A Pilot Study Examining a Reinforcement Approach to Improve Diabetes Management

Completed · Not applicable

Conditions studied: Type 1 Diabetes

In brief

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.

Key facts

Study ID: NCT01829555
Run by: UConn Health
People needed: 10
Starts: 2013-02-01
Expected to finish: 2014-08-01
Last updated by the study team: 2014-11-10

Who can join

Age: 15 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

age 15-21 years old
diagnosis of type 1 diabetes (T1D) >12 months via ADA guidelines (Silverstein et al., 2005)
average A1c >7.5% and <11% during the year before study entry, and most recent A1c >7.5% but <11%
SMBG user with clinical recommendations to test >4 times/day
past month SMBG <4 times/ day on average
English speaking and able to read at >5th grade level

You may not qualify if…

have a major psychiatric or neurocognitive disorder that would inhibit participation
have a major visual impairment
meet DSM-IV criteria for pathological gambling
have a significant other medical condition that impacts diabetes management
plan to switch insulin delivery mode (injection to pump or vice versa) in the next 12 months, or have recently switched
are pregnant or trying to become pregnant
are participating in another clinical trial

Where it is running

Pediatric Endocrinology, Yale University — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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