CGM Use in Poorly Controlled Youth With Type 1 Diabetes

Type 1 Diabetes Clinical Trial

— IMPaCT  

Official title:

IMPaCT: IMPlementing Continuous Glucose Monitoring in High-risk, Poorly Controlled Children With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04721145
• Other study ID #: IRB00255470
• Status: Completed
• Phase: N/A
• Start date: January 25, 2021
• Est. completion date: June 28, 2022

Study information

• Verified date: July 2023
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 28, 2022
• Est. primary completion date: June 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 21 Years

Eligibility

Inclusion Criteria:

• Diagnosis of Type 1 diabetes for >3 months

Exclusion Criteria:

• CGM use in the last 6 months

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• High Blood Sugar
• Hyperglycemia
• Hypoglycemia
• Type 1 Diabetes

Intervention

Device:
• Dexcom G6 Continuous Glucose Monitor
Eligible patients will have a Dexcom G6 Continuous Glucose Monitor placed for 10 days.

Locations

Country	Name	City	State
United States	Johns Hopkins Pediatric Diabetes Center	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	DexCom, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Personal CGM Use	Evaluate whether there is any change in uptake of personal CGM after 10-day trial.	Baseline and 3 months
Secondary	Change in the Percent Time in Range Glucose Control	Changes in time in range glucose control from 1-5 days to 6-10 days from the Dexcom CGM	1-5 days and 6-10 days
Secondary	Change in Hemoglobin A1c	Changes in HbA1c from baseline to next available A1c at 3-6 month follow up visit	Baseline, 3-6 months
Secondary	Using Personal CGM	Percentage of participants using CGM at time of follow up, of those who reported wanting a personal CGM	3-6 months