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NCT04836546 · ClinicalTrials.gov registry record · NA
Eversense® Non-adjunctive Use Post Approval Study
A NA study of Diabetes, sponsored by Senseonics.
- Active
- Registry status
- NA
- Development phase
- 925
- Enrollment target
- 20
- Study locations
NCT04836546: Active NA study of Diabetes, sponsored by Senseonics.
NCT04836546 is a NA study of Diabetes that is active but no longer recruiting, run by Senseonics. The registered enrollment target is 925 participants, below the 3,026-participant average among 338 other Diabetes trials with a reported enrollment target (69% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04836546, a NA study of Diabetes, is active but no longer recruiting, sponsored by Senseonics.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 925 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- DEVICE Blood glucose meter
- DEVICE Eversense CGM System
Study Locations (20)
Florida
- The Center for Diabetes and Endocrine Care - Fort Lauderdale
- MedCare Research - Miami
- Miami Lakes Clinical Trials INC - Miami Lakes
Connecticut
- CMR of Greater New Haven - Hamden
- Chase Medical Research - Waterbury
North Carolina
- Physician's East Endocrinology - Greenville
- Superior Clinical Research - Smithfield
Texas
- Texas Diabetes and Endocrinology - Austin
- Southwest Family Medicine Associates - Dallas
California
- LA Universal Research Center, Inc. - Los Angeles
Colorado
- Denver Endocrinology, Diabetes & Thyroid Center - Englewood
Georgia
- Atlanta Diabetes Associates - Atlanta
Idaho
- Rocky Mountain Clinical Research - Idaho Falls
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 925 participants |
| Start Date | 2021-04-13 |
| Est. Completion | 2026-03-31 |
| Phase | NA |
What the registry record for NCT04836546 still lists
NCT04836546 is an interventional study that assigns participants to a tested intervention. The registered 925 participants enrollment target is mid-sized for trials with a published cap, below the 3,026-participant average among 338 other Diabetes trials with a reported enrollment target (69% lower).
The record links to 1 condition, with Diabetes appearing as the primary indexed condition, and to 2 interventions - of which Blood glucose meter is the first listed.
NCT04836546 names 20 study sites across 15 states, led by Florida, Connecticut, North Carolina.
Frequently Asked Questions
What is clinical trial NCT04836546 about?
NCT04836546 is a clinical study titled "Eversense® Non-adjunctive Use Post Approval Study". 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...
What is the current status of trial NCT04836546?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 925 participants. The study started on 2021-04-13. Estimated completion is 2026-03-31.
What conditions does trial NCT04836546 study?
This clinical trial studies the following conditions: Diabetes.
What interventions are being tested in trial NCT04836546?
The interventions under investigation include: Blood glucose meter (DEVICE), Eversense CGM System (DEVICE).
Who is sponsoring clinical trial NCT04836546?
This trial is sponsored by Senseonics, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04836546 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetes
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04836546's enrollment target sits among peer trials
925 46th of 338 higher than 293 of 338 other Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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