Eversense® Non-adjunctive Use Post Approval Study
- Conditions
- Diabetes
- Interventions
- Device: Blood glucose meterDevice: Eversense CGM System
- Registration Number
- NCT04836546
- Lead Sponsor
- Senseonics, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 925
- 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
-
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
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Subject is on dialysis at the time of enrollment
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Female subjects who are pregnant, planning on becoming pregnant or nursing
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Self monitoring of blood glucose, then CGM System Blood glucose meter All participants will first manage their diabetes with SMBG for 6 months followed by managing their diabetes with Eversense CGM system for the next 6 months Self monitoring of blood glucose, then CGM System Eversense CGM System All participants will first manage their diabetes with SMBG for 6 months followed by managing their diabetes with Eversense CGM system for the next 6 months
- Primary Outcome Measures
Name Time Method Incidence of moderate and severe hypoglycemic and diabetic ketoacidosis events First 6 months (phase 1) compared to second 6 months (phase 2) Incidence of moderate and severe hypoglycemic and diabetic ketoacidosis events with SMBG use for 6 months compared to Eversense CGM system used non-adjunctively for 6 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (25)
LA Universal Research Center, Inc.
🇺🇸Los Angeles, California, United States
CMR of Greater New Haven
🇺🇸Hamden, Connecticut, United States
MedCare Research
🇺🇸Miami, Florida, United States
Rocky Mountain Clinical Research
🇺🇸Idaho Falls, Idaho, United States
Southwest Family Medicine Associates
🇺🇸Dallas, Texas, United States
Springfield Clinic
🇺🇸Springfield, Illinois, United States
Physician's East Endocrinology
🇺🇸Greenville, North Carolina, United States
Southern Maryland Medical Group
🇺🇸Camp Springs, Maryland, United States
Metro Detroit Endocrinology
🇺🇸Dearborn, Michigan, United States
The Center for Diabetes and Endocrine Care
🇺🇸Fort Lauderdale, Florida, United States
Tandem Clinical Research
🇺🇸Marrero, Louisiana, United States
Miami Lakes Clinical Trials INC
🇺🇸Miami Lakes, Florida, United States
Chase Medical Research
🇺🇸Waterbury, Connecticut, United States
Superior Clinical Research
🇺🇸Smithfield, North Carolina, United States
Diabetes and Endocinology Specialists, Inc.
🇺🇸Chesterfield, Missouri, United States
Clinical Research Solution Institute
🇺🇸Houston, Texas, United States
Green Mountain Research Institute
🇺🇸Rutland, Vermont, United States
RGV Endocrine Center
🇺🇸McAllen, Texas, United States
Denver Endocrinology, Diabetes & Thyroid Center
🇺🇸Englewood, Colorado, United States
Atlanta Diabetes Associates
🇺🇸Atlanta, Georgia, United States
MODEL Clinical Research
🇺🇸Baltimore, Maryland, United States
AM Diabetes & Endocrinology
🇺🇸Bartlett, Tennessee, United States
Texas Diabetes and Endocrinology
🇺🇸Austin, Texas, United States
Javara, Inc
🇺🇸Houston, Texas, United States
Endocrine Associates of West Village
🇺🇸Long Island City, New York, United States