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Набор скоро начнётся NCT06606509

The Survey of Treatment and Metabolic Status of Type 1 Diabetes Mellitus (T1DM).

— Наблюдательное Type1 Diabetes Mellitus

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: Continuous Glucose Monitoring System (GX-01S).
Кому может быть актуально
Состояния в реестре: Type1 Diabetes Mellitus. 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
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Официальное название

The Chinese Clinical Research Plan for the Survey of Treatment and Metabolic Status of Type 1 Diabetes Mellitus (T1DM).

Обзор

This study is a multicenter cross-sectional research project, planning to enroll 1000 patients with Type 1 Diabetes Mellitus (T1DM). By reviewing clinical data, physical examinations, questionnaires, continuous glucose monitoring, and subcutaneous fat ultrasound, we aim to understand the current status of treatment and metabolism in Chinese T1DM patients and analyze the potential factors that may affect their blood sugar control and metabolic indicators. A cost-effectiveness analysis will be conducted on Chinese T1DM patients using continuous glucose monitoring systems to identify the groups that benefit most from these systems.

Подробное описание

This study is a multicenter cross-sectional research project, planning to enroll 1000 patients with Type 1 Diabetes Mellitus (T1DM). This study will collect multicenter data on T1DM patients, including sociodemographic information, anthropometric measurements, glycemic indices (glycated hemoglobin, fasting blood glucose, postprandial blood glucose), acute and chronic complications, other important metabolic indicators (blood lipids, vitamin D), insulin treatment methods, blood glucose monitoring status, diabetes education, diet and exercise, social and psychological support, and extra-pancreatic autoimmune diseases. The aims are: 1. To understand the current state of treatment and glycemic metabolism in Chinese T1DM patients and to analyze the potential factors that may affect their glycemic indices. 2. To understand the current status of continuous glucose monitoring (CGM) usage in Chinese T1DM patients and to analyze the impact of CGM on blood glucose control, acute and chronic complications, and quality of life in T1DM patients. 3. Through cost-benefit analysis, to identify potential beneficiary groups for CGM, providing objective evidence for the demand of this technology to healthcare professionals and diabetes patients; to provide effective information for the formulation of medical insurance reimbursement policies for continuous glucose monitoring.

Вмешательства

  • Устройство Continuous Glucose Monitoring System (GX-01S)
    Patients with Type 1 Diabetes Mellitus (T1DM) will receive Continuous Glucose Monitoring System (GX-01S) for seven days.

Первичные конечные точки

  • Current status of blood sugar control in Chinese patients with type 1 diabetes [Срок оценки: 3 years]
  • Understand the current status of the use of continuous glucose monitoring in China for type 1 diabetes [Срок оценки: 3 years]
  • Potential beneficiary groups of continuous glucose monitoring [Срок оценки: 3 years]
Вторичные конечные точки (2)
  • Current treatment status of Chinese patients with type 1 diabetes [Срок оценки: 3 years]
  • Current status of extra-pancreatic autoimmune diseases in Chinese patients with type 1 diabetes [Срок оценки: 3 years]

Критерии участия

Критерии включения

  • Volunteer to participate and be able to sign informed consent
  • Patients with type 1 diabetes
  • At least one of the following three clinical characteristics must be met: The disease presents initially with diabetic ketoacidosis (DKA) or ketonuria; The presence of islet-related autoantibodies, such as islet cell antibodies, tyrosine phosphatase antibodies, or glutamic acid decarboxylase (GAD) antibodies, is detected positively; Both fasting and postprandial C-peptide levels are ≤0.6 ng/mL.

Критерии исключения

  • Other types of diabetes.
  • Patients who cannot cooperate with the use of continuous glucose monitoring, clinical data collection, and questionnaire completion.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Китай · 101 центр
  • Anqing Municipal Hospital — Anqing
  • The First Affiliated Hospital of Bengbu Medical University — Bengbu
  • Hefei First People's Hospital — Хэфэй
  • The First Affiliated Hospital of Anhui Medical University — Хэфэй
  • The First Affiliated Hospital of USTC, — Хэфэй
  • The second People's Hospital,wuhu — Wuhu
  • China-Japan Friendship Hospital — Пекин
  • Peking Union Medical College Hospital — Пекин
  • … и ещё 93 центра

Идентификаторы

NCT: NCT06606509 · KY20240514-10

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