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Our July 2023 endocrinology month in review features an FDA approval, topline results from a pair of major trials, and a pair of new guidelines related to the management and diagnosis of diabetes.
Following a historic June, which featured flagship meetings from major professional organizations and multiple pieces of FDA news, the bar was set for July 2023 and, although it did not feature a pair of flagship meetings and the same number of regulatory decisions, the field of endocrinology experienced what many fields would consider a year’s worth of innovation and advancement during the month of July 2023.
In the month in review, the editorial team of HCPLive Endocrinology highlights our most popular stories and content from July 2023, which includes approval of the world’s smallest durable insulin pump, new guidelines, and topline data from the SURMOUNT 3- and SURMOUNT-4 trials.
Tandem Mobi Insulin Pump, Billed as World's Smallest Insulin Pump, Receives FDA Clearance
On July 11, 2023, Tandem Diabetes Care announced the US Food and Drug Administration had granted clearance to their Tandem Mobi Insulin Pump. At less than half the size of the t:slim X2 pump, the Tandem Mobi Insulin Pump is billed as the world’s smallest durable automated insulin delivery device and is able to fit in a coin pocket, be clipped to clothing, or be worn on-body with an adhesive slide. The device, which is fully controllable from a mobile app or on-pump button, features a 200-unit insulin cartridge.
Eli Lilly and Company Announce Topline Data from SURMOUNT-3 and SURMOUNT-4
Just a month and a day after SURMOUNT-2 data was presented at the 83rd Scientific Sessions of the American Diabetes Association, Eli Lilly and Company announced topline results of the SURMOUNT-3 and SURMOUNT-4 trials. In SURMOUNT-3, which examined use with a 12-week lifestyle intervention, results suggest the combination was associated with a total mean weight loss of 26.6% at 84 weeks. The SURMOUNT-4 trial, which included an open-label lead-in period followed by a double-blind treatment period, met all primary and key secondary objectives for tirzepatide compared to placebo, with results underlining the importance of continued use of the medication.
ADA Releases Guidance on Use of Laboratory Analysis in Diagnosis, Management of Diabetes
Few fields have been the beneficiary of the sheer level of advancement witnessed within endocrinology and diabetes care since the turn of the century. In an effort to provide contemporary guidance incorporating best practices with the latest technology, the American Diabetes Association jointly published new guidance for use of laboratory analysis in the diagnosis and management of diabetes in collaboration with the American Association of Clinical Chemistry.
Released on July 20, 2023, the document is aimed at streamlining the diagnostic process, standardizing laboratory procedures, and ensuring people with diabetes receive the most comprehensive and accurate care.
ASA Urges Withholding GLP-1 RA Therapy Prior to Elective Procedures
The American Society of Anesthesiologists released new guidance recommending the withholding of GLP-1 receptor agonists ahead of elective procedures or surgeries. The recommendations, which were created by an ASA Task Force on Preoperative Fasting, come as the popularity of the class surges to an all-time high with interest in their weight-lowering benefits and includes recommendations for days preceding and the day of the surgery or procedure. In their release announcing the recommendations, the ASA underlined evidence of regurgitation and pulmonary aspiration of gastric contents is sparse limited only to several case reports.
Expanded CGM Access Could Usher in New Era of Diabetes Management
The HCPLive editorial team launched their latest collaborative feature series in early July. This series, titled “The Unreached”, examined unique, often overlooked patient populations from across different fields in medicine. Among these installments is a feature examining the impact of the recent expansions in access to continuous glucose monitoring technology by the Centers for Medicare and Medicaid Services.
Hear perspective on what these changes mean for people with diabetes and care providers from leading experts, including Christine Schumacher, PharmD, of Midwestern University College of Pharmacy, Eugene Wright, MD, of the Charlotte Area Health Education Center and Duke University Medical Center, and Cara Liday, PharmD, of Idaho State University.