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Идёт набор NCT07097805

Glycemic Improvement With Team, Technology, Education and Peer Resources in Type 1 Diabetes-GLITTER Study

Без фазы С лечением Type 1 Diabetes (T1D)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: GLITTER comprehensive management.
Кому может быть актуально
Состояния в реестре: Type 1 Diabetes (T1D). Базовые параметры: Без ограничений · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

The GLITTER study is comprised of four key components: Team, Technology, Education, and Peer Resources. The aim of the GLITTER Study is to improve the metabolic control rate in patients with type 1 diabetes through a comprehensive management approach.

Подробное описание

Patients with type 1 diabetes (T1D) face significant glycemic fluctuations, posing substantial challenges in disease management. Current clinical evidence indicates that although interventions such as structured education programs, peer support, and novel diabetes technologies demonstrate positive outcomes when applied individually, the glycemic target attainment rate remains suboptimal, with fewer than 30% achieving this benchmark. To address this clinical dilemma, the investigators has proposed the GLITTER (Glycemic Improvement with Team, Technology, Education and Peer Resources in type 1 diabetes) study, which aims to establish a four-in-one integrated management model combining multidisciplinary collaborative teams, structured educational frameworks, peer support systems, and diabetes technologies. The research team comprises T1D-specialized physicians and diabetes educators. Structured education is delivered through dedicated T1D specialty clinics and by local clinicians. Technological support involves informing patients about access to continuous glucose monitors (CGM) and insulin pumps without mandating their use, while peer support is established through patient communication groups (volunteer matching mechanisms are not yet implemented). This GLITTER study seeks to achieve dual objectives: population-wide coverage and whole-disease-course management for individuals with T1D.

This is a multicenter, prospective, cohort study. This longitudinal investigation systematically collects multidimensional clinical datasets encompassing glycemic control parameters, pancreatic β-cell function, and complication risk profiles through regular follow-up visits. This study explores the metabolic control, psychological outcomes, and their associated influencing factors among patients with T1D.

Вмешательства

  • Поведенческое GLITTER comprehensive management
    The GLITTER comprehensive management represents a management approach that effectively combines multidisciplinary professional team care, diabetes technology empowerment, structured education steering, and peer support.

Первичные конечные точки

  • Change in HbA1c [Срок оценки: Trough study completion, an average of 1 year]
Вторичные конечные точки (12)
  • Percentage of patients using continuous glucose monitors [Срок оценки: Trough study completion, an average of 1 year]
  • Percentage of patients using insulin pump [Срок оценки: Trough study completion, an average of 1 year]
  • Diabetes-related complications [Срок оценки: Trough study completion, an average of 1 year]
  • Urine Albumin-to-Creatinine Ratio [Срок оценки: Trough study completion, an average of 1 year]
  • Change in titer of autoantibodies [Срок оценки: Trough study completion, an average of 1 year]
  • Change in C-peptide [Срок оценки: Trough study completion, an average of 1 year]
  • Change in blood glucose [Срок оценки: Trough study completion, an average of 1 year]
  • Systolic blood pressure [Срок оценки: Trough study completion, an average of 1 year]
  • Diastolic blood pressure [Срок оценки: Trough study completion, an average of 1 year]
  • Change in lipid profiles [Срок оценки: Trough study completion, an average of 1 year]
  • Self-Management of Type 1 Diabetes for Chinese Adults [Срок оценки: Trough study completion, an average of 1 year]
  • 23-item Chinese Version of Self-Report Measure of Self-Management of Type 1 Diabetes for Adolescents [Срок оценки: Trough study completion, an average of 1 year]

Критерии участия

Критерии включения

1\. Patients with type 1 diabetes of all age groups, regardless of disease duration.

The diagnosis criteria for type 1 diabetes are met by fulfilling any one point from the first two criteria plus any one point from the third criterion.

  • Clinically diagnosed as Type 1 Diabetes by a specialist physician.
  • Meet any one of the following criteria:

A. Age of onset <15 years B. No obesity at the time of onset C. diabetic ketoacidosis onset D. Maximum random C-peptide <200 pmol/L

  • Meet any one of the following criteria:

A. Initiation and continuation of insulin therapy after diagnosis (excluding pancreas or islet transplantation) B. Positive for islet cell antibodies

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

Китай · 10 центров
  • Department of Endocrinology and Metabolism, Peking University People's Hospital — Пекин
  • Department of Endocrinology, Beijing Tongren Hospital, Capital Medical University — Пекин
  • Department of Endocrinology and Metabolism, the Third Affiliated Hospital of Sun Yat-sen U — Гуанчжоу
  • Department of Endocrinology, Shenzhen Second People's Hospital, The First Affiliated Hospi — Шэньчжэнь
  • Endocrinology and Metabolism Center, The First Affiliated Hospital, and College of Clinica — Luoyang
  • Institute of Metabolism and Endocrinology, Second Xiangya Hospital of Centra South Univers — Чанша
  • Department of Endocrinology, The First Affiliated Hospital of Nanjing Medical University — Нанкин
  • Department of Endocrinology and Metabolism, Institute of Endocrinology, The First Affiliat — Шэньян
  • … и ещё 2 центра

Идентификаторы

NCT: NCT07097805 · KYZ20240193

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