Manasi Talwadekar

TOPLINE:

Monthly cycles of a fasting-mimicking diet (FMD) may slow metabolic and immune system aging and reduce the risk for metabolic disease.

METHODOLOGY:

• In two clinical trials, monthly 5-day cycles of an FMD (a proprietary line of plant-based, low-calorie, and low-protein food products) showed lower body weight, body fat, and blood pressure at 3 months.
• Researchers assessed secondary outcomes for the impact of the diet on risk factors for metabolic syndrome and biomarkers associated with aging and age-related diseases.
• This study looked at data from nearly half of the original 184 participants (aged 18-70 years) from the two clinical trials who went through three to four monthly cycles, adhering to 5 days of an FMD in either a crossover design compared with a normal diet or an intervention group compared with people following a Mediterranean diet.
• Abdominal fat and hepatic fat were measured using an MRI in a subset of representative participants. The study also assessed metabolic blood markers and lipids and lymphoid-to-myeloid ratios (for immune aging).
• Biological age estimation was calculated from seven clinical chemistry measures, and life expectancy and mortality risk estimates and a simulation of continued FMD cycles were based on the National Health and Nutrition Examination Survey.

TAKEAWAY:

• In 15 volunteers measured by MRI, the body mass index (P = .0002), total body fat (P = .002), subcutaneous adipose tissue (P = .008), visceral adipose tissue (P = .002), and hepatic fat fraction (P = .049) reduced after the third FMD cycle, with a 50% reduction in liver fat for the five people with hepatic steatosis.
• In 11 participants with prediabetes, insulin resistance (measured by homeostatic model assessment) reduced from 1.473 to 1.209 (P = .046), while A1c levels dropped from 5.8 to 5.43 (P = .032) after the third FMD cycle.

• The lymphoid-to-myeloid ratio improved (P = .005) in all study participants receiving three FMD cycles, indicating an immune aging reversal.
• The estimated median biological age of the 86 participants who completed three FMD cycles in both trials decreased by nearly 2.5 years, independent of weight loss.

IN PRACTICE:

“Together our findings indicate that the FMD is a feasible periodic dietary intervention that reduces disease risk factors and biological age,” the authors wrote.

SOURCE:

The study, led by Sebastian Brandhorst, PhD, Leonard Davis School of Gerontology, University of Southern California (USC), Los Angeles, and Morgan E. Levine, PhD, Department of Pathology, Yale School of Medicine, New Haven, Connecticut, was published in Nature Communications.

LIMITATIONS:

The study estimated the effects of monthly FMD cycles based on results from two clinical trials and included a small subset of trial volunteers. By study measures, the cohort was healthier and biologically younger than average people of similar chronological age. Of the 86 participants, 24 who underwent FMD cycles exhibited increased biological age. The simulation did not consider compliance, dropout, mortality, or the bias that may arise owing to enthusiastic volunteers. Estimated risk reductions assume an effect of change in biological age, which hasn’t been proven. Projections from extending the effects of FMD to a lifelong intervention may require cautious interpretation.

DISCLOSURES:

The study was supported by the USC Edna Jones chair fund and funds from NIH/NIA and the Yale PEPPER Center. The experimental diet was provided by L-Nutra Inc. Some authors declared an equity interest in L-Nutra, with one author’s equity to be assigned to the nonprofit foundation Create Cures. Others disclosed no conflicts of interest.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Monthly cycles of a fasting-mimicking diet (FMD) may slow metabolic and immune system aging and reduce the risk for metabolic disease.

METHODOLOGY:

• In two clinical trials, monthly 5-day cycles of an FMD (a proprietary line of plant-based, low-calorie, and low-protein food products) showed lower body weight, body fat, and blood pressure at 3 months.
• Researchers assessed secondary outcomes for the impact of the diet on risk factors for metabolic syndrome and biomarkers associated with aging and age-related diseases.
• This study looked at data from nearly half of the original 184 participants (aged 18-70 years) from the two clinical trials who went through three to four monthly cycles, adhering to 5 days of an FMD in either a crossover design compared with a normal diet or an intervention group compared with people following a Mediterranean diet.
• Abdominal fat and hepatic fat were measured using an MRI in a subset of representative participants. The study also assessed metabolic blood markers and lipids and lymphoid-to-myeloid ratios (for immune aging).
• Biological age estimation was calculated from seven clinical chemistry measures, and life expectancy and mortality risk estimates and a simulation of continued FMD cycles were based on the National Health and Nutrition Examination Survey.

TAKEAWAY:

• In 15 volunteers measured by MRI, the body mass index (P = .0002), total body fat (P = .002), subcutaneous adipose tissue (P = .008), visceral adipose tissue (P = .002), and hepatic fat fraction (P = .049) reduced after the third FMD cycle, with a 50% reduction in liver fat for the five people with hepatic steatosis.
• In 11 participants with prediabetes, insulin resistance (measured by homeostatic model assessment) reduced from 1.473 to 1.209 (P = .046), while A1c levels dropped from 5.8 to 5.43 (P = .032) after the third FMD cycle.

• The lymphoid-to-myeloid ratio improved (P = .005) in all study participants receiving three FMD cycles, indicating an immune aging reversal.
• The estimated median biological age of the 86 participants who completed three FMD cycles in both trials decreased by nearly 2.5 years, independent of weight loss.

IN PRACTICE:

“Together our findings indicate that the FMD is a feasible periodic dietary intervention that reduces disease risk factors and biological age,” the authors wrote.

SOURCE:

The study, led by Sebastian Brandhorst, PhD, Leonard Davis School of Gerontology, University of Southern California (USC), Los Angeles, and Morgan E. Levine, PhD, Department of Pathology, Yale School of Medicine, New Haven, Connecticut, was published in Nature Communications.

LIMITATIONS:

The study estimated the effects of monthly FMD cycles based on results from two clinical trials and included a small subset of trial volunteers. By study measures, the cohort was healthier and biologically younger than average people of similar chronological age. Of the 86 participants, 24 who underwent FMD cycles exhibited increased biological age. The simulation did not consider compliance, dropout, mortality, or the bias that may arise owing to enthusiastic volunteers. Estimated risk reductions assume an effect of change in biological age, which hasn’t been proven. Projections from extending the effects of FMD to a lifelong intervention may require cautious interpretation.

DISCLOSURES:

The study was supported by the USC Edna Jones chair fund and funds from NIH/NIA and the Yale PEPPER Center. The experimental diet was provided by L-Nutra Inc. Some authors declared an equity interest in L-Nutra, with one author’s equity to be assigned to the nonprofit foundation Create Cures. Others disclosed no conflicts of interest.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Monthly cycles of a fasting-mimicking diet (FMD) may slow metabolic and immune system aging and reduce the risk for metabolic disease.

METHODOLOGY:

• In two clinical trials, monthly 5-day cycles of an FMD (a proprietary line of plant-based, low-calorie, and low-protein food products) showed lower body weight, body fat, and blood pressure at 3 months.
• Researchers assessed secondary outcomes for the impact of the diet on risk factors for metabolic syndrome and biomarkers associated with aging and age-related diseases.
• This study looked at data from nearly half of the original 184 participants (aged 18-70 years) from the two clinical trials who went through three to four monthly cycles, adhering to 5 days of an FMD in either a crossover design compared with a normal diet or an intervention group compared with people following a Mediterranean diet.
• Abdominal fat and hepatic fat were measured using an MRI in a subset of representative participants. The study also assessed metabolic blood markers and lipids and lymphoid-to-myeloid ratios (for immune aging).
• Biological age estimation was calculated from seven clinical chemistry measures, and life expectancy and mortality risk estimates and a simulation of continued FMD cycles were based on the National Health and Nutrition Examination Survey.

TAKEAWAY:

• In 15 volunteers measured by MRI, the body mass index (P = .0002), total body fat (P = .002), subcutaneous adipose tissue (P = .008), visceral adipose tissue (P = .002), and hepatic fat fraction (P = .049) reduced after the third FMD cycle, with a 50% reduction in liver fat for the five people with hepatic steatosis.
• In 11 participants with prediabetes, insulin resistance (measured by homeostatic model assessment) reduced from 1.473 to 1.209 (P = .046), while A1c levels dropped from 5.8 to 5.43 (P = .032) after the third FMD cycle.

• The lymphoid-to-myeloid ratio improved (P = .005) in all study participants receiving three FMD cycles, indicating an immune aging reversal.
• The estimated median biological age of the 86 participants who completed three FMD cycles in both trials decreased by nearly 2.5 years, independent of weight loss.

IN PRACTICE:

“Together our findings indicate that the FMD is a feasible periodic dietary intervention that reduces disease risk factors and biological age,” the authors wrote.

SOURCE:

The study, led by Sebastian Brandhorst, PhD, Leonard Davis School of Gerontology, University of Southern California (USC), Los Angeles, and Morgan E. Levine, PhD, Department of Pathology, Yale School of Medicine, New Haven, Connecticut, was published in Nature Communications.

