Back to resultsA Reinforcement Approach to Improve Diabetes Management
Primary Purpose
Type 1 Diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Reinforcement for BG testing
Standard of care
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes
Eligibility Criteria
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.
Sites / Locations
- Yale University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Reinforcement for performing BG testing
No reinforcement for BG testing
Arm 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.
Subjects will receive standard of care without reinforcement for Self Monitoring Blood Glucose
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02167243
First Posted
June 16, 2014
Last Updated
January 15, 2021
Sponsor
Yale University
Collaborators
National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT02167243
Brief Title
A Reinforcement Approach to Improve Diabetes Management
Official Title
A Reinforcement Approach to Improve Diabetes Management - Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
November 2019 (Actual)
Study Completion Date
November 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Reinforcement for performing BG testing
Arm Type
Experimental
Arm 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.
Arm Title
No reinforcement for BG testing
Arm Type
Active Comparator
Arm Description
Subjects will receive standard of care without reinforcement for Self Monitoring Blood Glucose
Intervention Type
Behavioral
Intervention Name(s)
Reinforcement for BG testing
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard of care
Intervention Description
Subjects receive standard of care
Primary Outcome Measure Information:
Title
To determine if the reinforcement intervention increases SMBG testing.
Description
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.
Time Frame
6 Months
Title
To assess if the intervention reduces A1c
Description
Patients randomized to the reinforcement intervention are expected to have greater decreases in A1c over time than patients assigned to usual care.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Tamborlane, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Reinforcement Approach to Improve Diabetes Management
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