Use of Continuous Glucose Monitors in Publicly-Insured Youth With Type 2 Diabetes - A Pilot and Feasibility Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Stanford University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Number of Participants With at Least 75% Wear Time Over 14 Days as a Measure of Sustained CGM Use
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 4 Years to 19 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Continuous Glucose Monitor
All participants will be included in this arm
Intervention: Continuous Glucose Monitor (Device)
Continuous Glucose Monitor
All participants will be included in this arm
Intervention: Patient Reported Outcome Questionnaires (Other)
Outcomes
Primary Outcomes
Number of Participants With at Least 75% Wear Time Over 14 Days as a Measure of Sustained CGM Use
Time Frame: months 2,3,6,9 and 12 (assessed over the 14 days prior to each clinic visit)
Secondary Outcomes
- PROMIS Global Health Overall Scale Score(baseline, months 3 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))
- PedsQL 3.2 Scale Score - Parent Rated(baseline and months 3 and 12)
- Problem Areas in Diabetes (P-PAID) Overall Scale Score - Parent Rated(baseline, months 3 and 12)
- Mean HbA1C(baseline and months 2,3,6,9 and 12)
- PedsQL 3.2 Overall Scale Score - Participant Rated(baseline and months 3 and 12)
- Diabetes Technology Attitudes (DTA) - Participant Rated(1 year (assessed at baseline, 3 months and 12 months))
- Problem Areas in Diabetes-Teen Version (PAID-T) Overall Scale Score - Participant Rated(baseline, months 3 and 12)
- Diabetes Technology Attitudes (DTA) - Parent Rated(1 year (assessed at baseline, 3 months and 12 months))
Investigators
Sejal Shah
Clinical Assistant Professor of Pediatrics
Stanford University