A Post Approval Study to Evaluate the Safety and Effectiveness of the Eversense® Continuous Glucose Monitoring (CGM) System Used Non-adjunctively
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes
- Sponsor
- Senseonics, Inc.
- Enrollment
- 925
- Locations
- 23
- Primary Endpoint
- Incidence of moderate and severe hypoglycemic and diabetic ketoacidosis events
- Status
- Active, not recruiting
- Last Updated
- 8 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Incidence of moderate and severe hypoglycemic and diabetic ketoacidosis events
Time Frame: 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