CGM Use in Poorly Controlled Youth With Type 1 Diabetes

Not Applicable

Completed

• Conditions: Type 1 Diabetes; Hypoglycemia; High Blood Sugar
• Interventions: Device: Dexcom G6 Continuous Glucose Monitor

• Registration Number: NCT04721145
• Lead Sponsor: Johns Hopkins University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-19
• Study First Submitted QC: 2021-01-19
• Study First Posted: 2021-01-22
• Study Start: 2021-01-25
• Primary Completion: 2022-06-28
• Study Completion: 2022-06-28
• Results First Submitted: 2023-06-05
• Status Verified: 2023-07
• Results First Submitted QC: 2023-07-17
• Last Update Submitted: 2023-07-17
• Results First Posted: 2023-08-04
• Last Update Posted: 2023-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• Diagnosis of Type 1 diabetes for >3 months

Exclusion Criteria

• CGM use in the last 6 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dexcom G6 Continuous Glucose Monitor	Dexcom G6 Continuous Glucose Monitor	Children with type 1 diabetes will wear a continuous glucose monitor (CGM) for 10 days.

Primary Outcome Measures

Name	Time	Method
Change in Personal CGM Use	Baseline and 3 months	Evaluate whether there is any change in uptake of personal CGM after 10-day trial.

Secondary Outcome Measures

Name	Time	Method
Change in Hemoglobin A1c	Baseline, 3-6 months	Changes in HbA1c from baseline to next available A1c at 3-6 month follow up visit
Using Personal CGM	3-6 months	Percentage of participants using CGM at time of follow up, of those who reported wanting a personal CGM
Change in the Percent Time in Range Glucose Control	1-5 days and 6-10 days	Changes in time in range glucose control from 1-5 days to 6-10 days from the Dexcom CGM

Trial Locations

Locations (1)

Johns Hopkins Pediatric Diabetes Center; 🇺🇸 Baltimore, Maryland, United States