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

Not Applicable

Terminated

• Conditions: Type1diabetes
• Interventions: Behavioral: Use of Dexcom G5; Behavioral: gamification

• Registration Number: NCT03297762
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study First Submitted: 2017-09-25
• Study First Submitted QC: 2017-09-25
• Study First Posted: 2017-09-29
• Study Start: 2018-05-07
• Primary Completion: 2019-05-01
• Study Completion: 2019-06-01
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-16
• Last Update Posted: 2020-04-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard care	Use of Dexcom G5	Use of continuous glucose monitor (Dexcom G5) per usual care.
Gamification	gamification	Use of continuous glucose monitor (Dexcom G5) with proactive intervention and incentives for time in use.
Gamification	Use of Dexcom G5	Use of continuous glucose monitor (Dexcom G5) with proactive intervention and incentives for time in use.

Primary Outcome Measures

Name	Time	Method
CGM use	baseline to 6 months	amount of time per week CGM is used

Secondary Outcome Measures

Name	Time	Method
Hgb A1c	baseline to 6 months	glycemic control as measured by Hgb A1c

Trial Locations

Locations (1)

Stanford Children's; 🇺🇸 Stanford, California, United States