The purpose of this study is to examine the feasibility, acceptability, and preliminary efficacy of a web-based intervention addressing adherence barriers in adolescents with T1D.
Type 1 diabetes (T1D) treatment adherence is complex and involves glucose monitoring, counting carbohydrates, and intensive insulin delivery via injections or insulin pump in response to food intake, exercise, and illness to achieve near-normal blood glucose levels. Evidence demonstrates that adhering to T1D treatment is challenging, especially during adolescence. Non-adherence leads to suboptimal glycemic levels that severely compromise health and quality of life. Suboptimal adherence to T1D treatment regimen is common in \>50% of adolescents and directly related to suboptimal glycemic control, increased risk of hospitalizations for diabetic ketoacidosis, and decreased health-related quality of life (HRQOL). The maximum benefits of current diabetes technology are limited by the knowledge, skills, adherence barriers, and non-adherence behaviors.10-14 Ultimately, adolescents have to overcome these barriers in order to benefit from technological advances. Thus, there is a clear need for behaviorally focused interventions to identify and reduce adherence barriers. The overall objective of this study is to identify adolescents with elevated adherence barriers and provide novel tailored mHealth intervention (Diabetes Journey) targeting these barriers. This study is two phases and includes a small pilot of up to 12 adolescents with type 1 diabetes (Phase 1) and a randomized controlled clinical trial (Phase 2). The randomized controlled clinical trial will examine feasibility, acceptability and preliminary efficacy of Diabetes Journey versus enhanced standard of care (control group) in approximately 256 adolescents with type 1 diabetes. Primary and secondary outcomes include adherence barriers, adherence, health-related quality of life and A1C. Satisfaction and acceptability will also be examined. Mediators and moderators will include executive functioning, diabetes distress, family conflict, depressive symptoms, fear of hypoglycemia and sleep.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
195
Web-based telehealth intervention focused on adherence barriers and problem-solving
General education via the T1DToolkit website, as well as 4 phone calls with certified diabetes educators (CDEs) will be provided.
University of Florida
Gainesville, Florida, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Barriers to Diabetes Adherence Questionnaire-Youth Report Stress/Burnout Subscale
Stress and Burnout Scale - assesses frustration and feeling burned out by diabetes and its management. Score range from 1-5, with higher scores representing greater barriers.
Time frame: 6-month follow-up
Barriers to Diabetes Adherence Questionnaire - Youth Report Time Pressure/Planning Subscale
Time Pressure and Planning Subscale - assesses the time and energy it takes to plan for diabetes self-management, including carrying supplies and making management decisions. Score range from 1-5, with higher scores representing greater barriers.
Time frame: 6-month follow-up
Hemoglobin A1C
A blood test that measures the average blood sugar levels over the past two to three months.
Time frame: 6-month follow-up
Type 1 Diabetes and Life -Youth Report
Total Quality of Life Scores range from 0-100, with higher scores indicating better quality of life
Time frame: 6-month follow-up
Adherence for Continuous Glucose Monitors
% Time in Range for those on continuous glucose monitors.
Time frame: 6-month follow-up
Adherence
\# blood glucose checks per day
Time frame: 6-month follow-up
Adherence for Insulin Pump Users
\# carbohydrate entries per day for insulin pump users
Time frame: 6-month follow-up
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Adherence to Insulin Boluses
The average of the frequency of insulin boluses delivered per day
Time frame: 6-month follow-up