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Each month, our editorial staff compiles a recap of the top news in endocrinology from the past month. Our April 2023 month in review features top new studies, FDA approvals, and an overview of news surrounding Abbott readers.
The month of April was a busy one for the diabetes research community, with a plethora of new studies released and data announced. Although many top stories are featured in sections further along in this recap, a group of 4 studies not related to therapeutic pipelines or regulatory news stood out in terms of popularity among our audience.
An analysis of data from the Rotterdam Study suggests elevated heart rate could signal increased risk of type 2 diabetes, with this potential association strongest among younger people. Using data from more than 8000 people, Maryam Kavousi, PhD, of Erasmus University Medical Center, and a team of investigators performed bidirectional Mendelian randomization analyses and determined one standard deviation (SD) increase in heart rate was associated with the risk of developing type 2 diabetes (hazard ratio [HR], 1.20 [95% CI, 1.09-1.33]).
A systematic review and meta-analysis containing data from more than 29 million individuals diagnosed with COVID-19 from 60 countries is providing what might be the most comprehensive overview yet of the potential risk of COVID-19 and mortality associated with diabetes. Results of the study, which was conducted by Researchers from the China-Australia Joint Research Center for Infectious Diseases, found that diabetes contributed to 9.5% of severe COVID-19 cases and 16.8% of deaths.
The June 2021 approval of semaglutide 2.4 mg (Wegovy) for chronic weight management in adults with obesity or overweight with at least 1 weight-related condition, forever changed the landscape of obesity management. Since, GLP-1 receptor agonists and other weight loss therapies have come into the spotlight for their popularity, pricing, and even shortages of supply. In the current study, a team from the Royal Free Hospital NHS Trust found several anti-obesity medications could be manufactured and sold at low costs, but prices range widely between countries and hinder access to those most in need.
Few comorbidities go as underrecognized for their long-term mortality risk and impact on quality of life in people with overweight or obesity as nonalcoholic fatty liver disease (NAFLD). A retrospective, propensity score-matched analysis published in JAMA Network Open sought to compare the risk of cardiovascular events among people with NAFLD and obesity. Results of the study, which included matching cohorts of 4687 patients, indicated a significant reduction in relative risk was observed for new-onset heart failure (HR, 0.60 [95% CI, 0.51-0.70]), cardiovascular events (HR, 0.53 [95% CI, 0.44-0.65]), cerebrovascular events (HR, 0.59 [95% CI, 0.51-0.69]), coronary artery interventions (HR, 0.47 [95% CI, 0.35-0.63]), and all-cause mortality (HR, 0.56 [95% CI, 0.42-0.74]) for the bariatric surgery group.
Not a month has gone by in 2023 without major, potentially, practice-changing regulatory decisions. April was no different, with multiple companies announcing approvals or top line results in the world of diabetes management, including Omnipod GO, MiniMed 780G, and tirzepatide. Of note, this list does not include news related to Abbott readers from April 2023, which is highlighted in the next section.
On April 21, 2023, Medtronic announced the long-awaited US approval of their MiniMed 780G System with Smart Guard Technology and the Guardian 4 Sensor, which has been available in Europe for nearly 3 years. The system is approved for users 7 years or older with type 1 diabetes and Medtronic noted it will begin taking pre-orders for the device on May 15, 2023. The company also noted first shipments of the device are planned for later this summer and those using the MiniMed 770G System will be eligible to upgrade through a no-cost remote software upgrade.
On April 25, 2023, Insulet announced the FDA’s approval of the Omnipod GO for people with type 12 diabetes aged 18 years or older. A first-of-its-kind, basal-only insulin pod, the device is billed as a standalone, wearable, insulin delivery system capable a fixed rate of continuous rapid-acting insulin for 72 hours and was designed by Insulet with the intent of serving people with type 2 diabetes earlier in their treatment journey.
On April 27, 2023, Eli Lilly and Company announced topline data from the SURMOUNT-2 trial—just 364 days after the announcement of SURMOUNT-1 topline results. The latest release of data from the SURMOUNT program and tirzepatide, results of the study indicate use of tirzepatide was associated with mean weight changes of −13.4% (29.8 lb. or 13.5 kg) on 10 mg and −15.7% (34.4 lb.) on 15 mg compared to −3.3% (7.0 lb.) with placebo at 72 weeks. Further analysis of the coprimary endpoints indicated 81.6% and 86.4% of those taking the 10 mg and 15 mg tirzepatide achieved a body weight reduction of at least 5% compared to just 30.5% of those taking placebo.
In their announcement, Eli Lilly and Company noted plans to present full data at ADA 2023 and the company also plans to complete the US submissions for tirzepatide in adults with obesity or overweight with weight-related comorbidities in the coming weeks.
It was a month of highs and lows as it pertains to headlines for Abbott technology during the month of April. In the early half of the month, the FDA issued a Class I recall of Abbott readers, citing a risk of overheating. Later in the month, the company announced the FDA clearance of readers for their FreeStyle Libre 3 system, which paves the way for potential coverage by the Centers for Medicare and Medicaid Services. Later in the month, we recorded a special edition episode of Diabetes Dialogue to help the community make sense of the latest news and take a deep dive into what the CMS expansion of CGM coverage means for people with diabetes.