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

NCT ID: NCT03297762

Last Updated: 2020-04-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-07
• Study Completion Date: 2019-06-01

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.

Conditions

Type1diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Gamification

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

Group Type: EXPERIMENTAL

gamification

Intervention Type: BEHAVIORAL

incentives/rewards and contact between standard visits

Use of Dexcom G5

Intervention Type: BEHAVIORAL

Dexcom G5 continuous glucose monitor

Standard care

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

Group Type: ACTIVE_COMPARATOR

Use of Dexcom G5

Intervention Type: BEHAVIORAL

Dexcom G5 continuous glucose monitor

Interventions

gamification

incentives/rewards and contact between standard visits

Intervention Type: BEHAVIORAL

Use of Dexcom G5

Dexcom G5 continuous glucose monitor

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Darrell M Wilson

Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maria Chang, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford Children's

Stanford, California, United States

Countries

United States

Other Identifiers

IRB-36423

Identifier Type: -

Identifier Source: org_study_id