CGM Use in Poorly Controlled Youth With Type 1 Diabetes

NCT ID: NCT04721145

Last Updated: 2023-08-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-25

Study Completion Date

2022-06-28

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 high risk, poorly controlled pediatric Type 1 diabetes patients increases uptake of personal CGM use, and improves short-term time in range glucose control.

Detailed Description

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Conditions

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Type 1 Diabetes Hypoglycemia High Blood Sugar

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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Dexcom G6 Continuous Glucose Monitor

Children with type 1 diabetes will wear a continuous glucose monitor (CGM) for 10 days.

Group Type EXPERIMENTAL

Dexcom G6 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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Dexcom G6 Continuous Glucose Monitor

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of Type 1 diabetes for \>3 months

Exclusion Criteria

* CGM use in the last 6 months
Minimum Eligible Age

5 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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DexCom, Inc.

INDUSTRY

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Risa Wolf, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

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)

Lin T, Manfredo JA, Illesca N, Abiola K, Hwang N, Salsberg S, Akhtar Y, Mathioudakis N, Brown EA, Wolf RM. Improving Continuous Glucose Monitoring Uptake in Underserved Youth with Type 1 Diabetes: The IMPACT Study. Diabetes Technol Ther. 2023 Jan;25(1):13-19. doi: 10.1089/dia.2022.0347. Epub 2022 Nov 7.

Reference Type DERIVED
PMID: 36223197 (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

Identifier Type: -

Identifier Source: org_study_id

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