LIMITATIONS:

The study estimated the effects of monthly FMD cycles based on results from two clinical trials and included a small subset of trial volunteers. By study measures, the cohort was healthier and biologically younger than average people of similar chronological age. Of the 86 participants, 24 who underwent FMD cycles exhibited increased biological age. The simulation did not consider compliance, dropout, mortality, or the bias that may arise owing to enthusiastic volunteers. Estimated risk reductions assume an effect of change in biological age, which hasn’t been proven. Projections from extending the effects of FMD to a lifelong intervention may require cautious interpretation.

DISCLOSURES:

The study was supported by the USC Edna Jones chair fund and funds from NIH/NIA and the Yale PEPPER Center. The experimental diet was provided by L-Nutra Inc. Some authors declared an equity interest in L-Nutra, with one author’s equity to be assigned to the nonprofit foundation Create Cures. Others disclosed no conflicts of interest.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Long naps of an hour or more, naps in the morning, or regular siestas may increase blood glucose levels in older people with type 2 diabetes (T2D).

METHODOLOGY:

• Napping is common in China and other cultures and may play a role in cardiometabolic health, but previous studies on the relationship between napping and glycemic control in T2D have reported conflicting results.
• In a cross-sectional study, the researchers assessed 226 individuals with T2D (median age, 67 years; about half women; mostly retired) from two community healthcare centers in China between May 2023 and July 2023.
• Using questionnaires, the participants were evaluated for A1c levels, as well as frequency, duration (shorter or longer than 1 hour), timing, and type of napping behavior (restorative for lack of sleep vs appetitive by habit or for enjoyment).
• Multivariate analysis controlled for age, sex, body mass index, T2D treatment regimen, diabetes duration, cognitive impairment, depression, night sleep duration, and insomnia symptoms.

TAKEAWAY:

• Among 180 participants who reported napping, 61 (33.9%) took long naps of 60 minutes and more, 162 (90%) reported afternoon napping, and 131 (72.8%) displayed appetitive napping.
• Restorative napping was linked to lower A1c levels than appetitive napping (β, −0.176; P = 0.028).
• Napping frequency was not associated with A1c levels.

IN PRACTICE:

“In clinical practice, healthcare professionals may offer tips about napping, eg, taking a nap less than an hour, taking a nap in the afternoon instead of in the morning, avoiding appetitive napping,” the authors concluded.

SOURCE:

The study, from corresponding author Bingqian Zhu, PhD, of the Shanghai Jiao Tong University School of Nursing, Shanghai, was published in Frontiers in Endocrinology.

LIMITATIONS:

The participants were older individuals, mostly retired, who may have had less need for restorative napping and more time for appetitive napping, limiting generalizability. The sample size may have been too small to find a link to napping frequency. Self-reported data could introduce recall bias. Only A1c levels were used as a measure of glycemic control.

DISCLOSURES:

The study was supported by the National Natural Science Foundation of China and other sources. The authors declared no potential conflict of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Long naps of an hour or more, naps in the morning, or regular siestas may increase blood glucose levels in older people with type 2 diabetes (T2D).

METHODOLOGY:

• Napping is common in China and other cultures and may play a role in cardiometabolic health, but previous studies on the relationship between napping and glycemic control in T2D have reported conflicting results.
• In a cross-sectional study, the researchers assessed 226 individuals with T2D (median age, 67 years; about half women; mostly retired) from two community healthcare centers in China between May 2023 and July 2023.
• Using questionnaires, the participants were evaluated for A1c levels, as well as frequency, duration (shorter or longer than 1 hour), timing, and type of napping behavior (restorative for lack of sleep vs appetitive by habit or for enjoyment).
• Multivariate analysis controlled for age, sex, body mass index, T2D treatment regimen, diabetes duration, cognitive impairment, depression, night sleep duration, and insomnia symptoms.

TAKEAWAY:

• Among 180 participants who reported napping, 61 (33.9%) took long naps of 60 minutes and more, 162 (90%) reported afternoon napping, and 131 (72.8%) displayed appetitive napping.
• Restorative napping was linked to lower A1c levels than appetitive napping (β, −0.176; P = 0.028).
• Napping frequency was not associated with A1c levels.

IN PRACTICE:

“In clinical practice, healthcare professionals may offer tips about napping, eg, taking a nap less than an hour, taking a nap in the afternoon instead of in the morning, avoiding appetitive napping,” the authors concluded.

SOURCE:

The study, from corresponding author Bingqian Zhu, PhD, of the Shanghai Jiao Tong University School of Nursing, Shanghai, was published in Frontiers in Endocrinology.

LIMITATIONS:

The participants were older individuals, mostly retired, who may have had less need for restorative napping and more time for appetitive napping, limiting generalizability. The sample size may have been too small to find a link to napping frequency. Self-reported data could introduce recall bias. Only A1c levels were used as a measure of glycemic control.

DISCLOSURES:

The study was supported by the National Natural Science Foundation of China and other sources. The authors declared no potential conflict of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Long naps of an hour or more, naps in the morning, or regular siestas may increase blood glucose levels in older people with type 2 diabetes (T2D).

METHODOLOGY:

• Napping is common in China and other cultures and may play a role in cardiometabolic health, but previous studies on the relationship between napping and glycemic control in T2D have reported conflicting results.
• In a cross-sectional study, the researchers assessed 226 individuals with T2D (median age, 67 years; about half women; mostly retired) from two community healthcare centers in China between May 2023 and July 2023.
• Using questionnaires, the participants were evaluated for A1c levels, as well as frequency, duration (shorter or longer than 1 hour), timing, and type of napping behavior (restorative for lack of sleep vs appetitive by habit or for enjoyment).
• Multivariate analysis controlled for age, sex, body mass index, T2D treatment regimen, diabetes duration, cognitive impairment, depression, night sleep duration, and insomnia symptoms.

TAKEAWAY:

• Among 180 participants who reported napping, 61 (33.9%) took long naps of 60 minutes and more, 162 (90%) reported afternoon napping, and 131 (72.8%) displayed appetitive napping.
• Restorative napping was linked to lower A1c levels than appetitive napping (β, −0.176; P = 0.028).
• Napping frequency was not associated with A1c levels.

IN PRACTICE:

“In clinical practice, healthcare professionals may offer tips about napping, eg, taking a nap less than an hour, taking a nap in the afternoon instead of in the morning, avoiding appetitive napping,” the authors concluded.

SOURCE:

The study, from corresponding author Bingqian Zhu, PhD, of the Shanghai Jiao Tong University School of Nursing, Shanghai, was published in Frontiers in Endocrinology.

LIMITATIONS:

The participants were older individuals, mostly retired, who may have had less need for restorative napping and more time for appetitive napping, limiting generalizability. The sample size may have been too small to find a link to napping frequency. Self-reported data could introduce recall bias. Only A1c levels were used as a measure of glycemic control.

DISCLOSURES:

The study was supported by the National Natural Science Foundation of China and other sources. The authors declared no potential conflict of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Inflammatory bowel disease (IBD) therapies for patients may need to be briefly halted during treatment for COVID-19, but it does not escalate IBD flares, with prior vaccination for COVID-19 helping reduce complications from the virus.

METHODOLOGY:

• Patients with IBD who receive immunosuppressive agents are at an increased risk of developing severe SARS-CoV-2 infection; however, the effects of COVID-19 vaccination and treatment on the outcomes in patients with IBD are less known.
• Researchers assessed the effect of COVID-19 medications in 127 patients with IBD (age ≥ 18 years; 54% women) who were diagnosed with COVID-19 after the advent of vaccines and release of antiviral therapies.
• Patients were stratified into those who received treatment for COVID-19 (n = 44), defined as the use of antivirals and/or intravenous antibodies, and those who did not receive treatment for COVID-19 (n = 83).
• The primary outcome was the development of a severe SARS-CoV-2 infection (defined by the need for oxygen supplements, corticosteroids and/or antibiotic treatment, or hospitalization).
• The secondary outcomes were the percentage of patients who had their IBD therapy withheld and rates of IBD flare post COVID-19.

TAKEAWAY:

• The likelihood of being treated for COVID-19 was higher in patients on corticosteroids (odds ratio [OR], 4.61; P = .002) or in those undergoing advanced IBD therapies (OR, 2.78; P = .041) prior to infection.
• Advanced age at the time of infection (adjusted OR [aOR], 1.06; P = .018) and corticosteroid treatment prior to contracting COVID-19 (aOR, 9.86; P = .001) were associated with an increased risk for severe infection.
• After adjustment for multiple factors, the likelihood of withholding IBD treatment was higher in patients being treated for COVID-19 (aOR, 6.95; P = .007).

IN PRACTICE:

“Patients with IBD on advanced therapies were frequently treated for acute COVID-19. Although COVID-19 treatment was associated with temporary withholding of IBD therapy, it did not result in increased IBD flares,” the authors wrote.

SOURCE:

The investigation, led by Laura C. Sahyoun, MD, Section of Digestive Diseases, Yale School of Medicine, New Haven, Connecticut, was published online in Digestive Diseases and Sciences.

LIMITATIONS:

Owing to the small sample size, the outcomes comparing antivirals to intravenous antibodies and SARS-CoV-2 strain prevalence could not be assessed. This single-center study also may not reflect the different clinical practices pertaining to IBD and COVID-19 treatments.

