Continuous Monitoring and Control of Hypoglycemia

Last updated: September 17, 2021
Sponsor: DexCom, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetic Macular Edema

Diabetic Vitreous Hemorrhage

Diabetic Foot Ulcers

Treatment

N/A

Clinical Study ID

NCT03340831
PTL-901895
  • Ages > 2
  • All Genders

Study Summary

Evaluate safety of non-adjunctive CGM use in CGM naive participants.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Naïve to real-time CGM
  • Type 1 or insulin-requiring Type 2 diabetes
  • ≥ 2 years old

Exclusion

Exclusion Criteria:

  • Use of RT-CGM, within the past 12 months
  • Pregnancy
  • Concomitant disease or condition that may compromise patient safety including and notlimited to severe mental illness, a diagnosed or suspected eating disorder or anyuncontrolled long term medical condition that would interfere with study related tasksor visits, or ongoing treatment for a significant malignancy.
  • Known (or suspected) significant allergy to medical grade adhesives
  • Dialysis

Study Design

Total Participants: 1388
Study Start date:
October 20, 2017
Estimated Completion Date:
December 30, 2023

Study Description

The study comprises recruitment and consenting of pediatric and adult participants. At entry, the following information will be collected: demographics, labs, clinical and diabetes history information (history of mild/severe hypoglycemia or DKA events in the past 6 months and SMBG testing frequency). There are 3 clinic visits: Study Entry, Month 6 and Month 12 . Monthly phone contacts will be made to assess for any mild/severe hypoglycemic or DKA events and any details surrounding an event. Clinic visits at Months 6 and 12 will capture frequency of SMBG testing, A1C level and PRO information. CGM data will be obtained during the study to assess for CGM adherence.

Connect with a study center

  • Scripps Whittier Diabetes Institute

    La Jolla, California 92037
    United States

    Completed

  • Diabetes and Endocrine Associates

    La Mesa, California 91942
    United States

    Completed

  • Centre of Excellence in Diabetes and Endocrinology

    Sacramento, California 95821
    United States

    Active - Recruiting

  • Mills-Peninsula Medical Center

    San Mateo, California 94401
    United States

    Completed

  • Sansum Diabetes Research Institute

    Santa Barbara, California 93105
    United States

    Completed

  • University of Florida Pediatric Endocrinology

    Gainesville, Florida 32608
    United States

    Site Not Available

  • Intervent Clinical Research Center

    Pembroke Pines, Florida 33024
    United States

    Active - Recruiting

  • University of South Florida Clinical Research Center

    Tampa, Florida 33612
    United States

    Active - Recruiting

  • Atlanta Diabetes

    Atlanta, Georgia 30318
    United States

    Completed

  • Rocky Mountain Diabetes Center

    Idaho Falls, Idaho 83404
    United States

    Completed

  • Northshore University Health System

    Skokie, Illinois 60077
    United States

    Completed

  • Iowa Diabetes & Endocrinology Research Center

    Des Moines, Iowa 50314
    United States

    Completed

  • Cotton O'Neil Clinical Research

    Topeka, Kansas 66606
    United States

    Active - Recruiting

  • International Diabetes Research Center

    Minneapolis, Minnesota 55416
    United States

    Completed

  • Children's Mercy Hospital

    Kansas City, Missouri 64108
    United States

    Active - Recruiting

  • Methodist Physicians Clinic - Diabetes and Endocrine Specialists

    Omaha, Nebraska 68114
    United States

    Completed

  • Mountain Diabetes and Endocrine Center

    Asheville, North Carolina 28803
    United States

    Completed

  • Carteret Medical Group

    Morehead City, North Carolina 28557
    United States

    Completed

  • Diabetes & Endocrinology Consultants, PC

    Morehead City, North Carolina 28557
    United States

    Completed

  • University of Oklahoma Health Sciences Center Department of Pediatric Diabetes and Endocrinology

    Oklahoma City, Oklahoma 73104
    United States

    Active - Recruiting

  • Vanderbilt Eskind Diabetes Clinic

    Nashville, Tennessee 37212
    United States

    Completed

  • Amarillo Medical Specialists, LLP

    Amarillo, Texas 79106
    United States

    Active - Recruiting

  • Texas Diabetes and Endocrine

    Austin, Texas 78731
    United States

    Completed

  • Research Institute of Dallas

    Dallas, Texas 75231
    United States

    Completed

  • Advanced Research Associates

    Ogden, Utah 84405
    United States

    Active - Recruiting

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