 29), comprising vegetables, grains, legumes, and fruits, or the portion-controlled diet (n = 29), which reduced daily energy intake by 500-1000 kcal/d in participants with overweight while maintaining a stable carbohydrate intake.
• The primary clinical outcomes were insulin requirement (total daily dose of insulin), insulin sensitivity, and glycemic control (A1c).
• Other assessments included the blood, lipid profile, blood urea nitrogen, blood urea nitrogen-to-creatinine ratio, and body weight.

TAKEAWAY:

• The study was completed by 18 participants in the vegan-diet group and 17 in the portion-controlled group.
• In the vegan group, the total daily dose of insulin decreased by 12.1 units/d (P = .007) and insulin sensitivity increased by 6.6 g of carbohydrate per unit of insulin on average (P = .002), with no significant changes in the portion-controlled diet group.
• Participants on the vegan diet had lower levels of total and low-density lipoprotein cholesterol and blood urea nitrogen and a lower blood urea nitrogen-to-creatinine ratio (P for all < .001), whereas both vegan and portion-controlled groups had lower A1c levels.
• Body weight decreased by 5.2 kg (P < .001) in the vegan group; there were no significant changes in the portion-controlled group.
• For every 1-kg weight loss, there was a 2.16-unit decrease in the insulin total daily dose and a 0.9-unit increase in insulin sensitivity.

IN PRACTICE:

“This study provides substantial support for a low-fat vegan diet that is high in fiber and carbohydrates, low in fat, and moderate in protein” and suggests the potential therapeutic use of this diet in type 1 diabetes management, the authors wrote.

SOURCE:

The study led by Hana Kahleova, MD, PhD, Physicians Committee for Responsible Medicine, Washington, was published in Clinical Diabetes.

LIMITATIONS:

Dietary intake was recorded on the basis of self-reported data. A higher attrition rate was observed due to meal and blood glucose monitoring. The findings may have limited generalizability as the study participants comprised those seeking help for T1D.

DISCLOSURES:

The study was supported by the Physicians Committee for Responsible Medicine and a grant from the Institute for Technology in Healthcare. Some authors reported receiving compensation, being cofounders of a coaching program, writing books, providing nutrition coaching, giving lectures, or receiving royalties and honoraria from various sources.

A version of this article appeared on Medscape.com.

TOPLINE:

A low-fat vegan diet — high in fiber and carbohydrates and moderate in protein — reduces insulin requirement, increases insulin sensitivity, and improves glycemic control in individuals with type 1 diabetes (T1D) compared with a conventional portion-controlled diet.

METHODOLOGY:

• The effects of a low-fat vegan diet (without carbohydrate or portion restriction) were compared with those of a conventional portion-controlled, carbohydrate-controlled diet in 58 patients with T1D (age, ≥ 18 years) who had been receiving stable insulin treatment for the past 3 months.
• Participants were randomly assigned to receive either the vegan diet (n = 29), comprising vegetables, grains, legumes, and fruits, or the portion-controlled diet (n = 29), which reduced daily energy intake by 500-1000 kcal/d in participants with overweight while maintaining a stable carbohydrate intake.
• The primary clinical outcomes were insulin requirement (total daily dose of insulin), insulin sensitivity, and glycemic control (A1c).
• Other assessments included the blood, lipid profile, blood urea nitrogen, blood urea nitrogen-to-creatinine ratio, and body weight.

TAKEAWAY:

• The study was completed by 18 participants in the vegan-diet group and 17 in the portion-controlled group.
• In the vegan group, the total daily dose of insulin decreased by 12.1 units/d (P = .007) and insulin sensitivity increased by 6.6 g of carbohydrate per unit of insulin on average (P = .002), with no significant changes in the portion-controlled diet group.
• Participants on the vegan diet had lower levels of total and low-density lipoprotein cholesterol and blood urea nitrogen and a lower blood urea nitrogen-to-creatinine ratio (P for all < .001), whereas both vegan and portion-controlled groups had lower A1c levels.
• Body weight decreased by 5.2 kg (P < .001) in the vegan group; there were no significant changes in the portion-controlled group.
• For every 1-kg weight loss, there was a 2.16-unit decrease in the insulin total daily dose and a 0.9-unit increase in insulin sensitivity.

IN PRACTICE:

“This study provides substantial support for a low-fat vegan diet that is high in fiber and carbohydrates, low in fat, and moderate in protein” and suggests the potential therapeutic use of this diet in type 1 diabetes management, the authors wrote.

