A provider toolkit with clinically relevant resources related to diagnosis and management of central precocious puberty.

CPP Provider Toolkit

A pair of experts in the management of diabetes review the role of insulin therapy and review the approval process for biosimilars, including the FDA's approval of the first interchangeable insulin biosimilar.

Interchangeable Insulin Biosimilars: A Game Changer in Diabetes Management

Podcast hosted by Diana Isaacs, PharmD, and Natalie Bellini, DNP aimed at providing real-world perspective on the latest advances in diabetes management.

Each course of antibiotics during young adulthood was associated with a 2-4% increase in risk of developing 

, according to the results of a new analysis.

Using data from the Cardiovascular Risk in Young Finns Study (YFS) and the national FINRISK study, investigators determined each additional exposure to an antibiotic course was associated with increased risk of subset type 2 diabetes in both studies, with exposure to 5 or more courses associated with a potential doubling in risk of type 2 diabetes later in life.

“The results of this study show that prior exposure to systemic antibiotics was associated with increased risk of incident type 2 diabetes in more than 25,000 participants. Furthermore, prior exposure to antibiotics was also associated with overweight/obesity. The observed risks persisted even after adjustment for numerous potential confounding factors, including BMI at baseline,” wrote investigators.

As more and more data emerge detailing the impact of antibiotic exposure on intestinal microbiome and overall health, some have hypothesized these changes could contribute to increased risk of developing diabetes. The current study was born out of an interest in exploring the potential impact of antibiotic exposure on type 2 diabetes risk using data from the YFS and FINRISK studies.

Launched in 1978, the YFS 2209 participants aged 24-39 years in 2001 with data available related to exposure to antibiotic courses from 1993-2001, which provided investigators with information from 2209 individuals. Of these, 110 patients were diagnosed with diabetes. Using information obtained from clinical examinations conducted in 2001, 2007, and 2011, investigators assessed prevalence of diabetes beginning in and after 2001, with those with prevalent diabetes excluded from the analyses. For the purpose of analysis, investigators used 4 population-based cohorts derived from the National FINRISK studies for replication. These 4 population-based cohorts included 24,674 individuals. Of these, 1866 had incident diabetes. Overall, the total study cohort included 26,883 participants.

Upon analysis, investigators found prior antibiotic exposure, which was defined as more than 5 antibiotic courses, was associated with an increased likelihood of developing type 2 diabetes in both the YFS (OR, 2.29 [95% CI, 1.33-3.96]) and the FINRISK cohorts 

 compared to their counterparts with 1 or fewer antibiotic course exposures. When assessing the impact of exposure per course, results indicated each antibiotic course was associated with a 4% increase in likelihood of type 2 diabetes in the YFS cohort (OR, 1.043 [95% CI, 1.013-1.074]) and a 2% increase in likelihood in the FINRISK cohort (HR, 1.022 [95% CI, 1.016-1.029]).

Further analysis, which assessed risk of overweight/obesity associated with exposure to antibiotics, suggested exposure to antibiotics was associated with a 4% increase in likelihood of overweight/obesity in the YFS cohort (OR, 1.043 [95% CI, 1.019-1.068]) at the 10-year follow-up and a 2% increase in likelihood of overweight/obesity in the FINRISK cohort (OR, 1.023 [95% CI, 1.018-1.029]) at baseline. Investigators pointed out additional adjustments for confounders from early life in YFS and at baseline in FINRISK did not have an appreciable impact on the aforementioned findings.

“We found that prior exposure to systemic antibiotics was associated with increased risk for future type 2 diabetes and overweight and obesity. Our findings support judicious use of antibiotics. Future studies are needed to further investigate the relationship between antibiotic exposure and type 2 diabetes and excess body weight as well as to examine the direct impact of antibiotic exposure on human gut microbiome.”

Use of antibiotics and risk of type 2 diabetes, overweight and obesity: the Cardiovascular Risk in Young Finns Study and the national FINRISK study

,” was published in BMC Endocrine Disorders.

Slideshows

An analysis of data from a pair of studies examining cardiovascular risk in individuals from countries in Europe provides insight into an apparent increase in the likelihood of developing type 2 diabetes among people with a history of exposure to antibiotics. 

European Study Links Antibiotic Exposure to Increased Risk of Type 2 Diabetes Later in Life

Use of flash glucose monitoring could promote lifestyle changes in people with diabetes, according to a new study.

A single-arm, prospective study conducted among people with prediabetes, results of the study demonstrate people with prediabetes using a flash glucose monitoring system felt use of the system would allow them to make lifestyle changes aimed at preventing progression to diabetes, with the majority of patients noting they would recommend use to other people with prediabetes.

