Меню
Идёт набор NCT06805786

Effect of Switching From Intermittently Scanned to Real-time Continuous Glucose Monitoring on Diabetes Management in Adults With Type 2 Diabetes (Switch CGM T2D)

— Наблюдательное Type 2 Diabetes

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 continuous glucose monitor.
Кому может быть актуально
Состояния в реестре: Type 2 Diabetes. Базовые параметры: от 18 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
Канада
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Effect of Switching From Intermittently Scanned Continuous Glucose Monitoring to Real-time Continuous Glucose Monitoring on Glycemic Outcomes in Adults With Type 2 Diabetes

Обзор

The goal of this prospective study is to evaluate diabetes outcomes and patient experience following a switch from second generation intermittently scanned continuous glucose monitor (isCGM) to real-time continuous glucose monitor (rtCGM) compared with participants with continued isCGM use among adults with insulin-treated type 2 diabetes (T2D) in a specialist endocrinology clinic setting in Canada. The study aims include: Primary outcome - Evaluate change in percent time in range (TIR) at 3-6 months follow-up after switching from a second generation isCGM system to a rtCGM system compared with participants with continued second generation isCGM use. Secondary outcomes - Compare glycemic and metabolic outcomes (ie. additional CGM metrics, HbA1c, and weight), and outcomes related to diabetes management (ie. self-reported hypoglycemia and change in total daily dose \[TDD\] of insulin) at 3-6 months follow-up in the rtCGM switch and isCGM cohorts among adults with insulin-treated T2D. Exploratory outcomes - Evaluate patient-reported outcomes (PROs) in the rtCGM switch cohort only. PROs will include questions about device satisfaction and psychological distress at baseline and 3-6 months follow-up, and protocol-specific questions about Dexcom Care following use of the rtCGM device at 3-6 months follow-up. Additionally this study will compare percent TIR, percent TBR, percent TAR, and HbA1c between rtCGM switch and isCGM cohorts by insulin therapy subgroup (basal vs MDI therapy). rtCGM switch participants will be enrolled at an LMC location and asked to complete PROs at baseline and 3-6 month follow-up. Continued isCGM participants will not be asked to complete PROs.

Вмешательства

  • Устройство real-time continuous glucose monitor
    Individuals who switched from using isCGM to rtCGM

Первичные конечные точки

  • Change in Percent Time in Range (TIR) [Срок оценки: from enrollment to 6 months follow up]
Вторичные конечные точки (12)
  • Change in Percent Time Below Range (TBR) [Срок оценки: from enrollment to 6 months follow up]
  • Change In Percent Time Below Range (TBR) in Level 2 Hypoglycemia [Срок оценки: from enrollment to 6 months follow up]
  • Change in Percent Time Above Target Glucose Range (TAR) [Срок оценки: from enrollment to 6 months follow up]
  • Change in Mean Glucose [Срок оценки: from enrollment to 6 months follow up]
  • Change in Glycemic Variability measured as Standard Deviation of Glucose (mmol/L) [Срок оценки: from enrollment to 6 months follow up]
  • Change in Glycemic Variability measured as the Coefficient of Variation of Glucose (%) [Срок оценки: from enrollment to 6 months follow up]
  • Change in Frequency of Hypoglycemia Episodes [Срок оценки: from enrollment to 6 months follow up]
  • Percent Sensor Capture and Change in Percent Capture [Срок оценки: from enrollment to 6 months follow up]
  • Change in HbA1c [Срок оценки: from enrollment to 6 months follow up]
  • Portion of Participants Achieving HbA1c ≤7.0% at Follow-Up [Срок оценки: from enrollment to 6 months follow up]
  • Change in Weight [Срок оценки: from enrollment to 6 months follow up]
  • Change in Weekly Incidence of Self-Reported Hypoglycemia [Срок оценки: from enrollment to 6 months follow up]

Критерии участия

Критерии включения

  • 18 years or older
  • Clinical diagnosis of T2D ≥ one year
  • Using insulin for ≥ 6 months
  • Continued FreeStyle Libre® 2 isCGM device (isCGM cohort) as of the study start date
  • Would like to switch from a FreeStyle Libre® 2 isCGM device to a Dexcom® G7 rtCGM device (rtCGM switch cohort) as of the study start date
  • Baseline HbA1c ≥ 7.5%
  • Known rtCGM/isCGM start date (month and year)
  • Exclusive use of isCGM for ≥ 3 months
  • Data on LibreView platforms have percent sensor capture ≥ 70% for 14 days of available data up to 6 months prior to index date
  • ≥ 1 value for TIR (%) up to 6 months (± 6 weeks) prior to index date
  • ≥ 1 value for HbA1c (%) up to 6 months (± 6 weeks) prior to index date
  • Data consent

Критерии исключения

  • Have a prior history of rtCGM within 12 months of the index date
  • Recent or expectant change to antihyperglycemic medications or doses within 30 days of index date
  • Recent or expectant titration of insulin dose ≥ 20% within 30 days of index date
  • Are pregnant at the time of study enrollment or intending to become pregnant during the study
  • Used the isCGM or rtCGM for < 3 months
  • Using continuous subcutaneous insulin infusion

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Канада · 1 центр
  • LMC Diabetes & Endocrinology Ltd. — Toronto

Идентификаторы

NCT: NCT06805786 · Switch CGM T2D

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