SOURCE:

The study led by Hana Kahleova, MD, PhD, Physicians Committee for Responsible Medicine, Washington, was published in Clinical Diabetes.

LIMITATIONS:

Dietary intake was recorded on the basis of self-reported data. A higher attrition rate was observed due to meal and blood glucose monitoring. The findings may have limited generalizability as the study participants comprised those seeking help for T1D.

DISCLOSURES:

The study was supported by the Physicians Committee for Responsible Medicine and a grant from the Institute for Technology in Healthcare. Some authors reported receiving compensation, being cofounders of a coaching program, writing books, providing nutrition coaching, giving lectures, or receiving royalties and honoraria from various sources.

A version of this article appeared on Medscape.com.

In a 2023 study published in the Annals of Emergency Medicine, European researchers fed the AI system ChatGPT information on 30 ER patients. Details included physician notes on the patients’ symptoms, physical exams, and lab results. ChatGPT made the correct diagnosis in 97% of patients compared to 87% for human doctors.

AI 1, Physicians 0

JAMA Cardiology reported in 2021 that an AI trained on nearly a million ECGs performed comparably to or exceeded cardiologist clinical diagnoses and the MUSE (GE Healthcare) system›s automated ECG analysis for most diagnostic classes.

AI 2, Physicians 0

Google’s medically focused AI model (Med-PaLM2) scored 85%+ when answering US Medical Licensing Examination–style questions. That›s an «expert» physician level and far beyond the accuracy threshold needed to pass the actual exam.

AI 3, Physicians 0

A new AI tool that uses an online finger-tapping test outperformed primary care physicians when assessing the severity of Parkinson’s disease.

AI 4, Physicians 0

JAMA Ophthalmology reported in 2024 that a chatbot outperformed glaucoma specialists and matched retina specialists in diagnostic and treatment accuracy.

AI 5, Physicians 0

Should we stop? Because we could go on. In the last few years, these AI vs Physician studies have proliferated, and guess who’s winning?

65% of Doctors are Concerned

Now, the standard answer with anything AI-and-Medicine goes something like this: AI is coming, and it will be a transformative tool for physicians and improve patient care.

But the underlying unanswered question is: Physicians spend many years and a lot of money to become really good at what they do. How, exactly, should a doctor feel about a machine that can suddenly do the job better and faster?

The Medscape 2023 Physician and AI Report surveyed 1043 US physicians about their views on AI. In total, 65% are concerned about AI making diagnosis and treatment decisions, but 56% are enthusiastic about having it as an adjunct.

Cardiologists, anesthesiologists, and radiologists are most enthusiastic about AI, whereas family physicians and pediatricians are the least enthusiastic.

To get a more personal view of how physicians and other healthcare professionals are feeling about this transformative tech, I spoke with a variety of practicing doctors, a psychotherapist, and a third-year Harvard Medical School student.

‘Abysmally Poor Understanding’

Alfredo A. Sadun, MD, PhD, has been a neuro-ophthalmologist for nearly 50 years. A graduate of MIT and vice-chair of ophthalmology at UCLA, he’s long been fascinated by AI’s march into medicine. He’s watched it accomplish things that no ophthalmologist can do, such as identify gender, age, and risk for heart attack and stroke from retinal scans. But he doesn›t see the same level of interest and comprehension among the medical community.

“There’s still an abysmally poor understanding of AI among physicians in general,” he said. “It’s striking because these are intelligent, well-educated people. But we tend to draw conclusions based on what we’re familiar with, and most doctors’ experience with computers involves EHRs [electronic health records] and administrative garbage. It’s the reason they’re burning out.”

Easing the Burden

Anthony Philippakis, MD, PhD, left his cardiology practice in 2015 to become the chief data officer at the Broad Institute of MIT and Harvard. While there, he helped develop an AI-based method for identifying patients at risk for atrial fibrillation. Now, he’s a general partner at Google Ventures with the goal of bridging the gap between data sciences and medicine. His perspective on AI is unique, given that he’s seen the issue from both sides.

“I am not a bitter physician, but to be honest, when I was practicing, way too much of my time was spent staring at screens and not enough laying hands on patients,” he said. “Can you imagine what it would be like to speak to the EHR naturally and say, ‘Please order the following labs for this patient and notify me when the results come in.’ Boy, would that improve healthcare and physician satisfaction. Every physician I know is excited and optimistic about that. Almost everyone I’ve talked to feels like AI could take a lot of the stuff they don’t like doing off their plates.”

