Eversense® Non-adjunctive Use Post Approval Study (NCT04836546)
A Post Approval Study to Evaluate the Safety and Effectiveness of the Eversense® Continuous Glucose Monitoring (CGM) System Used Non-adjunctively
🩺 Plain-English Summary (8th-Grade Level)
This is a non-blinded, prospective, multi-center, single arm longitudinal cohort study (patient serving as their own control), to evaluate the effectiveness of diabetes with the Eversense CGM System non-adjunctively compared to self-monitoring of blood glucose (SMBG) using a blood glucose (BG) meter in participants with either Type 1 or Type 2 diabetes. Subjects will serve as their own control, with their baseline based on using SMBG to manage their diabetes for the first 6 months followed by using Eversense CGM System non-adjunctively for the second 6 months. Total follow-up duration is 12 months. The investigation will include both clinic visits and home use of Eversense CGM System. The nonadjunctive phase will have two sensors, up to 90-day duration, inserted sequentially. All care decisions specific to diabetes will be based on blood glucose (BG) values in the first phase and the Eversense CGM system values in the second phase.
Who can join: Review the eligibility criteria below.
Location: LA Universal Research Center, Inc. — Los Angeles, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (23 Sites)
- LA Universal Research Center, Inc. — Los Angeles, California
- Denver Endocrinology, Diabetes & Thyroid Center — Englewood, Colorado
- CMR of Greater New Haven — Hamden, Connecticut
- Chase Medical Research — Waterbury, Connecticut
- The Center for Diabetes and Endocrine Care — Fort Lauderdale, Florida
- MedCare Research — Miami, Florida
- Miami Lakes Clinical Trials INC — Miami Lakes, Florida
- Atlanta Diabetes Associates — Atlanta, Georgia
- Rocky Mountain Clinical Research — Idaho Falls, Idaho
- Springfield Clinic — Springfield, Illinois
- Tandem Clinical Research — Marrero, Louisiana
- Southern Maryland Medical Group — Camp Springs, Maryland
- Metro Detroit Endocrinology — Dearborn, Michigan
- Diabetes and Endocinology Specialists, Inc. — Chesterfield, Missouri
- Endocrine Associates of West Village — Long Island City, New York
- Physician's East Endocrinology — Greenville, North Carolina
- Superior Clinical Research — Smithfield, North Carolina
- AM Diabetes & Endocrinology — Bartlett, Tennessee
- Texas Diabetes and Endocrinology — Austin, Texas
- Southwest Family Medicine Associates — Dallas, Texas
- Clinical Research Solution Institute — Houston, Texas
- RGV Endocrine Center — McAllen, Texas
- Green Mountain Research Institute — Rutland, Vermont
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.