Eversense® Non-adjunctive Use Post Approval Study

Description

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

Diabetes

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Study Overview

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Study Details

Study overview

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.

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

Eversense® Non-adjunctive Use Post Approval Study

Condition
Diabetes
Intervention / Treatment

-

Contacts and Locations

Los Angeles

LA Universal Research Center, Inc., Los Angeles, California, United States, 90057

Englewood

Denver Endocrinology, Diabetes & Thyroid Center, Englewood, Colorado, United States, 80113

Hamden

CMR of Greater New Haven, Hamden, Connecticut, United States, 06517

Waterbury

Chase Medical Research, Waterbury, Connecticut, United States, 06708

Fort Lauderdale

The Center for Diabetes and Endocrine Care, Fort Lauderdale, Florida, United States, 33312

Miami Lakes

Miami Lakes Clinical Trials INC, Miami Lakes, Florida, United States, 33014

Miami

MedCare Research, Miami, Florida, United States, 33165

Atlanta

Atlanta Diabetes Associates, Atlanta, Georgia, United States, 30318

Idaho Falls

Rocky Mountain Clinical Research, Idaho Falls, Idaho, United States, 83404

Springfield

Springfield Clinic, Springfield, Illinois, United States, 62702

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Senseonics, Inc.,

Study Record Dates

2026-03-31