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

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.

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

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Device: Continuous Glucose Monitor
* Other: Patient Reported Outcome Questionnaires


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Continuous Glucose Monitor<br>All participants will be included in this arm | Device: Continuous Glucose Monitor<br>* Participants will be provided a continuous glucose monitor for use in self-glucose monitoring as per standard clinical care<br>Other: Patient Reported Outcome Questionnaires<br>* Participants and their parents will be asked to complete patient reported outcome questionnaires at 3 study time points.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Participants with sustained CGM use | Days of CGM use per each 14 day period | 1 year (assessed over the 14 days prior to each clinic visit) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from Baseline in HbA1C at 12 months | change in HbA1C from baseline to 12 months of CGM use | 1 year (assessed at each in person clinic visit, minimum is baseline and 12 months) | 
| Mean percentage of glucose values in target range of 70-180 mg/dL | percentage time in range, time in hypoglycemia, time in hyperglycemia | 1 year (assessed over the 14 days prior to each clinic visit) | 
| Mean percentage of glucose values below 70 mg/dL | percentage time in hypoglycemia | 1 year (assessed over the 14 days prior to each clinic visit) | 
| Mean percentage of glucose values above 180 mg/dL | percentage time in hyperglycemia | 1 year (assessed over the 14 days prior to each clinic visit) | 
| Change in Promis Global Health Scale score from baseline | Promis Global Health (Minimum=1, maximum=5 for each question, higher score for physical health questions is better outcome, higher score for mental health is worse outcome) | 1 year (assessed at baseline, 3 months and 12 months) | 
| Change in PedsQoL3.2 score from baseline | PedsQL Diabetes Module version 3.2, (minimum 0, maximum 4, for each question, higher score is worse outcome) | 1 year (assessed at baseline, 3 months and 12 months) | 
| Change in Use of and Comfort with Technology score from baseline | Use of and Comfort With Technology (Minimum = 1, Maximum =5 for each question, Higher score is better outcome) | 1 year (assessed at baseline, 3 months and 12 months) | 
| Change in Problem Areas in Diabetes score from baseline | Problem Areas in Diabetes - Pediatric PRO Scale (Minimum 1, Maximum 6, from baseline, higher dose is worse outcome) | 1 year (assessed at baseline, 3 months and 12 months) | 
| Mean change in BMI from baseline | change in BMI over study duration while using CGM | baseline and 1 year study visit |