A Reinforcement Approach to Improve Diabetes Management - Randomized Trial

Status: Completed
Location: See location...
Intervention Type: Other, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this project is to evaluate the efficacy of a behavioral economic intervention to improve self monitoring of blood glucose (SMBG) in adolescents and young adults with T1D. The intervention will reinforce patients for conducting SMBG, with escalating reinforcers provided when patients achieved sustained periods of testing at least 4 times/day at appropriate intervals. A 6-month trial will be conducted in which 60 patients will be randomized to: (1) standard care or (2) standard care plus the reinforcement intervention.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 21
Healthy Volunteers: f
View:

• age 12-21 years old;

• diagnosis of type 1 diabetes (T1D) \>12 months via ADA guidelines

• receiving diabetes treatment at Yale Pediatric Diabetes Clinic and not meeting clinical care guidelines

• SMBG user with clinical recommendations to test \>4 times/day and using a device that allows for remote uploading (e.g., Aviva, Contour, Freestyle, Lifescan, etc.; equipment for uploading will be provided);

• access to a computer with internet for uploading and sending SMBG data;

• access to a cell phone with text messaging capabilities and willing to text after SMBG testing and receive messages about reinforcement;

• English speaking, able to read at \>5th grade level, and pass an informed consent quiz; and adequate knowledge of insulin dosing and dietary recommendations for managing T1D.

Locations
United States
Connecticut
Yale University School of Medicine
New Haven
Time Frame
Start Date: 2014-07
Completion Date: 2019-11
Participants
Target number of participants: 62
Treatments
Experimental: Reinforcement for performing BG testing
Subjects will receive reinforcement for BG testing. The intervention will reinforce subjects for conducting Self Monitoring of Blood Glucose (SMBG), with escalating reinforcers provided when subjects achieved sustained periods of testing at least 4 times/day at appropriate intervals.
Active_comparator: No reinforcement for BG testing
Subjects will receive standard of care without reinforcement for Self Monitoring Blood Glucose
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)
Leads: Yale University

This content was sourced from clinicaltrials.gov