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Active, not recruiting Not applicable Interventional

Eversense® Non-adjunctive Use Post Approval Study

ClinicalTrials.gov ID: NCT04836546

Public ClinicalTrials.gov record NCT04836546. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 1, 2026, 6:39 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Post Approval Study to Evaluate the Safety and Effectiveness of the Eversense® Continuous Glucose Monitoring (CGM) System Used Non-adjunctively

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT04836546
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Not applicable
Lead sponsor
Senseonics, Inc.
Industry
Enrollment
925 participants

Conditions and interventions

Conditions

Interventions

Device

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 12, 2021
Primary completion
Mar 30, 2026
Completion
Mar 30, 2026
Last update posted
Aug 12, 2025

2021 – 2026

United States locations

U.S. sites
23
U.S. states
16
U.S. cities
23
Facility City State ZIP Site status
LA Universal Research Center, Inc. Los Angeles California 90057
Denver Endocrinology, Diabetes & Thyroid Center Englewood Colorado 80113
CMR of Greater New Haven Hamden Connecticut 06517
Chase Medical Research Waterbury Connecticut 06708
The Center for Diabetes and Endocrine Care Fort Lauderdale Florida 33312
MedCare Research Miami Florida 33165
Miami Lakes Clinical Trials INC Miami Lakes Florida 33014
Atlanta Diabetes Associates Atlanta Georgia 30318
Rocky Mountain Clinical Research Idaho Falls Idaho 83404
Springfield Clinic Springfield Illinois 62702
Tandem Clinical Research Marrero Louisiana 70072
Southern Maryland Medical Group Camp Springs Maryland 20746
Metro Detroit Endocrinology Dearborn Michigan 48126
Diabetes and Endocinology Specialists, Inc. Chesterfield Missouri 63017
Endocrine Associates of West Village Long Island City New York 11101
Physician's East Endocrinology Greenville North Carolina 27834
Superior Clinical Research Smithfield North Carolina 27577
AM Diabetes & Endocrinology Bartlett Tennessee 38133
Texas Diabetes and Endocrinology Austin Texas 78749
Southwest Family Medicine Associates Dallas Texas 75235
Clinical Research Solution Institute Houston Texas 77095
RGV Endocrine Center McAllen Texas 78503
Green Mountain Research Institute Rutland Vermont 05701

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04836546, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 12, 2025 · Synced Sep 1, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04836546 live on ClinicalTrials.gov.

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