FDA Approves Dexcom's Pediatric Continuous Glucose Monitor for Sale
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jun 12 2026
0mins
The U.S. Food and Drug Administration cleared for marketing the first over-the-counter continuous glucose monitor for children, Dexcom Inc.'s Stelo Glucose Biosensor System, an integrated CGM indicated for people two years of age and older who do not use insulin. The FDA previously cleared the Stelo Glucose Biosensor System OTC for individuals 18 years and older in March 2024. "Children deserve access to the best tools available to manage their health," said Center for Devices and Radiological Health Director Michelle Tarver, M.D., Ph.D. "Today's clearance reflects the FDA's commitment to fostering innovation for pediatric patients and supporting the safe and effective use of medical devices where children live, learn, and play."
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Analyst Views on DXCM
Wall Street analysts forecast DXCM stock price to rise
16 Analyst Rating
13 Buy
2 Hold
1 Sell
Strong Buy
Current: 71.230
Low
68.00
Averages
82.54
High
100.00
Current: 71.230
Low
68.00
Averages
82.54
High
100.00
About DXCM
DexCom, Inc. is a medical device company. The Company is primarily focused on the design, development, and commercialization of continuous glucose monitoring (CGM), systems for the management of diabetes and metabolic health by patients, caregivers, and clinicians. It enables people to take control of health through innovative biosensing technology. The G7 is an integrated continuous glucose monitoring system. Stelo is designed specifically for people with type II diabetes who do not use insulin as the first over-the-counter glucose biosensor in the United States. The Dexcom Share remote monitoring system, offered for use with any Dexcom system, uses an app on the patient’s compatible mobile device. Its Dexcom G7 is for adults and children (2+ years) living with type I or type II diabetes who are on any insulin or medications, at risk of hypoglycemia, and those with gestational diabetes. The G7 and G7 15 Day includes finger stick elimination, continuous glucose readings and others.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
FDA Approves DexCom's OTC Glucose Monitor for Children
- FDA Approval: The US FDA has approved DexCom's Stelo continuous glucose monitor for children aged two and older, marking it as the first OTC CGM approved for pediatric use, which is expected to significantly enhance DexCom's market share in children's diabetes management.
- Product Features: Stelo features a wearable sensor that provides glucose data every 15 minutes, with a sensor replacement every 15 days, offering a convenient monitoring solution that will help parents manage their children's diabetes more effectively.
- Market Potential: With the launch of Stelo, DexCom can meet the growing demand among pediatric diabetes patients, which is anticipated to drive revenue growth and further solidify its leadership position in the medical device market.
- Technological Innovation: Stelo not only enhances the convenience of diabetes monitoring but also improves user experience through its pairing with a smartphone app, potentially attracting more families to choose DexCom's products.
See More
Dexcom CONNECT Trial Significantly Improves Glucose Control in Type 2 Diabetes Patients
- Clinical Significance: The CONNECT randomized controlled trial demonstrated that participants using Dexcom G7 experienced an average A1C reduction of 1.6%, decreasing from a baseline of 8.8% to 7.2%, indicating its effectiveness in Type 2 diabetes management and potential to establish CGM as a new global standard of care.
- Combination Therapy Benefits: The study revealed that using Dexcom G7 in conjunction with various diabetes medications, including metformin, GLP-1s, and SGLT2s, resulted in a more significant A1C reduction, particularly for patients with initial A1C levels over 10%, who saw an average decrease of 3.1%, highlighting its additive therapeutic value.
- Improved Time in Range: Participants using Dexcom G7 spent an average of five more hours per day in the target glucose range compared to the control group, achieving 62% time in range at 26 weeks, which significantly enhances patient quality of life and satisfaction, underscoring its importance in daily diabetes management.
- Education and Support: All participants received education on diet and exercise at the study's outset, ensuring comprehensive support, and the 97% daily usage rate of Dexcom G7 further demonstrates its acceptability and practicality in patients' everyday lives.
See More
Dexcom CONNECT Trial Significantly Improves Glucose Control in Type 2 Diabetes Patients
- Clinical Trial Results: The CONNECT randomized controlled trial demonstrated that Dexcom G7 led to a significant average reduction of 1.6% in A1C, which is 0.9% greater than the control group, potentially establishing a new standard of care for Type 2 diabetes management globally.
- Combination Therapy Impact: Participants using Dexcom G7 in conjunction with various diabetes medications, including metformin, GLP-1s, and SGLT2s, experienced a clinically significant A1C reduction, particularly those with initial A1C levels above 10%, who saw an average decrease of 3.1%, highlighting its additive benefits across treatment regimens.
- Improved Time in Range: Patients using Dexcom G7 achieved an average of five additional hours per day in the glucose target range, reaching 62% time in range at 26 weeks compared to 41% in the control group, indicating its effectiveness in enhancing patient quality of life.
