Clinical Trials
35
5 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
N/A
Active, not recruiting
4
11.4%
Completed
24
68.6%
Not yet recruiting
1
2.9%
Unknown
6
17.1%
No approval data available
- DexCom reported FY 2025 revenue of nearly $4.7 billion, a 15.6% increase, with net income of approximately $836.3 million and a net margin of 17.9%. - Insulet generated FY 2025 revenue of just over $2.7 billion, representing 30.9% growth, with net income of approximately $354.4 million and a net margin near 10.4%. - Both companies face competitive pressures from Abbott, Medtronic, and the rising popularity of GLP-1 drugs, while DexCom is also navigating a March 2025 FDA warning letter. - Insulet is favored for 2026 based on lower price-to-earnings and price-to-sales ratios, plus significant market upside with only 40-45% of type 1 and 5% of type 2 diabetes patients using automated treatment devices.
- Dexcom announced the December 1, 2025 US launch of its G7 15 Day continuous glucose monitoring system, offering industry-leading 15.5 days of wear time for adults with diabetes. - The extended-wear CGM system maintains best-in-class accuracy with an 8.0% MARD while reducing monthly sensor changes and providing Medicare coverage for eligible beneficiaries. - Simultaneously, Dexcom expanded its G7 CGM availability in Kuwait through partnership with Central Circle Company, addressing the country's 24% diabetes prevalence rate. - Both launches represent significant advances in diabetes management technology, with the G7 system providing real-time glucose monitoring, predictive alerts, and smartphone connectivity for improved patient outcomes.
- The FDA has cleared Dexcom Smart Basal, the first and only continuous glucose monitor-integrated basal insulin dosing optimizer designed for adults with Type 2 diabetes using glargine U-100 long-acting insulin therapy. - The system uses data from the Dexcom G7 sensor and logged insulin doses to provide daily personalized recommendations for adjusting long-acting insulin under healthcare provider guidance. - Dexcom Smart Basal is designed to remove barriers to insulin initiation by giving healthcare providers confidence to start patients on basal therapy sooner and with greater ease. - The technology will be available as part of the Dexcom G7 15-Day experience shortly after its U.S. launch, with international expansion planned for the future.
- Dexcom announced its Smart Basal integrated titration module for easier basal insulin management, currently under FDA and CE mark review. - New clinical data from the GRACE trial showed CGM reduced risk of large-for-gestational-age babies in women with gestational diabetes compared to fingerstick monitoring. - Research demonstrated that switching from fingersticks to Dexcom CGM reduced hypoglycemic events by nearly 65% in the COACH study. - Cost-effectiveness modeling in Japan projected CGM as more cost-effective than fingersticks for Type 2 diabetes patients on insulin therapy.
- The Federal Circuit upheld the Patent Trial and Appeal Board's decision to cancel six claims from DexCom's US Patent No. 10,702,193 covering implantable glucose monitoring sensors. - The patent dispute originated from DexCom's June 2021 lawsuit against Abbott Diabetes Care for infringement of five patents, which settled after three years. - Abbott's validity challenge to the patent continued despite the settlement, with the USPTO defending the PTAB's obviousness determination that led to the patent claims cancellation.
• DexCom received an FDA warning letter citing manufacturing process and quality management system deficiencies at its San Diego and Mesa facilities following inspections conducted in 2024. • The warning does not restrict DexCom's ability to produce, market or distribute products, nor does it impede the company's capacity to seek FDA clearance for new products. • Despite a 7% drop in stock price following the announcement, DexCom maintains its fiscal year 2025 revenue guidance and does not anticipate material impact on manufacturing capacity.
• The FDA has cleared Medtronic's InPen app, facilitating the launch of the Smart MDI system integrated with the Simplera CGM, enhancing type 1 diabetes management. • The Smart MDI system offers automated dose tracking and personalized recommendations, reducing the burden on patients and improving adherence to insulin therapy. • Medtronic's system integrates real-time monitoring of insulin doses and glucose levels via Bluetooth, enabling precise and timely insulin adjustments for better glycemic control. • The Smart MDI system uniquely provides recommendations for missed or inaccurate insulin doses, simplifying diabetes management and potentially improving patient outcomes.
