NCT04721145CompletedNot Applicable
IMPaCT: IMPlementing Continuous Glucose Monitoring in High-risk, Poorly Controlled Children With Type 1 Diabetes
Johns Hopkins University1 site in 1 country26 target enrollmentStarted: January 25, 2021Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Johns Hopkins University
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Change in Personal CGM Use
Study Overview
Brief Summary
The purpose of this prospective study is to determine if trial use of a Dexcom G6 CGM system for a 10 day wear period in high risk, poorly controlled pediatric Type 1 diabetes patients increases uptake of personal CGM use, and improves short-term time in range glucose control.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 5 Years to 21 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of Type 1 diabetes for >3 months
Exclusion Criteria
- •CGM use in the last 6 months
Arms & Interventions
Dexcom G6 Continuous Glucose Monitor
Experimental
Children with type 1 diabetes will wear a continuous glucose monitor (CGM) for 10 days.
Intervention: Dexcom G6 Continuous Glucose Monitor (Device)
Outcomes
Primary Outcomes
Change in Personal CGM Use
Time Frame: Baseline and 3 months
Evaluate whether there is any change in uptake of personal CGM after 10-day trial.
Secondary Outcomes
- Change in Hemoglobin A1c(Baseline, 3-6 months)
- Using Personal CGM(3-6 months)
- Change in the Percent Time in Range Glucose Control(1-5 days and 6-10 days)
Investigators
Study Sites (1)
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