- Increased Patient Satisfaction: Participants reported higher satisfaction with Dexcom G7 compared to self-monitoring blood glucose, with a median daily usage rate of 97% throughout the 26-week study, underscoring its significance in daily diabetes management.
See More
Competitive Analysis of Diabetes Monitoring Market
- DexCom Financial Performance: In FY 2025, DexCom achieved nearly $4.7 billion in revenue, a 15.6% increase, with a net income of approximately $836.3 million and a net margin of 17.9%, indicating strong growth potential in the continuous glucose monitoring market.
- Insulet Market Position: Insulet generated over $2.7 billion in revenue in FY 2025, representing a 30.9% growth, with a net income of about $354.4 million and a net margin close to 10.4%, demonstrating its leadership and market expansion capabilities in the tubeless insulin pump sector.
- Competitive Risk Analysis: DexCom faces intense competition from large medical technology firms and is navigating a March 2025 FDA warning letter, which could impact its market performance, while Insulet's reliance on a single Omnipod product platform exposes it to risks from shifts in consumer preferences.
- Future Growth Potential: Despite the rise of GLP-1 drugs potentially affecting demand for both companies' products, the ongoing need for diabetes monitoring and treatment remains strong, with both DexCom and Insulet seeking to leverage technological innovation and market expansion to capture future growth opportunities.
See More
Comparative Analysis of Diabetes Management Innovations
- DexCom Financial Performance: In FY 2025, DexCom reported nearly $4.7 billion in revenue, a 15.6% increase year-over-year, with a net income of approximately $836.3 million and a net margin of 17.9%, indicating strong growth potential in the continuous glucose monitoring market.
- Insulet Market Expansion: Insulet achieved over $2.7 billion in revenue for FY 2025, representing a 30.9% growth rate, with a net income of about $354.4 million, demonstrating robust demand for its products despite fierce competition in the medical technology sector.
- Risk Analysis: DexCom faces intense competition from large medical technology firms and is navigating an FDA warning letter that could impact its market position; meanwhile, Insulet's reliance on its single Omnipod product makes it vulnerable to losing partnerships with DexCom, which would impair product functionality.
- Valuation Comparison: Insulet's forward P/E ratio stands at 22.0x, lower than DexCom's 28.4x, and its P/S ratio is 3.6x, indicating a more attractive investment value, especially given the significant upside potential in the automated treatment device market.
See More
Dexcom Unveils Key Findings at ADA Conference
- CONNECT Study Results: Dexcom will present findings from the CONNECT randomized controlled trial at the ADA Scientific Sessions, which is expected to significantly influence care standards for Type 2 diabetes patients not using insulin, further establishing CGM as an effective tool for preventative care.
- Stelo App Redesign: The reimagined Stelo app has received FDA clearance and will provide non-insulin users with a smarter way to track their metabolism, launching new features such as pattern recognition and personalized AI coaching, which are anticipated to enhance user health management capabilities.
- Nutrisense Acquisition: Dexcom plans to acquire Nutrisense, with the transaction expected to close in the coming weeks, which will enhance its ability to provide personalized nutrition education and guidance, helping users better understand the relationship between food choices and glucose responses.
- Strategic Investment: The series of announcements at the ADA conference reflects Dexcom's ongoing investment in evidence-based, technology-enabled solutions aimed at expanding CGM accessibility, supporting early intervention, and offering more personalized diabetes management.
See More
FDA Approves DexCom's OTC Glucose Monitor for Children
- FDA Approval: The US FDA has approved DexCom's Stelo continuous glucose monitor for children aged two and older, marking it as the first OTC CGM approved for pediatric use, which is expected to significantly enhance DexCom's market share in children's diabetes management.
- Product Features: Stelo features a wearable sensor that provides glucose data every 15 minutes, with a sensor replacement every 15 days, offering a convenient monitoring solution that will help parents manage their children's diabetes more effectively.
- Market Potential: With the launch of Stelo, DexCom can meet the growing demand among pediatric diabetes patients, which is anticipated to drive revenue growth and further solidify its leadership position in the medical device market.
- Technological Innovation: Stelo not only enhances the convenience of diabetes monitoring but also improves user experience through its pairing with a smartphone app, potentially attracting more families to choose DexCom's products.
See More
Dexcom CONNECT Trial Significantly Improves Glucose Control in Type 2 Diabetes Patients
- Clinical Significance: The CONNECT randomized controlled trial demonstrated that participants using Dexcom G7 experienced an average A1C reduction of 1.6%, decreasing from a baseline of 8.8% to 7.2%, indicating its effectiveness in Type 2 diabetes management and potential to establish CGM as a new global standard of care.
- Combination Therapy Benefits: The study revealed that using Dexcom G7 in conjunction with various diabetes medications, including metformin, GLP-1s, and SGLT2s, resulted in a more significant A1C reduction, particularly for patients with initial A1C levels over 10%, who saw an average decrease of 3.1%, highlighting its additive therapeutic value.