“To the best of our knowledge, this is the first study that explored the feasibility and acceptability of wearing [flash glucose monitoring system] sensors among people with prediabetes,” wrote investigators. “While we confirmed that people with prediabetes were receptive to wearing [flash glucose monitoring system] sensors, our study endured a high uncontactable rate, which was likely due to recruiting participants from medically underserved communities and the impact of the COVID-19 pandemic.”

continuous glucose monitoring (CGM) technology

 continues to advance at a rapid rate, improved systems have led to questions surrounding potential application in populations beyond those with a diagnosis of type 1 or type 2 diabetes, including in-hospital settings and, in the present study, people with prediabetes. With an interest in exploring use in those with prediabetes, the current endeavor was designed by investigators from the University of California, Irvine as a single-arm, prospective study with the specific intent of describing the feasibility and acceptability of flash glucose monitoring system sensors for empowering lifestyle changes in this patient population.

Recruiting patients receiving care within a pair of federally qualified health care centers, investigators invited patients to wear flash glucose monitoring sensors for 28 days. Investigators measured feasibility through subject recruitment, which was assessed via subject adherence rates and subject retention rates. For the purpose of analysis, acceptability was assessed via a semistructured, 1-on-1 interview, which consisted of an 11-item flash glucose monitoring system satisfaction scale and 4 open-ended questions on sensor-related preferences.

Overall, 136 subjects were referred to the study. Of these, 33.3% were uncontactable, 17.6% were undecided, 25.0% declined due to disinterest or lack of time, and 23.5% agreed to partake in the study. The 32-subject cohort included the study had a mean age of 52 years and a mean duration of prediabetes of 1.5 years. When asked to rate the importance of reversing prediabetes on a scale of 0-10, with 10 indicating very important, the mean score was 9.7.

During the 28-day period, all subjects were adherent to wearing the first followed by the second sensor. A total of 16 sensors fell off and required replacement, with the overall average days of sensor wear among participants at 25 days.

In regard to the open-ended questions, investigators pointed out a pair of themes that arose when questioning the “best thing” about wearing a sensor, which were “positive behavior change” and “improved understanding from real-time feedback”. When assessing the “worst thing” about wearing a sensor, “mechanics of the sensor” was the only theme identified by investigators.

Highlights of the 11-item satisfaction scale are listed below:

62.5% disagreed or strongly disagreed wearing sensors caused others to ask too many questions about health status.

75% disagreed or strongly disagreed wearing the sensor was uncomfortable or painful.

81.3% agreed or strongly agreed the sensor reminded them to stay healthy on a daily basis.

68.8% agreed or strongly agreed that they would pay a copay to use a flash glucose monitoring system sensor for people with prediabetes if it were covered by insurance.

78.1% agreed or strongly agreed they would want to use the device when the research study was over, if possible.

“Future studies should incorporate larger randomized controlled studies to better evaluate the advantages and disadvantages of incorporating [flash glucose monitoring system] sensors into the care of people with prediabetes,” investigators added.

Feasibility and Acceptability of Using Flash Glucose Monitoring System Sensors to Empower Lifestyle Changes in People With Prediabetes

Articles

A single-arm study provides insight into the feasibility and acceptability of flash glucose monitoring use for promoting positive lifestyle changes among people with prediabetes. 

Study Finds Flash Glucose Monitoring Could Prompt Lifestyle Changes in Prediabetes

An analysis of more than 11,000 people from half a dozen countries in Europe suggests people with type 2 diabetes were more likely to be diagnosed with some forms of advanced stage cancer than their counterparts without 

Using data from the European Prospective Investigation into Cancer and Nutrition (EPIC) study, a team of investigators from the International Agency for Research on Cancer (IARC) found individuals with preexisting type 2 diabetes were at an increased risk of advanced tumor stage at diagnosis for unscreened cancers, but investigators noted this was not seen for screened cancers such as breast and colorectal cancers.

“Our results underline the importance of paying particular attention to patients with pre-existing diseases of the heart, blood vessels or metabolism, such as type 2 diabetes, so that signs of cancer can be identified at an earlier stage when it is more likely to be treated successfully,” said lead investigator Anna Jansana, RN, MPH, a postdoctoral researcher at the Nutrition and Cancer Multimorbidity group at the IARC in Lyon, France, who presented the data at the European Breast Cancer Conference, 

Citing a lack of evidence on the subject, the current research effort was conducted by Janna and colleagues with an interest in assessing whether people with cardiometabolic diseases were at an increased risk of having cancer diagnosed at a more advanced stage. To do so, investigators designed their study as an analysis of patients diagnosed with cancer from within the EPIC study, which collected data from 400,577 participants who were cancer-free at baseline between 1992-2012. Among this cohort, investigators identified 11,945 individuals with a cancer diagnosis during the aforementioned time period.

