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CGM Use in Children With Type 2 Diabetes (IMPaCT2)

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ClinicalTrials.gov Identifier: NCT04721158
Recruitment Status : Recruiting
First Posted : January 22, 2021
Last Update Posted : January 22, 2021
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Study Description
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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

Study Design
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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

Arms and Interventions
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Arm Intervention/treatment
CGM Arm
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


Outcome Measures
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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.


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

Inclusion Criteria:

  • Type 2 diabetes, diabetes duration >3 months

Exclusion Criteria:

  • Prior use of CGM
Contacts and Locations
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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): NCT04721158


Contacts
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Contact: Risa M Wolf, MD 410955-6463 rwolf@jhu.edu
Contact: Sheela N Magge, MD, MSCE 410-955-6463 smagge3@jhmi.edu

Locations
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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    rwolf@jhu.edu   
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Risa M Wolf, MD Johns Hopkins School of Medicine
More Information
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov 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
Hyperglycemia
 Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases