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CGM Use in Children With Type 2 Diabetes (IMPaCT2)

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. Identifier: NCT04721158
Recruitment Status : Recruiting
First Posted : January 22, 2021
Last Update Posted : January 22, 2021
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 pediatric Type 2 diabetes patients improves short term time in range glucose control and 3-6 month glycemic control.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Hyperglycemia Due to Type 2 Diabetes Mellitus Device: Continuous glucose monitor Not Applicable

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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: IMPlementation of Continuous Glucose Monitoring in Children With Type 2 Diabetes
Actual Study Start Date : January 17, 2021
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Arm Intervention/treatment
Children with type 2 diabetes will wear a continuous glucose monitor for 10 days.
Device: Continuous glucose monitor
Eligible patients will have a Dexcom G6 Continuous Glucose Monitor placed for 10 days.
Other Name: Dexcom G6 CGM

Primary Outcome Measures :
  1. Change in Time in range glucose control [ Time Frame: Baseline and 10 days ]
    Change 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.

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

Inclusion Criteria:

  • Type 2 diabetes, diabetes duration >3 months

Exclusion Criteria:

  • Prior use of CGM

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 identifier (NCT number): NCT04721158

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Contact: Risa M Wolf, MD 410955-6463
Contact: Sheela N Magge, MD, MSCE 410-955-6463

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United States, Maryland
Johns Hopkins Pediatric Diabetes Center Recruiting
Baltimore, Maryland, United States, 21287
Contact: Risa M Wolf, MD    410-955-6463   
Sponsors and Collaborators
Johns Hopkins University
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Principal Investigator: Risa M Wolf, MD Johns Hopkins School of Medicine
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Responsible Party: Johns Hopkins University Identifier: NCT04721158    
Other Study ID Numbers: IRB00255470-2
First Posted: January 22, 2021    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Johns Hopkins University:
continuous glucose monitoring (CGM)
Hemoglobin A1c
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases