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Clinical Trials/NCT02568501
NCT02568501
Completed
Phase 3

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

University of Pennsylvania1 site in 1 country90 target enrollmentJanuary 2016

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Diabetes
Sponsor
University of Pennsylvania
Enrollment
90
Locations
1
Primary Endpoint
Change in HbA1c by 3 months
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2016
End Date
November 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in HbA1c by 3 months

Time Frame: 3 months

Change in HbA1c from baseline to 3 months

Secondary Outcomes

  • Glucose Monitoring Adherence by 6 months(6 months)
  • Change in HbA1c by 6 months(6 months)
  • Glucose Monitoring Adherence by 3 months(3 months)

Study Sites (1)

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