DISCLOSURES:

The study did not receive any specific funding. One author reported receiving speaker fees and being part of advisory boards, and another author received research support and reported being a part of advisory boards.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Inflammatory bowel disease (IBD) therapies for patients may need to be briefly halted during treatment for COVID-19, but it does not escalate IBD flares, with prior vaccination for COVID-19 helping reduce complications from the virus.

METHODOLOGY:

• Patients with IBD who receive immunosuppressive agents are at an increased risk of developing severe SARS-CoV-2 infection; however, the effects of COVID-19 vaccination and treatment on the outcomes in patients with IBD are less known.
• Researchers assessed the effect of COVID-19 medications in 127 patients with IBD (age ≥ 18 years; 54% women) who were diagnosed with COVID-19 after the advent of vaccines and release of antiviral therapies.
• Patients were stratified into those who received treatment for COVID-19 (n = 44), defined as the use of antivirals and/or intravenous antibodies, and those who did not receive treatment for COVID-19 (n = 83).
• The primary outcome was the development of a severe SARS-CoV-2 infection (defined by the need for oxygen supplements, corticosteroids and/or antibiotic treatment, or hospitalization).
• The secondary outcomes were the percentage of patients who had their IBD therapy withheld and rates of IBD flare post COVID-19.

TAKEAWAY:

• The likelihood of being treated for COVID-19 was higher in patients on corticosteroids (odds ratio [OR], 4.61; P = .002) or in those undergoing advanced IBD therapies (OR, 2.78; P = .041) prior to infection.
• Advanced age at the time of infection (adjusted OR [aOR], 1.06; P = .018) and corticosteroid treatment prior to contracting COVID-19 (aOR, 9.86; P = .001) were associated with an increased risk for severe infection.
• After adjustment for multiple factors, the likelihood of withholding IBD treatment was higher in patients being treated for COVID-19 (aOR, 6.95; P = .007).

IN PRACTICE:

“Patients with IBD on advanced therapies were frequently treated for acute COVID-19. Although COVID-19 treatment was associated with temporary withholding of IBD therapy, it did not result in increased IBD flares,” the authors wrote.

SOURCE:

The investigation, led by Laura C. Sahyoun, MD, Section of Digestive Diseases, Yale School of Medicine, New Haven, Connecticut, was published online in Digestive Diseases and Sciences.

LIMITATIONS:

Owing to the small sample size, the outcomes comparing antivirals to intravenous antibodies and SARS-CoV-2 strain prevalence could not be assessed. This single-center study also may not reflect the different clinical practices pertaining to IBD and COVID-19 treatments.

DISCLOSURES:

The study did not receive any specific funding. One author reported receiving speaker fees and being part of advisory boards, and another author received research support and reported being a part of advisory boards.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Inflammatory bowel disease (IBD) therapies for patients may need to be briefly halted during treatment for COVID-19, but it does not escalate IBD flares, with prior vaccination for COVID-19 helping reduce complications from the virus.

METHODOLOGY:

• Patients with IBD who receive immunosuppressive agents are at an increased risk of developing severe SARS-CoV-2 infection; however, the effects of COVID-19 vaccination and treatment on the outcomes in patients with IBD are less known.
• Researchers assessed the effect of COVID-19 medications in 127 patients with IBD (age ≥ 18 years; 54% women) who were diagnosed with COVID-19 after the advent of vaccines and release of antiviral therapies.
• Patients were stratified into those who received treatment for COVID-19 (n = 44), defined as the use of antivirals and/or intravenous antibodies, and those who did not receive treatment for COVID-19 (n = 83).
• The primary outcome was the development of a severe SARS-CoV-2 infection (defined by the need for oxygen supplements, corticosteroids and/or antibiotic treatment, or hospitalization).
• The secondary outcomes were the percentage of patients who had their IBD therapy withheld and rates of IBD flare post COVID-19.

TAKEAWAY:

• The likelihood of being treated for COVID-19 was higher in patients on corticosteroids (odds ratio [OR], 4.61; P = .002) or in those undergoing advanced IBD therapies (OR, 2.78; P = .041) prior to infection.
• Advanced age at the time of infection (adjusted OR [aOR], 1.06; P = .018) and corticosteroid treatment prior to contracting COVID-19 (aOR, 9.86; P = .001) were associated with an increased risk for severe infection.
• After adjustment for multiple factors, the likelihood of withholding IBD treatment was higher in patients being treated for COVID-19 (aOR, 6.95; P = .007).

IN PRACTICE:

“Patients with IBD on advanced therapies were frequently treated for acute COVID-19. Although COVID-19 treatment was associated with temporary withholding of IBD therapy, it did not result in increased IBD flares,” the authors wrote.

SOURCE:

The investigation, led by Laura C. Sahyoun, MD, Section of Digestive Diseases, Yale School of Medicine, New Haven, Connecticut, was published online in Digestive Diseases and Sciences.

LIMITATIONS:

Owing to the small sample size, the outcomes comparing antivirals to intravenous antibodies and SARS-CoV-2 strain prevalence could not be assessed. This single-center study also may not reflect the different clinical practices pertaining to IBD and COVID-19 treatments.

DISCLOSURES:

The study did not receive any specific funding. One author reported receiving speaker fees and being part of advisory boards, and another author received research support and reported being a part of advisory boards.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Treatment of patients with rheumatoid arthritis (RA) with non–tumor necrosis factor inhibitor (TNFi) biologic disease-modifying antirheumatic drugs (bDMARDs) may not pose an increased risk for cancer, compared with TNFis and conventional synthetic DMARDs.

METHODOLOGY:

• Previous research has presented conflicting results on the association between non-TNFi bDMARDs and the risk for cancer, with abatacept drawing particular attention owing to its mode of action.
• By utilizing information from Danish registers (January 2006-December 2020), researchers compared the risk for cancer in 14,944 patients with RA (age > 18 years) who were initiated on non-TNFi bDMARDs (tocilizumab/sarilumab, abatacept, or rituximab), TNFis, or were in the conventional synthetic DMARDs (bDMARD-naive) group.
• The patient population contributed to 21,982 treatment initiations, which corresponded to 1457, 1016, 690, 7458, and 11,361 treatment initiations for the tocilizumab/sarilumab, abatacept, rituximab, TNFi, and bDMARD-naive groups, respectively.
• Patients were followed up until a diagnosis was obtained for cancer, death, emigration, the initiation of a different bDMARD or a targeted synthetic DMARD, or the end of the study, whichever was earlier.
• The primary outcome was defined as any primary cancer diagnosis (except nonmelanoma skin cancer).

TAKEAWAY:

• The risk for overall cancer was not significantly higher in the tocilizumab/sarilumab-, abatacept-, or rituximab-initiated groups than in the TNFi-treated and bDMARD-naive groups.

• The likelihood of cancer appeared to be higher in patients with more than 5 years of exposure to abatacept than in the TNFi-treated (hazard ratio [HR], 1.41; 95% CI, 0.60-2.60) and bDMARD-naive groups (HR, 1.14; 95% CI, 0.51-2.33). However, the results were not statistically significant.
• Treatment with rituximab may be associated with a lower risk for hematologic cancers than for TNFi-treated (HR, 0.09; 95% CI, 0.00-2.06) or bDMARD-naive groups (HR, 0.13; 95% CI, 0.00-1.89), although the findings did not show statistical significance.

IN PRACTICE:

The authors wrote, “bDMARD-associated cancer risk remains a clinically important research question, and more future studies specifically investigating non-TNFi bDMARDs in terms of cancer risk in patients with RA are warranted.”

SOURCE:

The investigation, led by Rasmus Westermann, MD, of Aalborg University Hospital, Aalborg, Denmark, was published online on March 7 in Rheumatology.

LIMITATIONS:

Many patients received more than one type of non-TNFi bDMARD treatment during the study. Because the temporal relationship of DMARD treatment with cancer was not certain, potential carcinogenic treatment effects could not be distinguished. Limited data were available on cancer risk factors.

DISCLOSURES:

The study was supported by the Danish Rheumatism Association and the Danish Cancer Society. Some authors reported financial relationships with pharmaceutical companies outside of the submitted work.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Treatment of patients with rheumatoid arthritis (RA) with non–tumor necrosis factor inhibitor (TNFi) biologic disease-modifying antirheumatic drugs (bDMARDs) may not pose an increased risk for cancer, compared with TNFis and conventional synthetic DMARDs.

METHODOLOGY:

• Previous research has presented conflicting results on the association between non-TNFi bDMARDs and the risk for cancer, with abatacept drawing particular attention owing to its mode of action.
• By utilizing information from Danish registers (January 2006-December 2020), researchers compared the risk for cancer in 14,944 patients with RA (age > 18 years) who were initiated on non-TNFi bDMARDs (tocilizumab/sarilumab, abatacept, or rituximab), TNFis, or were in the conventional synthetic DMARDs (bDMARD-naive) group.
• The patient population contributed to 21,982 treatment initiations, which corresponded to 1457, 1016, 690, 7458, and 11,361 treatment initiations for the tocilizumab/sarilumab, abatacept, rituximab, TNFi, and bDMARD-naive groups, respectively.
• Patients were followed up until a diagnosis was obtained for cancer, death, emigration, the initiation of a different bDMARD or a targeted synthetic DMARD, or the end of the study, whichever was earlier.
• The primary outcome was defined as any primary cancer diagnosis (except nonmelanoma skin cancer).

