FDA Clears First Over-the-Counter Continuous Glucose Monitor for Children

FDA Clears Dexcom's Stelo CGM for Over-the-Counter Pediatric Use

The U.S. Food and Drug Administration (FDA) has cleared Dexcom Inc.'s Stelo Glucose Biosensor System, an integrated continuous glucose monitor (iCGM), for over-the-counter (OTC) use in children aged two years and older who do not use insulin. This marks the first OTC CGM clearance for pediatric patients, expanding access for children with prediabetes, those with diabetes on oral medication, and individuals seeking to understand how lifestyle impacts their glucose levels. The system was previously cleared for OTC use in adults 18 years and older in March 2024. This clearance aims to address the rising concern of prediabetes in children by providing real-time glucose data to help manage glycemic awareness and support healthier long-term outcomes.

• The clearance of Dexcom's Stelo Glucose Biosensor System for pediatric OTC use is a significant advancement in addressing the growing issue of prediabetes in U.S. children. It provides a crucial tool for children aged two and older who do not use insulin, as well as those with diabetes managed by oral medication, and individuals interested in monitoring glucose responses to diet and exercise, fostering greater glycemic awareness and supporting proactive health management.
• The Stelo Glucose Biosensor System consists of a wearable sensor paired with a compatible smartphone application, continuously measuring and displaying glucose values every 15 minutes. Each sensor is designed to last up to 15 days, though wear time may vary in pediatric users. This functionality empowers pediatric patients and caregivers to track glucose patterns and make informed lifestyle adjustments, with the important caveat that medication adjustments should always be made in consultation with a healthcare provider.
• The FDA's regulatory decision was supported by real-world evidence (RWE) combined with previous clinical study data from both pediatric and adult populations to assess device performance. While mild adverse events such as local infection and skin irritation were reported, the system is not indicated for individuals with problematic hypoglycemia or those on dialysis. For children, the device must be used under adult caregiver supervision, and individuals with a history of disordered eating should consult their healthcare provider before use.

Stelo's OTC Clearance: Shifting the Pediatric Glucose Monitoring Landscape

The treatment landscape for glucose monitoring in children not using insulin and diabetes patients on oral medication has undergone significant transformation over the past five years, driven by expanding continuous glucose monitoring (CGM) capabilities and growing evidence supporting its use in non-intensive therapy populations. A growing body of evidence suggests that CGM use may confer similar glycemic benefits in type 2 diabetes individuals who are treated with less-intensive therapies, with investigators exploring the potential use of CGM as an aid in weight management and to improve glycemic control while promoting adoption of desired health behaviors within broader type 2 diabetes and prediabetes populations.

Numerous prospective, retrospective, and observational studies have investigated the impact of CGM in various diabetes populations treated with nonintensive therapies, with results from these studies contributing to changes in payer coverage, prescriber behaviors, and expanding use of CGM technology. Blood glucose monitoring is now routinely used for patients with type 2 diabetes, even without intensified insulin therapy, as capillary blood glucose testing with glucose meters has been largely replaced by continuous glucose monitoring with subcutaneous sensors since the early 2000s. The performance of glucose sensors has been well established in terms of improving glycemic control and preventing certain complications associated with diabetes, justifying an extension of their reimbursement coverage.

Professional guidelines have evolved to reflect this expanding evidence base, with the American Diabetes Association updating its evidence-based Standards of Medical Care in Diabetes in 2022 around the use of CGM, as has the American Association of Clinical Endocrinology. However, research indicates that in normoglycemic participants with obesity, fasting insulin and HOMA-IR values may be more clinically useful than CGM data alone, despite excitement surrounding the use of commercial CGM products in obesity management, suggesting the need for targeted application of these technologies based on specific patient populations and clinical contexts.

Addressing Unmet Needs in Pediatric Prediabetes and Diabetes Management

Recent evidence highlights significant gaps in glucose monitoring access and implementation for pediatric populations and patients on non-insulin therapies. Current utilization patterns show CGM prescriptions were recorded for only 5.6% of treated Type 2 diabetes patients in late 2022, with 94% of these users requiring insulin therapy. This indicates that approximately 0.34% of all treated patients were using CGM without insulin, demonstrating substantial underutilization in non-insulin populations.

• Coverage and access barriers remain a primary unmet need, as many policymakers and payers are reluctant to provide CGM coverage for patients treated with noninsulin therapies, despite evidence showing these individuals experience the same glycemic benefits from CGM use as those on more intensive treatment regimens

• Educational and communication gaps persist in diabetes management, with compliance for regular checkups at only 45.1% and 68.3% of caregivers reporting insufficient counseling from healthcare providers

• Technology adoption disparities exist between insulin-dependent and non-insulin populations, as CGM use remains predominantly limited to insulin users, representing a significant unmet need for oral medication-only patients

• Clinical workflow integration requires improvement, though pharmacist-led CGM programs have demonstrated statistically significant A1c reductions averaging 1.2% (baseline 8.3% to 7.1%) over 3-6 months in diverse patient populations

• Specialized population needs include older adults with Type 2 diabetes and comorbid conditions such as dementia or cognitive impairment, who have shown high feasibility and good adherence with CGM use

• Geographic healthcare disparities affect access to diabetes technologies, particularly in overseas departments where insulin use rates are higher (25.5% vs. 20.0% in metropolitan regions) but technology access may be limited

Stelo Glucose Biosensor System: Safety and Usage Considerations

Available safety data for glucose monitoring systems primarily focuses on insulin-using populations, with limited specific information for children not using insulin or adults on oral medications only. The existing evidence suggests that adverse events are generally infrequent but require ongoing monitoring and analysis.

• Device-Related Adverse Events: A 2022 study on flash glucose-sensing technology reported no device-related serious adverse events, though nine participants experienced 16 instances of device-related adverse events including infection and allergy reactions

• Skin-Related Reactions: In the same study, 28 participants (20.1%) experienced 134 occurrences of anticipated skin symptoms and sensor-insertion events, including erythema, itching, and rash - reactions expected with continuous glucose monitoring device use

• Overall Safety Profile: A 2022 report on diabetes devices (2018-2020 data) found that while adverse event rates per test result remain exceedingly small, the rate per patient using diabetes monitoring devices raises some concern and warrants routine safety analysis

• Measurement Interference: Standardized testing identified several nutritional, pharmaceutical, and endogenous substances that substantially influenced continuous glucose monitoring sensor signals, though clinical relevance during routine care requires further investigation

• Psychological Considerations: Some studies suggest potential adverse psychological effects from self-monitoring of blood glucose, indicating that the impact on patient wellbeing must be considered alongside physical safety concerns