Overview

This trial has been completed.

Conditions diabetes, type 1 diabetes
Treatments daily feedback, financial incentive
Phase phase 3
Sponsor University of Pennsylvania
Collaborator Children's Hospital of Philadelphia
Start date January 2016
End date August 2016
Trial size 90 participants
Trial identifier NCT02568501, 15-012160

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose treatment
Arm
(Experimental)
Participants receive daily feedback from wireless glucometers that transmit data on glucose monitoring adherence.
daily feedback
Daily feedback on glucose levels from wireless glucometers
(Experimental)
Participants receive daily feedback from wireless glucometers that transmit data on glucose monitoring adherence. Participants are eligible for a financial incentive if adherent.
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

Primary Outcomes

Measure
Change in HbA1c by 3 months
time frame: 3 months

Secondary Outcomes

Measure
Change in HbA1c by 6 months
time frame: 6 months
Glucose Monitoring Adherence by 3 months
time frame: 3 months
Glucose Monitoring Adherence by 6 months
time frame: 6 months

Eligibility Criteria

Male or female participants from 14 years up to 20 years old.

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

Additional Information

Official title Behavioral Economic Incentives to Improve Glycemic Control Among Adolescents and Young Adults
Principal investigator Mitesh Patel, MD, MBA, MS
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by University of Pennsylvania.