Indeed, the dividing line between physician support for AI and physician suspicion or skepticism of AI is just that. In our survey, more than three quarters of physicians said they would consider using AI for office administrative tasks, scheduling, EHRs, researching medical conditions, and even summarizing a patient’s record before a visit. But far fewer are supportive of it delivering diagnoses and treatments. This, despite an estimated 800,000 Americans dying or becoming permanently disabled each year because of diagnostic error.

Could AI Have Diagnosed This?

John D. Nuschke, MD, has been a primary care physician in Allentown, Pennsylvania, for 40 years. He’s a jovial general physician who insists his patients call him Jack. He’s recently started using an AI medical scribe called Freed. With the patient’s permission, it listens in on the visit and generates notes, saving Dr. Nuschke time and helping him focus on the person. He likes that type of assistance, but when it comes to AI replacing him, he’s skeptical.

“I had this patient I diagnosed with prostate cancer,” he explained. “He got treated and was fine for 5 years. Then, he started losing weight and feeling awful — got weak as a kitten. He went back to his urologist and oncologist who thought he had metastatic prostate cancer. He went through PET scans and blood work, but there was no sign his cancer had returned. So the specialists sent him back to me, and the second he walked in, I saw he was floridly hyperthyroid. I could tell across the room just by looking at him. Would AI have been able to make that diagnosis? Does AI do physical exams?”

Dr. Nuschke said he’s also had several instances where patients received their cancer diagnosis from the lab through an automated patient-portal system rather than from him. “That’s an AI of sorts, and I found it distressing,” he said.

Empathy From a Robot

All the doctors I spoke to were hopeful that by freeing them from the burden of administrative work, they would be able to return to the reason they got into this business in the first place — to spend more time with patients in need and support them with grace and compassion.

But suppose AI could do that too?

In a 2023 study conducted at the University of California San Diego and published in JAMA Internal Medicine, three licensed healthcare professionals compared the responses of ChatGPT and physicians to real-world health questions. The panel rated the AI’s answers nearly four times higher in quality and almost 10 times more empathetic than physicians’ replies.

A similar 2024 study in Nature found that Google’s large-language model AI matched or surpassed physician diagnostic accuracy in all six of the medical specialties considered. Plus, it outperformed doctors in 24 of 26 criteria for conversation quality, including politeness, explanation, honesty, and expressing care and commitment.

Nathaniel Chin, MD, is a gerontologist at the University of Wisconsin and advisory board member for the Alzheimer’s Foundation of America. Although he admits that studies like these “sadden me,” he’s also a realist. “There was hesitation among physicians at the beginning of the pandemic to virtual care because we missed the human connection,” he explained, “but we worked our way around that. We need to remember that what makes a chatbot strong is that it’s nothuman. It doesn’t burn out, it doesn’t get tired, it can look at data very quickly, and it doesn’t have to go home to a family and try to balance work with other aspects of life. A human being is very complex, whereas a chatbot has one single purpose.”

“Even if you don’t have AI in your space now or don’t like the idea of it, that doesn’t matter,” he added. “It’s coming. But it needs to be done right. If AI is implemented by clinicians for clinicians, it has great potential. But if it’s implemented by businesspeople for business reasons, perhaps not.”

‘The Ones Who Use the Tools the Best Will Be the Best’

One branch of medicine that stands to be dramatically affected by AI is mental health. Because bots are natural data-crunchers, they are becoming adept at analyzing the many subtle clues (phrasing in social media posts and text messages, smartwatch biometrics, therapy session videos…) that could indicate depression or other psychological disorders. In fact, its availability via smartphone apps could help democratize and destigmatize the practice.

“There is a day ahead — probably within 5 years — when a patient won’t be able to tell the difference between a real therapist and an AI therapist,” said Ken Mallon, MS, LMFT, a clinical psychotherapist and data scientist in San Jose, California. “That doesn’t worry me, though. It’s hard on therapists’ egos, but new technologies get developed. Things change. People who embrace these tools will benefit from them. The ones who use the tools the best will be the best.”

Time to Restructure Med School

Aditya Jain is in his third year at Harvard Medical School. At age 24, he’s heading into this brave new medical world with excitement and anxiety. Excitement because he sees AI revolutionizing healthcare on every level. Although the current generations of physicians and patients may grumble about its onset, he believes younger ones will feel comfortable with “DocGPT.” He’s excited that his generation of physicians will be the “translators and managers of this transition” and redefine “what it means to be a doctor.”

