Behavioral Economic Incentives to Improve Glycemic Control Among Adolescents and Young Adults

Phase 3

Completed

• Conditions: Diabetes; Type 1 Diabetes

• Registration Number: NCT02568501
• Lead Sponsor: University of Pennsylvania

Brief Summary

In this study the investigators will compare a novel approach using daily financial incentives and a tiered sponsor network to motivate adolescents and young adults with type 1 diabetes to improve glycemic control.

Detailed Description

Participants will be given daily glucose monitoring goals of ≥4 glucose checks per day with ≥1 readings within goal range (70-180 mg/dL) and provided with iHealth wireless glucometers. Half of the study participants will be randomized to the 3-month intervention arm on Way to Health. The intervention includes daily financial incentives ($60 in an account at beginning of each month with $2 daily loss if non-adherent) and a 2-level tiered sponsor network (youth select 2 people who will be notified of non-adherence after 2 and 5 consecutive days). The primary outcome will be HbA1c at 3 months compared to baseline. Secondary outcomes will include HbA1c at 6 months and the proportion of participants adherent to daily glucose monitoring goals. Exit interviews will elicit intervention feasibility and feedback from a youth perspective.

Study Timeline

• Study First Submitted: 2015-10-02
• Study First Submitted QC: 2015-10-02
• Study First Posted: 2015-10-06
• Study Start: 2016-01
• Primary Completion: 2016-08
• Status Verified: 2016-11
• Study Completion: 2016-11
• Last Update Submitted: 2016-11-10
• Last Update Posted: 2016-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Diagnosis of type 1 diabetes
• HbA1c of 8 or greater
• Receiving care from the Childrens Hospital of Philadelphia Diabetes Center
• English-speaking
• Owns a smartphone

Exclusion Criteria

• New diagnosis of type 1 diabetes within past year
• Unable to provide informed consent
• Already participating in another study to improve glycemic control
• Any medical conditions that would prevent completion of the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in HbA1c by 3 months	3 months	Change in HbA1c from baseline to 3 months

Secondary Outcome Measures

Name	Time	Method
Glucose Monitoring Adherence by 6 months	6 months	Proportion of time adherence to glucose monitoring during 3 month follow-up period
Change in HbA1c by 6 months	6 months	Change in HbA1c from baseline to 6 months
Glucose Monitoring Adherence by 3 months	3 months	Proportion of time adherence to glucose monitoring during 3 month intervention

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States