TAKEAWAY:

• The risk for overall cancer was not significantly higher in the tocilizumab/sarilumab-, abatacept-, or rituximab-initiated groups than in the TNFi-treated and bDMARD-naive groups.

• The likelihood of cancer appeared to be higher in patients with more than 5 years of exposure to abatacept than in the TNFi-treated (hazard ratio [HR], 1.41; 95% CI, 0.60-2.60) and bDMARD-naive groups (HR, 1.14; 95% CI, 0.51-2.33). However, the results were not statistically significant.
• Treatment with rituximab may be associated with a lower risk for hematologic cancers than for TNFi-treated (HR, 0.09; 95% CI, 0.00-2.06) or bDMARD-naive groups (HR, 0.13; 95% CI, 0.00-1.89), although the findings did not show statistical significance.

IN PRACTICE:

The authors wrote, “bDMARD-associated cancer risk remains a clinically important research question, and more future studies specifically investigating non-TNFi bDMARDs in terms of cancer risk in patients with RA are warranted.”

SOURCE:

The investigation, led by Rasmus Westermann, MD, of Aalborg University Hospital, Aalborg, Denmark, was published online on March 7 in Rheumatology.

LIMITATIONS:

Many patients received more than one type of non-TNFi bDMARD treatment during the study. Because the temporal relationship of DMARD treatment with cancer was not certain, potential carcinogenic treatment effects could not be distinguished. Limited data were available on cancer risk factors.

DISCLOSURES:

The study was supported by the Danish Rheumatism Association and the Danish Cancer Society. Some authors reported financial relationships with pharmaceutical companies outside of the submitted work.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Treatment of patients with rheumatoid arthritis (RA) with non–tumor necrosis factor inhibitor (TNFi) biologic disease-modifying antirheumatic drugs (bDMARDs) may not pose an increased risk for cancer, compared with TNFis and conventional synthetic DMARDs.

METHODOLOGY:

• Previous research has presented conflicting results on the association between non-TNFi bDMARDs and the risk for cancer, with abatacept drawing particular attention owing to its mode of action.
• By utilizing information from Danish registers (January 2006-December 2020), researchers compared the risk for cancer in 14,944 patients with RA (age > 18 years) who were initiated on non-TNFi bDMARDs (tocilizumab/sarilumab, abatacept, or rituximab), TNFis, or were in the conventional synthetic DMARDs (bDMARD-naive) group.
• The patient population contributed to 21,982 treatment initiations, which corresponded to 1457, 1016, 690, 7458, and 11,361 treatment initiations for the tocilizumab/sarilumab, abatacept, rituximab, TNFi, and bDMARD-naive groups, respectively.
• Patients were followed up until a diagnosis was obtained for cancer, death, emigration, the initiation of a different bDMARD or a targeted synthetic DMARD, or the end of the study, whichever was earlier.
• The primary outcome was defined as any primary cancer diagnosis (except nonmelanoma skin cancer).

TAKEAWAY:

• The risk for overall cancer was not significantly higher in the tocilizumab/sarilumab-, abatacept-, or rituximab-initiated groups than in the TNFi-treated and bDMARD-naive groups.

• The likelihood of cancer appeared to be higher in patients with more than 5 years of exposure to abatacept than in the TNFi-treated (hazard ratio [HR], 1.41; 95% CI, 0.60-2.60) and bDMARD-naive groups (HR, 1.14; 95% CI, 0.51-2.33). However, the results were not statistically significant.
• Treatment with rituximab may be associated with a lower risk for hematologic cancers than for TNFi-treated (HR, 0.09; 95% CI, 0.00-2.06) or bDMARD-naive groups (HR, 0.13; 95% CI, 0.00-1.89), although the findings did not show statistical significance.

IN PRACTICE:

The authors wrote, “bDMARD-associated cancer risk remains a clinically important research question, and more future studies specifically investigating non-TNFi bDMARDs in terms of cancer risk in patients with RA are warranted.”

SOURCE:

The investigation, led by Rasmus Westermann, MD, of Aalborg University Hospital, Aalborg, Denmark, was published online on March 7 in Rheumatology.

LIMITATIONS:

Many patients received more than one type of non-TNFi bDMARD treatment during the study. Because the temporal relationship of DMARD treatment with cancer was not certain, potential carcinogenic treatment effects could not be distinguished. Limited data were available on cancer risk factors.

DISCLOSURES:

The study was supported by the Danish Rheumatism Association and the Danish Cancer Society. Some authors reported financial relationships with pharmaceutical companies outside of the submitted work.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Changes in plasma growth hormone mediators such as growth hormone receptor (GHR) and insulin-like growth factor-binding protein 1 (IGFBP-1) were associated with glycemic failure in youth-onset type 2 diabetes (T2D), an analysis of the TODAY trial showed.

METHODOLOGY:

• In youth, T2D often occurs during or after puberty, hinting at hormonal influences in the development and/or progression of the disease.
• This secondary analysis assessed the role of growth hormone mediators including insulin-like growth factor-1 (IGF-1), GHR, and IGFBP-1 in glycemic failure in a subset of 398 youths, aged 10-17 years, with a T2D duration of less than 2 years (62% girls; 21% White).
• The participants were followed up for a mean of 3.9 years.
• The primary outcomes included glycemic failure, defined as an A1c level of 8% or more for 6 months, or acute metabolic decompensation requiring insulin.
• Other assessments included baseline and 36-month measures of glycemia, insulin sensitivity, high molecular weight adiponectin, and beta cell function.

TAKEAWAY:

• Of 398 participants, 182 (46%) experienced glycemic failure, while 216 (54%) retained glycemic control.
• At 36 months, youths with glycemic failure had lower IGF-1 levels (P < .001) and higher log₂ GHR (P = .03) and log₂ IGFBP-1 (P = .009) levels than those who maintained glycemic control.
• A greater increase in IGF-1 level at 36 months was associated with lower odds of glycemic failure (odds ratio [OR], 0.995; P < .001).
• Increased levels of log₂ GHR and log₂ IGFBP-1 were associated with higher odds of glycemic failure (OR, 1.75; P = .04 and OR, 1.37; P = .007, respectively). Results were adjusted for body mass index (BMI), suggesting that associations between GHR level and glycemic outcomes exist independent of BMI.
• Interhormonal correlations suggested an association between glucose metabolism and growth hormone signaling or a shared process leading to changes in both processes.

IN PRACTICE:

“Our study has identified GHR level as a novel biomarker of decrease in glycemic control in youths with T2D,” the study authors wrote. Future research is needed, with an emphasis on assessing alterations in growth hormone mediators which may contribute to diabetes complications in youth.

SOURCE:

The study, published online in JAMA Network Open, was led by Chang Lu, MD, Division of Endocrinology, Boston Children’s Hospital, and Joslin Diabetes Center at Harvard Medical School, Boston, Massachusetts.

LIMITATIONS:

The study did not include a control group (individuals without diabetes). The cohort largely included youth in late puberty or after puberty, affecting subgroup analysis. Moreover, only circulating growth hormone mediators were measured, limiting the identity of the source tissue of the hormone and the target organs.

DISCLOSURES:

Some authors reported receiving grants from the National Institutes of Health and National Institute of Diabetes and Digestive and Kidney Diseases while conducting the study. Also, certain authors reported receiving grants and personal fees from various trusts as well as pharmaceutical, healthcare, and medical technology companies outside the submitted work.

TOPLINE:

Changes in plasma growth hormone mediators such as growth hormone receptor (GHR) and insulin-like growth factor-binding protein 1 (IGFBP-1) were associated with glycemic failure in youth-onset type 2 diabetes (T2D), an analysis of the TODAY trial showed.

METHODOLOGY:

• In youth, T2D often occurs during or after puberty, hinting at hormonal influences in the development and/or progression of the disease.
• This secondary analysis assessed the role of growth hormone mediators including insulin-like growth factor-1 (IGF-1), GHR, and IGFBP-1 in glycemic failure in a subset of 398 youths, aged 10-17 years, with a T2D duration of less than 2 years (62% girls; 21% White).
• The participants were followed up for a mean of 3.9 years.
• The primary outcomes included glycemic failure, defined as an A1c level of 8% or more for 6 months, or acute metabolic decompensation requiring insulin.
• Other assessments included baseline and 36-month measures of glycemia, insulin sensitivity, high molecular weight adiponectin, and beta cell function.

TAKEAWAY:

• Of 398 participants, 182 (46%) experienced glycemic failure, while 216 (54%) retained glycemic control.
• At 36 months, youths with glycemic failure had lower IGF-1 levels (P < .001) and higher log₂ GHR (P = .03) and log₂ IGFBP-1 (P = .009) levels than those who maintained glycemic control.
• A greater increase in IGF-1 level at 36 months was associated with lower odds of glycemic failure (odds ratio [OR], 0.995; P < .001).
• Increased levels of log₂ GHR and log₂ IGFBP-1 were associated with higher odds of glycemic failure (OR, 1.75; P = .04 and OR, 1.37; P = .007, respectively). Results were adjusted for body mass index (BMI), suggesting that associations between GHR level and glycemic outcomes exist independent of BMI.
• Interhormonal correlations suggested an association between glucose metabolism and growth hormone signaling or a shared process leading to changes in both processes.

