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Completed

NCT Number: NCT04721158

CGM Use in Children With Type 2 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 pediatric Type 2 diabetes patients improves short term time in range glucose control and 3-6 month glycemic control.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperglycemia Due to Type 2 Diabetes Mellitus 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

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 2 diabetes, diabetes duration >3 months

Exclusion criteria

  • Prior use of CGM

Treatment and study plan

Continuous Glucose Monitor

Device

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

Other names: Dexcom G6 CGM

Primary outcomes

  1. Percentage of Time in Range Glucose Control

    Time frame: 5 days, 10 days

    The percentage of total time that the patient uses the continuous glucose monitor (CGM) where the blood glucose falls between 70 and 180 mg/dL

  2. Hemoglobin A1c

    Time frame: Baseline, 3 - 6 months

    HbA1c at baseline and 3-6 month follow-up.

  3. More Frequent Insulin Administration

    Time frame: 10 days from CGM placement

    Response to "Did you take your insulin more often than before?"

  4. More Frequent Glycemic Control Monitoring

    Time frame: 10 days

    Response to "Do you look at or check your blood sugar more often than before?"

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

IMPlementation of Continuous Glucose Monitoring in Children With Type 2 Diabetes

Acronym: IMPaCT2

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 22, 2021
Registry last updated
Sep 15, 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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