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Continuous Monitoring and Control of Hypoglycemia (COACH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03340831
Recruitment Status : Recruiting
First Posted : November 14, 2017
Last Update Posted : May 23, 2019
Information provided by (Responsible Party):
DexCom, Inc.

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

Condition or disease Intervention/treatment
Diabetes Device: Continuous Glucose Monitoring (CGM)

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.

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Study Type : Observational
Estimated Enrollment : 1388 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post Approval Study for Non-Adjunctive Use of Dexcom G5 CGM System for Diabetes Management
Actual Study Start Date : October 20, 2017
Estimated Primary Completion Date : May 15, 2020
Estimated Study Completion Date : May 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia

Group/Cohort Intervention/treatment
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 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)

Primary Outcome Measures :
  1. Change in hypoglycemic events [ Time Frame: 6 months ]
    Change in average number of hypoglycemic events per patient between CGM use compared to BGM use

Secondary Outcome Measures :
  1. Change in A1C [ Time Frame: 6 months ]
    Percent change in A1C lab between CGM use period compared to BGM use period.

  2. 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.

  3. 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.

  4. 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.

  5. 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. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03340831

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Contact: Paul Genge 3109384075
Contact: Tom Arant 8582036209

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United States, California
Scripps Whittier Diabetes Institute Recruiting
La Jolla, California, United States, 92037
Contact: Cherrie Rosal    858-336-3414   
Principal Investigator: Athena Philis-Tsimikas, MD         
Diabetes and Endocrine Associates Recruiting
La Mesa, California, United States, 91942
Contact: Denise Humphries   
Principal Investigator: Raymond Fink, M.D.         
Centre of Excellence in Diabetes and Endocrinology Recruiting
Sacramento, California, United States, 95821
Contact: Mila Melnik   
Principal Investigator: Gnanagurudasan Prakasam, M.D.         
Mills-Peninsula Medical Center Recruiting
San Mateo, California, United States, 94401
Contact: Irina Nayberg   
Principal Investigator: David Klonoff, MD         
Sansum Diabetes Research Institute Recruiting
Santa Barbara, California, United States, 93105
Contact: Christian Farfan   
Principal Investigator: Kristin Castorino, DO         
United States, Georgia
Atlanta Diabetes Recruiting
Atlanta, Georgia, United States, 30318
Contact: Jennifer Boyd, PA-C    404-355-4393 ext 850   
Principal Investigator: Bruce Bode, MD         
United States, Idaho
Rocky Mountain Diabetes Center Active, not recruiting
Idaho Falls, Idaho, United States, 83404
United States, Illinois
Northshore University Health System Recruiting
Skokie, Illinois, United States, 60077
Contact: Allison Monie   
Principal Investigator: Lianna Billings, MD         
United States, Iowa
Iowa Diabetes & Endocrinology Research Center Recruiting
Des Moines, Iowa, United States, 50314
Contact: Tara Herrold, RN    515-643-5122   
Principal Investigator: Anuj Bhargava, MD         
United States, Minnesota
International Diabetes Research Center Recruiting
Minneapolis, Minnesota, United States, 55416
Contact: Diana Martin   
Principal Investigator: Amy Criego, MD         
Principal Investigator: Anders Carlson, MD         
United States, Missouri
Children's Mercy Hospital Recruiting
Kansas City, Missouri, United States, 64108
Contact: Jennifer L James;   
Principal Investigator: Mark Clements, M.D.,Ph.D.         
United States, Nebraska
Diabetes & Endocrine Associates, PC Recruiting
Omaha, Nebraska, United States, 68114
Contact: Jennifer Rahman    402-561-2662   
Principal Investigator: Sarah Konigsberg, MD         
United States, North Carolina
Mountain Diabetes and Endocrine Center Recruiting
Asheville, North Carolina, United States, 28803
Contact: Julia Sacha    828-684-9588 ext 7   
Principal Investigator: Wendy Lane, MD         
United States, Tennessee
Vanderbilt Eskind Diabetes Clinic Recruiting
Nashville, Tennessee, United States, 37212
Contact: Janet Fry       janet.fry@Vanderbilt.Edu   
Principal Investigator: Shichun Bao, M.D.         
United States, Texas
Amarillo Medical Specialists, LLP Recruiting
Amarillo, Texas, United States, 79106
Contact: Becky Cota, RN, CDE    806-358-8331   
Principal Investigator: William Biggs, MD         
Texas Diabetes and Endocrine Recruiting
Austin, Texas, United States, 78731
Contact: Cory Fields    512-334-3505 ext 2   
Principal Investigator: Thomas Blevins, MD         
Principal Investigator: Lindsay Harrison, MD         
Principal Investigator: Kerem Ozer, MD         
Research Institute of Dallas Recruiting
Dallas, Texas, United States, 75231
Contact: Satanya Brooks    214-265-2137   
Principal Investigator: Stephen Aronoff, MD         
United States, Utah
Advanced Research Associates Recruiting
Ogden, Utah, United States, 84405
Contact: Hilary Wahlen    801-409-2040   
Principal Investigator: Jack Wahlen, MD, PhD         
Sponsors and Collaborators
DexCom, Inc.
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Study Director: David Price, MD Dexcom-Medical Affairs

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Responsible Party: DexCom, Inc. Identifier: NCT03340831     History of Changes
Other Study ID Numbers: PTL-901895
First Posted: November 14, 2017    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes