Back to resultsCGM Use in Poorly Controlled Youth With Type 1 Diabetes (IMPaCT)
Primary Purpose
Type 1 Diabetes, Hypoglycemia, High Blood Sugar
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dexcom G6 Continuous Glucose Monitor
Sponsored by
About this trial
This is an interventional supportive care trial for Type 1 Diabetes focused on measuring Continuous Glucose Monitoring, Time in range, Hemoglobin A1c
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of Type 1 diabetes for >3 months
Exclusion Criteria:
- CGM use in the last 6 months
Sites / Locations
- Johns Hopkins Pediatric Diabetes Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dexcom G6 Continuous Glucose Monitor
Arm Description
Children with type 1 diabetes will wear a continuous glucose monitor (CGM) for 10 days.
Outcomes
Primary Outcome Measures
Change in Personal CGM Use
Evaluate whether there is any change in uptake of personal CGM after 10-day trial.
Secondary Outcome Measures
Change in the Percent Time in Range Glucose Control
Changes in time in range glucose control from 1-5 days to 6-10 days from the Dexcom CGM
Change in Hemoglobin A1c
Changes in HbA1c from baseline to next available A1c at 3-6 month follow up visit
Using Personal CGM
Percentage of participants using CGM at time of follow up, of those who reported wanting a personal CGM
Full Information
NCT ID
NCT04721145
First Posted
January 19, 2021
Last Updated
July 17, 2023
Sponsor
Johns Hopkins University
Collaborators
DexCom, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04721145
Brief Title
CGM Use in Poorly Controlled Youth With Type 1 Diabetes
Acronym
IMPaCT
Official Title
IMPaCT: IMPlementing Continuous Glucose Monitoring in High-risk, Poorly Controlled Children With Type 1 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 25, 2021 (Actual)
Primary Completion Date
June 28, 2022 (Actual)
Study Completion Date
June 28, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
DexCom, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
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 high risk, poorly controlled pediatric Type 1 diabetes patients increases uptake of personal CGM use, and improves short-term time in range glucose control.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes, Hypoglycemia, High Blood Sugar
Keywords
Continuous Glucose Monitoring, Time in range, 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
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dexcom G6 Continuous Glucose Monitor
Arm Type
Experimental
Arm Description
Children with type 1 diabetes will wear a continuous glucose monitor (CGM) for 10 days.
Intervention Type
Device
Intervention Name(s)
Dexcom G6 Continuous Glucose Monitor
Intervention Description
Eligible patients will have a Dexcom G6 Continuous Glucose Monitor placed for 10 days.
Primary Outcome Measure Information:
Title
Change in Personal CGM Use
Description
Evaluate whether there is any change in uptake of personal CGM after 10-day trial.
Time Frame
Baseline and 3 months
Secondary Outcome Measure Information:
Title
Change in the Percent Time in Range Glucose Control
Description
Changes in time in range glucose control from 1-5 days to 6-10 days from the Dexcom CGM
Time Frame
1-5 days and 6-10 days
Title
Change in Hemoglobin A1c
Description
Changes in HbA1c from baseline to next available A1c at 3-6 month follow up visit
Time Frame
Baseline, 3-6 months
Title
Using Personal CGM
Description
Percentage of participants using CGM at time of follow up, of those who reported wanting a personal CGM
Time Frame
3-6 months
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:
Diagnosis of Type 1 diabetes for >3 months
Exclusion Criteria:
CGM use in the last 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Risa Wolf, MD
Organizational Affiliation
Johns Hopkins University
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
Citations:
PubMed Identifier
36223197
Citation
Lin T, Manfredo JA, Illesca N, Abiola K, Hwang N, Salsberg S, Akhtar Y, Mathioudakis N, Brown EA, Wolf RM. Improving Continuous Glucose Monitoring Uptake in Underserved Youth with Type 1 Diabetes: The IMPACT Study. Diabetes Technol Ther. 2023 Jan;25(1):13-19. doi: 10.1089/dia.2022.0347. Epub 2022 Nov 7.
Results Reference
derived
Learn more about this trial
CGM Use in Poorly Controlled Youth With Type 1 Diabetes
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