Investigators planned to use logistic regression to estimate odds ratio (OR) of diagnosis of metastatic cancer according to presence of preexisting cardiovascular disease, type 2 diabetes, both, or no cardiometabolic disease among this cohort. For the purpose of analysis, investigators assessed cancers as all cancers combined and separately for screened cancers, which included breast and colorectal cancer, and nonscreened cancers, which was defined as all other cancers except breast and colorectal cancer. Investigators pointed out these analyses would be adjusted for country, age at cancer diagnosis, sex, physical activity, BMI, alcohol intake, smoking status, education level, and self-reported hypertension at baseline.

Of the 11,945 individuals identified for inclusion, 86.8% had no preexisting cardiometabolic disease at cancer diagnosis. Among those with preexisting cardiometabolic disease, 4.8% had a history of cardiovascular disease, 7.1% had a diagnosis of type 2 diabetes, and 1.3% had both.

Upon analysis, results indicated the ORs for metastatic compared with localized cancer for individuals with type 2 diabetes, cardiovascular and both compared to those without a cardiometabolic disease prior to cancer were 1.12 (95% CI, 0.95-1.30), 1.02 (95% CI, 0.79-1.16), and 1.11 (95% CI, 0.78-1.58), respectively. Further analysis revealed ORs for nonscreened cancers were 1.26 (95% CI, 1.04-1.55), 1.07 (95% CI 0.85-1.34), and 1.18 (95% CI 0.78-1.78), respectively, for those with type 2 diabetes, cardiovascular disease, and both prior to cancer diagnosis, with no associations observed for screened cancers.

“The good news is that for patients with breast or colorectal cancer, the national screening programmes seem to be detecting cancer often before it has started to spread, both for those with and without pre-existing diagnoses of cardiovascular disease and type 2 diabetes. Our findings underline the importance of participating in screening when invited,” Jansana added. “However, for cancers for which there are no national screening programmes, our results may prompt policymakers to broaden the scope of public health recommendations to encompass patients affected by cardiometabolic diseases and cancer.”

Impact of pre-existing cardiometabolic diseases on cancer stage at diagnosis in the EPIC study

,” was presented at the European Breast Cancer Conference.

An analysis of data from the EPIC study provides insight into an apparent increase in risk of having an advanced stage cancer at time of diagnosis for patients with cardiometabolic diseases compared to their counterparts without cardiometabolic diseases.

People with Type 2 Diabetes at Greater Risk of Having Advanced Stage Cancer at Time of Diagnosis

Natalie Bellini, DNP, FNP-BC, is a nurse practitioner specializing in diabetes management with the R&B Medical Group based out of Niagara Falls, NY. 

In 1922, Leonard Thompson, a 14-year-old boy, became the first person to receive insulin as a treatment for type 1 diabetes, which would forever change the prognosis of the disease from a certain death sentence to a chronic, but manageable illness.

In an almost poetic fashion, 100 years later, the 

US Food and Drug Administration’s approval of teplizumab (Tzield)

 for delaying the onset of stage 3 type 1 diabetes could prove to be an even more profound moment in the history of diabetes. Fewer than 70 days from the 100-year anniversary of Sir Frederick Banting’s sale of insulin and his famous “Insulin does not belong to me, it belongs to the world,”, quote, the approval has the potential to fundamentally alter the approach to type 1 diabetes in clinical settings.

Although the effects on progression to type 1 diabetes were described in phase 2 trial data published in 

, the reality is such a significant change in the care continuum will likely require extensive education and re-education around the agent as well as staging of type 1 diabetes for specialists and providers within and beyond endocrinology.

Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives

hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, break down the implications of adding an agent like teplizumab to the treatment armamentarium based on clinical trial data. During the episode, hosts also take a deep dive into type 1 diabetes staging and the role of certified diabetes care and education specialists in educating primary care and other specialties on these topics to optimize the potential of teplizumab.


 is available in an audio-only format on 

In this special edition episode of Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives, hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, break down what the approval of teplizumab means for type 1 diabetes. During the episode, hosts take a deep dive into type 1 diabetes staging and hypothesize around the role of CDCES in educating primary care and other specialties to optimize the potential of teplizumab.


Diabetes Dialogue: What Teplizumab Means for Type 1 Diabetes

The US Food and Drug Administration (FDA) has issued a Class I recall for the Insulet Omnipod DASH Insulin Management System Personal Diabetes Manager over risk of battery issues that may pose a fire hazard.

, the recall, which is the most serious type of recall issued by the FDA, is indicated for 3 specific product models distributed from July 27, 2018 through August 31, 2022 and encompasses 248,288 devices in the US. In their announcement of the recall, the FDA reported Insulet has received at least 455 complaints involving battery issues for the device, including 3 fires, but there had been no reports of serious injuries or deaths.

