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Use of Continuous Glucose Monitors in Publicly-Insured Youth With Type 2 Diabetes - A Pilot and Feasibility Study

NCT05074667 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-07-31

Study results available
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Summary

The purpose of this pilot feasibility study is to provide continued CGM access to youth with type 2 diabetes and collect descriptive data about feasibility of use of CGM in youth with type 2 diabetes ages 4 years and older. From this study the investigators hope to learn if CGM use in youth with type 2 diabetes can be tolerated and sustained with good adherence and to describe blood glucose patterns in youth with type 2 diabetes. The primary aim will be to evaluate the feasibility of CGM start and continuation in youth with T2D and describe glucose metrics and patient reported outcomes (PROs). The investigators will pilot and refine a program to test the hypothesis that CGM start and continuation in youth with T2D is feasible and then evaluate glucose metrics and PROs.

Conditions

Interventions

DEVICE

Continuous Glucose Monitor

Participants will be provided a continuous glucose monitor for use in self-glucose monitoring as per standard clinical care

OTHER

Patient Reported Outcome Questionnaires

Participants and their parents will be asked to complete patient reported outcome questionnaires at 3 study time points.

Sponsors & Collaborators

Principal Investigators

  • Sejal Shah, MD · Stanford University

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2023-06-25
Completion
2023-06-25
FDA Device
Yes

Countries

  • United States

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05074667 on ClinicalTrials.gov