A Pilot Study Examining a Reinforcement Approach to Improve Diabetes Management

• ClinicalTrials.gov Identifier: NCT01829555
• Recruitment Status: Completed
• First Posted: April 11, 2013
• Last Update Posted: November 10, 2014
• Sponsor: UConn Health
• Collaborators: Yale University; National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Information provided by (Responsible Party): UConn Health

Study Description

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

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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 ]

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

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)

Investigators

• Principal Investigator: Nancy M Petry, Ph.D.; UConn Health
• Principal Investigator: William Tamborlane, M.D.; Yale University

More Information

• Responsible Party: UConn Health
• ClinicalTrials.gov Identifier: NCT01829555
• Other Study ID Numbers: 13-043-2; 1DP3DK097705 ( U.S. NIH Grant/Contract )
• First Posted: April 11, 2013
• Last Update Posted: November 10, 2014
• Last Verified: November 2014

Additional relevant MeSH terms:

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases