A Pilot Study Examining a Reinforcement Approach to Improve Diabetes Management
NCT ID: NCT01829555
Last Updated: 2014-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
10 participants
INTERVENTIONAL
2013-02-28
2014-08-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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contingency management
The intervention will provide escalating financial reinforcement for self-monitored blood glucose testing.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
15 Years
21 Years
ALL
No
Sponsors
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Yale University
OTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
UConn Health
OTHER
Responsible Party
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Principal Investigators
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Nancy M Petry, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
UConn Health
William Tamborlane, M.D.
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Pediatric Endocrinology, Yale University
New Haven, Connecticut, United States
Countries
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Other Identifiers
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13-043-2
Identifier Type: -
Identifier Source: org_study_id