Eversense Non-adjunctive Use Post Approval Study

  • STATUS
    Recruiting
  • End date
    Mar 31, 2026
  • participants needed
    925
  • sponsor
    Senseonics, Inc.
Updated on 14 April 2021

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.

Details
Condition NIDDM, Diabetes Mellitus, Diabetes Mellitus, Type 2, Diabetes Prevention, Diabetes Mellitus Types I and II, Diabetes (Pediatric), Diabetes Mellitus Type 2, Diabetes, type 2 diabetes mellitus, diabetes mellitus (dm), type 2 diabetes, type ii diabetes, noninsulin-dependent diabetes mellitus, diabetes type 2
Treatment Blood glucose meter, Eversense CGM System
Clinical Study IdentifierNCT04836546
SponsorSenseonics, Inc.
Last Modified on14 April 2021

Eligibility

Yes No Not Sure

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
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