Clinical trial NCT02568501: Behavioral Economic Incentives to Improve Glycemic Control Among Adolescents and Young Adults
Official title: Behavioral Economic Incentives to Improve Glycemic Control Among Adolescents and Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Type 1 Diabetes
Keywords: diabetes
adolescent
young adult
behavioral economics
financial incentives
social incentives
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Philadelphia
First posted: 2015-10-06
Enrollment: 90
Sex: ALL
Minimum age (years): 14
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in HbA1c by 3 months
timeFrame: 3 months
Secondary outcomes:
measure: Change in HbA1c by 6 months
timeFrame: 6 months
measure: Glucose Monitoring Adherence by 3 months
timeFrame: 3 months
measure: Glucose Monitoring Adherence by 6 months
timeFrame: 6 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Mitesh Patel, MD, MBA, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Charlene Wong, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.