The 3 specific models indicated in the recall are as follows:

PT-000010: Assembly, DASH Final PDM U100, mg/dL

PT-000011: Assembly, DASH Final PDM U100, mmol/L

Used to deliver insulin at set and variable rates to manage diabetes in people who need insulin, the Omnipod DASH Insulin Management System, includes 2 main parts: a wearable, tubeless pump that delivers insulin, called the Pod, and a remote controller called the Personal Diabetes Manager (PDM). The FDA statement describes the PDM as a “small, reusable handheld rechargeable battery-powered locked-down Android mobile device with features similar to a smartphone”. The specific reasons cited by the FDA for the recall were battery swelling, fluid leakage from the battery, and extreme overheating that may pose a fire hazard.

, Insulet detailed receiving 50 complaints related to PDM battery issues, including battery swelling and leakage, and in rare cases, extreme overheating, which has resulted in reports of fire. No serious injuries or deaths have been reported as a result of this potential issue. In the statement, Insulet warned excess heat may cause minor burns or could lead to fire, but no serious injuries had been reported as a result of the issue.

“Safety is our top priority, and we have been urgently addressing this issue,” said Michael Spears Senior Vice President, Regulatory Affairs & Compliance, in the aforementioned statement from November 4. “We are committed to helping our customers navigate the replacement process and address any concerns they have. We are confident that a software update will resolve this issue.”

On November 14, Insulet released a statement

 announcing a nationwide voluntary medical device for the Omnipod 5 Automated Insulin Delivery System, which was 

, due to an issue with the Omnipod 5 Controller charging port and cable. In this statement, Insulet reported the receipt of 24 reports that the Omnipod 5 Controller charging port (USB-C port) or cable (USB cable) are melting, deforming, or discoloring due to heat generated by a poor connection between the cable and the port, which the company warned can cause minor burns or lead to fire although no serious injuries had been reported to Insulet as a result of this issue.

Insulet directed those seeking additional information, including instructions on how to mitigate risk related to any of the aforementioned issue to: 

Announced on November 17, the US FDA Class I recall for the Insulet Omnipod DASH Insulin Management System Personal Diabetes Manager comes after the company had received more than 450 complaints related to battery swelling, fluid leakage from battery, and extreme overheating, including 3 instances that included fires.

FDA Issues Recall for Insulet Devices for Battery, Overheating Issues that Could Cause Fire

An analysis of data from nearly 900,000 women is providing clinicians with an overview of the cardiovascular risk associated with concomitant occurrence of a pair of conditions common among expectant mothers in the US and abroad.

Using data from the Ministry of Health and Long-Term Care of Ontario administrative databases, results of the analysis demonstrated concomitant occurrence gestational diabetes and gestational hypertensive disorder was associated with a 2.4-fold increase in risk of incident cardiovascular disease compared to their counterparts with neither condition, which investigators noted was significantly higher than the increase in risk observed for either condition individually.

“This cohort study found that over time, co-occurrence of [Gestational Diabetes] and [Gestational Hypertensive Disorder] was associated with a much greater postpartum CVD risk than the individual conditions. The systematic identification of both [Gestational Hypertensive Disorder] and [Gestational Diabetes] in obstetrical practice offers an opportunity for a more effective CVD prevention among young women of childbearing age.”

Despite advances across medicine, pitfalls in care and maternal morbidity remain persistent issues for health care systems in North America. With this in mind, a team from Johns Hopkins University School of Medicine, Mount Sinai Hospital, and the Institute for Clinical Evaluative Studies in Toronto, Canada sought to further explore the impact of gestational hypertensive disorders and gestational diabetes on subsequent cardiovascular risk. To do so, they designed a population-based cohort study using data from the Ministry of Health and Long-Term Care of Ontario health care administrative databases, which is that provide investigators with information related to 866,295 women in Ontario with a gestational hypertensive disorder and/or gestational diabetes diagnosis, and a live-birth singleton delivery from July 1, 2007-March 31, 2018 for inclusion in their analyses.

Study participants were identified using diagnostic coding. Investigators pointed out women with pregravid diabetes, hypertension, or cardiovascular disease were excluded from the study. The 866,295-person cohort included in final analyses had a mean age of 30 (SD, 5.6) years.

The primary outcome of interest for the investigators analyses was incident cardiovascular disease, which was a composite of myocardial infarction, acute coronary syndrome, stroke, coronary artery bypass grafting, percutaneous coronary intervention, or carotid endarterectomy. Associations were assessed using Cox regression models, with adjustment for relevant cardiometabolic risk factors.

Overall, 4.9% had an isolated gestational hypertensive disorder, 6.1% had isolated gestational diabetes, and 0.6% had both a gestational hypertensive disorder and gestational diabetes. During the follow-up period, which lasted a mean of 12.8 years and included 7.0 million person-years, a total of 1999 cardiovascular disease events were observed among the study cohort, with 867 occurring during the first 5 years postpartum and 1162 events occurring during the period subsequent to the first 5 years post index delivery.

