CGM Use in Poorly Controlled Youth With Type 1 Diabetes (IMPaCT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04721145|
Recruitment Status : Recruiting
First Posted : January 22, 2021
Last Update Posted : February 2, 2021
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Hypoglycemia High Blood Sugar||Device: Dexcom G6 Continuous Glucose Monitor||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|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 :||January 25, 2021|
|Estimated Primary Completion Date :||April 30, 2022|
|Estimated Study Completion Date :||April 30, 2022|
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.
- Change in personal CGM use [ Time Frame: Baseline and 3 months ]Evaluate whether there is any change in uptake of personal CGM use after 10-day trial.
- Change in the Time in range glucose control [ Time Frame: Baseline and 10 days ]Changes in time in range glucose control from baseline to 10 days.
- Change in Hemoglobin A1c [ Time Frame: Baseline, 3 months and 6 months ]Changes in HbA1c from baseline to follow-up.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04721145
|Contact: Risa Wolf, MD||410-955-6463||RWolf@jhu.edu|
|Contact: Sandra L Salsbergemail@example.com|
|United States, Maryland|
|Johns Hopkins Pediatric Diabetes Center||Recruiting|
|Baltimore, Maryland, United States, 21287|
|Contact: Risa M Wolf, MD 410-955-6463 firstname.lastname@example.org|
|Principal Investigator:||Risa Wolf, MD||Johns Hopkins University|