Continuous Monitoring and Control of Hypoglycemia

Diabetes Clinical Trial

— COACH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03340831
• Other study ID #: PTL-901895
• Status: Recruiting
• Start date: October 20, 2017
• Est. completion date: December 30, 2023

Study information

• Verified date: September 2021
• Source: DexCom, Inc.
• Contact: Stayce Beck, PhD, MPH
• Phone: 8582036454
• Email: stayce.beck[@]dexcom.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1388
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes

Intervention

Device:
• Continuous Glucose Monitoring (CGM)
Use of CGM to compare incidence of diabetes events compared to use of a blood glucose meter (BGM)

Locations

Country	Name	City	State
United States	Amarillo Medical Specialists, LLP	Amarillo	Texas
United States	Mountain Diabetes and Endocrine Center	Asheville	North Carolina
United States	Atlanta Diabetes	Atlanta	Georgia
United States	Texas Diabetes and Endocrine	Austin	Texas
United States	Research Institute of Dallas	Dallas	Texas
United States	Iowa Diabetes & Endocrinology Research Center	Des Moines	Iowa
United States	University of Florida Pediatric Endocrinology	Gainesville	Florida
United States	Rocky Mountain Diabetes Center	Idaho Falls	Idaho
United States	Children's Mercy Hospital	Kansas City	Missouri
United States	Scripps Whittier Diabetes Institute	La Jolla	California
United States	Diabetes and Endocrine Associates	La Mesa	California
United States	International Diabetes Research Center	Minneapolis	Minnesota
United States	Carteret Medical Group	Morehead City	North Carolina
United States	Diabetes & Endocrinology Consultants, PC	Morehead City	North Carolina
United States	Vanderbilt Eskind Diabetes Clinic	Nashville	Tennessee
United States	Advanced Research Associates	Ogden	Utah
United States	University of Oklahoma Health Sciences Center Department of Pediatric Diabetes and Endocrinology	Oklahoma City	Oklahoma
United States	Methodist Physicians Clinic - Diabetes and Endocrine Specialists	Omaha	Nebraska
United States	Intervent Clinical Research Center	Pembroke Pines	Florida
United States	Centre of Excellence in Diabetes and Endocrinology	Sacramento	California
United States	Mills-Peninsula Medical Center	San Mateo	California
United States	Sansum Diabetes Research Institute	Santa Barbara	California
United States	Northshore University Health System	Skokie	Illinois
United States	University of South Florida Clinical Research Center	Tampa	Florida
United States	Cotton O'Neil Clinical Research	Topeka	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
DexCom, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in hypoglycemic events	Change in average number of hypoglycemic events per patient between CGM use compared to BGM use	6 months
Secondary	Change in A1C	Percent change in A1C lab between CGM use period compared to BGM use period.	6 months
Secondary	Change in incidence of hypoglycemic events	Percent change of participants with at least one event between CGM use period compared to BGM use period.	6 months
Secondary	Change in GMSS PRO scores	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
Secondary	Change in Diabetes Distress Scale (DDS) PRO scores	Percent change in mean scores for the DDS between CGM use period compared to BGM use period.	6 months
Secondary	Change in Hypoglycemia Fear PRO scores	Percent change in mean scores for the Hypoglycemia Fear Survey between CGM use period compared to BGM use period.	6 months
Secondary	Change in Hypoglycemia Confidence PRO scores	Percent change in mean scores for the Hypoglycemia Confidence Scale between CGM use period compared to BGM use period.	6 months