Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

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
Type 1 Diabetes Hypoglycemia High Blood Sugar Device: Dexcom G6 Continuous Glucose Monitor Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 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 : January 25, 2021
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : April 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
Drug Information available for: Dextrose

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Change in Hemoglobin A1c [ Time Frame: Baseline, 3 months and 6 months ]
    Changes in HbA1c from baseline to follow-up.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   5 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Type 1 diabetes for >3 months

Exclusion Criteria:

  • CGM use in the last 6 months

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Risa Wolf, MD 410-955-6463 RWolf@jhu.edu
Contact: Sandra L Salsberg 410-955-6463 ssalsbe1@jhmi.edu

Locations
Layout table for location information
United States, Maryland
Johns Hopkins Pediatric Diabetes Center Recruiting
Baltimore, Maryland, United States, 21287
Contact: Risa M Wolf, MD    410-955-6463    rwolf@jhu.edu   
Sponsors and Collaborators
Johns Hopkins University
Investigators
Layout table for investigator information
Principal Investigator: Risa Wolf, MD Johns Hopkins University
Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT04721145    
Other Study ID Numbers: IRB00255470
First Posted: January 22, 2021    Key Record Dates
Last Update Posted: February 2, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Johns Hopkins University:
Continuous Glucose Monitoring
Time in range
Hemoglobin A1c
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 1
Hypoglycemia
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases