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Clinical Trial NCT03340831 (COACH) for Diabetes is unknown status. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Continuous Monitoring and Control of Hypoglycemia (COACH) 1,388
Clinical Trial NCT03340831 (COACH) is an observational study for Diabetes that is unknown status. It started on 20 October 2017 with plans to enroll 1,388 participants. Led by DexCom, Inc., it is expected to complete by 30 December 2023. The latest data from ClinicalTrials.gov was last updated on 21 September 2021.
Brief Summary
Evaluate safety of non-adjunctive CGM use in CGM naive participants.
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 m...Show More
Official Title
Post Approval Study for Non-Adjunctive Use of Dexcom G5 and G6 CGM System for Diabetes Management
Conditions
DiabetesOther Study IDs
- COACH
- PTL-901895
NCT ID Number
Start Date (Actual)
2017-10-20
Last Update Posted
2021-09-21
Completion Date (Estimated)
2023-12-30
Enrollment (Estimated)
1,388
Study Type
Observational
Status
Unknown status
Arms / Interventions
| Participant Group/Arm | 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). | 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
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Change in hypoglycemic events | Change in average number of hypoglycemic events per patient between CGM use compared to BGM use | 6 months |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Change in A1C | Percent change in A1C lab between CGM use period compared to BGM use period. | 6 months |
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 |
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 |
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 |
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 |
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 |
Eligibility Criteria
Eligible Ages
Child, Adult, Older Adult
Minimum Age
2 Years
Eligible Sexes
All
- 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
- 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
DexCom, Inc.Study Central Contact
Contact: Stayce Beck, PhD, MPH, 8582036454, [email protected]
Contact: Nelly Njeru, 8582036379, [email protected]
25 Study Locations in 1 Countries
California
Scripps Whittier Diabetes Institute, La Jolla, California, 92037, United States
Completed
Diabetes and Endocrine Associates, La Mesa, California, 91942, United States
Completed
Centre of Excellence in Diabetes and Endocrinology, Sacramento, California, 95821, United States
Mila Melnik, Contact, [email protected]
Gnanagurudasan Prakasam, M.D., Principal Investigator
Recruiting
Mills-Peninsula Medical Center, San Mateo, California, 94401, United States
Completed
Sansum Diabetes Research Institute, Santa Barbara, California, 93105, United States
Completed
Florida
University of Florida Pediatric Endocrinology, Gainesville, Florida, 32608, United States
Active, not recruiting
Intervent Clinical Research Center, Pembroke Pines, Florida, 33024, United States
Marisela Rodriguez, Contact, 954-507-6627, [email protected]
Diego Montes, MD, Principal Investigator
Recruiting
University of South Florida Clinical Research Center, Tampa, Florida, 33612, United States
Ponja Hemphill, Contact, [email protected]
Janet Rodriguez, Contact, [email protected]
Henry Rodriguez, M.D., Principal Investigator
Recruiting
Georgia
Atlanta Diabetes, Atlanta, Georgia, 30318, United States
Completed
Idaho
Rocky Mountain Diabetes Center, Idaho Falls, Idaho, 83404, United States
Completed
Illinois
Northshore University Health System, Skokie, Illinois, 60077, United States
Completed
Iowa
Iowa Diabetes & Endocrinology Research Center, Des Moines, Iowa, 50314, United States
Completed
Kansas
Cotton O'Neil Clinical Research, Topeka, Kansas, 66606, United States
Jaime Berroth, Contact, [email protected]
Susan Brian, M.D., Principal Investigator
Recruiting
Minnesota
International Diabetes Research Center, Minneapolis, Minnesota, 55416, United States
Completed
Missouri
Children's Mercy Hospital, Kansas City, Missouri, 64108, United States
Jennifer L James, Contact, [email protected];
Mark Clements, M.D.,PhD., Principal Investigator
Recruiting
Nebraska
Methodist Physicians Clinic - Diabetes and Endocrine Specialists, Omaha, Nebraska, 68114, United States
Completed
North Carolina
Mountain Diabetes and Endocrine Center, Asheville, North Carolina, 28803, United States
Completed
Carteret Medical Group, Morehead City, North Carolina, 28557, United States
Completed
Diabetes & Endocrinology Consultants, PC, Morehead City, North Carolina, 28557, United States
Completed
Oklahoma
University of Oklahoma Health Sciences Center Department of Pediatric Diabetes and Endocrinology, Oklahoma City, Oklahoma, 73104, United States
LInda Weber, Contact, [email protected]
David Sparling, M.D., Principal Investigator
Recruiting
Tennessee
Vanderbilt Eskind Diabetes Clinic, Nashville, Tennessee, 37212, United States
Completed
Texas
Amarillo Medical Specialists, LLP, Amarillo, Texas, 79106, United States
Becky Cota, RN, CDE, Contact, 806-358-8331, [email protected]
William Biggs, M.D., Principal Investigator
Recruiting
Texas Diabetes and Endocrine, Austin, Texas, 78731, United States
Completed
Research Institute of Dallas, Dallas, Texas, 75231, United States
Completed
Utah
Advanced Research Associates, Ogden, Utah, 84405, United States
Hilary Wahlen, Contact, 801-409-2040, [email protected]
Jack Wahlen, M.D., PhD, Principal Investigator
Recruiting