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A Pilot Study Examining a Reinforcement Approach to Improve Diabetes Management

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01829555
Recruitment Status : Completed
First Posted : April 11, 2013
Last Update Posted : November 10, 2014
Yale University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
UConn Health

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Behavioral: contingency management Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Pilot Study Examining a Reinforcement Approach to Improve Diabetes Management
Study Start Date : February 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. change from baseline in number of self-monitoring of blood glucose tests conducted [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. change from baseline in hemoglobin A1c levels [ Time Frame: 6 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   15 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01829555

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United States, Connecticut
Pediatric Endocrinology, Yale University
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
UConn Health
Yale University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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Principal Investigator: Nancy M Petry, Ph.D. UConn Health
Principal Investigator: William Tamborlane, M.D. Yale University
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Responsible Party: UConn Health Identifier: NCT01829555    
Other Study ID Numbers: 13-043-2
1DP3DK097705 ( U.S. NIH Grant/Contract )
First Posted: April 11, 2013    Key Record Dates
Last Update Posted: November 10, 2014
Last Verified: November 2014
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases