Stelo by Dexcom First Glucose Biosensor to be Cleared by FDA as Over-the-Counter
- 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†
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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
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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.
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
“Use of CGM can help empower people with diabetes to understand the impact of different foods and activity on their glucose values,” said Dr.
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
*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.
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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.
Category: IR
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Media Contact
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