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Clinical Trials/NCT04721158
NCT04721158CompletedNot Applicable

IMPlementation of Continuous Glucose Monitoring in Children With Type 2 Diabetes

Johns Hopkins University2 sites in 1 country41 target enrollmentStarted: January 17, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
41
Locations
2
Primary Endpoint
Percentage of Time in Range Glucose Control

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

Detailed 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.

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

  • Type 2 diabetes, diabetes duration >3 months

Exclusion Criteria

  • Prior use of CGM

Outcomes

Primary Outcomes

Percentage of Time in Range Glucose Control

Time Frame: 5 days, 10 days

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

Hemoglobin A1c

Time Frame: Baseline, 3 - 6 months

HbA1c at baseline and 3-6 month follow-up.

More Frequent Glycemic Control Monitoring

Time Frame: 10 days

Response to "Do you look at or check your blood sugar more often than before?"

More Frequent Insulin Administration

Time Frame: 10 days from CGM placement

Response to "Did you take your insulin more often than before?"

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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