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OpenTrials
Completed

NCT Number: NCT04721145

CGM Use in Poorly Controlled Youth With Type 1 Diabetes

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders High Blood Sugar Hyperglycemia Hypoglycemia Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

5 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Pediatric Diabetes Center

Baltimore, Maryland, 21287, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of Type 1 diabetes for >3 months

Exclusion criteria

  • CGM use in the last 6 months

Treatment and study plan

Dexcom G6 continuous glucose monitor

Device

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

Primary outcomes

  1. Change in Personal CGM Use

    Time frame: Baseline and 3 months

    Evaluate whether there is any change in uptake of personal CGM after 10-day trial.

Secondary outcomes

  1. Change in the Percent Time in Range Glucose Control

    Time frame: 1-5 days and 6-10 days

    Changes in time in range glucose control from 1-5 days to 6-10 days from the Dexcom CGM

  2. Change in Hemoglobin A1c

    Time frame: Baseline, 3-6 months

    Changes in HbA1c from baseline to next available A1c at 3-6 month follow up visit

  3. Using Personal CGM

    Time frame: 3-6 months

    Percentage of participants using CGM at time of follow up, of those who reported wanting a personal CGM

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • DexCom, Inc.

Registry information

Official study title

IMPaCT: IMPlementing Continuous Glucose Monitoring in High-risk, Poorly Controlled Children With Type 1 Diabetes

Acronym: IMPaCT

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 22, 2021
Registry last updated
Aug 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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