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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02568501
• Other study ID #: 15-012160
• Status: Completed
• Phase: Phase 3
• First received: October 2, 2015
• Last updated: November 10, 2016
• Start date: January 2016
• Est. completion date: November 2016

Study information

• Verified date: November 2016
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: November 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 14 Years to 20 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Type 1 Diabetes

Intervention

Behavioral:
• Daily feedback
Daily feedback on glucose levels from wireless glucometers
• Financial incentive
Participant receive a $2 daily financial incentive framed as a loss with money allocated upfront and taken away each day of non-adherence to goal

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c by 3 months	Change in HbA1c from baseline to 3 months	3 months	No
Secondary	Change in HbA1c by 6 months	Change in HbA1c from baseline to 6 months	6 months	No
Secondary	Glucose Monitoring Adherence by 3 months	Proportion of time adherence to glucose monitoring during 3 month intervention	3 months	No
Secondary	Glucose Monitoring Adherence by 6 months	Proportion of time adherence to glucose monitoring during 3 month follow-up period	6 months	No