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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02568501
Recruitment Status : Completed
First Posted : October 6, 2015
Last Update Posted : November 11, 2016
Sponsor:
Collaborator:
Children's Hospital of Philadelphia
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Diabetes Type 1 Diabetes Behavioral: Daily feedback Behavioral: Financial incentive Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Behavioral Economic Incentives to Improve Glycemic Control Among Adolescents and Young Adults
Study Start Date : January 2016
Actual Primary Completion Date : August 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Daily feedback
Participants receive daily feedback from wireless glucometers that transmit data on glucose monitoring adherence.
Behavioral: Daily feedback
Daily feedback on glucose levels from wireless glucometers

Experimental: Daily Feedback, incentives
Participants receive daily feedback from wireless glucometers that transmit data on glucose monitoring adherence. Participants are eligible for a financial incentive if adherent.
Behavioral: Daily feedback
Daily feedback on glucose levels from wireless glucometers

Behavioral: 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 Outcome Measures :
  1. Change in HbA1c by 3 months [ Time Frame: 3 months ]
    Change in HbA1c from baseline to 3 months


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02568501


Locations
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United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Children's Hospital of Philadelphia
Investigators
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Principal Investigator: Mitesh Patel, MD, MBA, MS University of Pennsylvania
Principal Investigator: Charlene Wong, MD, MS University of Pennsylvania
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02568501    
Other Study ID Numbers: 15-012160
First Posted: October 6, 2015    Key Record Dates
Last Update Posted: November 11, 2016
Last Verified: November 2016
Keywords provided by University of Pennsylvania:
diabetes
adolescent
young adult
behavioral economics
financial incentives
social incentives
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases