Stelo by Dexcom First Glucose Biosensor to be Cleared by FDA as Over-the-Counter

DexCom, Inc. (NASDAQ:DXCM), the global leader in real-time continuous glucose monitoring for people with diabetes, announced today that the FDA has cleared Stelo by Dexcom – the first glucose biosensor that doesn’t require a prescription. There are approximately 25 million people in the U.S. living with Type 2 diabetes who do not use insulin and who can benefit from continuous glucose monitoring (CGM) technology. Today, Dexcom G7 is available for them with a prescription. Stelo, cleared for use without a prescription, will make it even easier for this population to access leading CGM technology, and will provide an option for those who do not have insurance coverage for CGM.

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Stelo will be the first glucose biosensor in the US cleared for use without a prescription (Photo: Business Wire)

“Dexcom continues to lead innovation in the CGM market, with a long list of first-in-market advances. Dexcom was the first to connect CGM to multiple insulin delivery devices, the first to connect CGM to a smartphone, the first to replace fingersticks^‡ for treatment decisions, and now is creating a new category by bringing the first glucose biosensor cleared for use over-the-counter,” said Jake Leach, executive vice president and chief operating officer at Dexcom. “Based on our experience serving people with Type 2 diabetes not using insulin, we have developed Stelo with their unique needs in mind.”

Continuous glucose monitoring plays an integral role in the management of Type 2 diabetes and the benefits are proven when used alone, or alongside other diabetes and weight management medications.⁸ Studies show the use of Dexcom continuous glucose monitoring by people with Type 2 diabetes is associated with clinically meaningful improvement in time in range, A1c and quality of life.^9-12

“Use of CGM can help empower people with diabetes to understand the impact of different foods and activity on their glucose values,” said Dr. Tamara Oser, MD, Family Physician. “For people newly diagnosed with Type 2 diabetes or not taking insulin, these devices are often not covered by insurance and Stelo presents an opportunity to provide valuable information that can impact their diabetes management.”

Stelo will be available for purchase online without a prescription starting summer 2024. To learn more about Stelo and do a benefits check to see if you’re eligible to get started now with Dexcom G7, visit https://www.dexcom.com/en-us/stelo.

About DexCom, Inc.

DexCom, Inc. empowers people to take real-time control of health through innovative continuous glucose monitoring (CGM) systems. Headquartered in San Diego, Calif., and with operations across Europe and select parts of Asia/Oceania, Dexcom has emerged as a leader of diabetes care technology. By listening to the needs of users, caregivers, and providers, Dexcom works to simplify and improve diabetes management around the world. For more information about Dexcom CGM, visit www.dexcom.com.

^*Adults 18 years and older .^†Smart device sold separately. For a list of compatible devices, visit www.Dexcom.com/compatibility. ^‡If your glucose alerts and readings from Dexcom G7 do not match symptoms or expectations, use a blood glucose meter to make diabetes treatment decisions.

1 Dexcom, data on file, 2023. 2 Dexcom G7 User Guide, 2023. 3 Beck RW, et al. JAMA. 2017;317(4):371-378. 4 Beck RW, et al. Ann Intern Med. 2017;167(6):365-374. 5 Martens T, et al. JAMA. 2021;325(22):2262-2272. 6 Laffel LM, et al. JAMA. 2020;323(23):2388-2396. 7 Welsh JB, et al. J Diabetes Sci Technol. 2022:19322968221099879. 8 Grace T, Salyer J. Diabetes Technol Ther. 2022 Jan;24(1):26-31. doi: 10.1089/dia.2021.0212. PMID: 34524013; PMCID: PMC8783626. 9 Cox DJ, Banton T, Moncrief M, et al. J Endocr Soc 2020;4(11):bvaa118. 10 Hannah K, Nemlekar P, Norman G. Improved glycemic control after real-time continuous glucose monitor (rtCGM) initiation in patients with type 2 diabetes (PWT2D) stratified by insulin therapy and race/ethnicity. Presented at the 17th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD 2024), March 6-9, 2024, Florence, Italy and online. 11 Jepson LH, Welsh J, Green CR, et al. Diabetes 2023;72(Supplement_1):941-P. 12 Layne J, Jepson, Thomas R, et al. Non-insulin treated adults with type 2 diabetes benefit from CGM use: real-world data. Presented at the 17th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD 2024), March 6-9, 2024, Florence, Italy and online.

STELO IMPORTANT INFORMATION: Consult your healthcare provider before making any medication adjustments based on your sensor readings and do not take any other medical action based on your sensor readings without consulting your healthcare provider. Do not use if you have problematic hypoglycemia. Failure to use Stelo and its components according to the instructions for use provided and to properly consider all indications, contraindications, warnings, precautions, and cautions in those instructions for use may result in you missing a severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) occurrence. If your sensor readings are not consistent with your symptoms, a blood glucose meter may be an option as needed and consult your healthcare provider. Seek medical advice and attention when appropriate, including before making any medication adjustments and/or for any medical emergency.

DEXCOM PRESCRIPTION CGM BRIEF SAFETY STATEMENT: Failure to use the Dexcom Continuous Glucose Monitoring System and its components according to the instructions for use provided with your device and available at https://www.dexcom.com/safety-information and to properly consider all indications, contraindications, warnings, precautions, and cautions in those instructions for use may result in you missing a severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) occurrence and/or making a treatment decision that may result in injury. If your glucose alerts and readings from the Dexcom CGM do not match symptoms, use a blood glucose meter to make diabetes treatment decisions. Seek medical advice and attention when appropriate, including for any medical emergency.

Dexcom, Stelo, and any related logos and design marks are either registered trademarks or trademarks of Dexcom, Inc. in the United States and/or other countries.

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