Diabetes Journey: An Adolescent Adherence Barriers Intervention

Study Overview
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Brief Summary
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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
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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.

Official Title
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Diabetes Journey: An Intervention to Improve Adherence Barriers for Adolescents With Type 1 Diabetes

Conditions
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Type 1 Diabetes, Adherence, Patient

Intervention / Treatment
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* Behavioral: Diabetes Journey
* Behavioral: Enhanced Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria T1D diagnosis >1 year Adolescents with T1D ages 13-17 Elevations on the Barriers to Diabetes Adherence questionnaire (scores of ≥3 of 53 for the Stress/Burnout and/or Time Pressure/Planning subscales) based on their previous clinic visit scores Ability to read/speak English (all measures are in English) Exclusion Criteria Diagnosis of significant developmental disorders (e.g., autism spectrum disorder, moderate/severe developmental or intellectual disability) Comorbid medical diagnoses (e.g., cystic fibrosis, asthma) with the exception of endocrine disorders (e.g., Celiac disease, thyroid) No use of/plans to use non-insulin medication for blood glucose control

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomized to one of two conditions: 1) Diabetes Journey or 2) Enhanced Standard of Care.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diabetes Journey<br>Diabetes Journey is a web-based intervention to address key adherence barriers. Participants randomized to this arm will first receive the mandatory Introduction and Problem-Solving Module. Based on their elevations on the Barriers to Diabetes Adherence measure, participants will receive up to 7 modules in total. Participants will navigate through the web-based theme park map and complete modules independently and then will have accompanying Zoom telehealth sessions with a therapist. | Behavioral: Diabetes Journey<br>* Web-based telehealth intervention focused on adherence barriers and problem-solving<br>* Other names: mHealth problem-solving adherence barriers intervention;|
| Active Comparator: Enhanced Standard of Care<br>Participants randomized to Enhanced Standard of Care will receive general education via the T1DToolkit website, as well as 4 phone calls with certified diabetes educators (CDEs) from each site across 12-weeks. Content to address adherence barriers were modified and or newly developed for the Enhanced Standard of Care group via the T1DToolkit website. | Behavioral: Enhanced Standard of Care<br>* General education via the T1DToolkit website, as well as 4 phone calls with certified diabetes educators (CDEs) will be provided.<br>* Other names: t1dtoolkit;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Barriers to Diabetes Adherence questionnaire-Youth report Stress/Burnout Subscale | Adherence Barrier | 6-month follow-up | 
| Barriers to Diabetes Adherence questionnaire - Youth report Time Pressure/Planning Subscale | Adherence Barrier2 | 6-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence for Continuous Glucose Monitors | % Time in Range for those on continuous glucose monitors | 6-month follow-up | 
| Adherence | # blood glucose checks per day | 6-month follow-up | 
| Adherence for Insulin Pump Users | # carbohydrate entries per day for insulin pump users | 6-month follow-up | 
| Adherence for Insulin Pump Users 1 | # insulin boluses per day for insulin pump users | 6-month follow-up | 
| Adherence for Insulin Pump Users 2 | # insulin boluses followed by high blood glucose input per day for insulin pump users | 6-month follow-up | 
| Hemoglobin A1C | Fingerstick Blood Sample | 6-month follow-up | 
| Type 1 Diabetes and Life -Youth Report | Quality of Life Scores range from 0-100, with higher scores indicating better quality of life | 6-month follow-up | 
| Type 1 Diabetes and Life -Parent Report | Quality of Life Scores range from 0-100, with higher scores indicating better quality of life | 6-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adolescent, mHealth, executive functioning skills, adherence barriers