The FDA cleared the first over-the-counter (OTC) continuous glucose monitoring system (CGM) on March 5, 2024. The Dexcom Stelo glucose biosensor system is an integrated CGM (iCGM) suitable for individuals aged 18 and above who do not use insulin, including those using oral medications to treat diabetes or those non-diabetic individuals who wish to better understand how diet and exercise affect blood sugar levels. This system is not suitable for individuals with severe hypoglycemia problems, as it is not designed to alert users to this potential danger.
We helped Dexcom obtain NMPA Class III device approval certificate. Contact us at info.accelgroups.com to expedite your China or U.S market entry.
For NMPA guideline on continuous glucose monitoring system, please click HERE
Significance to Industry
Dr. Jeff Shuren, Director of the FDA’s Center for Devices and Radiological Health, pointed out that CGMs can be powerful tools for monitoring blood sugar. The approval expands access to patents by allowing individuals to purchase CGMs without the involvement of a healthcare provider. He said that providing valuable information about their own health, regardless of whether they have access to a doctor or health insurance, is an important step forward in advancing health equity for American patients.
This clearance marks the maturity of CGM technology and its potential for broader adoption beyond traditional patient populations. It opens the door to intensified competition in the CGM market, which may drive cost reductions and innovations in sensor technology, application development, and user experience.
More CGM products worldwide will become OTC products, greatly promoting consumer purchasing and use. The Chinese big players in the space include Huawei, POCTech, Yuyue Medical, Sinocare, and Weitai Medical, etc.
What’s the Device
The Dexcom Stelo glucose biosensor system provides continuous 15-day blood glucose monitoring without the need for traditional fingerstick blood sampling, providing users with comprehensive blood glucose level information.
Users can observe trends and patterns in blood glucose levels, helping them make informed decisions about diet, exercise, and medications (after consulting with healthcare professionals).
It has several advanced features:
- Sensor: A small wearable sensor implanted subcutaneously measures interstitial fluid glucose levels every 15 minutes.
- Transmitter: Wireless communication transmission between the sensor and the application collects the data.
- Mobile Application: Displays blood glucose readings and trends, enabling users to visualize and track their blood glucose levels.
- Algorithms: Analyze sensor data, providing blood glucose trends, directions (rising, falling, or stable), and potential alerts.
- Clinical Performance: Clinical study data provided to the FDA shows that the device’s performance is similar to other iCGMs. Adverse events reported in the studies include local infections, skin irritation, and pain or discomfort.
- Increased Accessibility: Consumers, especially those with prediabetes or undiagnosed diabetes, can now access CGM technology without a prescription, which may lead to increased awareness of diabetes risk populations and earlier interventions.
Potential Challenges
- Data Misinterpretation: The disclaimer that the device is not intended for making treatment decisions without consulting healthcare professionals requires robust educational efforts to ensure responsible use and interpretation of data by non-medical users.
- Reimbursement Issues: Uncertainty about insurance coverage for OTC CGMs may pose affordability barriers for some users.
- Regulatory Considerations: As the first OTC CGM, Stelo sets a precedent for the future regulatory pathway of similar devices. Regulatory agencies need to strike a balance between accessibility and patient safety, particularly regarding Stelo’s limitations in alerting low blood sugar.
About Accel
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