NCT02568501

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at below P25 for phase_3 diabetes

Timeline
Completed

Started Jan 2016

Shorter than P25 for phase_3 diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 6, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

November 11, 2016

Status Verified

November 1, 2016

Enrollment Period

7 months

First QC Date

October 2, 2015

Last Update Submit

November 10, 2016

Conditions

Keywords

diabetesadolescentyoung adultbehavioral economicsfinancial incentivessocial incentives

Outcome Measures

Primary Outcomes (1)

  • Change in HbA1c by 3 months

    Change in HbA1c from baseline to 3 months

    3 months

Secondary Outcomes (3)

  • Change in HbA1c by 6 months

    6 months

  • Glucose Monitoring Adherence by 3 months

    3 months

  • Glucose Monitoring Adherence by 6 months

    6 months

Study Arms (2)

Daily feedback

EXPERIMENTAL

Participants receive daily feedback from wireless glucometers that transmit data on glucose monitoring adherence.

Behavioral: Daily feedback

Daily Feedback, incentives

EXPERIMENTAL

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 feedbackBehavioral: Financial incentive

Interventions

Daily feedbackBEHAVIORAL

Daily feedback on glucose levels from wireless glucometers

Daily Feedback, incentivesDaily feedback

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

Daily Feedback, incentives

Eligibility Criteria

Age14 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • Wong CA, Miller VA, Murphy K, Small D, Ford CA, Willi SM, Feingold J, Morris A, Ha YP, Zhu J, Wang W, Patel MS. Effect of Financial Incentives on Glucose Monitoring Adherence and Glycemic Control Among Adolescents and Young Adults With Type 1 Diabetes: A Randomized Clinical Trial. JAMA Pediatr. 2017 Dec 1;171(12):1176-1183. doi: 10.1001/jamapediatrics.2017.3233.

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Mitesh Patel, MD, MBA, MS

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR
  • Charlene Wong, MD, MS

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2015

First Posted

October 6, 2015

Study Start

January 1, 2016

Primary Completion

August 1, 2016

Study Completion

November 1, 2016

Last Updated

November 11, 2016

Record last verified: 2016-11

Locations