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A Reinforcement Approach to Improve Diabetes Management

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ClinicalTrials.gov Identifier: NCT02167243
Recruitment Status : Recruiting
First Posted : June 19, 2014
Last Update Posted : January 24, 2017
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Yale University

Brief Summary:
The purpose of this project is to evaluate the efficacy of a behavioral economic intervention to improve self monitoring of blood glucose (SMBG) in adolescents and young adults with T1D. The intervention will reinforce patients for conducting SMBG, with escalating reinforcers provided when patients achieved sustained periods of testing at least 4 times/day at appropriate intervals. A 6-month trial will be conducted in which 60 patients will be randomized to: (1) standard care or (2) standard care plus the reinforcement intervention.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Behavioral: Reinforcement for BG testing Other: Standard of care Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Reinforcement Approach to Improve Diabetes Management - Randomized Trial
Study Start Date : July 2014
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Reinforcement for performing BG testing
Subjects will receive reinforcement for BG testing. The intervention will reinforce subjects for conducting Self Monitoring of Blood Glucose (SMBG), with escalating reinforcers provided when subjects achieved sustained periods of testing at least 4 times/day at appropriate intervals.
Behavioral: Reinforcement for BG testing
Subjects will receive reinforcement for BG tests. The intervention will reinforce subjects for conducting Self Monitoring of Blood Glucose (SMBG), with escalating reinforcers provided when subjects achieved sustained periods of testing at least 4 times/day at appropriate intervals.

Other: Standard of care
Subjects receive standard of care

Active Comparator: No reinforcement for BG testing
Subjects will receive standard of care without reinforcement for Self Monitoring Blood Glucose
Other: Standard of care
Subjects receive standard of care




Primary Outcome Measures :
  1. To determine if the reinforcement intervention increases SMBG testing. [ Time Frame: 6 Months ]
    The number of SMBG tests will be assessed via glucometer uploads, and the proportion of days on which at least 4 tests occurred as well as the longest number of consecutive days on which SMBG tests occurred at frequencies of >4 times/day will be calculated. The hypothesis is that patients assigned to the reinforcement intervention will conduct more SMBG tests, have greater proportions of days with >4 tests, and have longer durations of appropriate testing frequencies than patients assigned to usual care.

  2. To assess if the intervention reduces A1c [ Time Frame: 6 months ]
    Patients randomized to the reinforcement intervention are expected to have greater decreases in A1c over time than patients assigned to usual care.



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Ages Eligible for Study:   12 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. age 12-21 years old;
  2. diagnosis of type 1 diabetes (T1D) >12 months via ADA guidelines
  3. receiving diabetes treatment at Yale Pediatric Diabetes Clinic and not meeting clinical care guidelines
  4. SMBG user with clinical recommendations to test >4 times/day and using a device that allows for remote uploading (e.g., Aviva, Contour, Freestyle, Lifescan, etc.; equipment for uploading will be provided);
  5. access to a computer with internet for uploading and sending SMBG data;
  6. access to a cell phone with text messaging capabilities and willing to text after SMBG testing and receive messages about reinforcement;
  7. English speaking, able to read at >5th grade level, and pass an informed consent quiz; and adequate knowledge of insulin dosing and dietary recommendations for managing T1D.

Exclusion Criteria:

  1. have a major psychiatric or neurocognitive disorder (e.g., severe learning impairment) that would inhibit participation;
  2. have a major visual impairment;
  3. have a significant other medical condition that impacts diabetes management (e.g., asthma, rheumatoid arthritis, or other condition that requires steroid treatment);
  4. plan to switch insulin delivery mode (injection to pump or vice versa) in the next 12 months, or have recently switched;
  5. 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 ClinicalTrials.gov identifier (NCT number): NCT02167243


Contacts
Contact: Marcia DeSousa, BA 203-737-6877 DeSousa@uchc.edu

Locations
United States, Connecticut
Yale University School of Medicine Recruiting
New Haven, Connecticut, United States, 06520
Contact: Marcia DeSousa, BA    203-737-6877    DeSousa@uchc.edu   
Principal Investigator: William Tamborlane, MD         
Sponsors and Collaborators
Yale University
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: William Tamborlane, MD Yale University

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02167243     History of Changes
Other Study ID Numbers: 1403013607
1DP3DK097705-01 ( U.S. NIH Grant/Contract )
First Posted: June 19, 2014    Key Record Dates
Last Update Posted: January 24, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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