A Reinforcement Approach to Improve Diabetes Management

NCT02167243 | Completed

• 2 other identifiers: 14030136071DP3DK097705-01
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (2)

• To determine if the reinforcement intervention increases SMBG testing.

  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.

  6 Months

• To assess if the intervention reduces A1c

  Patients randomized to the reinforcement intervention are expected to have greater decreases in A1c over time than patients assigned to usual care.

  6 months

Study Arms (2)

Reinforcement for performing BG testing

EXPERIMENTAL

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; Other: Standard of care

No reinforcement for BG testing

ACTIVE COMPARATOR

Subjects will receive standard of care without reinforcement for Self Monitoring Blood Glucose

Other: Standard of care

Interventions

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.

Reinforcement for performing BG testing

Standard of care OTHER

Subjects receive standard of care

No reinforcement for BG testing; Reinforcement for performing BG testing

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• William Tamborlane, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2014
• First Posted: June 19, 2014
• Study Start: July 1, 2014
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: January 19, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)