Status:

COMPLETED

Diabetes Journey: An Adolescent Adherence Barriers Intervention

Lead Sponsor:

Children's Hospital Medical Center, Cincinnati

Collaborating Sponsors:

University of Florida

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Conditions:

Type 1 Diabetes

Adherence, Patient

Eligibility:

All Genders

13-17 years

Phase:

NA

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, ...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    August 10 2020

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    March 31 2024

    Estimated Enrollment :

    195 Patients enrolled

    Trial Details

    Trial ID

    NCT04404556

    Start Date

    August 10 2020

    End Date

    March 31 2024

    Last Update

    July 15 2025

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    University of Florida

    Gainesville, Florida, United States, 32610-0165

    2

    Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, United States, 45229