A Reinforcement Approach to Improve Diabetes Management

Type 1 Diabetes Clinical Trial

Official title:

A Reinforcement Approach to Improve Diabetes Management - Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02167243
• Other study ID #: 1403013607
• Secondary ID: 1DP3DK097705-01
• Status: Completed
• Phase: N/A
• Start date: July 2014
• Est. completion date: November 2019

Study information

• Verified date: January 2021
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: November 2019
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 21 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Type 1 Diabetes

Intervention

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

Locations

Country	Name	City	State
United States	Yale University School of Medicine	New Haven	Connecticut

Sponsors (3)

Lead Sponsor	Collaborator
Yale University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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