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

• Sponsor: Stanford University (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT05074667
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 14
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes	Device: Continuous Glucose Monitor; Other: Patient Reported Outcome Questionnaires	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Use of Continuous Glucose Monitors in Publicly-Insured Youth With Type 2 Diabetes - A Pilot and Feasibility Study
• Actual Study Start Date: Dec 1, 2021
• Anticipated Primary Completion Date: Feb 1, 2023
• Anticipated Study Completion Date: Feb 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Continuous Glucose Monitor All participants will be included in this arm	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.

Outcome Measures

Primary Outcome Measures

1. Proportion of Participants with sustained CGM use [1 year (assessed over the 14 days prior to each clinic visit)]

   Days of CGM use per each 14 day period

Secondary Outcome Measures

1. Mean change from Baseline in HbA1C at 12 months [1 year (assessed at each in person clinic visit, minimum is baseline and 12 months)]

   change in HbA1C from baseline to 12 months of CGM use

2. Mean percentage of glucose values in target range of 70-180 mg/dL [1 year (assessed over the 14 days prior to each clinic visit)]

   percentage time in range, time in hypoglycemia, time in hyperglycemia

3. Mean percentage of glucose values below 70 mg/dL [1 year (assessed over the 14 days prior to each clinic visit)]

   percentage time in hypoglycemia

4. Mean percentage of glucose values above 180 mg/dL [1 year (assessed over the 14 days prior to each clinic visit)]

   percentage time in hyperglycemia

5. Change in Promis Global Health Scale score from baseline [1 year (assessed at baseline, 3 months and 12 months)]

   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)

6. Change in PedsQoL3.2 score from baseline [1 year (assessed at baseline, 3 months and 12 months)]

   PedsQL Diabetes Module version 3.2, (minimum 0, maximum 4, for each question, higher score is worse outcome)

7. Change in Use of and Comfort with Technology score from baseline [1 year (assessed at baseline, 3 months and 12 months)]

   Use of and Comfort With Technology (Minimum = 1, Maximum =5 for each question, Higher score is better outcome)

8. Change in Problem Areas in Diabetes score from baseline [1 year (assessed at baseline, 3 months and 12 months)]

   Problem Areas in Diabetes - Pediatric PRO Scale (Minimum 1, Maximum 6, from baseline, higher dose is worse outcome)

9. Mean change in BMI from baseline [baseline and 1 year study visit]

   change in BMI over study duration while using CGM

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years to 19 Years
• Sexes Eligible for Study: 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford Children's Health	Palo Alto	California	United States	94304

Sponsors and Collaborators

• Stanford University

Investigators

• Principal Investigator: Sejal Shah, MD, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sejal Shah, Clinical Assistant Professor of Pediatrics, Stanford University
• ClinicalTrials.gov Identifier: NCT05074667
• Other Study ID Numbers: 62166
• First Posted: Oct 12, 2021
• Last Update Posted: Apr 6, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Apr 6, 2022