Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Eversense® Non-adjunctive Use Post Approval Study
NCT04836546 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04836546
The ClinicalTrials.gov registry entry for NCT04836546 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 925 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Senseonics, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04836546 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Florida, Connecticut, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04836546?
The interventions under investigation include: Blood glucose meter (DEVICE), Eversense CGM System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04836546?
This trial is sponsored by Senseonics, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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