Results of the investigators’ analysis indicated there was no association of co-occurrence of gestational hypertensive disorders and gestational diabetes (aHR, 1.42 [95% CI, 0.78-2.58]) or gestational diabetes alone (aHR, 0.80 [95% CI, 0.60-1.06]) with incident cardiovascular disease in the first 5 years postpartum. However, investigators noted there was an association observed between isolated gestational hypertensive disorders and incident CVD compared with no gestational hypertensive disorders and no gestational diabetes (aHR, 1.90 [95% CI, 1.51-2.35]) during this time period. 

When assessing risk after the initial 5-year period, results suggested isolated gestational hypertensive disorder (aHR, 1.41 [95% CI, 1.12-1.76]) and co-occurrence of gestational hypertensive disorders and gestational diabetes (aHR, 2.43 [95% CI, 1.60-3.67]) were each associated with a higher risk of incident cardiovascular disease compared to no gestational diabetes and no gestational hypertensive disorder. Investigators pointed out no association was observed between isolated gestational diabetes and incident cardiovascular disease.

“In this large population-based cohort study, extended follow-up after delivery found that while [Gestational Hypertensive Disorder] and [Gestational Diabetes] would each be individually associated with a high risk of CVD, women who experienced both [Gestational Hypertensive Disorder] and [Gestational Diabetes] during a pregnancy were ultimately at significantly higher absolute and relative risk of CVD, as compared to those without either of these conditions,” investigators wrote. “Over time, this risk became more pronounced than that observed among women with each of these conditions separately.”

Association of Concomitant Gestational Hypertensive Disorders and Gestational Diabetes With Cardiovascular Disease

An analysis of more than 800k women in Canada provides insight into the apparent increase in risk of incident cardiovascular disease associated with co-occurrence of gestational diabetes and gestational hypertensive disorders in pregnant women. 

Co-Occuring Gestational Diabetes, Hypertension Linked with Doubling of Future Cardiovascular Risk

The last weekend of each month, our editorial team compiles a list of our most popular endocrinology content from the past month for a month in review recap. The November 2022 endocrinology month in review features coverage of the FDA’s approval of teplizumab, new data related to use of GLP-1 receptor agonists, and a trio of stories on topics pertaining to diabetes technology.

The month of November played host to what some suggest is the greatest advance in diabetes management since the discovery of insulin more than 100 years ago. More than 3 years had elapse since the release of phase 2 data detailing the effects of teplizumab, that included the receipt of a Complete Response Letter and being the subject of an FDA Advisory Committee meeting, but on November 17, 2022 the community witnessed the approval of the first agent indicated to delay the onset of type 1 diabetes in pediatric and adult patients. As part of the month in review, we are highlighting our the 

coverage of the approval announcements from the US FDA and Provention Bio, as well as a special edition episode of 

Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives 

that provides in-depth insights into what the approval means for the community and the next steps for education and rollout of the agent.

Teplizumab Receives FDA Approval for Delaying Type 1 Diabetes

On November 17, the US FDA announced the approval of teplizumab (Tzield), which is administered through IV infusion once daily for 14 consecutive days, for delaying the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years and older who currently have stage 2 type 1 diabetes.

Diana Isaacs, PharmD, and Natalie Bellini, DNP, break down what the approval of teplizumab means for type 1 diabetes. During the episode, hosts take a deep dive into type 1 diabetes staging and hypothesize around the role of CDCES in educating primary care and other specialties to optimize the potential of teplizumab.

News & Updates in Use of GLP-1 Receptor Agonists

Recently, not a week goes by without clinically impactful data related to GLP-1 receptor agonists being published. The month of November saw a slew of new studies and information surrounding agents within the class in scientific journals and meetings, such as Obesity Week and the Obesity Medicine Association (OMA) annual meeting. For the November month in review, we’re highlighting our coverage of the STEP TEENS trial, which was published in the 

 featuring Lydia Alexander,president-elect of the OMA, discussing the latest updates in obesity management.

STEP TEENS: Semaglutide 2.4 mg (Wegovy) Weight Loss Benefits Translate to Adolescent Populations

Data from the STEP TEENS trial, which assessed the benefits of semaglutide 2.4 mg (Wegovy) in individuals aged 12-18 years with overweight or obesity, indicates use of the GLP-1 receptor agonist was associated with a mean reduction in body weight of 16% during the 68-week trial.

Diabetes Dialogue: Obesity Updates, with Lydia Alexander, MD

In this episode, Diana Isaacs, PharmD, and Natalie Bellini, DNP, are joined by Lydia Alexander, MD, president-elect of the Obesity Medicine Association, to discuss the updates in the landscape of obesity management as well as a deep dive into the recent American Gastroenterological Association guidelines for pharmacological management and the OMA's annual meeting.

