CGM Use in Children With Type 2 Diabetes

Type 2 Diabetes Clinical Trial

— IMPaCT2  

Official title:

IMPlementation of Continuous Glucose Monitoring in Children With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04721158
• Other study ID #: IRB00255470-2
• Status: Completed
• Phase: N/A
• Start date: January 17, 2021
• Est. completion date: July 28, 2022

Study information

• Verified date: August 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 pediatric Type 2 diabetes patients improves short term time in range glucose control and 3-6 month glycemic control.

Description:

The purpose of this prospective study is to determine if trial use of a Dexcom G6 CGM system for 10 days has an impact on short and long term glycemic control and behavior in youth onset Type 2 diabetes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: July 28, 2022
• Est. primary completion date: July 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 21 Years

Eligibility

Inclusion Criteria:

• Type 2 diabetes, diabetes duration >3 months

Exclusion Criteria:

• Prior use of CGM

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hyperglycemia
• Hyperglycemia Due to Type 2 Diabetes Mellitus
• Type 2 Diabetes

Intervention

Device:
• 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 (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Time in Range Glucose Control	The percentage of total time that the patient uses the continuous glucose monitor (CGM) where the blood glucose falls between 70 and 180 mg/dL	5 days, 10 days
Primary	Hemoglobin A1c	HbA1c at baseline and 3-6 month follow-up.	Baseline, 3 - 6 months
Primary	More Frequent Insulin Administration	Response to "Did you take your insulin more often than before?"	10 days from CGM placement
Primary	More Frequent Glycemic Control Monitoring	Response to "Do you look at or check your blood sugar more often than before?"	10 days