IMPaCT: CGM Use in Poorly Controlled Youth With Type 1 Diabetes
Sponsor
Johns Hopkins University (Other)
Overall Status
Completed
CT.gov ID
NCT04721145
Collaborator
DexCom, Inc. (Industry)
26
1
1
17.1
1.5
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
26 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
IMPaCT: IMPlementing Continuous Glucose Monitoring in High-risk, Poorly Controlled Children With Type 1 Diabetes
Actual Study Start Date
:
Jan 25, 2021
Actual Primary Completion Date
:
Jun 28, 2022
Actual Study Completion Date
:
Jun 28, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Dexcom G6 Continuous Glucose Monitor Children with type 1 diabetes will wear a continuous glucose monitor (CGM) for 10 days. |
Device: Dexcom G6 Continuous Glucose Monitor
Eligible patients will have a Dexcom G6 Continuous Glucose Monitor placed for 10 days.
|
Outcome Measures
Primary Outcome Measures
- Change in personal CGM use [Baseline and 3 months]
Evaluate whether there is any change in uptake of personal CGM use after 10-day trial.
Secondary Outcome Measures
- Change in the Time in range glucose control [Baseline and 10 days]
Changes in time in range glucose control from baseline to 10 days.
- Change in Hemoglobin A1c [Baseline, 3 months and 6 months]
Changes in HbA1c from baseline to follow-up.
Eligibility Criteria
Criteria
Ages Eligible for Study:
5 Years
to 21 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Diagnosis of Type 1 diabetes for >3 months
Exclusion Criteria:
- CGM use in the last 6 months
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Johns Hopkins Pediatric Diabetes Center | Baltimore | Maryland | United States | 21287 |
Sponsors and Collaborators
- Johns Hopkins University
- DexCom, Inc.
Investigators
- Principal Investigator: Risa Wolf, MD, Johns Hopkins University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT04721145
Other Study ID Numbers:
- IRB00255470
First Posted:
Jan 22, 2021
Last Update Posted:
Jul 8, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by Johns Hopkins University
Additional relevant MeSH terms: