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

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! 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