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

NCT05074667 | Completed Results FDA Device

• 1 other identifier: 62166
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Number of Participants With at Least 75% Wear Time Over 14 Days as a Measure of Sustained CGM Use

  months 2,3,6,9 and 12 (assessed over the 14 days prior to each clinic visit)

Secondary Outcomes (9)

• Mean HbA1C

  baseline and months 2,3,6,9 and 12

• Time With Glucose Values in Target Range of 70-180 mg/dL

  months 2,3,6,9 and 12 (assessed over the 14 days prior to each clinic visit)

• PROMIS Global Health Overall Scale Score

  baseline, months 3 and 12

• PedsQL 3.2 Overall Scale Score - Participant Rated

  baseline and months 3 and 12

• PedsQL 3.2 Scale Score - Parent Rated

  baseline and months 3 and 12

Study Arms (1)

Continuous Glucose Monitor

OTHER

All participants will be included in this arm

Device: Continuous Glucose Monitor; Other: Patient Reported Outcome Questionnaires

Interventions

Continuous Glucose Monitor DEVICE

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

Continuous Glucose Monitor

Patient Reported Outcome Questionnaires OTHER

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

Continuous Glucose Monitor

Eligibility Criteria

• Age: 4 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Children's Health

Palo Alto, California, 94304, United States

Location

Related Publications (1)

• 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.

  PMID: 40974209 DERIVED

Related Links

• PROMIS scoring manual

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Sejal Shah, MD
• Organization: Stanford University

sshah2@stanford.edu

650-498-7351

Study Officials

• Sejal Shah, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: October 12, 2021
• Study Start: December 1, 2021
• Primary Completion: June 25, 2023
• Study Completion: June 25, 2023
• Last Updated: July 31, 2024
• Results First Posted: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: immediately following publication. No end date.
• Access Criteria: Researchers who provide a methodologically sound proposal, for purpose of achieving aims in the approved proposal. Proposals should be directed to the protocol director and data sharing requests will need to follow current protocols in place at Stanford University.

Locations

US (1)