Announcement • 7h
Dexcom Inc Clears First Over-The-Counter Continuous Glucose Monitor For Children Dexcom Inc.'s Stelo Glucose Biosensor System, an integrated CGM (iCGM) indicated for people two years of age and older who do not use insulin, was cleared for marketing as the first over-the-counter (OTC) continuous glucose monitor (CGM) for children. The FDA previously cleared the Stelo Glucose Biosensor System OTC for individuals 18 years and older in March 2024. Prediabetes is increasingly impacting children in the United States, placing millions at heightened risk for progressing to Type 2 diabetes. OTC CGMs can play a critical role in addressing this public health concern for pediatric users who do not use insulin. By providing real-time glucose data, these devices can help pediatric patients and their caregivers build greater glycemic awareness, track patterns in response to meals and exercise, and make informed adjustments to support healthier long-term outcomes and quality of life. The product is indicated for children, including those with diabetes, who receive oral medication to manage their condition and people who want to understand how diet, exercise, and other lifestyle changes affect their glucose levels. The Stelo Glucose Biosensor System uses a wearable sensor, paired with an application installed on a compatible smartphone, or other smart device, such as a parent's or caregiver's smartphone, to continuously measure, record, analyze and display glucose values. Each sensor lasts for up to 15 days before it must be replaced, although sensor wear time may be shorter in pediatric users than in adults due to several interconnected physiological and behavioral factors. The app displays glucose measurements and trends every 15 minutes. Users and their caregivers should consult their health care provider before making any medication adjustments based on the device's output. Dexcom and the FDA used previous clinical study data from both pediatrics and adults, along with real-world evidence derived from real-world data on current iCGM use among both groups, to understand expected device performance in pediatric users over the full 15-day wear period. Participants in the previous study reported mild adverse events including local infection, skin irritation, and pain or discomfort. For children, the device should be used under the supervision of an adult caregiver. This system is not for people with problematic hypoglycemia (low blood sugar) because it is not designed to alert users when this potentially dangerous condition occurs. This system is also not for people on dialysis. People with a history of disordered eating or eating disorders should talk with their health care provider before using Stelo. This clearance is also aligned with the FDA's Home as a Health Care Hub Initiative, which focuses on advancing the development of innovative, patient-centered devices that fit more seamlessly into people's daily lives at home. DXCM
Live News • Jun 12
DexCom Expands Type 2 Diabetes Reach With G7 Data Nutrisense Acquisition and Stelo App Plans DexCom reported new clinical data from the CONNECT randomized controlled trial showing its G7 continuous glucose monitor led to clinically and statistically significant HbA1c reductions and improved glycemic control in adults with Type 2 diabetes not using insulin, including those on metformin, GLP-1 receptor agonists and SGLT2 inhibitors.
The company announced the acquisition of Nutrisense, a wellness app that uses CGM data to provide personalized nutrition education, and plans to roll it into a broader ecosystem focused on earlier intervention and preventative care.
DexCom also plans to roll out an updated Stelo app with FDA-cleared pattern recognition and AI coaching tools, targeting users who are not on insulin therapy.
Over the past month the stock gained about 21% and about 7% over three months, and is trading roughly 25.5% below its GF Value estimate, with a GF Score of 92/100, while recent insider selling totaled US$3.0 million with no insider buying reported.
These developments point to DexCom pushing CGM deeper into the Type 2 diabetes market and building a broader software and services layer around its hardware.
Investors may want to weigh the GF Value gap and strong GF Score against the recent insider selling and the execution risk involved in integrating Nutrisense and scaling new apps like Stelo.