The highlights from our editorial coverage related to diabetes technologies for the month of November include a trio of stories that could be described as the Good, the Bad, and the Ugly. The Good: A new study assessing ease of use of the newest generation of the Dexcom CGM system in older people with type 2 diabetes suggests setup of the Dexcom G7 CGM required half as many steps to set up and deploy as the G6 system. The Bad: On November 17, the US FDA issued a Class I Recall, the most serious type of recall, for Insulet Omnipod DASH Insulin Management System PDMs over issues with device batteries, including instances that led to fires. The Ugly: A new study from Johns Hopkins draws attention to racial disparities in prescription and frequency of patient-provider discussions surrounding CGM and insulin pumps, an unfortunate reality that plagues optimal uptake of these devices.

Study Finds Dexcom G7 Setup is Easier, Requires Fewer Tasks for Older Adults than Previous Generations

A formal task analysis conducted in older adults with type 2 diabetes provides insight into the ease of use and task burden associated with uptake of the Dexcom G7 CGM system, with results indicating use of the system required fewer than half as many steps to initiate as previous generations of the CGM system.

Black Patients Less Likely to be Prescribed, Have Discussions around CGMs, Insulin Pumps


A Johns Hopkins-led analysis provides a snapshot of trends in racial disparities seen in regard to both uptake and engagement in discussions with providers around continuous glucose monitoring and insulin pumps among adults with type 1 diabetes.

The November 2022 endocrine month in review features coverage of the FDA’s approval of teplizumab, new data related to use of GLP-1 receptor agonists, and a trio of stories on topics pertaining to diabetes technology.

Endocrine Month in Review: November 2022

Integration of weight training into weekly physical activity regimens was linked to a decreased risk of all-cause mortality among people with and without 

, according to an analysis of data from male health professionals in the US.

An analysis of data from the Health Professional Follow-up Study, results of the study, which included more than 30,000 men and 26 years of follow-up data, indicate integration of long-term weight training was associated with a reduction in all-cause mortality among participants without type 2 diabetes, even with adjustment for aerobic activity, while the benefits of weight training on all-cause mortality in those with type 2 diabetes appeared to be more complicated.

“Our study supports the current physical activity guidelines and provides additional evidence for the optimal amount of long-term weight training independently and jointly with aerobic activity to maximize longevity benefits in adults with and without type 2 diabetes," wrote investigators.

As the knowledge base surrounding the impact of different forms of aerobic and anaerobic activities, debate has emerged regarding the ideal amount of each form of activity as part of a person’s lifestyle routine. Without a dedicated randomized controlled trial, clinicians and researchers have turned to observational data and retrospective analyses to better understand what constitutes optimal levels of each form of physical activity in different patient groups.

To develop a greater understanding of the associations of long-term weight training and mortality in men, investigators designed the current study as an analysis of data recorded within the Health Professional Follow-up Study. Launched in 1986, the study enrolled 51,529 male health professionals aged 40-75 years. As part of the follow-up protocol, the study assessed patient information via a biennial questionnaire, which began assessments of weight training as part of their evaluations of physical activity in 1990.

Limiting their analyses to those with at least one 1 measure of weight training at baseline, investigators identified 31,140 men without type 2 diabetes and 2,588 men with type 2 diabetes for inclusion in the current study. The aforementioned questionnaires asked participants to report average weekly time spent weightlifting or using a nautilus or weight machine, with the options including 0 minutes, 1-4 min, 5-19 min, 20-59 min, 1 hour, 1-1.5 hours, 2-3 hours, 4-6 hours, 7-10 hours, or 11 or more hours. Investigators noted up to 13 repeated measures of weight training information were collected during the follow-up period, with a median of 11 measures occurring per participant.

For the purpose of analysis, Cox regression was used to estimate hazard ratios (HRs) for all-cause mortality. These models were adjusted for age, height, race, smoking status, family history of myocardial infarction, family history of cancer, baseline hypertension, alcohol consumption, AHEI score 2010, total calorie intake, time spent sitting to watch television, BMI, and aerobic activity level.

Among the 33,728 individuals included in the study, 12,607 deaths were documented, with 988 deaths occurring among men with type 2 diabetes. Upon analysis, results suggested 1-59 and 60-149 minutes per week of long-term weight training were associated with 14% (HR, 0.86 [95% CI, 0.82-0.89]) and 8% (HR, 0.92 [95% CI, 0.85-0.99]) lower mortality versus no weight training, respectively, among those without type 2 diabetes after adjustment for aerobic activity. Further analysis among men without type 2 diabetes indicated long-term weight training 150 minutes or more per week was not significantly associated with mortality (HR, 1.05 [95% CI, 0.91-1.20]; overall 

Among men with type 2 diabetes, results of the investigators’ analysis indicated those with 1-59 and 60-149 minutes per week of prediagnosis weight training had 32% (HR, 0.68 [95% CI, 0.48-0.96]) and 27% (HR, 0.73 [95% CI, 0.54-0.99]) lower risks of all-cause mortality, respectively. No decreased risk of mortality was observed for those with 150 minutes or more of per week weight training prediagnosis (HR, 1.11 [95% CI, 0.80-1.55]). Further analysis of this cohort suggested a weak inverse association between moderate levels of postdiagnosis weight training with all-cause mortality, but the association became nonsignificant after additional adjustment for postdiagnosis aerobic activity.

