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

Type1diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03297762
• Other study ID #: IRB-36423
• Status: Terminated
• Phase: N/A
• Start date: May 7, 2018
• Est. completion date: June 1, 2019

Study information

• Verified date: April 2020
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: June 1, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type1diabetes

Intervention

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

Locations

Country	Name	City	State
United States	Stanford Children's	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CGM use	amount of time per week CGM is used	baseline to 6 months
Secondary	Hgb A1c	glycemic control as measured by Hgb A1c	baseline to 6 months