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

NCT ID: NCT05074667

Last Updated: 2024-07-31

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2023-06-25

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Continuous Glucose Monitor

All participants will be included in this arm

Group Type OTHER

Continuous Glucose Monitor

Intervention Type DEVICE

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

Patient Reported Outcome Questionnaires

Intervention Type OTHER

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

Interventions

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Continuous Glucose Monitor

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

Intervention Type DEVICE

Patient Reported Outcome Questionnaires

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* public insurance
* between ages 4-19.99 years inclusive
* diagnosis of T2D (diabetes autoantibody negative) followed in the Pediatric Endocrinology clinic at Stanford Children's Health
* HbA1C greater than 6.5% at enrollment
* interested in starting on a continuous glucose monitor
* have access to a mobile device that is compatible with CGM applications or willing to use CGM receiver provided

Exclusion Criteria

* non-T2D diagnosis
* HgA1C \< 6.5%
* are not willing to wear CGM
* have private health insurance.
Minimum Eligible Age

4 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Sejal Shah

Clinical Assistant Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sejal Shah, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford Children's Health

Palo Alto, California, United States

Site Status

Countries

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United States

References

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Shah S, Tanenbaum ML, Loyola A, Sala NGL, Darji H, Hanes S, Bishop FK, Hood KK, Maahs DM. Use of Continuous Glucose Monitors in Publicly Insured Youth With Type 2 Diabetes: A 12-month Pilot and Feasibility Study. J Diabetes Sci Technol. 2025 Sep 20:19322968251368366. doi: 10.1177/19322968251368366. Online ahead of print.

Reference Type DERIVED
PMID: 40974209 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

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Other Identifiers

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62166

Identifier Type: -

Identifier Source: org_study_id

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