Diabetes Dialogue: Stelo OTC Availability and Omnipod 5 for Type 2 Diabetes

August 26, 2024 will be remembered as the start of a new era in glucose monitoring and management. A day beginning with Dexcom’s announcement of availability and pricing for the first OTC glucose sensor in the Dexcom Stelo and ending with the FDA’s announcement of clearance for the Omnipod 5 Automated Insulin Delivery System (AID) for adults with type 2 diabetes—the first AID to receive FDA clearance for type 1 and type 2 diabetes.

In this episode of Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives, hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, provide an overview of important facts surrounding the Dexcom Stelo, including price, personal experience, and outlook on future competitors, as well as a breakdown of the Omnipod 5 clearance and how SECURE-T2D informs use of the AID system in type 2 diabetes.

Dexcom Stelo Hits the Shelves

Dexcom announced the Dexcom Stelo would be available beginning on August 26, 2024 via the Stelo.com website at a price as low as $89.99 for a 2-pack of sensors. Cleared by the FDA on March 05, 2024, the Stelo is indicated for use by anyone 18 years and older who does not use insulin, such as 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.^1,2

According to Dexcom, the Stelo will be HSA/FSA eligible, available to pay-as-you-go customers for $99 for a single pack of 2 sensors for a total wear time of up to 30 days, and available to subscribers at a 10% savings by paying $89 per month for an ongoing subscription of the same 2-sensor pack delivered every 30 days.^1,2

The Stelo was the first of 3 OTC glucose monitors to receive FDA clearance through August 2024. In June 2024, On June 10, 2024, Abbott announced the FDA clearance of the Lingo and Libre Rio, which are intended for people 18 years and older looking to improve their overall health and those with type 2 diabetes not using insulin, respectively.^1,2

For more on the Stelo: check out this interview with Jake Leach, executive vice president and chief operating officer at Dexcom, from March 2024!

Omnipod 5 for T2D

Less than 12 hours after Dexcom made their announcement of availability and pricing, the FDA and Insulet announced expanded indications for the company’s SmartAdjust technology, which now means the Omnipod 5 AID system becomes the first FDA-cleared AID system for both type 1 and type 2 diabetes. According to Insulet Corporation, the FDA’s clearance is based, in part, on the results of the SECURE-T2D trial, which the company debuted at the 84th American Diabetes Association Scientific Sessions.^3,4

Results of the trial showed that, at 13 weeks, the mean HbA1c among the cohort decreased from 8.2% (SD, 1.3) at baseline to 7.4% (SD, 0.9) (treatment effect= -0.8%; 95% CI, -1.0 to -0.7; P <.001). When assessing secondary glycemic metrics, results indicated use was associated with a 20% increase in time in range of 70 to 180 mg/dL (4.8 hours per day) and a 20% decrease in time above 180 mg/dL (4.8 hours per day) (P <.001).^3,4

Relevant disclosures for Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Bellini include Abbott Diabetes Care, MannKind, Provention Bio, and others.

References:

1. Dexcom Inc. STELO BY DEXCOM, THE FIRST OVER-THE-COUNTER GLUCOSE BIOSENSOR IN THE U.S., IS NOW AVAILABLE. Dexcom Inc. August 26, 2024. Accessed August 26, 2024.
2. Campbell P. FDA clears Dexcom Stelo sensor, first OTC glucose sensor in agency history. HCP Live. March 5, 2024. Accessed August 65, 2024. https://www.hcplive.com/view/fda-clears-dexcom-stelo-sensor-first-otc-glucose-sensor-in-agency-history.
3. Office of the Commissioner. FDA clears first device to enable automated insulin dosing for individuals with type 2 diabetes. U.S. Food and Drug Administration. August 26, 2024. Accessed August 26, 2024. https://www.fda.gov/news-events/press-announcements/fda-clears-first-device-enable-automated-insulin-dosing-individuals-type-2-diabetes.
4. Insulet Corporation. Omnipod® 5 Automated Insulin Delivery System is now FDA-cleared for People with Type 2 Diabetes. Insulet Corporation. August 26, 2024. Accessed August 26, 2024. https://investors.insulet.com/news/news-details/2024/Omnipod-5-Automated-Insulin-Delivery-System-is-now-FDA-cleared-for-People-with-Type-2-Diabetes/default.aspx.