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Reproducibility of Continuous Glucose Monitoring (CGM) in the Assessment of Glucose Metabolism Disorders in Children With Cystic Fibrosis (CGMUCODIAB)

25 сентября 2026 г. обновлено: Hospices Civils de Lyon

Glucose metabolism disorders in cystic fibrosis (CF-GMD) are common and have a negative clinical impact. Screening currently relies on the oral glucose tolerance test (OGTT); however, this procedure is burdensome and complex for both patients and healthcare providers. Continuous glucose monitoring (CGM) is increasingly used in CF centers for CF-GMD screening, either alone or alongside the OGTT. While long-term (one-year) OGTT reproducibility is known to be poor, the short- and medium-term reproducibility of CGM remains unknown. This examination is poised to become a major tool in CF-GMD investigation, upon which critical therapeutic decisions could be based. The primary objective of this project is to evaluate the short-term variability of CGM data.

Обзор исследования

Статус

Еще не набирают

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Оцененный)

30

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

  • Имя: Kévin PERGE, Dr
  • Номер телефона: +33 04 72 11 88 90
  • Электронная почта: kevin.perge@chu-lyon.fr

Учебное резервное копирование контактов

  • Имя: Philippe REIX, Prof
  • Номер телефона: +33 04 27 85 54 70
  • Электронная почта: philippe.reix@chu-lyon.fr

Места учебы

  • Франция
      • Bron, Франция, 69677
        • Hôpital Femme Mère Enfant (HFME)
        • Контакт:
          • Philippe REIX, Prof
          • Номер телефона: +33 04 27 85 54 70
          • Электронная почта: philippe.reix@chu-lyon.fr

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 10 лет до 17 лет (Ребенок)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

Inclusion Criteria:

  • Patients aged 10 to 17 years
  • Diagnosed with cystic fibrosis (CF)
  • Managed by the pediatric CF care center (CRCM) of the Groupement Hospitalier Est
  • Patients presenting with one of the following three stages are included: normal glucose tolerance with or without indeterminate glucose tolerance (INDET), impaired fasting glucose (IFG), and impaired glucose tolerance (IGT)

Exclusion Criteria:

  • Patients with treated or untreated diabetes
  • Patients presenting with a pulmonary exacerbation and currently receiving antibiotic therapy
  • Patients participating in another clinical trial that could interfere, in the investigator's judgment, with the study findings
  • Refusal of the patient and/or the legal guardian(s) to participate in the study
  • Pregnant, parturient, or breastfeeding women
  • Persons deprived of liberty by a judicial or administrative decision
  • Persons undergoing psychiatric care
  • Persons admitted to a healthcare or social institution for purposes other than research
  • Persons not affiliated with a social security scheme or beneficiaries of a similar scheme

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Диагностика
  • Распределение: Н/Д
  • Интервенционная модель: Одногрупповое задание
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: Non-diabetic patient with cystic fibrosis

Children aged 10 to 17 years diagnosed with cystic fibrosis (CF). Patients presenting with one of the following three stages are included: normal glucose tolerance with or without indeterminate glucose tolerance (INDET), impaired fasting glucose (IFG), and impaired glucose tolerance (IGT).

Patients will be equipped with a continuous glucose monitoring (CGM) sensor (Dexcom ONE+).
Устройство: Continuous Glucose Monitoring

Upon enrollment, patients will be equipped with a continuous glucose monitoring (CGM) sensor (Dexcom ONE+). Sensors will be placed on the posterior aspect of the dominant arm at M0, M3, and M6, and additionally on the non-dominant arm at M0 only, in order to evaluate site-dependent variability. At each time point, the sensors will be worn for 7 days to record various CGM parameters, including glycemic variability (analyzed between M0-M3 and M0-M6).

Другой: Eating Habits Questionnaire

A 7-day dietary diary will be completed at M0, M3, and M6.

