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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.
 
ClinicalTrials.gov Identifier: NCT03340831
Recruitment Status : Recruiting
First Posted : November 14, 2017
Last Update Posted : September 21, 2021
Sponsor:
Information provided by (Responsible Party):
DexCom, Inc.

Study Description
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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.
Study Design
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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 and G6 CGM System for Diabetes Management
Actual Study Start Date : October 20, 2017
Estimated Primary Completion Date : December 30, 2023
Estimated Study Completion Date : December 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia

Groups and Cohorts
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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)


Outcome Measures
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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.


Eligibility Criteria
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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
Criteria

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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT03340831


Contacts
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Contact: Stayce Beck, PhD, MPH 8582036454 stayce.beck@dexcom.com
Contact: Nelly Njeru 8582036379 nelly.njeru@dexcom.com

Locations
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Sponsors and Collaborators
DexCom, Inc.
Investigators
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Study Director: David Price, MD Dexcom-Medical Affairs
More Information
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Responsible Party: DexCom, Inc.
ClinicalTrials.gov Identifier: NCT03340831    
Other Study ID Numbers: PTL-901895
First Posted: November 14, 2017    Key Record Dates
Last Update Posted: September 21, 2021
Last Verified: September 2021
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
Product Manufactured in and Exported from the U.S.: Yes