Eversense® Non-adjunctive Use Post Approval Study

NCT ID: NCT04836546

Last Updated: 2025-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

925 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-13

Study Completion Date

2026-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Self monitoring of blood glucose, then CGM System

All participants will first manage their diabetes with SMBG for 6 months followed by managing their diabetes with Eversense CGM system for the next 6 months

Group Type EXPERIMENTAL

Blood glucose meter

Intervention Type DEVICE

First phase: SMBG for 6 months

Eversense CGM System

Intervention Type DEVICE

Second phase: CGM for 6 months

Interventions

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Blood glucose meter

First phase: SMBG for 6 months

Intervention Type DEVICE

Eversense CGM System

Second phase: CGM for 6 months

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Subject has diabetes
2. Subject is ≥18 years of age
3. Subject has a smartphone that is internet enabled
4. Subject is able to comply with study protocol tasks and understand written and verbal instructions in the investigator's opinion
5. Subjects is willing and able to provide written signed and dated informed consent

Exclusion Criteria

1. Subject is critically ill or hospitalized
2. 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.
3. Subject has a known contraindication to dexamethasone or dexamethasone acetate
4. Subjects requiring intravenous mannitol or mannitol irrigation solutions
5. Subject is on dialysis at the time of enrollment
6. Female subjects who are pregnant, planning on becoming pregnant or nursing
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Senseonics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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LA Universal Research Center, Inc.

Los Angeles, California, United States

Site Status

Denver Endocrinology, Diabetes & Thyroid Center

Englewood, Colorado, United States

Site Status

CMR of Greater New Haven

Hamden, Connecticut, United States

Site Status

Chase Medical Research

Waterbury, Connecticut, United States

Site Status

The Center for Diabetes and Endocrine Care

Fort Lauderdale, Florida, United States

Site Status

MedCare Research

Miami, Florida, United States

Site Status

Miami Lakes Clinical Trials INC

Miami Lakes, Florida, United States

Site Status

Atlanta Diabetes Associates

Atlanta, Georgia, United States

Site Status

Rocky Mountain Clinical Research

Idaho Falls, Idaho, United States

Site Status

Springfield Clinic

Springfield, Illinois, United States

Site Status

Tandem Clinical Research

Marrero, Louisiana, United States

Site Status

Southern Maryland Medical Group

Camp Springs, Maryland, United States

Site Status

Metro Detroit Endocrinology

Dearborn, Michigan, United States

Site Status

Diabetes and Endocinology Specialists, Inc.

Chesterfield, Missouri, United States

Site Status

Endocrine Associates of West Village

Long Island City, New York, United States

Site Status

Physician's East Endocrinology

Greenville, North Carolina, United States

Site Status

Superior Clinical Research

Smithfield, North Carolina, United States

Site Status

AM Diabetes & Endocrinology

Bartlett, Tennessee, United States

Site Status

Texas Diabetes and Endocrinology

Austin, Texas, United States

Site Status

Southwest Family Medicine Associates

Dallas, Texas, United States

Site Status

Clinical Research Solution Institute

Houston, Texas, United States

Site Status

RGV Endocrine Center

McAllen, Texas, United States

Site Status

Green Mountain Research Institute

Rutland, Vermont, United States

Site Status

Countries

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United States

Other Identifiers

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CTP-0039

Identifier Type: -

Identifier Source: org_study_id

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