Continuous Monitoring and Control of Hypoglycemia (COACH)
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|ClinicalTrials.gov Identifier: NCT03340831|
Recruitment Status : Recruiting
First Posted : November 14, 2017
Last Update Posted : September 21, 2021
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|Condition or disease||Intervention/treatment|
|Diabetes||Device: Continuous Glucose Monitoring (CGM)|
|Study Type :||Observational|
|Estimated Enrollment :||1388 participants|
|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|
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)
- Change in hypoglycemic events [ Time Frame: 6 months ]Change in average number of hypoglycemic events per patient between CGM use compared to BGM use
- Change in A1C [ Time Frame: 6 months ]Percent change in A1C lab between CGM use period compared to BGM use period.
- 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.
- 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.
- 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.
- 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.
- 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.
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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|
- Naïve to real-time CGM
- Type 1 or insulin-requiring Type 2 diabetes
- ≥ 2 years old
- Use of RT-CGM, within the past 12 months
- 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
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
|Contact: Stayce Beck, PhD, MPHfirstname.lastname@example.org|
|Contact: Nelly Njeruemail@example.com|
|Study Director:||David Price, MD||Dexcom-Medical Affairs|
|Responsible Party:||DexCom, Inc.|
|Other Study ID Numbers:||
|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|
|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|