A Pilot Study Examining a Reinforcement Approach to Improve Diabetes Management

Study Overview
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Brief Summary
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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.

Official Title
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A Pilot Study Examining a Reinforcement Approach to Improve Diabetes Management

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Behavioral: contingency management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: contingency management<br>The intervention will provide escalating financial reinforcement for self-monitored blood glucose testing. | Behavioral: contingency management<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline in number of self-monitoring of blood glucose tests conducted |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline in hemoglobin A1c levels |  | 6 months |