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Increasing Use of Continuous Glucose Monitors in Publicly-insured Youth With Type 1 Diabetes

Primary Purpose

Type1diabetes

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

gamification

Use of Dexcom G5

About this trial

This is an interventional other trial for Type1diabetes

Eligibility Criteria

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

Inclusion Criteria:

type 1 diabetes for more than 6 months
on insulin pump or multiple daily injections without plans to change modality in next 6 months
insured by CCS or Medi-Cal
receiving care at Lucile Packard Children's Hospital or Stanford Children's Health outpatient clinics
English or Spanish-speaking

Exclusion Criteria:

major illness or condition that may alter glucose control or ability to complete the study including pregnancy, cystic fibrosis, cancer, liver disease, history of transplant, or hemoglobinopathy
current oral glucocorticoid use
prior use of a CGM system
hemoglobin A1C <7.5% or >12%
no wireless internet access

Sites / Locations

Stanford Children's

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Gamification

Standard care

Arm Description

Use of continuous glucose monitor (Dexcom G5) with proactive intervention and incentives for time in use.

Use of continuous glucose monitor (Dexcom G5) per usual care.

Outcomes

Primary Outcome Measures

CGM use

amount of time per week CGM is used

Secondary Outcome Measures

Hgb A1c

glycemic control as measured by Hgb A1c

Full Information

NCT ID

NCT03297762

First Posted

September 25, 2017

Last Updated

April 16, 2020

Sponsor

Stanford University

1. Study Identification

Unique Protocol Identification Number

NCT03297762

Brief Title

Increasing Use of Continuous Glucose Monitors in Publicly-insured Youth With Type 1 Diabetes

Official Title

Improving Adherence to Continuous Glucose Monitors in Publicly-insured Youth With Type 1 Diabetes

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Terminated

Why Stopped

Enrollment challenges

Study Start Date

May 7, 2018 (Actual)

Primary Completion Date

May 1, 2019 (Actual)

Study Completion Date

June 1, 2019 (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

Product Manufactured in and Exported from the U.S.

Yes

5. Study Description

Brief Summary

To use an enhanced continuous glucose monitor (CGM) experience, including an automated CGM-electronic health record (EHR) data integration system, proactive interventions, and gamification techniques, to increase CGM use among publicly-insured youth with type 1 diabetes (T1D).

Detailed Description

The investigators will use an automated data integration system to monitor hours per week the CGM is worn and target interventions/troubleshooting techniques as needed. The investigators will use gamification techniques (i.e. ability to gain points and achieve small rewards) to help encourage CGM use and potentially improve glycemic control in this at-risk population.

6. Conditions and Keywords

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

Type1diabetes

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Gamification

Arm Type

Experimental

Arm Description

Use of continuous glucose monitor (Dexcom G5) with proactive intervention and incentives for time in use.

Arm Title

Standard care

Arm Type

Active Comparator

Arm Description

Use of continuous glucose monitor (Dexcom G5) per usual care.

Intervention Type

Behavioral

Intervention Name(s)

gamification

Intervention Description

incentives/rewards and contact between standard visits

Intervention Type

Behavioral

Intervention Name(s)

Use of Dexcom G5

Intervention Description

Dexcom G5 continuous glucose monitor

Primary Outcome Measure Information:

Title

CGM use

Description

amount of time per week CGM is used

Time Frame

baseline to 6 months

Secondary Outcome Measure Information:

Title

Hgb A1c

Description

glycemic control as measured by Hgb A1c

Time Frame

baseline to 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

13 Years

Maximum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: type 1 diabetes for more than 6 months on insulin pump or multiple daily injections without plans to change modality in next 6 months insured by CCS or Medi-Cal receiving care at Lucile Packard Children's Hospital or Stanford Children's Health outpatient clinics English or Spanish-speaking Exclusion Criteria: major illness or condition that may alter glucose control or ability to complete the study including pregnancy, cystic fibrosis, cancer, liver disease, history of transplant, or hemoglobinopathy current oral glucocorticoid use prior use of a CGM system hemoglobin A1C <7.5% or >12% no wireless internet access

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maria Chang, MD

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford Children's

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Increasing Use of Continuous Glucose Monitors in Publicly-insured Youth With Type 1 Diabetes

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