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Идёт набор NCT07414277

CGM for Insulin-Treated T2DM During Post-Discharge Transition

Без фазы С лечением Type 2 Diabetes Mellitus (T2DM)

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: Type 2 Diabetes Mellitus (T2DM). 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Effects of Continuous Glucose Monitoring on Patients With Type 2 Diabetes Treated With Insulin During Post-Discharge Transition: A Multicenter Randomized Controlled Trial

Обзор

The transition from inpatient care to the home setting is a critical phase for glycemic management, often associated with decreased adherence and deterioration of glycemic control. This multicenter, randomized, open-label, controlled trial aims to evaluate the efficacy of Real-Time Continuous Glucose Monitoring (RT-CGM) versus Self-Monitoring of Blood Glucose (SMBG) in patients with Type 2 Diabetes Mellitus (T2DM) treated with insulin during the post-discharge transitional period. A total of 160 eligible participants will be randomized in a 1:1 ratio to either the RT-CGM group or the SMBG group. Participants will wear RT-CGM intermittently (every 4 weeks) or perform SMBG for the 12-week intervention period. They will also visit the clinic at Week 12 and Week 24 for follow-up assessments.

Вмешательства

  • Устройство RT-CGM
    RT-CGM can provide real-time tracking of glucose levels, and offer glucose trend graphs and user-configurable low and high glucose alerts.
  • Устройство SMBG
    SMBG provides discrete, point-in-time capillary blood glucose measurements via fingerstick testing.

Первичные конечные точки

  • Difference between change in HbA1c between the intervention group and the control group at Week 12 [Срок оценки: from baseline to Week 12]
Вторичные конечные точки (8)
  • Difference between change in HbA1c between the intervention group and the control group at Week 24 [Срок оценки: from baseline to Week 24]
  • Difference in CGM Time in Range (TIR) (3.9-10.0 mmol/L) between the intervention group and the control group at Week 14 and Week 26 [Срок оценки: at Week 14 and Week 26]
  • Difference in CGM Time Above Range (TAR) (>10.0 mmol/L; >13.9 mmol/L) between the intervention group and the control group at Week 14 and Week 26 [Срок оценки: at Week 14 and Week 26]
  • Difference in CGM Time Below Range (TBR) (<3.9 mmol/L; <3.0 mmol/L) between the intervention group and the control group at Week 14 and Week 26 [Срок оценки: at Week 14 and Week 26]
  • Difference in CGM coefficient of variation (CV) between the intervention group and the control group at Week 14 and Week 26 [Срок оценки: at Week 14 and Week 26]
  • Difference between change in self-efficacy score between the intervention group and the control group at Week 12 and Week 24 [Срок оценки: from baseline to Week 12 and Week 24]
  • Difference between change in diabetes-related distress between the intervention group and the control group at Week 12 and Week 24 [Срок оценки: from baseline to Week 12 and Week 24]
  • Difference between change in glucose monitoring satisfaction between the intervention group and the control group at Week 12 [Срок оценки: from baseline to Week 12 and Week 24]

Критерии участия

Критерии включения

  • Age 18 to 80 years (inclusive).
  • Confirmed diagnosis of type 2 diabetes mellitus (T2DM).
  • HbA1c between 8.0% and 13.0% (inclusive) within the last 1 month prior to screening/enrollment.
  • Planned to receive insulin therapy for at least 6 months after hospital discharge, as assessed/confirmed by the treating physician (principal physician).

Критерии исключения

  • Current use of a real-time continuous glucose monitoring (RT-CGM) device, or use within the 3 months prior to enrollment.
  • Severe skin disease at the sensor insertion site, or allergy to adhesive tape/adhesives.
  • Pregnant women; positive pregnancy test at screening; or planning pregnancy during the study period.
  • Currently participating in, or planning to participate in, another clinical trial.
  • Current use of oral corticosteroid therapy, or anticipated use during the trial period.
  • Severe liver disease, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 times the upper limit of normal (ULN).
  • Severe renal impairment or end-stage renal disease, defined as estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m².
  • Any condition that, in the investigator's opinion, makes the participant unsuitable for the trial, for example: history of ocular trauma or other diagnosed eye diseases causing visual impairment; unwillingness to participate or inability to adequately understand/comply due to speech/language impairment; or presence of psychiatric disorders.

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 · 4 центра
  • Shanghai 7th People's Hospital — Шанхай
  • Shanghai 6th People's Hospital — Шанхай
  • Shanghai Fengxian District Central Hospital — Шанхай
  • Shanghai General Hospital — Шанхай

Идентификаторы

NCT: NCT07414277 · 20260203

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