Diabetes Journey: An Adolescent Adherence Barriers Intervention

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04404556
• Other study ID #: 2020-0162
• Status: Completed
• Phase: N/A
• Start date: August 10, 2020
• Est. completion date: March 31, 2024

Study information

• Verified date: April 2024
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 195
• Est. completion date: March 31, 2024
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Adherence, Patient
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Behavioral:
• Diabetes Journey
Web-based telehealth intervention focused on adherence barriers and problem-solving
• Enhanced Standard of Care
General education via the T1DToolkit website, as well as 4 phone calls with certified diabetes educators (CDEs) will be provided.

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	University of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Barriers to Diabetes Adherence questionnaire-Youth report Stress/Burnout Subscale	Adherence Barrier	6-month follow-up
Primary	Barriers to Diabetes Adherence questionnaire - Youth report Time Pressure/Planning Subscale	Adherence Barrier2	6-month follow-up
Secondary	Adherence for Continuous Glucose Monitors	% Time in Range for those on continuous glucose monitors	6-month follow-up
Secondary	Adherence	# blood glucose checks per day	6-month follow-up
Secondary	Adherence for Insulin Pump Users	# carbohydrate entries per day for insulin pump users	6-month follow-up
Secondary	Adherence for Insulin Pump Users 1	# insulin boluses per day for insulin pump users	6-month follow-up
Secondary	Adherence for Insulin Pump Users 2	# insulin boluses followed by high blood glucose input per day for insulin pump users	6-month follow-up
Secondary	Hemoglobin A1C	Fingerstick Blood Sample	6-month follow-up
Secondary	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
Secondary	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