“Engaging in 30-60 minutes per week of long-term weight training was associated with lower risks of all-cause and cause-specific mortality, independently of aerobic activities. Moreover, the optimal benefit of mortality risk reduction was found in individuals performing above the recommended aerobic activity and any weight training,” investigators concluded. “Similar findings were observed in adults with type 2 diabetes, suggesting the benefit of engaging in moderate levels of pre- and postdiagnosis weight training, with aerobic activity, to reduce mortality.”

Long-term Weight Training and Mortality in U.S. Male Health Professionals With and Without Type 2 Diabetes

An analysis of data from the Health Professionals Follow-Up Study suggests incorporating weight training into physical activity regimens was associated with reduced mortality in patients with or without type 2 diabetes, with the association in those without diabetes present even after adjustment for aerobic activity levels. 

Incorporating Weight Training Into Physical Activity Regimen Linked to Reduced Mortality in Type 2 Diabetes

A new analysis of data from medical centers associated with Johns Hopkins Comprehensive Diabetes Center is underlining the existing racial disparities regarding 

continuous glucose monitoring (CGM) and insulin pumps

A retrospective analysis of data recorded from April 2013-January 2020, results of the study suggest Black patients with type 1 diabetes were not only less likely to receive a CGM system or insulin pump but also less likely to have their provider engage in discussions around use of newer diabetes technologies in analyses adjusted for social determinants of health and diabetes outcomes.

“Our findings revealed marked racial disparities in diabetes technology discussions, prescribing, and use in adults with [type 1 diabetes]. Further qualitative and well-designed prospective studies incorporating the perspectives of patients are needed to elucidate the causes behind these disparities in order to develop, implement, and evaluate strategies to reduce them,” wrote investigators.

Since the advent of CGM and insulin pumps into treatment algorithms for people with type 1 diabetes, mountains of data have emerged detailing the benefits of these technologies in management of type 1 diabetes. Despite the proven benefits on glycemic control and quality of life, suboptimal uptake reduces the potential population-level impact this technology could provide. With previous data outlining race-based disparities among diabetes technology uptake among children and adolescents with type 1 diabetes, a Johns Hopkins University School of Medicine-led team launched the current study to provide an overview of racial disparities related to diabetes technology among adults with type 1 diabetes receiving care at four diabetes clinics associated with the Johns Hopkins Comprehensive Diabetes Center.

A retrospective analysis focused on those who received care from April 2013-January 2020, investigators designed their analyses to examine baseline and prevalent technology use, rates of diabetes technology discussions, and prescribing of CGM systems and insulin pumps, with race categorized as Black and non-Black. For the purpose of analysis, investigators used multivariable logistic regression analysis to estimate associations of technology prescribing and discussions with patient race, with adjustment for social determinants of health and diabetes outcomes. Investigators noted CGM systems and insulin pumps were assessed separately.

Overall, 1258 patients were identified for inclusion in the current study. This cohort had a median age of 36 (IQR, 26-52) years and a median diabetes duration of 17 (IQR, 7-27) years. Of the 1258 included in the study, 19.2% were Black. Compared to their non-Black counterparts, Black adults with type 1 diabetes had fewer diabetes clinic visits (6 vs 7), more hospitalizations for diabetic ketoacidosis or hyperosmolar hyperglycemic state (10.4% vs 2.4%) and hypoglycemia (9.5% vs 2.0%), higher A1C levels (9.0% vs 7.5% for first HbA1c; 8.7% vs 7.4% for last HbA1c), and higher prevalence of microvascular complications (53.1% vs 36.5%).

Significantly lower baseline technology use was observed for both CGM (7.9% vs 30.3%) and insulin pumps (18.7% vs 49.6%) for Black patients compared with non-Black patients. Analysis of prevalent use revealed a similar trend, with CGM use observed among 43.6% of Black patients and 72.1% of non-Black patients and insulin pump use observed among 30.7% of Black patients and 64.2% of non-Black patients. When assessing CGM specifically, results indicated Black patients were 49% (aOR, 0.51 [95% CI, 0.29-0.90]) less likely to have a discussion around CGM with a provider and 39% (aOR, 0.51 [95% CI, 0.29-0.90]) less likely to receive a prescription for a CGM system. When assessing insulin pumps specifically, results indicated Black patients were 26% (aOR, 0.74 [95% CI, 0.44-1.25]) less likely to have a discussion around insulin pump use and 60% (aOR, 0.40 [95% CI, 0.22-0.70]) less likely to receive a prescription for an insulin pump.

