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COACH: Continuous Monitoring and Control of Hypoglycemia

Sponsor
DexCom, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03340831
Collaborator
(none)
1,388
Enrollment
25
Locations
74.3
Anticipated Duration (Months)
55.5
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • 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

Study Type:
Observational
Anticipated 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 :
Oct 20, 2017
Anticipated Primary Completion Date :
Dec 30, 2023
Anticipated Study Completion Date :
Dec 30, 2023

Arms and Interventions

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).

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

Primary Outcome Measures

  1. Change in hypoglycemic events [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 [6 months]

    Percent change in A1C lab between CGM use period compared to BGM use period.

  2. Change in incidence of hypoglycemic events [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 [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 [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 [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 [6 months]

    Percent change in mean scores for the Hypoglycemia Confidence Scale between CGM use period compared to BGM use period.

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Scripps Whittier Diabetes Institute La Jolla California United States 92037
2 Diabetes and Endocrine Associates La Mesa California United States 91942
3 Centre of Excellence in Diabetes and Endocrinology Sacramento California United States 95821
4 Mills-Peninsula Medical Center San Mateo California United States 94401
5 Sansum Diabetes Research Institute Santa Barbara California United States 93105
6 University of Florida Pediatric Endocrinology Gainesville Florida United States 32608
7 Intervent Clinical Research Center Pembroke Pines Florida United States 33024
8 University of South Florida Clinical Research Center Tampa Florida United States 33612
9 Atlanta Diabetes Atlanta Georgia United States 30318
10 Rocky Mountain Diabetes Center Idaho Falls Idaho United States 83404
11 Northshore University Health System Skokie Illinois United States 60077
12 Iowa Diabetes & Endocrinology Research Center Des Moines Iowa United States 50314
13 Cotton O'Neil Clinical Research Topeka Kansas United States 66606
14 International Diabetes Research Center Minneapolis Minnesota United States 55416
15 Children's Mercy Hospital Kansas City Missouri United States 64108
16 Methodist Physicians Clinic - Diabetes and Endocrine Specialists Omaha Nebraska United States 68114
17 Mountain Diabetes and Endocrine Center Asheville North Carolina United States 28803
18 Carteret Medical Group Morehead City North Carolina United States 28557
19 Diabetes & Endocrinology Consultants, PC Morehead City North Carolina United States 28557
20 University of Oklahoma Health Sciences Center Department of Pediatric Diabetes and Endocrinology Oklahoma City Oklahoma United States 73104
21 Vanderbilt Eskind Diabetes Clinic Nashville Tennessee United States 37212
22 Amarillo Medical Specialists, LLP Amarillo Texas United States 79106
23 Texas Diabetes and Endocrine Austin Texas United States 78731
24 Research Institute of Dallas Dallas Texas United States 75231
25 Advanced Research Associates Ogden Utah United States 84405

Sponsors and Collaborators

  • DexCom, Inc.

Investigators

  • Study Director: David Price, MD, Dexcom-Medical Affairs

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
DexCom, Inc.
ClinicalTrials.gov Identifier:
NCT03340831
Other Study ID Numbers:
  • PTL-901895
First Posted:
Nov 14, 2017
Last Update Posted:
Sep 21, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
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

Study Results

No Results Posted as of Sep 21, 2021