Discovery Diabetes

Официальное название

Discovery Diabetes: A Pilot Randomized Controlled Trial

Обзор

The goal of this clinical trial is to learn if the Discovery Program can help improve diabetes management in adolescents and young adults with type 1 diabetes (T1D). The main questions it aims to answer are: Does the Discovery Program lead to better glycemic control as measured by HbA1c levels? How does participation in the Discovery Program affect diabetes distress and self-management skills? Researchers will compare participants in the Discovery Program to those receiving standard diabetes care to see if the program has a positive effect on diabetes management. Participants will: Engage in a 3-month intervention that includes personalized mobile health communications and clinician support. Complete surveys and assessments at the beginning of the study, and again at 3 and 6 months. Allow the study team to access their electronic health records for additional data on diabetes management.

Подробное описание

The Discovery Diabetes study is a pilot randomized controlled trial designed to evaluate the effectiveness of the Discovery Program in improving diabetes management among adolescents and young adults with type 1 diabetes (T1D). This study focuses on participants aged 13 to 21 who have been diagnosed with T1D for at least one year.

Study Design: Participants will be randomly assigned to either the intervention group, which will receive the Discovery Program, or a control group receiving standard diabetes care. The Discovery Program includes personalized mobile health communications, clinician support, and structured problem-solving sessions aimed at addressing psychosocial barriers to effective diabetes management.

Objectives: The primary objective is to determine whether the Discovery Program leads to significant improvements in glycemic control, measured by changes in HbA1c levels over a 6-month period. Secondary objectives include assessing the impact on diabetes distress, self-management behaviors, and participants' problem-solving skills.

Data Collection: Data will be collected at baseline, 3 months, and 6 months, utilizing a variety of methods, including surveys and electronic health records (EHR). The study will ensure participant confidentiality through the use of unique study IDs and secure, HIPAA-compliant data storage systems, such as REDCap.

Eligibility Criteria: Eligible participants include those aged 13-21 with a diagnosis of type 1 diabetes, while individuals with type 2 diabetes or other conditions that may hinder participation will be excluded.

Retention and Use of Data: All collected data will be retained for at least six years post-study completion, in compliance with institutional and regulatory requirements. De-identified data may be used for research publications or presentations, ensuring participant privacy is maintained throughout the study.

This trial aims to provide valuable insights into improving diabetes management strategies for young individuals facing unique challenges in their care.

Вмешательства

• Поведенческое Discovery Program
  The Discovery Program is a novel, hybrid intervention specifically designed to address the psychosocial barriers faced by adolescents and young adults with T1D. This intervention integrates three key components: 1. Patient-Reported Measures 2. In-Clinic Collaborative Goal Setting 3. Personalized Mobile Health Communications The Discovery Program will be delivered over a 3-month intervention period, followed by a 6-month follow-up to assess outcomes. This approach not only aims to improve glyce

Первичные конечные точки

• Change in Glycemic Control (HbA1c) [Срок оценки: Baseline, 3 months, 6 months, and 9 months]

Вторичные конечные точки (5)

• Change in Diabetes Distress (PAID-T) [Срок оценки: Baseline, 3 months, and 6 months]
• Change in Self-Management Barriers (BDA) [Срок оценки: Baseline, 3 months, and 6 months.]
• Change in Problem-Solving Skills (SPSI-R:SF) [Срок оценки: Baseline, 3 months, and 6 months.]
• Change in Diabetes Self-Management Efficacy (SCI-R) [Срок оценки: Baseline, 3 months, and 6 months.]
• Change in Glycemic Control (Time in Range) [Срок оценки: Baseline, 3 months, 6 months, and 9 months]

Критерии участия

Критерии включения

• Adolescents (13-17 years) and young adults (aged 18-21 years),
• Diagnosed with T1D for at least one year,
• Access to a smartphone,
• A My Health at Vanderbilt (MHAV) patient portal account,
• Ability to read, speak, and understand English,
• An appointment with an NP in the VUMC Eskind Clinic within 7 months of initial contact

Критерии исключения

• Diagnosis of type 2 diabetes
• Any physical, cognitive, sensory or emotional condition precluding participation in the intervention (seeing/using a phone, hearing digital stories, answering questions).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Vanderbilt University — Nashville

Идентификаторы

NCT: NCT07116434 · 250525

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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