Status:
ACTIVE_NOT_RECRUITING
Eversense® Non-adjunctive Use Post Approval Study
Lead Sponsor:
Senseonics, Inc.
Conditions:
Diabetes
Eligibility:
All Genders
18+ years
Phase:
NA
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 n...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
925 Patients enrolled
Trial Details
Trial ID
NCT04836546
Start Date
April 13 2021
End Date
March 31 2026
Last Update
August 13 2025
Active Locations (23)
Enter a location and click search to find clinical trials sorted by distance.
1
LA Universal Research Center, Inc.
Los Angeles, California, United States, 90057
2
Denver Endocrinology, Diabetes & Thyroid Center
Englewood, Colorado, United States, 80113
3
CMR of Greater New Haven
Hamden, Connecticut, United States, 06517
4
Chase Medical Research
Waterbury, Connecticut, United States, 06708