Morgan Klein, PharmD; New Ulm Medical Center
There are approximately twenty-five million people in the United States living with type 2 diabetes (T2D) who do not use insulin. Continuous glucose monitors (CGMs) play an important role in the management of T2D. Studies have shown that CGMs are associated with clinically meaningful improvements for time in range, A1c, and quality of life. The Dexcom Stelo Glucose Biosensor is the first FDA approved CGM available to patients eighteen years and older without a prescription. The Dexcom Stelo will be available for purchase online starting summer 2024.
Dexcom Stelo is a wearable sensor that is applied to the back of the arm and can be paired with an application on the user’s smartphone. It continuously measures, records, and displays glucose values and presents blood glucose measurements and trends every fifteen minutes via the application. This sensor can be worn up to fifteen days before needing to be replaced. The Dexcom Stelo is not for individuals at risk for hypoglycemia as the system will not alert the user of low blood sugars.
An over-the-counter (OTC) CGM can also be used by those without diabetes who want to understand how diet and exercise can impact blood sugar levels. Additionally, glucose monitoring with smartphone connectivity eliminates the need for frequent finger sticks for treatment decisions which requires adequate hand dexterity, blood circulation, and adherence to the process. A CGM is able to overcome all these challenges. Providing this device OTC will increase access to CGM technology and will also provide options for those who do not have insurance coverage for a CGM. The Dexcom Stelo will help prevent many of the complications related to T2D by allowing patients to be more involved in their care.
References:
- Stelo by Dexcom first glucose biosensor to be cleared by FDA as over-the-counter. Business Wire. March 5, 2024. Accessed April 7, 2024. https://www.businesswire.com/news/home/20240305044213/en/Stelo-by-Dexcom-First-Glucose-Biosensor-to-be-Cleared-by-FDA-as-Over-the-Counter.
- Gallagher A. FDA clears first OTC continuous glucose monitoring, dexcom Stelo Glucose Biosensor system. Pharmacy Times. March 6, 2024. Accessed April 7, 2024. https://www.pharmacytimes.com/view/fda-clears-first-otc-continuous-glucose-monitoring-dexcom-stelo-glucose-biosensor-system.
- FDA clears first over-the-counter continuous glucose monitor. U.S. Food and Drug Administration. March 5, 2024. Accessed April 7, 2024. https://www.fda.gov/news-events/press-announcements/fda-clears-first-over-counter-continuous-glucose-monitor.