Endocrinology Month in Review: March 2024
In this endocrinology month in review for March 2024, we recap the most popular FDA news and pipeline updates as well as recognizing the 2-year anniversary of Diabetes Dialogue.
The month of March 2024 was a historic one for endocrinology and the diabetes community. Following February 2024 where the top headlines were related to survodutide and tirzepatide, March 2024 continued this rush of pipeline news and also featured numerous historic regulatory decisions for pharmacotherapies and devices in management of diabetes.
In this endocrinology month in review for March 2024, we recap the most popular FDA news and pipeline updates as well as celebrating the 2-year anniversary of Diabetes Dialogue.
FDA News and Pipeline Updates
FDA Clears Dexcom Stelo Sensor, First OTC Glucose Sensor in Agency History
On March 05, 2024, the US FDA and Dexcom made history with the clearance of the Stelo sensor as the first over-the-counter glucose sensor approved in agency history.
Designed for use by anyone 18 years and older who does not use insulin, including individuals with diabetes treating their condition with oral medications or those without diabetes who want to better understand how diet and exercise may impact blood sugar levels, the Stelo sensor will offer a 15-day sensor wear and a cash-pay option for consumers, with availability expected to begin in Summer 2024.
Semaglutide (Wegovy) Receives FDA Label Expansion to Include Cardiovascular Risk Reduction
Although no PDUFA date was publicly announced, a label expansion for cardiovascular risk reduction for semaglutide 2.4 mg (Wegovy) was a foregone conclusion to many following results of the SELECT trial. However, the field was unaware what the label expansion would entail.
This question was answered on March 08, 2024, when the FDA announced it had approved a label expansion indicating the GLP-1 receptor agonist reducing the risk of cardiovascular death, heart attack, and stroke in adults with cardiovascular disease and obesity or overweight. The approval marked the first time in agency history it had approved a treatment for reducing cardiovascular risk specifically for patients with overweight or obesity.
FDA Grants Clearance to Sequel's twiist AID System for Type 1 Diabetes
In a much more under-the-radar announcement relative to semaglutide new indication, the FDA clearance of Sequel Med Tech’s twiist automated insulin delivery system on March 18, 2024 caught many in the diabetes community by surprise. A system designed by the inventor of the world’s first wearable infusion insulin pump, the twiist will leverage the Tidepool Loop algorithm and is cleared for use in patients aged 6 years and older with type 1 diabetes.
Semaglutide 1.0 mg (Ozempic) Reduced Kidney Events 24% in FLOW Trial
On March 05, 2024, Novo Nordisk announced topline data from the FLOW trial indicate semaglutide 1.0 mg (Ozempic) was associated with a 24% reduction in risk of kidney disease-related events among individuals with type 2 diabetes and chronic kidney disease compared to placebo therapy.
Novo Nordisk Delivers Updates on Development of Semaglutide, CagriSema, Amycretin, and More
As part of their Capital Markets Day presentation on March 07, 2024, Novo Nordisk provided a host of updates for the medical community as it relates to the company’s cardiometabolic pipeline.
During the event, which was broadcast virtually, the company brought further updates related to the development of semaglutide 2.4 in cardiovascular conditions and osteoarthritis, information on the cagrisema phase 3 REDFINE program,an update on the oral small molecule CB1R inverse agonist monlunabant, and new information from the oral and subcutaneous versions of amycretin.
Diabetes Dialogue
The remainder of our month in review for March 2024 recognizes our flagship endocrinology podcast, which celebrated its 2-year anniversary on March 30, 2024. To celebrate, we launched 2 new episodes. In this section of our month in review, we highlight the 8 episodes of Diabetes Dialogue published during March 2024.
SELECT, Semaglutide, & the Future of Incretin Therapies, with A. Michael Lincoff, MD
In this episode, hosts are joined by co-chair of the SELECT steering committee A. Michael Lincoff, MD, to discuss results, potential explanations for cardiovascular benefit beyond weight reduction, FLOW trial implications, and the future of incretin therapies.
Tirzepatide and the Future of Incretin Therapies, with Timothy Garvey, MD
In this episode, hosts are joined by SURMOUNT-2 principal investigator Timothy Garvey, MD, to discuss the approval of the tirzepatide for chronic weight management, data from the SURMOUNT-2, -3, and 4 programs, the future of incretin therapies, and more.
Stelo News and Dexcom CGM Updates, with Jake Leach
In this episode, Jake Leach, COO of Dexcom, joins the podcast to discuss the historic clearance of the Stelo sensor and other updates in CGM from the company.
FLOW Trial and Chronic Kidney Disease Updates, with Brendon Neuen, MBBS, PhD
In this episode, Neuen talks about the FLOW trial, the concept of 4 pillars of guideline-directed medical therapy for CKD in type 2 diabetes, and how to approach sequencing of these therapies.
T1D Glycemic Improvement and CRISTAL at ATTD 2024
In this episode, hosts discuss top news and updates in automated insulin delivery from ATTD 2024, with a focus on new data from the T1D Exchange and a read-out from the CRISTAL study.
In this episode, all things automated insulin delivery from ATTD 2024, including updates from Insulet Corporation and Omnipod, study data from the Control IQ algorithm, the SMASH study, and a peak into the future with the Neural Network AID algorithm.
Hot Topics and Updates from ATTD 2024
In this episode, hosts discuss GLP-1 RA use and CGM technology, updates in once-weekly insulins, the concept of continuous ketone monitoring, and practical application of artificial intelligence into care.
What to Know about Sequel Med Tech's twiist AID System, with Alan Lotvin, MD
In this episode, Alan Lotvin, MD, of Sequel Med Tech, joins hosts for a deep dive into the twiist automated insulin delivery system, which received clearance for people with T1D in March 2024.
