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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05074667
• Other study ID #: 62166
• Status: Completed
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: June 25, 2023

Study information

• Verified date: September 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 25, 2023
• Est. primary completion date: June 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 19 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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.

Locations

Country	Name	City	State
United States	Stanford Children's Health	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Mean change in BMI from baseline	change in BMI over study duration while using CGM	baseline and 1 year study visit