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Eversense® Non-adjunctive Use Post Approval Study
Sponsor: Senseonics, Inc.
Summary
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.
Official title: A Post Approval Study to Evaluate the Safety and Effectiveness of the Eversense® Continuous Glucose Monitoring (CGM) System Used Non-adjunctively
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
925
Start Date
2021-04-13
Completion Date
2026-03-31
Last Updated
2025-08-13
Healthy Volunteers
No
Conditions
Interventions
Blood glucose meter
First phase: SMBG for 6 months
Eversense CGM System
Second phase: CGM for 6 months
Locations (23)
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