IN PRACTICE:

“Our study has identified GHR level as a novel biomarker of decrease in glycemic control in youths with T2D,” the study authors wrote. Future research is needed, with an emphasis on assessing alterations in growth hormone mediators which may contribute to diabetes complications in youth.

SOURCE:

The study, published online in JAMA Network Open, was led by Chang Lu, MD, Division of Endocrinology, Boston Children’s Hospital, and Joslin Diabetes Center at Harvard Medical School, Boston, Massachusetts.

LIMITATIONS:

The study did not include a control group (individuals without diabetes). The cohort largely included youth in late puberty or after puberty, affecting subgroup analysis. Moreover, only circulating growth hormone mediators were measured, limiting the identity of the source tissue of the hormone and the target organs.

DISCLOSURES:

Some authors reported receiving grants from the National Institutes of Health and National Institute of Diabetes and Digestive and Kidney Diseases while conducting the study. Also, certain authors reported receiving grants and personal fees from various trusts as well as pharmaceutical, healthcare, and medical technology companies outside the submitted work.

TOPLINE:

Changes in plasma growth hormone mediators such as growth hormone receptor (GHR) and insulin-like growth factor-binding protein 1 (IGFBP-1) were associated with glycemic failure in youth-onset type 2 diabetes (T2D), an analysis of the TODAY trial showed.

METHODOLOGY:

• In youth, T2D often occurs during or after puberty, hinting at hormonal influences in the development and/or progression of the disease.
• This secondary analysis assessed the role of growth hormone mediators including insulin-like growth factor-1 (IGF-1), GHR, and IGFBP-1 in glycemic failure in a subset of 398 youths, aged 10-17 years, with a T2D duration of less than 2 years (62% girls; 21% White).
• The participants were followed up for a mean of 3.9 years.
• The primary outcomes included glycemic failure, defined as an A1c level of 8% or more for 6 months, or acute metabolic decompensation requiring insulin.
• Other assessments included baseline and 36-month measures of glycemia, insulin sensitivity, high molecular weight adiponectin, and beta cell function.

TAKEAWAY:

• Of 398 participants, 182 (46%) experienced glycemic failure, while 216 (54%) retained glycemic control.
• At 36 months, youths with glycemic failure had lower IGF-1 levels (P < .001) and higher log₂ GHR (P = .03) and log₂ IGFBP-1 (P = .009) levels than those who maintained glycemic control.
• A greater increase in IGF-1 level at 36 months was associated with lower odds of glycemic failure (odds ratio [OR], 0.995; P < .001).
• Increased levels of log₂ GHR and log₂ IGFBP-1 were associated with higher odds of glycemic failure (OR, 1.75; P = .04 and OR, 1.37; P = .007, respectively). Results were adjusted for body mass index (BMI), suggesting that associations between GHR level and glycemic outcomes exist independent of BMI.
• Interhormonal correlations suggested an association between glucose metabolism and growth hormone signaling or a shared process leading to changes in both processes.

IN PRACTICE:

“Our study has identified GHR level as a novel biomarker of decrease in glycemic control in youths with T2D,” the study authors wrote. Future research is needed, with an emphasis on assessing alterations in growth hormone mediators which may contribute to diabetes complications in youth.

SOURCE:

The study, published online in JAMA Network Open, was led by Chang Lu, MD, Division of Endocrinology, Boston Children’s Hospital, and Joslin Diabetes Center at Harvard Medical School, Boston, Massachusetts.

LIMITATIONS:

The study did not include a control group (individuals without diabetes). The cohort largely included youth in late puberty or after puberty, affecting subgroup analysis. Moreover, only circulating growth hormone mediators were measured, limiting the identity of the source tissue of the hormone and the target organs.

DISCLOSURES:

Some authors reported receiving grants from the National Institutes of Health and National Institute of Diabetes and Digestive and Kidney Diseases while conducting the study. Also, certain authors reported receiving grants and personal fees from various trusts as well as pharmaceutical, healthcare, and medical technology companies outside the submitted work.

TOPLINE:

The remission period of type 1 diabetes (T1D) can be prolonged with high-dose ergocalciferol (a vitamin D analog), by preserving the function of insulin-producing beta cells in newly diagnosed patients.

METHODOLOGY:

• Beta cells may retain approximately 30%-50% function at the time of T1D diagnosis and continue producing insulin for months or years. Preserving beta-cell function early on can extend this remission period and improve long-term glycemic control.
• Researchers conducted a secondary post hoc analysis of a randomized clinical trial looking at residual beta function and vitamin D supplementation in 36 youths (age, 10-21 years; mean age, 13.5 years; 33.3% women) with recently diagnosed T1D.
• Participants were randomly assigned to receive vitamin D (50,000 international units) or placebo every week for 2 months and then biweekly for 10 months.
• Mixed-meal tolerance tests were performed after overnight fasting at 0, 3, 6, 9, and 12 months, and blood draws were obtained 30 minutes and 90 minutes for post-meal C-peptide and glucose estimations.
• The fasting proinsulin to C-peptide ratio (PI:C) and the percentage change in the area under the curve of C-peptide from baseline (%ΔAUC) were calculated to test the effect of vitamin D on beta-cell function.

TAKEAWAY: 

• Vitamin D supplementation improved the insulin secretion capacity of beta cells, as observed by the decrease in the mean fasting PI:C ratio compared with placebo (−0.0009 vs 0.0011; P =.01).
• The reduction in %ΔAUC of C-peptide was notably slower with vitamin D than placebo (−2.8% vs −4.7%; P =.03), indicating a longer delay in the loss of C-peptide.

IN PRACTICE:

“It is exciting to know that vitamin D could protect the beta cells of the pancreas and increase the natural production of good and functional insulin in these patients. This, in turn, prolongs the honeymoon phase of type 1 diabetes and leads to reduced long-term complications of this disease,” Benjamin Udoka Nwosu, MD, Northwell Health, Division of Endocrinology, Department of Pediatrics, Cohen Children’s Medical Center, New Hyde Park, New York, the principal author, said in a press release.

SOURCE:

The study was published online in JAMA Network Open.

LIMITATIONS:

It was a single-center study.

DISCLOSURES:

The study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases. The authors did not report any conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

The remission period of type 1 diabetes (T1D) can be prolonged with high-dose ergocalciferol (a vitamin D analog), by preserving the function of insulin-producing beta cells in newly diagnosed patients.

METHODOLOGY:

• Beta cells may retain approximately 30%-50% function at the time of T1D diagnosis and continue producing insulin for months or years. Preserving beta-cell function early on can extend this remission period and improve long-term glycemic control.
• Researchers conducted a secondary post hoc analysis of a randomized clinical trial looking at residual beta function and vitamin D supplementation in 36 youths (age, 10-21 years; mean age, 13.5 years; 33.3% women) with recently diagnosed T1D.
• Participants were randomly assigned to receive vitamin D (50,000 international units) or placebo every week for 2 months and then biweekly for 10 months.
• Mixed-meal tolerance tests were performed after overnight fasting at 0, 3, 6, 9, and 12 months, and blood draws were obtained 30 minutes and 90 minutes for post-meal C-peptide and glucose estimations.
• The fasting proinsulin to C-peptide ratio (PI:C) and the percentage change in the area under the curve of C-peptide from baseline (%ΔAUC) were calculated to test the effect of vitamin D on beta-cell function.

TAKEAWAY: 

• Vitamin D supplementation improved the insulin secretion capacity of beta cells, as observed by the decrease in the mean fasting PI:C ratio compared with placebo (−0.0009 vs 0.0011; P =.01).
• The reduction in %ΔAUC of C-peptide was notably slower with vitamin D than placebo (−2.8% vs −4.7%; P =.03), indicating a longer delay in the loss of C-peptide.

IN PRACTICE:

“It is exciting to know that vitamin D could protect the beta cells of the pancreas and increase the natural production of good and functional insulin in these patients. This, in turn, prolongs the honeymoon phase of type 1 diabetes and leads to reduced long-term complications of this disease,” Benjamin Udoka Nwosu, MD, Northwell Health, Division of Endocrinology, Department of Pediatrics, Cohen Children’s Medical Center, New Hyde Park, New York, the principal author, said in a press release.

SOURCE:

The study was published online in JAMA Network Open.

LIMITATIONS:

It was a single-center study.

DISCLOSURES:

The study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases. The authors did not report any conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

The remission period of type 1 diabetes (T1D) can be prolonged with high-dose ergocalciferol (a vitamin D analog), by preserving the function of insulin-producing beta cells in newly diagnosed patients.

