Dexcom Secures FDA Authorization for Stelo Glucose Biosensor System, First OTC CGM for Non-Diabetic and Non-Insulin Using Individuals

September 20, 2026

Devices@FDA (Dexcom) USA

Overview

Dexcom, Inc. has received FDA authorization for its ‘Stelo Glucose Biosensor System,’ marking it as the first over-the-counter (OTC) integrated continuous glucose monitor (iCGM) specifically for individuals without diabetes and type 2 diabetics not using insulin. This approval expands CGM technology beyond its traditional use for diabetic patients, offering a new tool for a broader population to understand and improve their glucose levels for better health management. This represents a significant milestone in expanding the CGM market and enhancing access to personal health monitoring.

In Depth

Key Findings

Dexcom, Inc. has obtained U.S. Food and Drug Administration (FDA) authorization for the ‘Stelo Glucose Biosensor System,’ making it the first integrated continuous glucose monitor (iCGM) available over-the-counter (OTC) for individuals who do not have diabetes and for adults with type 2 diabetes who do not use insulin. This landmark approval significantly broadens the accessibility of CGM technology, traditionally reserved for diabetes management, to a wider consumer base, empowering more people to leverage glucose data for proactive health understanding and improvement.

Technical / Clinical Details

Product Name: Stelo Glucose Biosensor System.
Regulatory Status: FDA authorization as an OTC iCGM, meaning it can be purchased without a prescription.
Intended User Population: Adults without diabetes and adults with type 2 diabetes who are not on insulin therapy. This distinguishes Stelo from existing CGM products, which typically require a prescription and are indicated primarily for insulin-treated diabetic patients.
Technological Foundation: The Stelo system utilizes a small, disposable sensor worn on the skin to continuously measure glucose levels in the interstitial fluid in real-time. This data is transmitted wirelessly to a smartphone application, allowing users to track their glucose trends and patterns throughout the day and night.
Health Applications: For non-diabetic individuals, Stelo provides insights into how diet, exercise, stress, and other lifestyle factors influence their glucose levels, facilitating informed decisions for lifestyle modifications. For non-insulin-using type 2 diabetics, it offers valuable information to optimize dietary management and physical activity plans.

Background & Context

Historically, continuous glucose monitors have been primarily prescribed for stringent glycemic control in individuals with insulin-dependent diabetes. However, there has been a growing recognition of the importance of glucose variability in metabolic health and disease risk, even among healthy individuals and those with prediabetes. The FDA’s OTC authorization for the Stelo system addresses this broader need, bolstering a consumer-driven approach to personal health monitoring. This move is anticipated to further accelerate the growth and innovation within the wider wearable health device market.

Strategic Significance & Outlook

The FDA authorization of the Stelo Glucose Biosensor System marks a pivotal moment in the future of personal healthcare. It enables individuals who are not diabetic or do not use insulin to access detailed physiological data that was previously only available in specialized medical settings. This data can contribute to achieving a wide range of health goals, including preventive care, personalized nutrition, and optimized exercise performance. Increased market competition and technological innovation are expected, potentially leading to the rapid development of more user-friendly and feature-rich OTC CGM devices, ultimately enhancing public health engagement and outcomes.

Source: https://www.accessdata.fda.gov/SCRIPTS/cdrh/devicesatfda/index.cfm?db=pmn&id=K234070

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