His anxiety, however, stems from the fact that AI has come on so fast that “it has not yet crossed the threshold of medical education,” he said. “Medical schools still largely prepare students to work as solo clinical decision makers. Most of my first 2 years were spent on pattern recognition and rote memorization, skills that AI can and will master.”

Indeed, Mr. Jain said AI was not a part of his first- or second-year curriculum. “I talk to students who are a year older than me, graduating, heading to residency, and they tell me they wish they had gotten a better grasp of how to use these technologies in medicine and in their practice. They were surprised to hear that people in my year hadn’t started using ChatGPT. We need to expend a lot more effort within the field, within academia, within practicing physicians, to figure out what our role will be in a world where AI is matching or even exceeding human intelligence. And then we need to restructure the medical education to better accomplish these goals.”

So Are You Ready for AI to Be a Better Doctor Than You?

“Yes, I am,” said Dr. Philippakis without hesitation. “When I was going through my medical training, I was continually confronted with the reality that I personally was not smart enough to keep all the information in my head that could be used to make a good decision for a patient. We have now reached a point where the amount of information that is important and useful in the practice of medicine outstrips what a human being can know. The opportunity to enable physicians with AI to remedy that situation is a good thing for doctors and, most importantly, a good thing for patients. I believe the future of medicine belongs not so much to the AI practitioner but to the AI-enabled practitioner.”

“Quick story,” added Dr. Chin. “I asked ChatGPT two questions. The first was ‘Explain the difference between Alzheimer’s and dementia’ because that’s the most common misconception in my field. And it gave me a pretty darn good answer — one I would use in a presentation with some tweaking. Then I asked it, ‘Are you a better doctor than me?’ And it replied, ‘My purpose is not to replace you, my purpose is to be supportive of you and enhance your ability.’ ”

A version of this article appeared on Medscape.com.

In a 2023 study published in the Annals of Emergency Medicine, European researchers fed the AI system ChatGPT information on 30 ER patients. Details included physician notes on the patients’ symptoms, physical exams, and lab results. ChatGPT made the correct diagnosis in 97% of patients compared to 87% for human doctors.

AI 1, Physicians 0

JAMA Cardiology reported in 2021 that an AI trained on nearly a million ECGs performed comparably to or exceeded cardiologist clinical diagnoses and the MUSE (GE Healthcare) system›s automated ECG analysis for most diagnostic classes.

AI 2, Physicians 0

Google’s medically focused AI model (Med-PaLM2) scored 85%+ when answering US Medical Licensing Examination–style questions. That›s an «expert» physician level and far beyond the accuracy threshold needed to pass the actual exam.

AI 3, Physicians 0

A new AI tool that uses an online finger-tapping test outperformed primary care physicians when assessing the severity of Parkinson’s disease.

AI 4, Physicians 0

JAMA Ophthalmology reported in 2024 that a chatbot outperformed glaucoma specialists and matched retina specialists in diagnostic and treatment accuracy.

AI 5, Physicians 0

Should we stop? Because we could go on. In the last few years, these AI vs Physician studies have proliferated, and guess who’s winning?

65% of Doctors are Concerned

Now, the standard answer with anything AI-and-Medicine goes something like this: AI is coming, and it will be a transformative tool for physicians and improve patient care.

But the underlying unanswered question is: Physicians spend many years and a lot of money to become really good at what they do. How, exactly, should a doctor feel about a machine that can suddenly do the job better and faster?

The Medscape 2023 Physician and AI Report surveyed 1043 US physicians about their views on AI. In total, 65% are concerned about AI making diagnosis and treatment decisions, but 56% are enthusiastic about having it as an adjunct.

Cardiologists, anesthesiologists, and radiologists are most enthusiastic about AI, whereas family physicians and pediatricians are the least enthusiastic.

To get a more personal view of how physicians and other healthcare professionals are feeling about this transformative tech, I spoke with a variety of practicing doctors, a psychotherapist, and a third-year Harvard Medical School student.

‘Abysmally Poor Understanding’

Alfredo A. Sadun, MD, PhD, has been a neuro-ophthalmologist for nearly 50 years. A graduate of MIT and vice-chair of ophthalmology at UCLA, he’s long been fascinated by AI’s march into medicine. He’s watched it accomplish things that no ophthalmologist can do, such as identify gender, age, and risk for heart attack and stroke from retinal scans. But he doesn›t see the same level of interest and comprehension among the medical community.

“There’s still an abysmally poor understanding of AI among physicians in general,” he said. “It’s striking because these are intelligent, well-educated people. But we tend to draw conclusions based on what we’re familiar with, and most doctors’ experience with computers involves EHRs [electronic health records] and administrative garbage. It’s the reason they’re burning out.”

Easing the Burden

Anthony Philippakis, MD, PhD, left his cardiology practice in 2015 to become the chief data officer at the Broad Institute of MIT and Harvard. While there, he helped develop an AI-based method for identifying patients at risk for atrial fibrillation. Now, he’s a general partner at Google Ventures with the goal of bridging the gap between data sciences and medicine. His perspective on AI is unique, given that he’s seen the issue from both sides.

“I am not a bitter physician, but to be honest, when I was practicing, way too much of my time was spent staring at screens and not enough laying hands on patients,” he said. “Can you imagine what it would be like to speak to the EHR naturally and say, ‘Please order the following labs for this patient and notify me when the results come in.’ Boy, would that improve healthcare and physician satisfaction. Every physician I know is excited and optimistic about that. Almost everyone I’ve talked to feels like AI could take a lot of the stuff they don’t like doing off their plates.”

Indeed, the dividing line between physician support for AI and physician suspicion or skepticism of AI is just that. In our survey, more than three quarters of physicians said they would consider using AI for office administrative tasks, scheduling, EHRs, researching medical conditions, and even summarizing a patient’s record before a visit. But far fewer are supportive of it delivering diagnoses and treatments. This, despite an estimated 800,000 Americans dying or becoming permanently disabled each year because of diagnostic error.

Could AI Have Diagnosed This?

John D. Nuschke, MD, has been a primary care physician in Allentown, Pennsylvania, for 40 years. He’s a jovial general physician who insists his patients call him Jack. He’s recently started using an AI medical scribe called Freed. With the patient’s permission, it listens in on the visit and generates notes, saving Dr. Nuschke time and helping him focus on the person. He likes that type of assistance, but when it comes to AI replacing him, he’s skeptical.

“I had this patient I diagnosed with prostate cancer,” he explained. “He got treated and was fine for 5 years. Then, he started losing weight and feeling awful — got weak as a kitten. He went back to his urologist and oncologist who thought he had metastatic prostate cancer. He went through PET scans and blood work, but there was no sign his cancer had returned. So the specialists sent him back to me, and the second he walked in, I saw he was floridly hyperthyroid. I could tell across the room just by looking at him. Would AI have been able to make that diagnosis? Does AI do physical exams?”

Dr. Nuschke said he’s also had several instances where patients received their cancer diagnosis from the lab through an automated patient-portal system rather than from him. “That’s an AI of sorts, and I found it distressing,” he said.

Empathy From a Robot

All the doctors I spoke to were hopeful that by freeing them from the burden of administrative work, they would be able to return to the reason they got into this business in the first place — to spend more time with patients in need and support them with grace and compassion.

But suppose AI could do that too?

In a 2023 study conducted at the University of California San Diego and published in JAMA Internal Medicine, three licensed healthcare professionals compared the responses of ChatGPT and physicians to real-world health questions. The panel rated the AI’s answers nearly four times higher in quality and almost 10 times more empathetic than physicians’ replies.

A similar 2024 study in Nature found that Google’s large-language model AI matched or surpassed physician diagnostic accuracy in all six of the medical specialties considered. Plus, it outperformed doctors in 24 of 26 criteria for conversation quality, including politeness, explanation, honesty, and expressing care and commitment.

Nathaniel Chin, MD, is a gerontologist at the University of Wisconsin and advisory board member for the Alzheimer’s Foundation of America. Although he admits that studies like these “sadden me,” he’s also a realist. “There was hesitation among physicians at the beginning of the pandemic to virtual care because we missed the human connection,” he explained, “but we worked our way around that. We need to remember that what makes a chatbot strong is that it’s nothuman. It doesn’t burn out, it doesn’t get tired, it can look at data very quickly, and it doesn’t have to go home to a family and try to balance work with other aspects of life. A human being is very complex, whereas a chatbot has one single purpose.”

“Even if you don’t have AI in your space now or don’t like the idea of it, that doesn’t matter,” he added. “It’s coming. But it needs to be done right. If AI is implemented by clinicians for clinicians, it has great potential. But if it’s implemented by businesspeople for business reasons, perhaps not.”

