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Идёт набор NCT06591286

Effects of Real-time Continuous Glucose Monitoring System on Hospital-to-home Transitional Blood Glucose Control

Без фазы С лечением Diabetes Mellitus, Type 2

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: RT-CGM, SMBG.
Кому может быть актуально
Состояния в реестре: Diabetes Mellitus, Type 2. Базовые параметры: 18 лет — 80 лет · 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

Effects of Real-time Continuous Glucose Monitoring System on Hospital-to-home Transitional Blood Glucose Control and Self-efficacy Among Patients With Type 2 Diabetes Treated With Insulin

Обзор

Glucose monitoring is an important part of self-management for patients with diabetes. The results of glucose monitoring not only help to assess the degree of glucose metabolism disorders in patients, but also help physicians to make clinical decisions and guide patients in self-management. Despite extensive efforts and advances in diabetes management during hospitalization, glucose control after patients is discharged home remains a challenge. This trial aims to explore the effect of real-time continuous glucose monitoring (RT-CGM) system compared to self-monitoring of blood glucose (SMBG) group on glucose and self-efficacy of type 2 diabetes patients treated with insulin after discharge from the hospital.

Подробное описание

Glycemic management of patients with diabetes after discharge home is extremely challenging, especially for those requiring insulin therapy. The use of a real-time continuous glucose monitoring (RT-CGM) system may improve glycemic control and self-efficacy in patients with type 2 diabetes treated with insulin after discharge from the hospital.

One hundred and fifty insulin-treated adults with type 2 diabetes were randomly assigned to receive either RT-CGM or self-monitoring of blood glucose (SMBG) at hospital discharge for a 12-week monitoring intervention and a 36-week follow-up.

Вмешательства

  • Устройство RT-CGM
    This group of patients will wear RT-CGM for blood glucose monitoring for three months.
  • Устройство SMBG
    This group of patients will use a a fingertip glucose meter for blood glucose monitoring for three months, and the monitoring frequency was not less than 4 times per week.

Первичные конечные точки

  • Time in range (3.9~10.0mmol/L, %) [Срок оценки: 12 weeks]
Вторичные конечные точки (9)
  • HbA1c (%) [Срок оценки: 4weeks, 8weeks, 12 weeks, 24weeks, 48weeks]
  • Time in range (3.9~10.0mmol/L, %) [Срок оценки: 4weeks, 8weeks, 24weeks, 48 weeks]
  • Time above range (>10.0mmol/L, %) [Срок оценки: 4weeks, 8weeks, 12 weeks, 24weeks, 48weeks]
  • Time below range (<3.9mmol/L, %) [Срок оценки: 4weeks, 8weeks, 12 weeks, 24weeks, 48weeks]
  • Coefficient of variation (CV) [Срок оценки: 4weeks, 8weeks, 12 weeks, 24weeks, 48weeks]
  • Standard deviation (SD) [Срок оценки: 4weeks, 8weeks, 12 weeks, 24weeks, 48weeks]
  • Mean amplitude of glycemic excursions (MAGE) [Срок оценки: 4weeks, 8weeks, 12 weeks, 24weeks, 48weeks]
  • Diabetes management self-efficacy [Срок оценки: 4weeks, 8weeks, 12 weeks, 24weeks, 48weeks]
  • Diabetes Self Care Activities [Срок оценки: 4weeks, 8weeks, 12 weeks, 24weeks, 48weeks]

Критерии участия

Критерии включения

  • 18 years old ≤ age ≤ 80 years old.
  • Type 2 diabetes admitted to Department of Endocrinology and Metabolism.
  • 8% ≤ HbA1c ≤ 12% in the last 1 month.
  • Insulin therapy within 1 month of planned discharge from hospital.
  • Frequency of self-monitoring of blood glucose <4 times per week and no use of real-time continuous glucose monitoring system in the 3 months prior to hospitalisation.
  • Willing and able to provide written informed consent and comply with the requirements of this study.

Критерии исключения

  • Oral steroid hormone therapy.
  • Patients with acute complications of diabetes (including Diabetic ketoacidosis, hyperglycemia and hyperosmolality, Lactic acidosis)
  • Patients with severe liver disease (alanine aminotransferase or glutamine aminotransferase exceeding more than three times the upper limit of normal).
  • Patients with severe kidney injury or end-stage renal disease (eGFR < 30 mL/min/1.73 m2).
  • Participants were unable to tolerate tape adhesive around sensor placement area, or with medically documented allergy towards the adhesive (glue) of plasters, or with serious skin diseases (e.g. psoriasis vulgaris, bacterial skin diseases) around sensor placement area.
  • Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
  • Pregnant, breastfeeding, women of childbearing age who are unwilling to use contraception during the study period.

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
Лечение

Центры проведения

Китай · 1 центр
  • Shanghai 6th People's Hospital — Шанхай

Идентификаторы

NCT: NCT06591286 · RT20240903

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