Stelo by Dexcom First Glucose Biosensor to be Cleared by FDA as Over-the-Counter
- FDA clearance for Stelo by Dexcom, the first glucose biosensor in the US without a prescription.
- Stelo aims to empower people with Type 2 diabetes not using insulin to manage their health.
- Stelo, a small wearable sensor, will provide glucose insights directly to a user's smartphone.
- Dexcom G7 creators bring Stelo to market, targeting the summer of 2024 for availability.
- Approximately 25 million people in the US with Type 2 diabetes not using insulin can benefit from Stelo.
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The FDA clearance of Stelo, a non-prescription glucose biosensor, represents a significant milestone in diabetes care technology. This development could potentially expand the continuous glucose monitoring (CGM) market by making it more accessible to a broader segment of the population. Unlike traditional CGM systems, Stelo's over-the-counter availability targets the substantial number of Type 2 diabetes patients not on insulin therapy. This group has historically had limited access to CGM due to insurance constraints.
From a medical research perspective, increased availability of CGM devices like Stelo could lead to better diabetes self-management and potentially reduce long-term healthcare costs associated with diabetes-related complications. Clinical studies have linked CGM use with improvements in glycemic control, exemplified by reductions in A1c levels, which could translate into decreased risks for diabetic complications.
Dexcom's strategic move to introduce Stelo into the market aligns with the growing demand for user-friendly and accessible healthcare technologies. The decision to make Stelo available without a prescription taps into the consumer health empowerment trend, where individuals are increasingly seeking tools that offer more control over their health management. This could potentially disrupt the current CGM market dynamics, where prescription-based products dominate.
By analyzing the addressable market size of 25 million non-insulin-using Type 2 diabetes patients in the U.S., the commercial potential for Stelo is considerable. The product's unique selling proposition of being the first FDA-cleared, prescription-free glucose biosensor could provide Dexcom with a first-mover advantage in this new market segment. However, it remains to be seen how competitors will respond and how price sensitivity will affect adoption rates among the target demographic.
The FDA clearance of Dexcom's Stelo is likely to have a positive impact on the company's financial health. By entering the over-the-counter market, Dexcom is not only diversifying its product portfolio but also potentially increasing its total addressable market. The financial implications of this move could include an uptick in sales volume and revenue growth, particularly as the product reaches market saturation.
Investors should monitor the adoption rate of Stelo post-launch, as it will be a critical determinant of its financial success. Furthermore, the cost structure of producing and distributing Stelo, as well as the pricing strategy adopted by Dexcom, will be key factors in assessing the product's profitability. It's important to note that while the market opportunity is significant, the actual impact on Dexcom's financials will depend on the execution of their go-to-market strategy and the competitive landscape.
- Stelo will be the first glucose biosensor in the US cleared for use without a prescription
- Indicated for use for people 18 years and older who are not using insulin therapy
- A small, wearable sensor worn on the back of the upper arm, Stelo will provide glucose insights directly to a user’s smartphone†
- Created by the makers of Dexcom G7, the most accurate,1 easy-to-use2 and clinically-proven CGM brand,3-7 Stelo will empower even more people with Type 2 diabetes not using insulin to take control of health
- Stelo will be available summer of 2024
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
*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,
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
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Source: DexCom, Inc.
