A Pilot Study Examining a Reinforcement Approach to Improve Diabetes Management
Glucose control is necessary to avoid the immediate and long-term adverse effects associated with type 1 diabetes, and frequent self-monitoring of blood glucose is the first important step to achieving glucose control. Data suggest that large proportions of adolescents and young adults fail to adhere to standard guidelines of self-monitored of blood glucose testing and have hemoglobin A1c levels >7.5%. A finite period of poor metabolic control can lead to increased risk of medical complications over an individual's lifespan, necessitating novel interventions to improve self-monitored blood glucose testing and metabolic control in emerging adults with type 1 diabetes. The investigators treatment approach, which provides direct tangible reinforcement for objective evidence of behavior change, is efficacious in decreasing substance use, reducing weight, and improving medication adherence.
The purpose of this project is to develop and pilot test an intervention based on behavioral economic principles for improving self-monitored blood glucose testing in young persons with type 1 diabetes. In this pilot study, patients will text in, via cell phones, each time they test, and a return text will inform them of reinforcer vouchers earned. The investigators will collect data on self-monitored blood glucose testing frequency and A1c levels preceding treatment initiation and throughout a 6 month treatment period. If promising, a randomized trial will lead to larger scale evaluations of reinforcement interventions alone, or in combination with multimodal treatment approaches, and it may be applied to other clinical issues such as adherence to continuous glucose monitoring. Importantly, this intervention can be administered remotely and in an automated fashion, allowing for widespread adoption if efficacious.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||A Pilot Study Examining a Reinforcement Approach to Improve Diabetes Management|
- change from baseline in number of self-monitoring of blood glucose tests conducted [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- change from baseline in hemoglobin A1c levels [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||April 2014|
|Estimated Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
Experimental: contingency management
The intervention will provide escalating financial reinforcement for self-monitored blood glucose testing.
Behavioral: contingency management
Participants will receive a voucher for each self-monitored blood glucose test completed during the target testing window, and a bonus amount for each day that 4 tests fall within the testing windows and are separated by more than 2 hours.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01829555
|Contact: Ellen M Ciesielskifirstname.lastname@example.org|
|United States, Connecticut|
|Pediatric Endocrinology, Yale University||Recruiting|
|New Haven, Connecticut, United States, 06519|
|Principal Investigator: William Tamborlane, M.D.|
|Principal Investigator:||Nancy M Petry, Ph.D.||University of Connecticut Health Center|
|Principal Investigator:||William Tamborlane, M.D.||Yale University|