CGM Use in Children With Type 2 Diabetes

NCT ID: NCT04721158

Last Updated: 2023-09-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-17

Study Completion Date

2022-07-28

Brief Summary

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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.

Detailed Description

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The purpose of this prospective study is to determine if trial use of a Dexcom G6 CGM system for 10 days has an impact on short and long term glycemic control and behavior in youth onset Type 2 diabetes.

Conditions

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Type 2 Diabetes Hyperglycemia Due to Type 2 Diabetes Mellitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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CGM Arm

Children with type 2 diabetes will wear a continuous glucose monitor for 10 days.

Group Type OTHER

Continuous glucose monitor

Intervention Type DEVICE

Eligible patients will have a Dexcom G6 Continuous Glucose Monitor placed for 10 days.

Interventions

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Continuous glucose monitor

Eligible patients will have a Dexcom G6 Continuous Glucose Monitor placed for 10 days.

Intervention Type DEVICE

Other Intervention Names

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Dexcom G6 CGM

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes, diabetes duration \>3 months

Exclusion Criteria

* Prior use of CGM
Minimum Eligible Age

5 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Risa M Wolf, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins School of Medicine

Locations

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Johns Hopkins Pediatric Diabetes Center

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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Phu A, Lin T, Manfredo JA, Brown EA, Wolf RM. Similar Perceptions on Continuous Glucose Monitor Use amongst Youth with Type 1 and Type 2 Diabetes. Pediatr Diabetes. 2023 Jun 19;2023:1979635. doi: 10.1155/2023/1979635. eCollection 2023.

Reference Type DERIVED
PMID: 40303266 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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IRB00255470-2

Identifier Type: -

Identifier Source: org_study_id

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