‘The Ones Who Use the Tools the Best Will Be the Best’

One branch of medicine that stands to be dramatically affected by AI is mental health. Because bots are natural data-crunchers, they are becoming adept at analyzing the many subtle clues (phrasing in social media posts and text messages, smartwatch biometrics, therapy session videos…) that could indicate depression or other psychological disorders. In fact, its availability via smartphone apps could help democratize and destigmatize the practice.

“There is a day ahead — probably within 5 years — when a patient won’t be able to tell the difference between a real therapist and an AI therapist,” said Ken Mallon, MS, LMFT, a clinical psychotherapist and data scientist in San Jose, California. “That doesn’t worry me, though. It’s hard on therapists’ egos, but new technologies get developed. Things change. People who embrace these tools will benefit from them. The ones who use the tools the best will be the best.”

Time to Restructure Med School

Aditya Jain is in his third year at Harvard Medical School. At age 24, he’s heading into this brave new medical world with excitement and anxiety. Excitement because he sees AI revolutionizing healthcare on every level. Although the current generations of physicians and patients may grumble about its onset, he believes younger ones will feel comfortable with “DocGPT.” He’s excited that his generation of physicians will be the “translators and managers of this transition” and redefine “what it means to be a doctor.”

His anxiety, however, stems from the fact that AI has come on so fast that “it has not yet crossed the threshold of medical education,” he said. “Medical schools still largely prepare students to work as solo clinical decision makers. Most of my first 2 years were spent on pattern recognition and rote memorization, skills that AI can and will master.”

Indeed, Mr. Jain said AI was not a part of his first- or second-year curriculum. “I talk to students who are a year older than me, graduating, heading to residency, and they tell me they wish they had gotten a better grasp of how to use these technologies in medicine and in their practice. They were surprised to hear that people in my year hadn’t started using ChatGPT. We need to expend a lot more effort within the field, within academia, within practicing physicians, to figure out what our role will be in a world where AI is matching or even exceeding human intelligence. And then we need to restructure the medical education to better accomplish these goals.”

So Are You Ready for AI to Be a Better Doctor Than You?

“Yes, I am,” said Dr. Philippakis without hesitation. “When I was going through my medical training, I was continually confronted with the reality that I personally was not smart enough to keep all the information in my head that could be used to make a good decision for a patient. We have now reached a point where the amount of information that is important and useful in the practice of medicine outstrips what a human being can know. The opportunity to enable physicians with AI to remedy that situation is a good thing for doctors and, most importantly, a good thing for patients. I believe the future of medicine belongs not so much to the AI practitioner but to the AI-enabled practitioner.”

“Quick story,” added Dr. Chin. “I asked ChatGPT two questions. The first was ‘Explain the difference between Alzheimer’s and dementia’ because that’s the most common misconception in my field. And it gave me a pretty darn good answer — one I would use in a presentation with some tweaking. Then I asked it, ‘Are you a better doctor than me?’ And it replied, ‘My purpose is not to replace you, my purpose is to be supportive of you and enhance your ability.’ ”

A version of this article appeared on Medscape.com.

In a 2023 study published in the Annals of Emergency Medicine, European researchers fed the AI system ChatGPT information on 30 ER patients. Details included physician notes on the patients’ symptoms, physical exams, and lab results. ChatGPT made the correct diagnosis in 97% of patients compared to 87% for human doctors.

AI 1, Physicians 0

JAMA Cardiology reported in 2021 that an AI trained on nearly a million ECGs performed comparably to or exceeded cardiologist clinical diagnoses and the MUSE (GE Healthcare) system›s automated ECG analysis for most diagnostic classes.

AI 2, Physicians 0

Google’s medically focused AI model (Med-PaLM2) scored 85%+ when answering US Medical Licensing Examination–style questions. That›s an «expert» physician level and far beyond the accuracy threshold needed to pass the actual exam.

AI 3, Physicians 0

A new AI tool that uses an online finger-tapping test outperformed primary care physicians when assessing the severity of Parkinson’s disease.

AI 4, Physicians 0

JAMA Ophthalmology reported in 2024 that a chatbot outperformed glaucoma specialists and matched retina specialists in diagnostic and treatment accuracy.

AI 5, Physicians 0

Should we stop? Because we could go on. In the last few years, these AI vs Physician studies have proliferated, and guess who’s winning?

65% of Doctors are Concerned

Now, the standard answer with anything AI-and-Medicine goes something like this: AI is coming, and it will be a transformative tool for physicians and improve patient care.

But the underlying unanswered question is: Physicians spend many years and a lot of money to become really good at what they do. How, exactly, should a doctor feel about a machine that can suddenly do the job better and faster?

The Medscape 2023 Physician and AI Report surveyed 1043 US physicians about their views on AI. In total, 65% are concerned about AI making diagnosis and treatment decisions, but 56% are enthusiastic about having it as an adjunct.

Cardiologists, anesthesiologists, and radiologists are most enthusiastic about AI, whereas family physicians and pediatricians are the least enthusiastic.

To get a more personal view of how physicians and other healthcare professionals are feeling about this transformative tech, I spoke with a variety of practicing doctors, a psychotherapist, and a third-year Harvard Medical School student.

‘Abysmally Poor Understanding’

Alfredo A. Sadun, MD, PhD, has been a neuro-ophthalmologist for nearly 50 years. A graduate of MIT and vice-chair of ophthalmology at UCLA, he’s long been fascinated by AI’s march into medicine. He’s watched it accomplish things that no ophthalmologist can do, such as identify gender, age, and risk for heart attack and stroke from retinal scans. But he doesn›t see the same level of interest and comprehension among the medical community.

“There’s still an abysmally poor understanding of AI among physicians in general,” he said. “It’s striking because these are intelligent, well-educated people. But we tend to draw conclusions based on what we’re familiar with, and most doctors’ experience with computers involves EHRs [electronic health records] and administrative garbage. It’s the reason they’re burning out.”

Easing the Burden

Anthony Philippakis, MD, PhD, left his cardiology practice in 2015 to become the chief data officer at the Broad Institute of MIT and Harvard. While there, he helped develop an AI-based method for identifying patients at risk for atrial fibrillation. Now, he’s a general partner at Google Ventures with the goal of bridging the gap between data sciences and medicine. His perspective on AI is unique, given that he’s seen the issue from both sides.

“I am not a bitter physician, but to be honest, when I was practicing, way too much of my time was spent staring at screens and not enough laying hands on patients,” he said. “Can you imagine what it would be like to speak to the EHR naturally and say, ‘Please order the following labs for this patient and notify me when the results come in.’ Boy, would that improve healthcare and physician satisfaction. Every physician I know is excited and optimistic about that. Almost everyone I’ve talked to feels like AI could take a lot of the stuff they don’t like doing off their plates.”

Indeed, the dividing line between physician support for AI and physician suspicion or skepticism of AI is just that. In our survey, more than three quarters of physicians said they would consider using AI for office administrative tasks, scheduling, EHRs, researching medical conditions, and even summarizing a patient’s record before a visit. But far fewer are supportive of it delivering diagnoses and treatments. This, despite an estimated 800,000 Americans dying or becoming permanently disabled each year because of diagnostic error.

Could AI Have Diagnosed This?

John D. Nuschke, MD, has been a primary care physician in Allentown, Pennsylvania, for 40 years. He’s a jovial general physician who insists his patients call him Jack. He’s recently started using an AI medical scribe called Freed. With the patient’s permission, it listens in on the visit and generates notes, saving Dr. Nuschke time and helping him focus on the person. He likes that type of assistance, but when it comes to AI replacing him, he’s skeptical.

“I had this patient I diagnosed with prostate cancer,” he explained. “He got treated and was fine for 5 years. Then, he started losing weight and feeling awful — got weak as a kitten. He went back to his urologist and oncologist who thought he had metastatic prostate cancer. He went through PET scans and blood work, but there was no sign his cancer had returned. So the specialists sent him back to me, and the second he walked in, I saw he was floridly hyperthyroid. I could tell across the room just by looking at him. Would AI have been able to make that diagnosis? Does AI do physical exams?”

Dr. Nuschke said he’s also had several instances where patients received their cancer diagnosis from the lab through an automated patient-portal system rather than from him. “That’s an AI of sorts, and I found it distressing,” he said.

Empathy From a Robot

All the doctors I spoke to were hopeful that by freeing them from the burden of administrative work, they would be able to return to the reason they got into this business in the first place — to spend more time with patients in need and support them with grace and compassion.

But suppose AI could do that too?

