Back to resultsCGM Use in Children With Type 2 Diabetes (IMPaCT2)
Primary Purpose
Type 2 Diabetes, Hyperglycemia Due to Type 2 Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Continuous glucose monitor
Sponsored by
About this trial
This is an interventional supportive care trial for Type 2 Diabetes focused on measuring continuous glucose monitoring (CGM), Hemoglobin A1c
Eligibility Criteria
Inclusion Criteria:
- Type 2 diabetes, diabetes duration >3 months
Exclusion Criteria:
- Prior use of CGM
Sites / Locations
- Johns Hopkins Pediatric Diabetes Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
CGM Arm
Arm Description
Children with type 2 diabetes will wear a continuous glucose monitor for 10 days.
Outcomes
Primary Outcome Measures
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
Hemoglobin A1c
HbA1c at baseline and 3-6 month follow-up.
More Frequent Insulin Administration
Response to "Did you take your insulin more often than before?"
More Frequent Glycemic Control Monitoring
Response to "Do you look at or check your blood sugar more often than before?"
Secondary Outcome Measures
Full Information
NCT ID
NCT04721158
First Posted
January 19, 2021
Last Updated
August 22, 2023
Sponsor
Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT04721158
Brief Title
CGM Use in Children With Type 2 Diabetes
Acronym
IMPaCT2
Official Title
IMPlementation of Continuous Glucose Monitoring in Children With Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
January 17, 2021 (Actual)
Primary Completion Date
July 28, 2022 (Actual)
Study Completion Date
July 28, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Hyperglycemia Due to Type 2 Diabetes Mellitus
Keywords
continuous glucose monitoring (CGM), Hemoglobin A1c
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CGM Arm
Arm Type
Other
Arm Description
Children with type 2 diabetes will wear a continuous glucose monitor for 10 days.
Intervention Type
Device
Intervention Name(s)
Continuous glucose monitor
Other Intervention Name(s)
Dexcom G6 CGM
Intervention Description
Eligible patients will have a Dexcom G6 Continuous Glucose Monitor placed for 10 days.
Primary Outcome Measure Information:
Title
Percentage of Time in Range Glucose Control
Description
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
Time Frame
5 days, 10 days
Title
Hemoglobin A1c
Description
HbA1c at baseline and 3-6 month follow-up.
Time Frame
Baseline, 3 - 6 months
Title
More Frequent Insulin Administration
Description
Response to "Did you take your insulin more often than before?"
Time Frame
10 days from CGM placement
Title
More Frequent Glycemic Control Monitoring
Description
Response to "Do you look at or check your blood sugar more often than before?"
Time Frame
10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Type 2 diabetes, diabetes duration >3 months
Exclusion Criteria:
Prior use of CGM
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Risa M Wolf, MD
Organizational Affiliation
Johns Hopkins School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Pediatric Diabetes Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
CGM Use in Children With Type 2 Diabetes
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