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

Primary Purpose

Type 2 Diabetes

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Continuous Glucose Monitor

Patient Reported Outcome Questionnaires

About this trial

This is an interventional other trial for Type 2 Diabetes

Eligibility Criteria

4 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Stanford Children's Health

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Continuous Glucose Monitor

Arm Description

All participants will be included in this arm

Outcomes

Primary Outcome Measures

Proportion of Participants with sustained CGM use

Days of CGM use per each 14 day period

Secondary Outcome Measures

Mean change from Baseline in HbA1C at 12 months

change in HbA1C from baseline to 12 months of CGM use

Mean percentage of glucose values in target range of 70-180 mg/dL

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

Mean percentage of glucose values below 70 mg/dL

percentage time in hypoglycemia

Mean percentage of glucose values above 180 mg/dL

percentage time in hyperglycemia

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)

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)

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)

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)

Mean change in BMI from baseline

change in BMI over study duration while using CGM

Full Information

NCT ID

NCT05074667

First Posted

September 29, 2021

Last Updated

September 24, 2023

Sponsor

Stanford University

1. Study Identification

Unique Protocol Identification Number

NCT05074667

Brief Title

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

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

December 1, 2021 (Actual)

Primary Completion Date

June 25, 2023 (Actual)

Study Completion Date

June 25, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Continuous Glucose Monitor

Arm Type

Other

Arm Description

All participants will be included in this arm

Intervention Type

Device

Intervention Name(s)

Continuous Glucose Monitor

Intervention Description

Participants will be provided a continuous glucose monitor for use in self-glucose monitoring as per standard clinical care

Intervention Type

Other

Intervention Name(s)

Patient Reported Outcome Questionnaires

Intervention Description

Participants and their parents will be asked to complete patient reported outcome questionnaires at 3 study time points.

Primary Outcome Measure Information:

Title

Proportion of Participants with sustained CGM use

Description

Days of CGM use per each 14 day period

Time Frame

1 year (assessed over the 14 days prior to each clinic visit)

Secondary Outcome Measure Information:

Title

Mean change from Baseline in HbA1C at 12 months

Description

change in HbA1C from baseline to 12 months of CGM use

Time Frame

1 year (assessed at each in person clinic visit, minimum is baseline and 12 months)

Title

Mean percentage of glucose values in target range of 70-180 mg/dL

Description

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

Time Frame

1 year (assessed over the 14 days prior to each clinic visit)

Title

Mean percentage of glucose values below 70 mg/dL

Description

percentage time in hypoglycemia

Time Frame

1 year (assessed over the 14 days prior to each clinic visit)

Title

Mean percentage of glucose values above 180 mg/dL

Description

percentage time in hyperglycemia

Time Frame

1 year (assessed over the 14 days prior to each clinic visit)

Title

Change in Promis Global Health Scale score from baseline

Description

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)

Time Frame

1 year (assessed at baseline, 3 months and 12 months)

Title

Change in PedsQoL3.2 score from baseline

Description

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

Time Frame

1 year (assessed at baseline, 3 months and 12 months)

Title

Change in Use of and Comfort with Technology score from baseline

Description

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

Time Frame

1 year (assessed at baseline, 3 months and 12 months)

Title

Change in Problem Areas in Diabetes score from baseline

Description

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

Time Frame

1 year (assessed at baseline, 3 months and 12 months)

Title

Mean change in BMI from baseline

Description

change in BMI over study duration while using CGM

Time Frame

baseline and 1 year study visit

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Years

Maximum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sejal Shah, MD

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford Children's Health

City

Palo Alto

State/Province

California

ZIP/Postal Code

94304

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

All of the individual participant data collected during the trial after deidentification

IPD Sharing Time Frame

immediately following publication. No end date.

IPD Sharing Access Criteria

Researchers who provide a methodologically sound proposal, for purpose of achieving aims in the approved proposal. Proposals should be directed to the protocol director and data sharing requests will need to follow current protocols in place at Stanford University.

Learn more about this trial

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

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