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Completed

NCT Number: NCT02167243

A Reinforcement Approach to Improve Diabetes Management

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.

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Key information

Age range

12 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age 12-21 years old;
  • diagnosis of type 1 diabetes (T1D) >12 months via ADA guidelines
  • receiving diabetes treatment at Yale Pediatric Diabetes Clinic and not meeting clinical care guidelines
  • 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);
  • access to a computer with internet for uploading and sending SMBG data;
  • access to a cell phone with text messaging capabilities and willing to text after SMBG testing and receive messages about reinforcement;
  • 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

  • have a major psychiatric or neurocognitive disorder (e.g., severe learning impairment) that would inhibit participation;
  • have a major visual impairment;
  • have a significant other medical condition that impacts diabetes management (e.g., asthma, rheumatoid arthritis, or other condition that requires steroid treatment);
  • plan to switch insulin delivery mode (injection to pump or vice versa) in the next 12 months, or have recently switched;
  • are participating in another clinical trial.

Treatment and study plan

Reinforcement for BG testing

Behavioral

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.

Standard of care

Other

Subjects receive standard of care

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • National Institutes of Health (NIH)

Registry information

Official study title

A Reinforcement Approach to Improve Diabetes Management - Randomized Trial

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Jun 19, 2014
Registry last updated
Jan 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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