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

Not Applicable

Completed

• Conditions: Type 2 Diabetes
• Interventions: Device: Continuous Glucose Monitor; Other: Patient Reported Outcome Questionnaires

• Registration Number: NCT05074667
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-09-29
• Study First Submitted QC: 2021-09-29
• Study First Posted: 2021-10-12
• Study Start: 2021-12-01
• Primary Completion: 2023-06-25
• Study Completion: 2023-06-25
• Results First Submitted: 2024-06-08
• Status Verified: 2024-07
• Results First Submitted QC: 2024-07-09
• Last Update Submitted: 2024-07-09
• Results First Posted: 2024-07-31
• Last Update Posted: 2024-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Continuous Glucose Monitor	Continuous Glucose Monitor	All participants will be included in this arm
Continuous Glucose Monitor	Patient Reported Outcome Questionnaires	All participants will be included in this arm

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
PROMIS Global Health Overall Scale Score	baseline, months 3 and 12	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.
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)
PedsQL 3.2 Scale Score - Parent Rated	baseline and months 3 and 12	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.
Problem Areas in Diabetes (P-PAID) Overall Scale Score - Parent Rated	baseline, months 3 and 12	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.
Mean HbA1C	baseline and months 2,3,6,9 and 12	HbA1C through 12 months of CGM use
PedsQL 3.2 Overall Scale Score - Participant Rated	baseline and months 3 and 12	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.
Diabetes Technology Attitudes (DTA) - Participant Rated	1 year (assessed at baseline, 3 months and 12 months)	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
Problem Areas in Diabetes-Teen Version (PAID-T) Overall Scale Score - Participant Rated	baseline, months 3 and 12	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).
Diabetes Technology Attitudes (DTA) - Parent Rated	1 year (assessed at baseline, 3 months and 12 months)	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.

Trial Locations

Locations (1)

Stanford Children's Health; 🇺🇸 Palo Alto, California, United States