Eversense® Non-adjunctive Use Post Approval Study

Last updated: April 11, 2024
Sponsor: Senseonics, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetic Kidney Disease

Diabetic Retinopathy

Diabetic Vitreous Hemorrhage

Treatment

Blood glucose meter

Eversense CGM System

Clinical Study ID

NCT04836546
CTP-0039
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

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 verbalinstructions in the investigator's opinion
  5. Subjects is willing and able to provide written signed and dated informed consent

Exclusion

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 totaluse in the past 3 years.
  1. Subject has a known contraindication to dexamethasone or dexamethasone acetate
  2. Subjects requiring intravenous mannitol or mannitol irrigation solutions
  3. Subject is on dialysis at the time of enrollment
  4. Female subjects who are pregnant, planning on becoming pregnant or nursing

Study Design

Total Participants: 925
Treatment Group(s): 2
Primary Treatment: Blood glucose meter
Phase:
Study Start date:
April 13, 2021
Estimated Completion Date:
March 31, 2026

Connect with a study center

  • LA Universal Research Center, Inc.

    Los Angeles, California 90057
    United States

    Active - Recruiting

  • Denver Endocrinology, Diabetes & Thyroid Center

    Englewood, Colorado 80113
    United States

    Active - Recruiting

  • CMR of Greater New Haven

    Hamden, Connecticut 06517
    United States

    Active - Recruiting

  • Chase Medical Research

    Waterbury, Connecticut 06708
    United States

    Active - Recruiting

  • The Center for Diabetes and Endocrine Care

    Fort Lauderdale, Florida 33312
    United States

    Active - Recruiting

  • MedCare Research

    Miami, Florida 33165
    United States

    Active - Recruiting

  • Miami Lakes Clinical Trials INC

    Miami Lakes, Florida 33014
    United States

    Active - Recruiting

  • Atlanta Diabetes Associates

    Atlanta, Georgia 30318
    United States

    Active - Recruiting

  • Rocky Mountain Clinical Research

    Idaho Falls, Idaho 83404
    United States

    Active - Recruiting

  • Springfield Clinic

    Springfield, Illinois 62702
    United States

    Active - Recruiting

  • Tandem Clinical Research

    Marrero, Louisiana 70072
    United States

    Active - Recruiting

  • MODEL Clinical Research

    Baltimore, Maryland 21204
    United States

    Site Not Available

  • Southern Maryland Medical Group

    Camp Springs, Maryland 20746
    United States

    Active - Recruiting

  • Metro Detroit Endocrinology

    Dearborn, Michigan 48126
    United States

    Active - Recruiting

  • Diabetes and Endocinology Specialists, Inc.

    Chesterfield, Missouri 63017
    United States

    Active - Recruiting

  • Endocrine Associates of West Village

    Long Island City, New York 11101
    United States

    Active - Recruiting

  • Physician's East Endocrinology

    Greenville, North Carolina 27834
    United States

    Active - Recruiting

  • Superior Clinical Research

    Smithfield, North Carolina 27577
    United States

    Active - Recruiting

  • AM Diabetes & Endocrinology

    Bartlett, Tennessee 38133
    United States

    Active - Recruiting

  • Texas Diabetes and Endocrinology

    Austin, Texas 78749
    United States

    Active - Recruiting

  • Southwest Family Medicine Associates

    Dallas, Texas 75235
    United States

    Active - Recruiting

  • Clinical Research Solution Institute

    Houston, Texas 77095
    United States

    Active - Recruiting

  • Javara, Inc

    Houston, Texas 77095
    United States

    Site Not Available

  • RGV Endocrine Center

    McAllen, Texas 78503
    United States

    Active - Recruiting

  • Green Mountain Research Institute

    Rutland, Vermont 05701
    United States

    Active - Recruiting

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