Diabetes Dialogue: Stelo News and Dexcom CGM Updates, with Jake Leach

In 2024, the diabetes community will celebrate an important anniversary: 25 years since the introduction of the first FDA-cleared continuous glucose monitor (CGM).

The MiniMed 620 from Medtronic provided 5-minute averages of glucose values based on readings taken every 10 seconds. In the more than 2 decades since the technology was introduced, advances in CGM have transformed diabetes management.¹

Now, 25 years later, the community is celebrating another major breakthrough in CGM technology: the first over-the-counter glucose sensor, which became a reality on March 05, 2024 with the FDA’s clearance of the Dexcom Stelo Glucose Biosensor System.

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.

To celebrate this historic win for the diabetes community and learn more about Stelo as well as other Dexcom products, hosts of Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives recorded a special edition episode with Jake Leach, chief operating officer of Dexcom. The episode itself represents a follow-up to a conversation a year ago at International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) 2022, where Leach discussed the ongoing global rollout of the Dexcom G7 and how he expected expanded coverage of the device to open doors to greater personalization of care for people with diabetes.

In the current episode, Leach and hosts touch upon the Stelo clearance, its accuracy relative to other CGM devices, plans for rollout and pricing, the importance of increased accessibility of CGM technology, and the push for greater accuracy in glucose monitoring devices.

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

References:

1. Campbell P. FDA clears dexcom Stelo sensor, first OTC glucose sensor in agency history. HCPLive. March 5, 2024. Accessed March 20, 2024. https://www.hcplive.com/view/fda-clears-dexcom-stelo-sensor-first-otc-glucose-sensor-in-agency-history.
2. Didyuk O, Econom N, Guardia A, Livingston K, Klueh U. Continuous Glucose Monitoring Devices: Past, Present, and Future Focus on the History and Evolution of Technological Innovation. J Diabetes Sci Technol. 2021;15(3):676-683. doi:10.1177/1932296819899394