A Pilot Study Examining a Reinforcement Approach to Improve Diabetes Management

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Connecticut Health Center
Sponsor:
Collaborators:
Yale University
Information provided by (Responsible Party):
University of Connecticut Health Center
ClinicalTrials.gov Identifier:
NCT01829555
First received: April 9, 2013
Last updated: February 24, 2014
Last verified: December 2013
  Purpose

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 Intervention
Type 1 Diabetes
Behavioral: contingency management

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Pilot Study Examining a Reinforcement Approach to Improve Diabetes Management

Resource links provided by NLM:


Further study details as provided by University of Connecticut Health Center:

Primary Outcome Measures:
  • change from baseline in number of self-monitoring of blood glucose tests conducted [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change from baseline in hemoglobin A1c levels [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: February 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   15 Years to 21 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01829555

Contacts
Contact: Ellen M Ciesielski 860.679.4556 eciesielski@uchc.edu

Locations
United States, Connecticut
Pediatric Endocrinology, Yale University Recruiting
New Haven, Connecticut, United States, 06519
Principal Investigator: William Tamborlane, M.D.         
Sponsors and Collaborators
University of Connecticut Health Center
Yale University
Investigators
Principal Investigator: Nancy M Petry, Ph.D. University of Connecticut Health Center
Principal Investigator: William Tamborlane, M.D. Yale University
  More Information

No publications provided

Responsible Party: University of Connecticut Health Center
ClinicalTrials.gov Identifier: NCT01829555     History of Changes
Other Study ID Numbers: 13-043-2, 1DP3DK097705
Study First Received: April 9, 2013
Last Updated: February 24, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 20, 2014