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OpenTrials
Completed

NCT Number: NCT02568501

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

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.

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Key information

Conditions

Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases Type 1 Diabetes

Age range

14 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Daily feedback

Behavioral

Daily feedback on glucose levels from wireless glucometers

Financial incentive

Behavioral

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

  1. Change in HbA1c by 3 months

    Time frame: 3 months

    Change in HbA1c from baseline to 3 months

Secondary outcomes

  1. Change in HbA1c by 6 months

    Time frame: 6 months

    Change in HbA1c from baseline to 6 months

  2. Glucose Monitoring Adherence by 3 months

    Time frame: 3 months

    Proportion of time adherence to glucose monitoring during 3 month intervention

  3. Glucose Monitoring Adherence by 6 months

    Time frame: 6 months

    Proportion of time adherence to glucose monitoring during 3 month follow-up period

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Children's Hospital of Philadelphia

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Oct 6, 2015
Registry last updated
Nov 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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