Continuous Monitoring and Control of Hypoglycemia
COACH
Post Approval Study for Non-Adjunctive Use of Dexcom G5 and G6 CGM System for Diabetes Management
1 other identifier
observational
1,388
1 country
25
Brief Summary
Evaluate safety of non-adjunctive CGM use in CGM naive participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2017
Longer than P75 for all trials
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 20, 2017
CompletedFirst Submitted
Initial submission to the registry
October 31, 2017
CompletedFirst Posted
Study publicly available on registry
November 14, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2023
CompletedSeptember 21, 2021
September 1, 2021
6.2 years
October 31, 2017
September 17, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Change in hypoglycemic events
Change in average number of hypoglycemic events per patient between CGM use compared to BGM use
6 months
Secondary Outcomes (6)
Change in A1C
6 months
Change in incidence of hypoglycemic events
6 months
Change in GMSS PRO scores
6 months
Change in Diabetes Distress Scale (DDS) PRO scores
6 months
Change in Hypoglycemia Fear PRO scores
6 months
- +1 more secondary outcomes
Study Arms (1)
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).
Interventions
Use of CGM to compare incidence of diabetes events compared to use of a blood glucose meter (BGM)
Eligibility Criteria
Adults and pediatrics (2 or older), naïve to CGM, with Type 1 or insulin-requiring Type 2 diabetes
You may qualify if:
- Naïve to real-time CGM
- Type 1 or insulin-requiring Type 2 diabetes
- ≥ 2 years old
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- DexCom, Inc.lead
Study Sites (25)
Scripps Whittier Diabetes Institute
La Jolla, California, 92037, United States
Diabetes and Endocrine Associates
La Mesa, California, 91942, United States
Centre of Excellence in Diabetes and Endocrinology
Sacramento, California, 95821, United States
Mills-Peninsula Medical Center
San Mateo, California, 94401, United States
Sansum Diabetes Research Institute
Santa Barbara, California, 93105, United States
University of Florida Pediatric Endocrinology
Gainesville, Florida, 32608, United States
Intervent Clinical Research Center
Pembroke Pines, Florida, 33024, United States
University of South Florida Clinical Research Center
Tampa, Florida, 33612, United States
Atlanta Diabetes
Atlanta, Georgia, 30318, United States
Rocky Mountain Diabetes Center
Idaho Falls, Idaho, 83404, United States
Northshore University Health System
Skokie, Illinois, 60077, United States
Iowa Diabetes & Endocrinology Research Center
Des Moines, Iowa, 50314, United States
Cotton O'Neil Clinical Research
Topeka, Kansas, 66606, United States
International Diabetes Research Center
Minneapolis, Minnesota, 55416, United States
Children's Mercy Hospital
Kansas City, Missouri, 64108, United States
Methodist Physicians Clinic - Diabetes and Endocrine Specialists
Omaha, Nebraska, 68114, United States
Mountain Diabetes and Endocrine Center
Asheville, North Carolina, 28803, United States
Carteret Medical Group
Morehead City, North Carolina, 28557, United States
Diabetes & Endocrinology Consultants, PC
Morehead City, North Carolina, 28557, United States
University of Oklahoma Health Sciences Center Department of Pediatric Diabetes and Endocrinology
Oklahoma City, Oklahoma, 73104, United States
Vanderbilt Eskind Diabetes Clinic
Nashville, Tennessee, 37212, United States
Amarillo Medical Specialists, LLP
Amarillo, Texas, 79106, United States
Texas Diabetes and Endocrine
Austin, Texas, 78731, United States
Research Institute of Dallas
Dallas, Texas, 75231, United States
Advanced Research Associates
Ogden, Utah, 84405, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
David Price, MD
Dexcom-Medical Affairs
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 31, 2017
First Posted
November 14, 2017
Study Start
October 20, 2017
Primary Completion
December 30, 2023
Study Completion
December 30, 2023
Last Updated
September 21, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share