Clinical trial NCT05074667: Use of Continuous Glucose Monitors in Publicly-Insured Youth With Type 2 Diabetes - A Pilot and Feasibility Study
Official title: Use of Continuous Glucose Monitors in Publicly-Insured Youth With Type 2 Diabetes - A Pilot and Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2021-10-12
Enrollment: 30
Sex: ALL
Minimum age (years): 4
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With at Least 75% Wear Time Over 14 Days as a Measure of Sustained CGM Use
timeFrame: months 2,3,6,9 and 12 (assessed over the 14 days prior to each clinic visit)
Secondary outcomes:
measure: Mean HbA1C
timeFrame: baseline and months 2,3,6,9 and 12
measure: Time With Glucose Values in Target Range of 70-180 mg/dL
timeFrame: months 2,3,6,9 and 12 (assessed over the 14 days prior to each clinic visit)
measure: PROMIS Global Health Overall Scale Score
timeFrame: baseline, months 3 and 12
measure: PedsQL 3.2 Overall Scale Score - Participant Rated
timeFrame: baseline and months 3 and 12
measure: PedsQL 3.2 Scale Score - Parent Rated
timeFrame: baseline and months 3 and 12
measure: Diabetes Technology Attitudes (DTA) - Participant Rated
timeFrame: 1 year (assessed at baseline, 3 months and 12 months)
measure: Diabetes Technology Attitudes (DTA) - Parent Rated
timeFrame: 1 year (assessed at baseline, 3 months and 12 months)
measure: Problem Areas in Diabetes-Teen Version (PAID-T) Overall Scale Score - Participant Rated
timeFrame: baseline, months 3 and 12
measure: Problem Areas in Diabetes (P-PAID) Overall Scale Score - Parent Rated
timeFrame: baseline, months 3 and 12
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Children's Health
state: California
Study officials:
affiliation: Stanford University
name: Sejal Shah, MD
role: PRINCIPAL_INVESTIGATOR
References: