- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04721158
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
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
-
-
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.
|
Eligible patients will have a Dexcom G6 Continuous Glucose Monitor placed for 10 days.
Other Names:
|
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
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
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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