Continuous Monitoring and Control of Hypoglycemia (COACH)

September 17, 2021 updated by: DexCom, Inc.

Post Approval Study for Non-Adjunctive Use of Dexcom G5 and G6 CGM System for Diabetes Management

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

1388

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92037
        • Completed
        • Scripps Whittier Diabetes Institute
      • La Mesa, California, United States, 91942
        • Completed
        • Diabetes and Endocrine Associates
      • Sacramento, California, United States, 95821
        • Recruiting
        • Centre of Excellence in Diabetes and Endocrinology
        • Principal Investigator:
          • Gnanagurudasan Prakasam, M.D.
        • Contact:
      • San Mateo, California, United States, 94401
        • Completed
        • Mills-Peninsula Medical Center
      • Santa Barbara, California, United States, 93105
        • Completed
        • Sansum Diabetes Research Institute
    • Florida
      • Gainesville, Florida, United States, 32608
        • Active, not recruiting
        • University of Florida Pediatric Endocrinology
      • Pembroke Pines, Florida, United States, 33024
        • Recruiting
        • Intervent Clinical Research Center
        • Contact:
        • Principal Investigator:
          • Diego Montes, MD
      • Tampa, Florida, United States, 33612
        • Recruiting
        • University of South Florida Clinical Research Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Henry Rodriguez, M.D.
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Completed
        • Atlanta Diabetes
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Completed
        • Rocky Mountain Diabetes Center
    • Illinois
      • Skokie, Illinois, United States, 60077
        • Completed
        • Northshore University Health System
    • Iowa
      • Des Moines, Iowa, United States, 50314
        • Completed
        • Iowa Diabetes & Endocrinology Research Center
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Recruiting
        • Cotton O'Neil Clinical Research
        • Contact:
        • Principal Investigator:
          • Susan Brian, M.D.
    • Minnesota
      • Minneapolis, Minnesota, United States, 55416
        • Completed
        • International Diabetes Research Center
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Recruiting
        • Children's Mercy Hospital
        • Contact:
        • Principal Investigator:
          • Mark Clements, M.D.,PhD.
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Completed
        • Methodist Physicians Clinic - Diabetes and Endocrine Specialists
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Completed
        • Mountain Diabetes and Endocrine Center
      • Morehead City, North Carolina, United States, 28557
        • Completed
        • Carteret Medical Group
      • Morehead City, North Carolina, United States, 28557
        • Completed
        • Diabetes & Endocrinology Consultants, PC
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma Health Sciences Center Department of Pediatric Diabetes and Endocrinology
        • Contact:
        • Principal Investigator:
          • David Sparling, M.D.
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Completed
        • Vanderbilt Eskind Diabetes Clinic
    • Texas
      • Amarillo, Texas, United States, 79106
        • Recruiting
        • Amarillo Medical Specialists, LLP
        • Contact:
        • Principal Investigator:
          • William Biggs, M.D.
      • Austin, Texas, United States, 78731
        • Completed
        • Texas Diabetes and Endocrine
      • Dallas, Texas, United States, 75231
        • Completed
        • Research Institute of Dallas
    • Utah
      • Ogden, Utah, United States, 84405
        • Recruiting
        • Advanced Research Associates
        • Contact:
        • Principal Investigator:
          • Jack Wahlen, M.D., PhD

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.

Eligibility Criteria

Ages Eligible for Study

7 months and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults and pediatrics (2 or older), naïve to CGM, with Type 1 or insulin-requiring Type 2 diabetes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Use of RT-CGM, within the past 12 months
  • Pregnancy
  • Concomitant disease or condition that may compromise patient safety including and not limited to severe mental illness, a diagnosed or suspected eating disorder or any uncontrolled long term medical condition that would interfere with study related tasks or visits, or ongoing treatment for a significant malignancy.
  • Known (or suspected) significant allergy to medical grade adhesives
  • Dialysis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CGM/BGM Group
single-group, whereby participant is their own control. Use of a Blood Glucose Meter (BGM) for 6 months is compared to use of the G5 and G6 CGM System for 6 months, with collection of major diabetes related events (mild/severe hypoglycemia and DKA).
Device: Continuous Glucose Monitoring (CGM)
Use of CGM to compare incidence of diabetes events compared to use of a blood glucose meter (BGM)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in hypoglycemic events
Time Frame: 6 months
Change in average number of hypoglycemic events per patient between CGM use compared to BGM use
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in A1C
Time Frame: 6 months
Percent change in A1C lab between CGM use period compared to BGM use period.
6 months
Change in incidence of hypoglycemic events
Time Frame: 6 months
Percent change of participants with at least one event between CGM use period compared to BGM use period.
6 months
Change in GMSS PRO scores
Time Frame: 6 months
Percent change in mean scores for the Glucose monitoring satisfaction survey (GMSS) [Emotional and Trust subscales] between CGM use period compared to BGM use period.
6 months
Change in Diabetes Distress Scale (DDS) PRO scores
Time Frame: 6 months
Percent change in mean scores for the DDS between CGM use period compared to BGM use period.
6 months
Change in Hypoglycemia Fear PRO scores
Time Frame: 6 months
Percent change in mean scores for the Hypoglycemia Fear Survey between CGM use period compared to BGM use period.
6 months
Change in Hypoglycemia Confidence PRO scores
Time Frame: 6 months
Percent change in mean scores for the Hypoglycemia Confidence Scale between CGM use period compared to BGM use period.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DexCom, Inc.

Investigators

  • Study Director: David Price, MD, Dexcom-Medical Affairs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2017

Primary Completion (Anticipated)

December 30, 2023

Study Completion (Anticipated)

December 30, 2023

Study Registration Dates

First Submitted

October 31, 2017

First Submitted That Met QC Criteria

November 8, 2017

First Posted (Actual)

November 14, 2017

Study Record Updates

Last Update Posted (Actual)

September 21, 2021

Last Update Submitted That Met QC Criteria

September 17, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • PTL-901895

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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