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

NCT03297762 | Terminated

• 1 other identifier: IRB-36423
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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).

Conditions

Type1diabetes

Outcome Measures

Primary Outcomes (1)

• CGM use

  amount of time per week CGM is used

  baseline to 6 months

Secondary Outcomes (1)

• Hgb A1c

  baseline to 6 months

Study Arms (2)

Gamification

EXPERIMENTAL

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

Behavioral: gamification; Behavioral: Use of Dexcom G5

Standard care

ACTIVE COMPARATOR

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

Behavioral: Use of Dexcom G5

Interventions

gamification BEHAVIORAL

incentives/rewards and contact between standard visits

Gamification

Use of Dexcom G5 BEHAVIORAL

Dexcom G5 continuous glucose monitor

Gamification; Standard care

Eligibility Criteria

• Age: 13 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Children's

Stanford, California, 94305, United States

Location

Study Officials

• Maria Chang, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: September 25, 2017
• First Posted: September 29, 2017
• Study Start: May 7, 2018
• Primary Completion: May 1, 2019
• Study Completion: June 1, 2019
• Last Updated: April 20, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)