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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Device: Continuous Glucose Monitor; Other: Patient Reported Outcome Questionnaires

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Stanford Children's Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Continuous Glucose Monitor; All participants will be included in this arm	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean HbA1C	HbA1C through 12 months of CGM use	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	PROMIS Global Health (7 questions, Minimum=1, maximum=5 for each question, higher score for physical health questions is better outcome, higher score for mental health is worse outcome). Scores for each question were summed then converted to a t-score (overall range 16 to 67.5, higher score = better health). A score of 50 is the average for the United States general population with a standard deviation of 10. A score below 22 in this study would result in a referral to social work or diabetes psychology.	baseline, months 3 and 12
PedsQL 3.2 Overall Scale Score - Participant Rated	Pediatric Quality of Life Inventory (PedsQL) Diabetes Module version 3.2, including 33 items (questions) comprising 5 dimensions (diabetes symptoms, treatment 1, treatment 2, worry, and communication). Each item scored from 0 to 4, higher scores correspond to lower problems. Each item is reversed scored and linearly transformed to a 0 to 100 scale (0=100,1=75,2=50,3=25,4=0), higher scores correspond to lower problems. The overall score is calculated as the sum of the transformed scores for each item divided by the total number of items answered by participants to create an overall score range of 0 to 100, higher scores correspond to lower problems.	baseline and months 3 and 12
PedsQL 3.2 Scale Score - Parent Rated	Pediatric Quality of Life Inventory (PedsQL) Diabetes Module version 3.2, including 33 items (questions) comprising 5 dimensions (diabetes symptoms, treatment 1, treatment 2, worry, and communication). Each item scored from 0 to 4, higher scores correspond to lower problems. Each item is reversed scored and linearly transformed to a 0 to 100 scale (0=100,1=75,2=50,3=25,4=0), higher scores correspond to lower problems. The overall score is calculated as the sum of the transformed scores for each item divided by the total number of items answered by parents to create an overall score range of 0 to 100, higher scores correspond to lower problems. Parents completed the survey at the same time as their child but were not considered to be enrolled in the study.	baseline and months 3 and 12
Diabetes Technology Attitudes (DTA) - Participant Rated	The DTA assesses use and comfort with technology. Each of the 5 items are responded to on a 5 point likert scale (from 1=Strongly Disagree to 5=Strongly Agree) Mean item score, higher score = more positive attitude, total score range 1-5	1 year (assessed at baseline, 3 months and 12 months)
Diabetes Technology Attitudes (DTA) - Parent Rated	The DTA assesses use and comfort with technology. Each of the 5 items are responded to on a 5 point likert scale (from 1=Strongly Disagree to 5=Strongly Agree) Mean item score, higher score = more positive attitude, total score range 1-5 Parents completed the survey at the same time as their child but were not considered to be enrolled in the study.	1 year (assessed at baseline, 3 months and 12 months)
Problem Areas in Diabetes-Teen Version (PAID-T) Overall Scale Score - Participant Rated	Problem Areas in Diabetes - survey Teen version with 14 questions each scored using a 6-point Likert Scale (1=not a problem, to 6=serious problem). The overall score is computed by summing responses for an overall range of 14 to 84 (higher score is worse outcome).	baseline, months 3 and 12
Problem Areas in Diabetes (P-PAID) Overall Scale Score - Parent Rated	Problem Areas in Diabetes - survey Teen Parent version with 15 questions each scored using a 6-point Likert Scale (1=not a problem, to 6=serious problem). The overall score is computed by summing responses for an overall range of 15 to 90 (higher score is worse outcome). Parents completed the survey at the same time as their child but were not considered to be enrolled in the study.	baseline, months 3 and 12

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Sejal Shah, MD, Stanford University

Publications and helpful links

Helpful Links

• PROMIS scoring manual

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): June 25, 2023
• Study Completion (Actual): June 25, 2023

Study Registration Dates

• First Submitted: September 29, 2021
• First Submitted That Met QC Criteria: September 29, 2021
• First Posted (Actual): October 12, 2021

Study Record Updates

• Last Update Posted (Actual): July 31, 2024
• Last Update Submitted That Met QC Criteria: July 9, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 62166

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the individual participant data collected during the trial after deidentification
• IPD Sharing Time Frame: immediately following publication. No end date.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No