- Improved Time in Range: Participants using Dexcom G7 spent an average of five more hours per day in the target glucose range compared to the control group, achieving 62% time in range at 26 weeks, which significantly enhances patient quality of life and satisfaction, underscoring its importance in daily diabetes management.
- Education and Support: All participants received education on diet and exercise at the study's outset, ensuring comprehensive support, and the 97% daily usage rate of Dexcom G7 further demonstrates its acceptability and practicality in patients' everyday lives.
See More
Dexcom CONNECT Trial Significantly Improves Glucose Control in Type 2 Diabetes Patients
- Clinical Trial Results: The CONNECT randomized controlled trial demonstrated that Dexcom G7 led to a significant average reduction of 1.6% in A1C, which is 0.9% greater than the control group, potentially establishing a new standard of care for Type 2 diabetes management globally.
- Combination Therapy Impact: Participants using Dexcom G7 in conjunction with various diabetes medications, including metformin, GLP-1s, and SGLT2s, experienced a clinically significant A1C reduction, particularly those with initial A1C levels above 10%, who saw an average decrease of 3.1%, highlighting its additive benefits across treatment regimens.
- Improved Time in Range: Patients using Dexcom G7 achieved an average of five additional hours per day in the glucose target range, reaching 62% time in range at 26 weeks compared to 41% in the control group, indicating its effectiveness in enhancing patient quality of life.
- Increased Patient Satisfaction: Participants reported higher satisfaction with Dexcom G7 compared to self-monitoring blood glucose, with a median daily usage rate of 97% throughout the 26-week study, underscoring its significance in daily diabetes management.
See More
Competitive Analysis of Diabetes Monitoring Market
- DexCom Financial Performance: In FY 2025, DexCom achieved nearly $4.7 billion in revenue, a 15.6% increase, with a net income of approximately $836.3 million and a net margin of 17.9%, indicating strong growth potential in the continuous glucose monitoring market.
- Insulet Market Position: Insulet generated over $2.7 billion in revenue in FY 2025, representing a 30.9% growth, with a net income of about $354.4 million and a net margin close to 10.4%, demonstrating its leadership and market expansion capabilities in the tubeless insulin pump sector.
- Competitive Risk Analysis: DexCom faces intense competition from large medical technology firms and is navigating a March 2025 FDA warning letter, which could impact its market performance, while Insulet's reliance on a single Omnipod product platform exposes it to risks from shifts in consumer preferences.
- Future Growth Potential: Despite the rise of GLP-1 drugs potentially affecting demand for both companies' products, the ongoing need for diabetes monitoring and treatment remains strong, with both DexCom and Insulet seeking to leverage technological innovation and market expansion to capture future growth opportunities.
See More
Comparative Analysis of Diabetes Management Innovations
- DexCom Financial Performance: In FY 2025, DexCom reported nearly $4.7 billion in revenue, a 15.6% increase year-over-year, with a net income of approximately $836.3 million and a net margin of 17.9%, indicating strong growth potential in the continuous glucose monitoring market.
- Insulet Market Expansion: Insulet achieved over $2.7 billion in revenue for FY 2025, representing a 30.9% growth rate, with a net income of about $354.4 million, demonstrating robust demand for its products despite fierce competition in the medical technology sector.
- Risk Analysis: DexCom faces intense competition from large medical technology firms and is navigating an FDA warning letter that could impact its market position; meanwhile, Insulet's reliance on its single Omnipod product makes it vulnerable to losing partnerships with DexCom, which would impair product functionality.
- Valuation Comparison: Insulet's forward P/E ratio stands at 22.0x, lower than DexCom's 28.4x, and its P/S ratio is 3.6x, indicating a more attractive investment value, especially given the significant upside potential in the automated treatment device market.
See More
Dexcom Unveils Key Findings at ADA Conference
- CONNECT Study Results: Dexcom will present findings from the CONNECT randomized controlled trial at the ADA Scientific Sessions, which is expected to significantly influence care standards for Type 2 diabetes patients not using insulin, further establishing CGM as an effective tool for preventative care.
- Stelo App Redesign: The reimagined Stelo app has received FDA clearance and will provide non-insulin users with a smarter way to track their metabolism, launching new features such as pattern recognition and personalized AI coaching, which are anticipated to enhance user health management capabilities.
- Nutrisense Acquisition: Dexcom plans to acquire Nutrisense, with the transaction expected to close in the coming weeks, which will enhance its ability to provide personalized nutrition education and guidance, helping users better understand the relationship between food choices and glucose responses.
- Strategic Investment: The series of announcements at the ADA conference reflects Dexcom's ongoing investment in evidence-based, technology-enabled solutions aimed at expanding CGM accessibility, supporting early intervention, and offering more personalized diabetes management.
See More