METHODOLOGY:

• Beta cells may retain approximately 30%-50% function at the time of T1D diagnosis and continue producing insulin for months or years. Preserving beta-cell function early on can extend this remission period and improve long-term glycemic control.
• Researchers conducted a secondary post hoc analysis of a randomized clinical trial looking at residual beta function and vitamin D supplementation in 36 youths (age, 10-21 years; mean age, 13.5 years; 33.3% women) with recently diagnosed T1D.
• Participants were randomly assigned to receive vitamin D (50,000 international units) or placebo every week for 2 months and then biweekly for 10 months.
• Mixed-meal tolerance tests were performed after overnight fasting at 0, 3, 6, 9, and 12 months, and blood draws were obtained 30 minutes and 90 minutes for post-meal C-peptide and glucose estimations.
• The fasting proinsulin to C-peptide ratio (PI:C) and the percentage change in the area under the curve of C-peptide from baseline (%ΔAUC) were calculated to test the effect of vitamin D on beta-cell function.

TAKEAWAY: 

• Vitamin D supplementation improved the insulin secretion capacity of beta cells, as observed by the decrease in the mean fasting PI:C ratio compared with placebo (−0.0009 vs 0.0011; P =.01).
• The reduction in %ΔAUC of C-peptide was notably slower with vitamin D than placebo (−2.8% vs −4.7%; P =.03), indicating a longer delay in the loss of C-peptide.

IN PRACTICE:

“It is exciting to know that vitamin D could protect the beta cells of the pancreas and increase the natural production of good and functional insulin in these patients. This, in turn, prolongs the honeymoon phase of type 1 diabetes and leads to reduced long-term complications of this disease,” Benjamin Udoka Nwosu, MD, Northwell Health, Division of Endocrinology, Department of Pediatrics, Cohen Children’s Medical Center, New Hyde Park, New York, the principal author, said in a press release.

SOURCE:

The study was published online in JAMA Network Open.

LIMITATIONS:

It was a single-center study.

DISCLOSURES:

The study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases. The authors did not report any conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Home or hospital insulin pumps are safe and improve glucose control in pediatric, adolescent, and young adult patients with type 1 diabetes hospitalized for noncritical illness.

METHODOLOGY:

• Clinical guidelines support the use of home insulin pumps in adults hospitalized for noncritical illnesses, but it has been unclear if adult safety data translate to pediatric inpatients.
• The study evaluated if insulin can be safely and precisely delivered using home insulin pumps managed by patients or caregivers in 2738 patients (0.5-25 years old; median age about 16) with insulin-dependent diabetes admitted to non–intensive care units of a tertiary children’s hospital between January 2016 and December 2021.
• Insulin was delivered either using home insulin pumps managed by patients or caregivers or using hospital insulin pumps or subcutaneous injections managed by hospital staff.
• Safety was measured by hyperglycemia (glucose level > 250 mg/dL), hypoglycemia (moderate: glucose level, 45-59 mg/dL or severe: glucose level, < 45 mg/dL), glucose variability, and the incidence of diabetic ketoacidosis for each delivery method.
• Results were calculated by the number of days a patient had one or more glucose levels meeting the definition of hyperglycemia or hypoglycemia and divided by the number of days a patient receive any insulin dose.

TAKEAWAY:

The number of hyperglycemic days was lower in patients using a hospital (15.7%) or a home (27.0%) insulin pump than in those receiving subcutaneous insulin injections (45.2%; P < .001).

At least one moderate hypoglycemic day was noted in patients receiving insulin through subcutaneous injections (5.1%) compared with those receiving it through hospital (3.1%) or home insulin pumps (4.5%; P = .02).

The proportion of days within the desired blood glucose range and glucose variability were similar in patients using hospital or home insulin pumps and worse in patients managed with injections (P < .001).

No patients using home or hospital pumps developed diabetic ketoacidosis, but two cases of diabetic ketoacidosis were noted among patients using injections.

IN PRACTICE:

“Safety is not sacrificed when patients or caregivers use home pumps during pediatric non–intensive care unit admissions,” the authors wrote.

SOURCE:

The investigation, led by Jodi Owens, MSN, RN, Division of Endocrinology, Cincinnati Children’s Hospital Medical Center, was published along with an invited commentary in JAMA Network Open.

LIMITATIONS:

The strategies employed for insulin safety and awareness by the institution may have led to improved rates of hypoglycemia and hyperglycemia. Moreover, the study did not assess changes in glycemic levels during transition in the insulin delivery method. The study was limited to non–intensive care units and hence cannot be generalized to intensive care unit settings or in patients with diabetic ketoacidosis. The study did not include patients using hybrid-closed loop insulin pumps.

DISCLOSURES:

The study did not disclose any source of funding. The authors did not report any conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Home or hospital insulin pumps are safe and improve glucose control in pediatric, adolescent, and young adult patients with type 1 diabetes hospitalized for noncritical illness.

METHODOLOGY:

• Clinical guidelines support the use of home insulin pumps in adults hospitalized for noncritical illnesses, but it has been unclear if adult safety data translate to pediatric inpatients.
• The study evaluated if insulin can be safely and precisely delivered using home insulin pumps managed by patients or caregivers in 2738 patients (0.5-25 years old; median age about 16) with insulin-dependent diabetes admitted to non–intensive care units of a tertiary children’s hospital between January 2016 and December 2021.
• Insulin was delivered either using home insulin pumps managed by patients or caregivers or using hospital insulin pumps or subcutaneous injections managed by hospital staff.
• Safety was measured by hyperglycemia (glucose level > 250 mg/dL), hypoglycemia (moderate: glucose level, 45-59 mg/dL or severe: glucose level, < 45 mg/dL), glucose variability, and the incidence of diabetic ketoacidosis for each delivery method.
• Results were calculated by the number of days a patient had one or more glucose levels meeting the definition of hyperglycemia or hypoglycemia and divided by the number of days a patient receive any insulin dose.

TAKEAWAY:

The number of hyperglycemic days was lower in patients using a hospital (15.7%) or a home (27.0%) insulin pump than in those receiving subcutaneous insulin injections (45.2%; P < .001).

At least one moderate hypoglycemic day was noted in patients receiving insulin through subcutaneous injections (5.1%) compared with those receiving it through hospital (3.1%) or home insulin pumps (4.5%; P = .02).

The proportion of days within the desired blood glucose range and glucose variability were similar in patients using hospital or home insulin pumps and worse in patients managed with injections (P < .001).

No patients using home or hospital pumps developed diabetic ketoacidosis, but two cases of diabetic ketoacidosis were noted among patients using injections.

IN PRACTICE:

“Safety is not sacrificed when patients or caregivers use home pumps during pediatric non–intensive care unit admissions,” the authors wrote.

SOURCE:

The investigation, led by Jodi Owens, MSN, RN, Division of Endocrinology, Cincinnati Children’s Hospital Medical Center, was published along with an invited commentary in JAMA Network Open.

LIMITATIONS:

The strategies employed for insulin safety and awareness by the institution may have led to improved rates of hypoglycemia and hyperglycemia. Moreover, the study did not assess changes in glycemic levels during transition in the insulin delivery method. The study was limited to non–intensive care units and hence cannot be generalized to intensive care unit settings or in patients with diabetic ketoacidosis. The study did not include patients using hybrid-closed loop insulin pumps.

DISCLOSURES:

The study did not disclose any source of funding. The authors did not report any conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Home or hospital insulin pumps are safe and improve glucose control in pediatric, adolescent, and young adult patients with type 1 diabetes hospitalized for noncritical illness.

METHODOLOGY:

• Clinical guidelines support the use of home insulin pumps in adults hospitalized for noncritical illnesses, but it has been unclear if adult safety data translate to pediatric inpatients.
• The study evaluated if insulin can be safely and precisely delivered using home insulin pumps managed by patients or caregivers in 2738 patients (0.5-25 years old; median age about 16) with insulin-dependent diabetes admitted to non–intensive care units of a tertiary children’s hospital between January 2016 and December 2021.
• Insulin was delivered either using home insulin pumps managed by patients or caregivers or using hospital insulin pumps or subcutaneous injections managed by hospital staff.
• Safety was measured by hyperglycemia (glucose level > 250 mg/dL), hypoglycemia (moderate: glucose level, 45-59 mg/dL or severe: glucose level, < 45 mg/dL), glucose variability, and the incidence of diabetic ketoacidosis for each delivery method.
• Results were calculated by the number of days a patient had one or more glucose levels meeting the definition of hyperglycemia or hypoglycemia and divided by the number of days a patient receive any insulin dose.

TAKEAWAY:

The number of hyperglycemic days was lower in patients using a hospital (15.7%) or a home (27.0%) insulin pump than in those receiving subcutaneous insulin injections (45.2%; P < .001).

At least one moderate hypoglycemic day was noted in patients receiving insulin through subcutaneous injections (5.1%) compared with those receiving it through hospital (3.1%) or home insulin pumps (4.5%; P = .02).

The proportion of days within the desired blood glucose range and glucose variability were similar in patients using hospital or home insulin pumps and worse in patients managed with injections (P < .001).

No patients using home or hospital pumps developed diabetic ketoacidosis, but two cases of diabetic ketoacidosis were noted among patients using injections.

IN PRACTICE:

“Safety is not sacrificed when patients or caregivers use home pumps during pediatric non–intensive care unit admissions,” the authors wrote.

