Eversense® Non-adjunctive Use Post Approval Study

Running, not enrolling · Not applicable

Conditions studied: Diabetes

In brief

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.

Key facts

Study ID

NCT04836546

Run by

Senseonics, Inc.

People needed

925

Starts

2021-04-13

Expected to finish

2026-03-31

Last updated by the study team

2025-08-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject has diabetes
• Subject is ≥18 years of age
• Subject has a smartphone that is internet enabled
• Subject is able to comply with study protocol tasks and understand written and verbal instructions in the investigator's opinion
• Subjects is willing and able to provide written signed and dated informed consent

You may not qualify if…

• Subject is critically ill or hospitalized
• Prior use of CGM defined as:
• No more than 1 week of continuous CGM use in the last 6 months, and
• At least 4 weeks of continuous use of CGM in the last 12 months or 12 weeks total use in the past 3 years.
• Subject has a known contraindication to dexamethasone or dexamethasone acetate
• Subjects requiring intravenous mannitol or mannitol irrigation solutions
• Subject is on dialysis at the time of enrollment
• Female subjects who are pregnant, planning on becoming pregnant or nursing

Where it is running

• LA Universal Research Center, Inc. — Los Angeles, California, United States
• Denver Endocrinology, Diabetes & Thyroid Center — Englewood, Colorado, United States
• CMR of Greater New Haven — Hamden, Connecticut, United States
• Chase Medical Research — Waterbury, Connecticut, United States
• The Center for Diabetes and Endocrine Care — Fort Lauderdale, Florida, United States
• MedCare Research — Miami, Florida, United States
• Miami Lakes Clinical Trials INC — Miami Lakes, Florida, United States
• Atlanta Diabetes Associates — Atlanta, Georgia, United States
• Rocky Mountain Clinical Research — Idaho Falls, Idaho, United States
• Springfield Clinic — Springfield, Illinois, United States
• Tandem Clinical Research — Marrero, Louisiana, United States
• Southern Maryland Medical Group — Camp Springs, Maryland, United States
• Metro Detroit Endocrinology — Dearborn, Michigan, United States
• Diabetes and Endocinology Specialists, Inc. — Chesterfield, Missouri, United States
• Endocrine Associates of West Village — Long Island City, New York, United States
• Physician's East Endocrinology — Greenville, North Carolina, United States
• Superior Clinical Research — Smithfield, North Carolina, United States
• AM Diabetes & Endocrinology — Bartlett, Tennessee, United States
• Texas Diabetes and Endocrinology — Austin, Texas, United States
• Southwest Family Medicine Associates — Dallas, Texas, United States
• Clinical Research Solution Institute — Houston, Texas, United States
• RGV Endocrine Center — McAllen, Texas, United States
• Green Mountain Research Institute — Rutland, Vermont, United States

Full record on ClinicalTrials.gov

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