In a 2023 study conducted at the University of California San Diego and published in JAMA Internal Medicine, three licensed healthcare professionals compared the responses of ChatGPT and physicians to real-world health questions. The panel rated the AI’s answers nearly four times higher in quality and almost 10 times more empathetic than physicians’ replies.

A similar 2024 study in Nature found that Google’s large-language model AI matched or surpassed physician diagnostic accuracy in all six of the medical specialties considered. Plus, it outperformed doctors in 24 of 26 criteria for conversation quality, including politeness, explanation, honesty, and expressing care and commitment.

Nathaniel Chin, MD, is a gerontologist at the University of Wisconsin and advisory board member for the Alzheimer’s Foundation of America. Although he admits that studies like these “sadden me,” he’s also a realist. “There was hesitation among physicians at the beginning of the pandemic to virtual care because we missed the human connection,” he explained, “but we worked our way around that. We need to remember that what makes a chatbot strong is that it’s nothuman. It doesn’t burn out, it doesn’t get tired, it can look at data very quickly, and it doesn’t have to go home to a family and try to balance work with other aspects of life. A human being is very complex, whereas a chatbot has one single purpose.”

“Even if you don’t have AI in your space now or don’t like the idea of it, that doesn’t matter,” he added. “It’s coming. But it needs to be done right. If AI is implemented by clinicians for clinicians, it has great potential. But if it’s implemented by businesspeople for business reasons, perhaps not.”

‘The Ones Who Use the Tools the Best Will Be the Best’

One branch of medicine that stands to be dramatically affected by AI is mental health. Because bots are natural data-crunchers, they are becoming adept at analyzing the many subtle clues (phrasing in social media posts and text messages, smartwatch biometrics, therapy session videos…) that could indicate depression or other psychological disorders. In fact, its availability via smartphone apps could help democratize and destigmatize the practice.

“There is a day ahead — probably within 5 years — when a patient won’t be able to tell the difference between a real therapist and an AI therapist,” said Ken Mallon, MS, LMFT, a clinical psychotherapist and data scientist in San Jose, California. “That doesn’t worry me, though. It’s hard on therapists’ egos, but new technologies get developed. Things change. People who embrace these tools will benefit from them. The ones who use the tools the best will be the best.”

Time to Restructure Med School

Aditya Jain is in his third year at Harvard Medical School. At age 24, he’s heading into this brave new medical world with excitement and anxiety. Excitement because he sees AI revolutionizing healthcare on every level. Although the current generations of physicians and patients may grumble about its onset, he believes younger ones will feel comfortable with “DocGPT.” He’s excited that his generation of physicians will be the “translators and managers of this transition” and redefine “what it means to be a doctor.”

His anxiety, however, stems from the fact that AI has come on so fast that “it has not yet crossed the threshold of medical education,” he said. “Medical schools still largely prepare students to work as solo clinical decision makers. Most of my first 2 years were spent on pattern recognition and rote memorization, skills that AI can and will master.”

Indeed, Mr. Jain said AI was not a part of his first- or second-year curriculum. “I talk to students who are a year older than me, graduating, heading to residency, and they tell me they wish they had gotten a better grasp of how to use these technologies in medicine and in their practice. They were surprised to hear that people in my year hadn’t started using ChatGPT. We need to expend a lot more effort within the field, within academia, within practicing physicians, to figure out what our role will be in a world where AI is matching or even exceeding human intelligence. And then we need to restructure the medical education to better accomplish these goals.”

So Are You Ready for AI to Be a Better Doctor Than You?

“Yes, I am,” said Dr. Philippakis without hesitation. “When I was going through my medical training, I was continually confronted with the reality that I personally was not smart enough to keep all the information in my head that could be used to make a good decision for a patient. We have now reached a point where the amount of information that is important and useful in the practice of medicine outstrips what a human being can know. The opportunity to enable physicians with AI to remedy that situation is a good thing for doctors and, most importantly, a good thing for patients. I believe the future of medicine belongs not so much to the AI practitioner but to the AI-enabled practitioner.”

“Quick story,” added Dr. Chin. “I asked ChatGPT two questions. The first was ‘Explain the difference between Alzheimer’s and dementia’ because that’s the most common misconception in my field. And it gave me a pretty darn good answer — one I would use in a presentation with some tweaking. Then I asked it, ‘Are you a better doctor than me?’ And it replied, ‘My purpose is not to replace you, my purpose is to be supportive of you and enhance your ability.’ ”

A version of this article appeared on Medscape.com.