“Prospective studies should assess the impact of provider type, training, and experience, racial concordance of provider and patient, quantity/quality of provider-patient discussions, patient sustained use of technologies, and ethnic disparities on technology use,” investigators concluded.

Racial Disparities in Access and Use of Diabetes Technology Among Adult Patients With Type 1 Diabetes in a U.S. Academic Medical Center

A Johns Hopkins-led analysis provides a snapshot of trends in racial disparities seen in both uptake of and engagement in discussions with providers around continuous glucose monitoring and insulin pumps among adults with type 1 diabetes.

An analysis of data from the UK Biobank study suggests universal screening programs for 

 among middle-aged adults could identify undiagnosed diabetes more than 2 years earlier than routine clinical care.

Using HbA1c measurements from individuals included within the UK Biobank cohort, results of the study indicate 1% of all those without a diabetes diagnosis had undiagnosed diabetes based on their HbA1c at baseline, with further analysis suggesting a screening initiative for adults aged 40-70 years could reduce the time to diagnosis by a median of 2.2 years.

“Our study provides the first population-based estimate of the impact of HbA1c-based screening on reducing the time to diabetes diagnosis. In UK Biobank, 1.0% of those aged 40–70 years had undiagnosed diabetes, and population-level HbA1c screening could have reduced the time to diabetes diagnosis in this group by a median of 2.2 years,” wrote investigators. “Earlier diagnosis would allow earlier intervention with the potential to reduce the risk of diabetes complications, but this requires further evaluation.”

As rates of type 2 diabetes continue to increase across the world, the potential of population-level interventions for early diagnosis and prevention have garnered considerable attention. With this in mind, a team from the University of Exeter launched the current study with the intent of producing the first study to detail how many diabetes diagnoses would be revealed earlier as a result of a population-level diabetes screening program.

As part of the UK Biobank study, individuals underwent clinical examinations at enrollment. Data from these examinations, which included an assessment of HbA1c, were not fed back to participants or clinicians. Of the 502,493 individuals recruited for the UK Biobank study, 466,488 had data related to HbA1c at enrollment. Further limiting their analyses to those with linked primary and secondary healthcare data as well as those without a preexisting diabetes diagnosis, investigators were left with a cohort of 166,846 individuals for inclusion in their analyses.

Using data from this cohort, investigators designed their study to estimate the reduction in time to diabetes diagnosis achieved by HbA1c-based screening among middle-aged adults using data from the UK Biobank cohort. To do so, investigators used Kaplan-Meier analysis to assess time between enrollment HbA1c measurement and subsequent clinical diabetes diagnosis in the next 10 years and to use Cox regression to identify factors associated with delayed diabetes diagnosis. For the purpose of analysis, undiagnosed diabetes was defined as an HbA1c level at or exceeding 6.5% at enrollment.

Of the 166,846 individuals included in the current study, 1703 (1.0%) had an HbA1c level meeting the criteria for undiagnosed diabetes at enrollment, with the mean HbA1c among this group at 6.8% (6.6–7.4). Investigators noted this group of 1703 would represent an additional 13% (95% CI, 12.4-13.6) of diabetes cases in the study population relative to the 13,077 with known diabetes. Compared to those without undiagnosed diabetes, those with undiagnosed diabetes at enrollment were on average older (61.4 [55.1–65.6] vs 60.9 [55.0–65.3] years)

<.001), were more predominately male (58.0% vs 58.3%), were living in more deprived areas, and were more likely to self-report being of non-white ethnicity (

Of the 1703 with undiagnosed diabetes at enrollment, 87.7% went on to receive a clinical diagnosis of diabetes during the follow-up period. Upon analysis, investigators found the median time to clinical diagnosis for those with undiagnosed diabetes was 2.2 years, with a median HbA1c at clinical diagnosis of 7.5% (IQR, 6.8-9.5). Investigators pointed out those enrolled in 2010 had a significantly shorter time to diagnosis than those enrolled in 2008 (1.8 years [95% CI 1.4-2.2] vs 2.3 years [95% CI, 2.1-2.6]; HR, 1.22 [95% CI, 1.04, 1.43], 

=.017). Further analysis suggested female participants with lower HbA1c and BMI measurements at enrollment experienced the greatest delays to clinical diagnosis.

“Unless diabetes risk scores are improved (especially in the low BMI group), population-based screening with HbA1c is the only way to reliably identify undiagnosed diabetes. However, the cost-effectiveness of this approach merits further assessment and will vary based on the degree of HbA1c testing in the underlying population,” investigators added.

The impact of population-level HbA1c screening on reducing diabetes diagnostic delay in middle-aged adults: a UK Biobank analysis