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

Overview

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).

Full Title of Study: “Improving Adherence to Continuous Glucose Monitors in Publicly-insured Youth With Type 1 Diabetes”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 1, 2019

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.

Interventions

  • Behavioral: gamification
    • incentives/rewards and contact between standard visits
  • Behavioral: Use of Dexcom G5
    • Dexcom G5 continuous glucose monitor

Arms, Groups and Cohorts

  • Experimental: Gamification
    • Use of continuous glucose monitor (Dexcom G5) with proactive intervention and incentives for time in use.
  • Active Comparator: Standard care
    • Use of continuous glucose monitor (Dexcom G5) per usual care.

Clinical Trial Outcome Measures

Primary Measures

  • CGM use
    • Time Frame: baseline to 6 months
    • amount of time per week CGM is used

Secondary Measures

  • Hgb A1c
    • Time Frame: baseline to 6 months
    • glycemic control as measured by Hgb A1c

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 13 Years

Maximum Age: 19 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Stanford University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Darrell M Wilson, Professor of Pediatrics – Stanford University
  • Overall Official(s)
    • Maria Chang, MD, Principal Investigator, Stanford University

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