SOURCE:

The investigation, led by Jodi Owens, MSN, RN, Division of Endocrinology, Cincinnati Children’s Hospital Medical Center, was published along with an invited commentary in JAMA Network Open.

LIMITATIONS:

The strategies employed for insulin safety and awareness by the institution may have led to improved rates of hypoglycemia and hyperglycemia. Moreover, the study did not assess changes in glycemic levels during transition in the insulin delivery method. The study was limited to non–intensive care units and hence cannot be generalized to intensive care unit settings or in patients with diabetic ketoacidosis. The study did not include patients using hybrid-closed loop insulin pumps.

DISCLOSURES:

The study did not disclose any source of funding. The authors did not report any conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Continued denosumab treatment is associated with a lower risk for diabetes in adults with osteoporosis older than 65 years, found a large-scale cohort study in Taiwan.

METHODOLOGY:

• Denosumab, used in osteoporosis treatment, has been suggested to improve glycemic parameters, but clinical evidence of its effects on diabetes risk is limited and inconsistent.
• Using data from Taiwan’s National Health Insurance Research Database (NHIRD), the study asked if continued denosumab treatment (60 mg) for osteoporosis reduced the risk for diabetes compared to those who discontinued denosumab.
• Researchers included all new users of denosumab between 2012 and 2019 who had no prior history of malignant neoplasms, Paget disease, or diabetes requiring antidiabetic medication.
• Patients in the treatment group (n = 34,255), who received a second dose of denosumab within 225 days, were 1:1 propensity matched with a control group (n = 34,255) of patients who had discontinued denosumab after the first dose.
• The 68,510 patients (mean age, 77.7 years; 84.3% women) were followed up for a mean of 1.9 years. The primary outcome was new-onset diabetes that required treatment with any antidiabetic drug.

TAKEAWAY:

• Continued denosumab treatment vs its discontinuation was associated with a lower risk for incident diabetes (hazard ratio [HR], 0.84; 95% CI, 0.78-0.90).
• In patients aged 65 years or older who were on continued treatment of denosumab, the risk for diabetes was lower (HR, 0.80; 95% CI, 0.75-0.85) but not among those younger than 65 years.
• A reduced risk for diabetes with continued denosumab treatment was observed in both men (HR, 0.85; 95% CI, 0.73-0.97) and women (HR, 0.81; 95% CI, 0.76-0.86).
• Lower diabetes risk with continued denosumab treatment was observed regardless of comorbidities, such as dyslipidemia, hypertension, ischemic heart disease, or kidney failure.

IN PRACTICE:

“Given the high osteoporosis prevalence, the extensive use of antiosteoporosis medications, and the negative effect of diabetes on both patient health and healthcare system burdens in the global aging population, our findings possess substantial clinical and public health significance,” the authors wrote.

SOURCE:

This study was led by Huei-Kai Huang, MD, Department of Family Medicine and Department of Medical Research, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Hualien, Taiwan, and published online in JAMA Network Open.

LIMITATIONS:

The research used claims-based data, so some clinical details, such as lifestyle, substance use, prediabetes weight status, and laboratory results, were not included. Owing to the anonymity policy of the NHIRD, patients could not be directly evaluated to validate incident diabetes. The study included the Taiwanese population, so the findings may not be generalizable to other populations. In Taiwan, the threshold for reimbursement of initiating denosumab treatment for osteoporosis includes below-normal bone density scores and a hip or vertebral fracture.

DISCLOSURES:

This study was supported by grants from the National Science and Technology Council of Taiwan and the National Health Research Institutes of Taiwan and a grant from the Buddhist Tzu Chi Medical Foundation. The corresponding author and a coauthor disclosed receiving funds from Amgen, Novartis, Pfizer, Sanofi, Takeda, and AbbVie, all outside the submitted work.

A version of this article appeared on Medscape.com.

TOPLINE:

Continued denosumab treatment is associated with a lower risk for diabetes in adults with osteoporosis older than 65 years, found a large-scale cohort study in Taiwan.

METHODOLOGY:

• Denosumab, used in osteoporosis treatment, has been suggested to improve glycemic parameters, but clinical evidence of its effects on diabetes risk is limited and inconsistent.
• Using data from Taiwan’s National Health Insurance Research Database (NHIRD), the study asked if continued denosumab treatment (60 mg) for osteoporosis reduced the risk for diabetes compared to those who discontinued denosumab.
• Researchers included all new users of denosumab between 2012 and 2019 who had no prior history of malignant neoplasms, Paget disease, or diabetes requiring antidiabetic medication.
• Patients in the treatment group (n = 34,255), who received a second dose of denosumab within 225 days, were 1:1 propensity matched with a control group (n = 34,255) of patients who had discontinued denosumab after the first dose.
• The 68,510 patients (mean age, 77.7 years; 84.3% women) were followed up for a mean of 1.9 years. The primary outcome was new-onset diabetes that required treatment with any antidiabetic drug.

TAKEAWAY:

• Continued denosumab treatment vs its discontinuation was associated with a lower risk for incident diabetes (hazard ratio [HR], 0.84; 95% CI, 0.78-0.90).
• In patients aged 65 years or older who were on continued treatment of denosumab, the risk for diabetes was lower (HR, 0.80; 95% CI, 0.75-0.85) but not among those younger than 65 years.
• A reduced risk for diabetes with continued denosumab treatment was observed in both men (HR, 0.85; 95% CI, 0.73-0.97) and women (HR, 0.81; 95% CI, 0.76-0.86).
• Lower diabetes risk with continued denosumab treatment was observed regardless of comorbidities, such as dyslipidemia, hypertension, ischemic heart disease, or kidney failure.

IN PRACTICE:

“Given the high osteoporosis prevalence, the extensive use of antiosteoporosis medications, and the negative effect of diabetes on both patient health and healthcare system burdens in the global aging population, our findings possess substantial clinical and public health significance,” the authors wrote.

SOURCE:

This study was led by Huei-Kai Huang, MD, Department of Family Medicine and Department of Medical Research, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Hualien, Taiwan, and published online in JAMA Network Open.

LIMITATIONS:

The research used claims-based data, so some clinical details, such as lifestyle, substance use, prediabetes weight status, and laboratory results, were not included. Owing to the anonymity policy of the NHIRD, patients could not be directly evaluated to validate incident diabetes. The study included the Taiwanese population, so the findings may not be generalizable to other populations. In Taiwan, the threshold for reimbursement of initiating denosumab treatment for osteoporosis includes below-normal bone density scores and a hip or vertebral fracture.

DISCLOSURES:

This study was supported by grants from the National Science and Technology Council of Taiwan and the National Health Research Institutes of Taiwan and a grant from the Buddhist Tzu Chi Medical Foundation. The corresponding author and a coauthor disclosed receiving funds from Amgen, Novartis, Pfizer, Sanofi, Takeda, and AbbVie, all outside the submitted work.

A version of this article appeared on Medscape.com.

TOPLINE:

Continued denosumab treatment is associated with a lower risk for diabetes in adults with osteoporosis older than 65 years, found a large-scale cohort study in Taiwan.

METHODOLOGY:

• Denosumab, used in osteoporosis treatment, has been suggested to improve glycemic parameters, but clinical evidence of its effects on diabetes risk is limited and inconsistent.
• Using data from Taiwan’s National Health Insurance Research Database (NHIRD), the study asked if continued denosumab treatment (60 mg) for osteoporosis reduced the risk for diabetes compared to those who discontinued denosumab.
• Researchers included all new users of denosumab between 2012 and 2019 who had no prior history of malignant neoplasms, Paget disease, or diabetes requiring antidiabetic medication.
• Patients in the treatment group (n = 34,255), who received a second dose of denosumab within 225 days, were 1:1 propensity matched with a control group (n = 34,255) of patients who had discontinued denosumab after the first dose.
• The 68,510 patients (mean age, 77.7 years; 84.3% women) were followed up for a mean of 1.9 years. The primary outcome was new-onset diabetes that required treatment with any antidiabetic drug.

TAKEAWAY:

• Continued denosumab treatment vs its discontinuation was associated with a lower risk for incident diabetes (hazard ratio [HR], 0.84; 95% CI, 0.78-0.90).
• In patients aged 65 years or older who were on continued treatment of denosumab, the risk for diabetes was lower (HR, 0.80; 95% CI, 0.75-0.85) but not among those younger than 65 years.
• A reduced risk for diabetes with continued denosumab treatment was observed in both men (HR, 0.85; 95% CI, 0.73-0.97) and women (HR, 0.81; 95% CI, 0.76-0.86).
• Lower diabetes risk with continued denosumab treatment was observed regardless of comorbidities, such as dyslipidemia, hypertension, ischemic heart disease, or kidney failure.

IN PRACTICE:

“Given the high osteoporosis prevalence, the extensive use of antiosteoporosis medications, and the negative effect of diabetes on both patient health and healthcare system burdens in the global aging population, our findings possess substantial clinical and public health significance,” the authors wrote.

SOURCE:

This study was led by Huei-Kai Huang, MD, Department of Family Medicine and Department of Medical Research, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Hualien, Taiwan, and published online in JAMA Network Open.

