Post Approval Study for Non-Adjunctive Use of Dexcom G5 and G6 CGM System for Diabetes Management
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- DexCom, Inc.
- Enrollment
- 1,388
- Locations
- 25
- Primary Endpoint
- Change in hypoglycemic events
Study Overview
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 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
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 2 Years to — (Child, Adult, Older Adult)
- Sex
- 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
Outcomes
Primary Outcomes
Change in hypoglycemic events
Time Frame: 6 months
Change in average number of hypoglycemic events per patient between CGM use compared to BGM use
Secondary Outcomes
- Change in A1C(6 months)
- Change in incidence of hypoglycemic events(6 months)
- Change in Hypoglycemia Confidence PRO scores(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)