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Идёт набор NCT07007676

Effect of Continuous Glucose Monitoring System on Glycemic Control in Non-insulin-Treated Elderly People With Type 2 Diabetes

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: real-time CGM.
Кому может быть актуально
Состояния в реестре: Diabetes Mellitus Type 2. Базовые параметры: от 60 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Effect of contINuous Glucose moniToring System on glycEmic controL in Non-insuLin-Treated Elderly People With Type 2 Diabetes: a Randomized Controlled Trial

Обзор

The goal of this clinical trial is to learn if continuous glucose monitoring system works to improve glucose control in non-insulin-treated older adults with type 2 diabetes. The main questions it aims to answer are: * Dose the use of continuous glucose monitoring system improve glucose control in older adults with type 2 diabetes treated with oral antidiabetic drugs only? * Dose the use of continuous glucose monitoring system affect psychological outcomes in older adults with type 2 diabetes treated with oral antidiabetic drugs only? Researchers will compare continuous glucose monitoring to standard blood glucose monitoring to see if continuous glucose monitoring works better in glucose management. Participants will: * Wear continuous glucose monitoring every 2 months or standard blood glucose monitoring for 6 months * Visit the clinic once every 2 months for follow-up * Keep a diary of their blood glucose when continuous glucose monitoring was not used

Вмешательства

  • Устройство real-time CGM
    real-time CGM can provide real-time tracking of glucose levels, and offer glucose trend graphs and user-configurable low and high glucose alerts.

Первичные конечные точки

  • Change in HbA1c [Срок оценки: 24 weeks from baseline]
Вторичные конечные точки (5)
  • Time in range of 70-180 mg/dL [Срок оценки: 24 weeks from baseline]
  • Time below range of 70 mg/dL [Срок оценки: 24 weeks from baseline]
  • Time above range of 180 mg/dL [Срок оценки: 24 weeks from baseline]
  • Glucose coefficient of variability [Срок оценки: 24 weeks from baseline]
  • Mean glucose [Срок оценки: 24 weeks from baseline]

Критерии участия

Критерии включения

  • Age ≥ 60 years at the time of screening;
  • Diagnosed with type 2 diabetes mellitus;
  • Treated with two or more oral antidiabetic drugs with a stable medication regimen (medication classes) during the 3 months prior to entry;
  • Suboptimal glycemic control, defined as HbA1c ≥ 7.5% and ≤ 10% at screening or within 30 days prior to screening visit;
  • Has a smart phone compatible with CGM and BGM systems;
  • Willing and able to provide written informed consent;
  • At least 240 hours (10 out of 14 days) of sensor glucose data from the blinded CGM pre-randomization phase.

Критерии исключения

  • Use of insulin or Glucagon-Like Peptide-1 （GLP-1） receptor agonists within 3 months prior to screening;
  • Use of any CGM device within 3 months prior to screening;
  • 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;
  • Considered unsuitable for participation by the investigators, including but not limited to individuals with dementia, psychiatric disorders, extreme visual or hearing impairment that would impair ability to use real-time CGM assessed;
  • Planned surgery or other procedures within the next 6 months that may interfere with scheduled follow-up visits;
  • Current or anticipated acute uses of glucocorticoids (oral, injectable, or IV), that will affect glycemic control;
  • Estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m2;
  • Participation in any other clinical trial within 3 month prior to screening, or concurrently enrolled, or planning to participate in another trial 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 · 15 центров
  • Shenzhen Jiangangshan Health Service Center — Шэньчжэнь
  • Shenzhen Fifth Avenue Health Service Station — Шэньчжэнь
  • Shenzhen Haifu Health Service Station — Шэньчжэнь
  • Shenzhen Haile Huafu Health Service Station — Шэньчжэнь
  • Shenzhen Haiyu Health Service Station — Шэньчжэнь
  • Shenzhen Jiaan Health Service Station — Шэньчжэнь
  • Shenzhen Jiari Mingju Health Service Station — Шэньчжэнь
  • Shenzhen Xinan Lake Health Service Station — Шэньчжэнь
  • … и ещё 7 центров

Идентификаторы

NCT: NCT07007676 · 20250522001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