LIMITATIONS:

The research used claims-based data, so some clinical details, such as lifestyle, substance use, prediabetes weight status, and laboratory results, were not included. Owing to the anonymity policy of the NHIRD, patients could not be directly evaluated to validate incident diabetes. The study included the Taiwanese population, so the findings may not be generalizable to other populations. In Taiwan, the threshold for reimbursement of initiating denosumab treatment for osteoporosis includes below-normal bone density scores and a hip or vertebral fracture.

DISCLOSURES:

This study was supported by grants from the National Science and Technology Council of Taiwan and the National Health Research Institutes of Taiwan and a grant from the Buddhist Tzu Chi Medical Foundation. The corresponding author and a coauthor disclosed receiving funds from Amgen, Novartis, Pfizer, Sanofi, Takeda, and AbbVie, all outside the submitted work.

A version of this article appeared on Medscape.com.

TOPLINE:

Despite diabetes technology, many with type 1 diabetes (T1D) miss glycemic targets and experience severe hypoglycemia and impaired awareness of hypoglycemia (IAH). 

METHODOLOGY:

• The clinical management of T1D through technology is now recognized as the standard of care, but its real-world impact on glycemic targets and severe hypoglycemic events and IAH is unclear.
• Researchers assessed the self-reported prevalence of glycemic metrics, severe hypoglycemia, and hypoglycemia awareness according to the use of continuous glucose monitoring (CGM) and automated insulin delivery (AID) systems.
• They enrolled 2044 individuals diagnosed with T1D for at least 2 years (mean age, 43.0 years; 72.1% women; 95.4% White) from the T1D Exchange Registry and online communities who filled an online survey.
• Participants were stratified on the basis of the presence or absence of CGM and different insulin delivery methods (multiple daily injections, conventional pumps, or AID systems).
• The primary outcome was the proportion of participants who achieved glycemic targets (self-reported A1c), had severe hypoglycemia (any low glucose incidence in 12 months), and/or IAH (a modified Gold score on a seven-point Likert scale).

TAKEAWAY:

• Most participants (91.7%) used CGM, and 50.8% of CGM users used an AID system.
• Despite advanced interventions, only 59.6% (95% CI, 57.3%-61.8%) of CGM users met the glycemic target (A1c < 7%), while nearly 40% of CGM users and 35.6% of AID users didn’t reach the target.
• At least one event of severe hypoglycemia in the previous 12 months was reported in 10.8% of CGM users and 16.6% of those using an AID system.
• IAH prevalence was seen in 31.1% (95% CI, 29.0%-33.2%) and 30.3% (95% CI, 17.5%-33.3%) of participants using CGM and CGM + AID, respectively.

IN PRACTICE:

“Educational initiatives continue to be important for all individuals with type 1 diabetes, and the development of novel therapeutic options and strategies, including bihormonal AID systems and beta-cell replacement, will be required to enable more of these individuals to meet treatment goals,” the authors wrote.

SOURCE:

The study, published online in Diabetes Care, was led by Jennifer L. Sherr, MD, PhD, Yale School of Medicine, New Haven, Connecticut.

LIMITATIONS:

The survey participants in this study were from the T1D Exchange online community, who tend to be highly involved, have technology experience, and are more likely to achieve glycemic targets. The data reported as part of the survey were based on self-reports by participants and may be subject to recall bias. Notably, severe hypoglycemic events may be overreported by individuals using CGM and AID systems due to sensor alarms.

DISCLOSURES:

The study was funded by Vertex Pharmaceuticals. Several authors disclosed financial relationships, including grants, consulting fees, honoraria, stock ownership, and employment with pharmaceutical and device companies and other entities.

A version of this article appeared on Medscape.com.

TOPLINE:

Despite diabetes technology, many with type 1 diabetes (T1D) miss glycemic targets and experience severe hypoglycemia and impaired awareness of hypoglycemia (IAH). 

METHODOLOGY:

• The clinical management of T1D through technology is now recognized as the standard of care, but its real-world impact on glycemic targets and severe hypoglycemic events and IAH is unclear.
• Researchers assessed the self-reported prevalence of glycemic metrics, severe hypoglycemia, and hypoglycemia awareness according to the use of continuous glucose monitoring (CGM) and automated insulin delivery (AID) systems.
• They enrolled 2044 individuals diagnosed with T1D for at least 2 years (mean age, 43.0 years; 72.1% women; 95.4% White) from the T1D Exchange Registry and online communities who filled an online survey.
• Participants were stratified on the basis of the presence or absence of CGM and different insulin delivery methods (multiple daily injections, conventional pumps, or AID systems).
• The primary outcome was the proportion of participants who achieved glycemic targets (self-reported A1c), had severe hypoglycemia (any low glucose incidence in 12 months), and/or IAH (a modified Gold score on a seven-point Likert scale).

TAKEAWAY:

• Most participants (91.7%) used CGM, and 50.8% of CGM users used an AID system.
• Despite advanced interventions, only 59.6% (95% CI, 57.3%-61.8%) of CGM users met the glycemic target (A1c < 7%), while nearly 40% of CGM users and 35.6% of AID users didn’t reach the target.
• At least one event of severe hypoglycemia in the previous 12 months was reported in 10.8% of CGM users and 16.6% of those using an AID system.
• IAH prevalence was seen in 31.1% (95% CI, 29.0%-33.2%) and 30.3% (95% CI, 17.5%-33.3%) of participants using CGM and CGM + AID, respectively.

IN PRACTICE:

“Educational initiatives continue to be important for all individuals with type 1 diabetes, and the development of novel therapeutic options and strategies, including bihormonal AID systems and beta-cell replacement, will be required to enable more of these individuals to meet treatment goals,” the authors wrote.

SOURCE:

The study, published online in Diabetes Care, was led by Jennifer L. Sherr, MD, PhD, Yale School of Medicine, New Haven, Connecticut.

LIMITATIONS:

The survey participants in this study were from the T1D Exchange online community, who tend to be highly involved, have technology experience, and are more likely to achieve glycemic targets. The data reported as part of the survey were based on self-reports by participants and may be subject to recall bias. Notably, severe hypoglycemic events may be overreported by individuals using CGM and AID systems due to sensor alarms.

DISCLOSURES:

The study was funded by Vertex Pharmaceuticals. Several authors disclosed financial relationships, including grants, consulting fees, honoraria, stock ownership, and employment with pharmaceutical and device companies and other entities.

A version of this article appeared on Medscape.com.

TOPLINE:

Despite diabetes technology, many with type 1 diabetes (T1D) miss glycemic targets and experience severe hypoglycemia and impaired awareness of hypoglycemia (IAH). 

METHODOLOGY:

• The clinical management of T1D through technology is now recognized as the standard of care, but its real-world impact on glycemic targets and severe hypoglycemic events and IAH is unclear.
• Researchers assessed the self-reported prevalence of glycemic metrics, severe hypoglycemia, and hypoglycemia awareness according to the use of continuous glucose monitoring (CGM) and automated insulin delivery (AID) systems.
• They enrolled 2044 individuals diagnosed with T1D for at least 2 years (mean age, 43.0 years; 72.1% women; 95.4% White) from the T1D Exchange Registry and online communities who filled an online survey.
• Participants were stratified on the basis of the presence or absence of CGM and different insulin delivery methods (multiple daily injections, conventional pumps, or AID systems).
• The primary outcome was the proportion of participants who achieved glycemic targets (self-reported A1c), had severe hypoglycemia (any low glucose incidence in 12 months), and/or IAH (a modified Gold score on a seven-point Likert scale).

TAKEAWAY:

• Most participants (91.7%) used CGM, and 50.8% of CGM users used an AID system.
• Despite advanced interventions, only 59.6% (95% CI, 57.3%-61.8%) of CGM users met the glycemic target (A1c < 7%), while nearly 40% of CGM users and 35.6% of AID users didn’t reach the target.
• At least one event of severe hypoglycemia in the previous 12 months was reported in 10.8% of CGM users and 16.6% of those using an AID system.
• IAH prevalence was seen in 31.1% (95% CI, 29.0%-33.2%) and 30.3% (95% CI, 17.5%-33.3%) of participants using CGM and CGM + AID, respectively.

IN PRACTICE:

“Educational initiatives continue to be important for all individuals with type 1 diabetes, and the development of novel therapeutic options and strategies, including bihormonal AID systems and beta-cell replacement, will be required to enable more of these individuals to meet treatment goals,” the authors wrote.

SOURCE:

The study, published online in Diabetes Care, was led by Jennifer L. Sherr, MD, PhD, Yale School of Medicine, New Haven, Connecticut.

LIMITATIONS:

The survey participants in this study were from the T1D Exchange online community, who tend to be highly involved, have technology experience, and are more likely to achieve glycemic targets. The data reported as part of the survey were based on self-reports by participants and may be subject to recall bias. Notably, severe hypoglycemic events may be overreported by individuals using CGM and AID systems due to sensor alarms.

DISCLOSURES:

The study was funded by Vertex Pharmaceuticals. Several authors disclosed financial relationships, including grants, consulting fees, honoraria, stock ownership, and employment with pharmaceutical and device companies and other entities.

A version of this article appeared on Medscape.com.