A Reinforcement Approach to Improve Diabetes Management

Yale University

Status: Completed

Conditions: Type 1 Diabetes

Treatments: Behavioral: Reinforcement for BG testing; Other: Standard of care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02167243

1403013607

1DP3DK097705-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 12 to 21 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

Reinforcement for performing BG testing

Experimental group

Description:

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.

Treatment:

Other: Standard of care

Behavioral: Reinforcement for BG testing

No reinforcement for BG testing

Active Comparator group

Description:

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

Treatment:

Other: Standard of care