Diabetes Journey: An Adolescent Adherence Barriers Intervention

Not Applicable

Completed

Conditions: Type 1 Diabetes
Adherence, Patient

Registration Number: NCT04404556

Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 195

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Barriers to Diabetes Adherence Questionnaire-Youth Report Stress/Burnout Subscale	6-month follow-up	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.
Barriers to Diabetes Adherence Questionnaire - Youth Report Time Pressure/Planning Subscale	6-month follow-up	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.

Secondary Outcome Measures

Name	Time	Method
Hemoglobin A1C	6-month follow-up	A blood test that measures the average blood sugar levels over the past two to three months.
Type 1 Diabetes and Life -Youth Report	6-month follow-up	Total Quality of Life Scores range from 0-100, with higher scores indicating better quality of life
Adherence for Continuous Glucose Monitors	6-month follow-up	% Time in Range for those on continuous glucose monitors.
Adherence	6-month follow-up	# blood glucose checks per day
Adherence for Insulin Pump Users	6-month follow-up	# carbohydrate entries per day for insulin pump users
Adherence to Insulin Boluses	6-month follow-up	The average of the frequency of insulin boluses delivered per day

Trial Locations

Locations (2): University of Florida
🇺🇸
Gainesville, Florida, United States
Cincinnati Children's Hospital Medical Center
🇺🇸
Cincinnati, Ohio, United States
University of Florida
🇺🇸Gainesville, Florida, United States