CGM Use in Children With Type 2 Diabetes (IMPaCT2)

August 22, 2023 updated by: Johns Hopkins University

IMPlementation of Continuous Glucose Monitoring in Children With Type 2 Diabetes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Pediatric Diabetes Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Type 2 diabetes, diabetes duration >3 months

Exclusion Criteria:

  • Prior use of CGM

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: CGM Arm
Children with type 2 diabetes will wear a continuous glucose monitor for 10 days.
Device: Continuous glucose monitor
Eligible patients will have a Dexcom G6 Continuous Glucose Monitor placed for 10 days.
Other Names:
  • Dexcom G6 CGM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
More Frequent Glycemic Control Monitoring
Time Frame: 10 days
Response to "Do you look at or check your blood sugar more often than before?"
10 days
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
5 days, 10 days
Hemoglobin A1c
Time Frame: Baseline, 3 - 6 months
HbA1c at baseline and 3-6 month follow-up.
Baseline, 3 - 6 months
More Frequent Insulin Administration
Time Frame: 10 days from CGM placement
Response to "Did you take your insulin more often than before?"
10 days from CGM placement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Investigators

  • Principal Investigator: Risa M Wolf, MD, Johns Hopkins School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2021

Primary Completion (Actual)

July 28, 2022

Study Completion (Actual)

July 28, 2022

Study Registration Dates

First Submitted

January 19, 2021

First Submitted That Met QC Criteria

January 19, 2021

First Posted (Actual)

January 22, 2021

Study Record Updates

Last Update Posted (Actual)

September 15, 2023

Last Update Submitted That Met QC Criteria

August 22, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00255470-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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