Другой: Use of an actigraphy watch

Participants will wear an actigraphy watch during 7 days at M0, M3 and M6

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
The variability of the "time in range" (%) parameter (70-140 mg/dL) between M0 and M3.
Временное ограничение: From enrollment to 3 months

The variability of the "time in range" (%) parameter (70-140 mg/dL) between M0 and M3.
From enrollment to 3 months

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
The variability of other CGM parameters between M0 and M3: percentage of time in hypoglycemia (<70 mg/dL)
Временное ограничение: From enrollment to 3 months

The variability of other CGM parameters between M0 and M3: percentage of time in hypoglycemia (<70 mg/dL)
From enrollment to 3 months
The variability of other CGM parameters between M0 and M3: percentage of time in hyperglycemia (>140 mg/dL)
Временное ограничение: From enrollment to 3 months

The variability of other CGM parameters between M0 and M3: percentage of time in hyperglycemia (>140 mg/dL)
From enrollment to 3 months
The variability of other CGM parameters between M0 and M3: glycemic variability (%)
Временное ограничение: From enrollment to 3 months

The variability of other CGM parameters between M0 and M3: glycemic variability (%)
From enrollment to 3 months
The variability of other CGM parameters between M0 and M3: mean glucose level (mg/dL)
Временное ограничение: From enrollment to 3 months

The variability of other CGM parameters between M0 and M3: mean glucose level (mg/dL)
From enrollment to 3 months
The variability of other CGM parameters between M0 and M3: number of glucose excursions >200 mg/dL
Временное ограничение: From enrollment to 3 months

The variability of other CGM parameters between M0 and M3: number of glucose excursions >200 mg/dL
From enrollment to 3 months
The variability of other CGM parameters between M0 and M3: estimated HbA1c (eA1c)
Временное ограничение: From enrollment to 3 months

The variability of other CGM parameters between M0 and M3: estimated HbA1c (eA1c)
From enrollment to 3 months
The variability of CGM parameters between M0 and M6: "time in range" (%) (70-140 mg/dL)
Временное ограничение: From enrollment to 6 months

The variability of CGM parameters between M0 and M6: "time in range" (%) (70-140 mg/dL)
From enrollment to 6 months
The variability of CGM parameters between M0 and M6: percentage of time in hypoglycemia (<70 mg/dL),
Временное ограничение: From enrollment to 6 months

The variability of CGM parameters between M0 and M6: percentage of time in hypoglycemia (<70 mg/dL),
From enrollment to 6 months
The variability of CGM parameters between M0 and M6: percentage of time in hyperglycemia (>140 mg/dL),
Временное ограничение: From enrollment to 6 months

The variability of CGM parameters between M0 and M6: percentage of time in hyperglycemia (>140 mg/dL),
From enrollment to 6 months
The variability of CGM parameters between M0 and M6: glycemic variability (%),
Временное ограничение: From enrollment to 6 months

The variability of CGM parameters between M0 and M6: glycemic variability (%),
From enrollment to 6 months
The variability of CGM parameters between M0 and M6: mean glucose level (mg/dL),
Временное ограничение: From enrollment to 6 months

The variability of CGM parameters between M0 and M6: mean glucose level (mg/dL),
From enrollment to 6 months
The variability of CGM parameters between M0 and M6: number of glucose excursions >200 mg/dL
Временное ограничение: From enrollment to 6 months

The variability of CGM parameters between M0 and M6: number of glucose excursions >200 mg/dL
From enrollment to 6 months
The variability of CGM parameters between M0 and M6: estimated HbA1c (eA1c)
Временное ограничение: From enrollment to 6 months

The variability of CGM parameters between M0 and M6: estimated HbA1c (eA1c)
From enrollment to 6 months
The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): "time in range" (%) (70-140 mg/dL)
Временное ограничение: From enrollment to 3 months

The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): "time in range" (%) (70-140 mg/dL)
From enrollment to 3 months
The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): percentage of time in hypoglycemia (<70 mg/dL),
Временное ограничение: From enrollment to 3 months

The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): percentage of time in hypoglycemia (<70 mg/dL),
From enrollment to 3 months
The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): percentage of time in hyperglycemia (>180 mg/dL)
Временное ограничение: From enrollment to 3 months

The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): percentage of time in hyperglycemia (>180 mg/dL)
From enrollment to 3 months
The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): glycemic variability (%)
Временное ограничение: From enrollment to 3 months

The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): glycemic variability (%)
From enrollment to 3 months
The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): mean glucose level (mg/dL)
Временное ограничение: From enrollment to 3 months

The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): mean glucose level (mg/dL)
From enrollment to 3 months
The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): number of glucose excursions >200 mg/dL
Временное ограничение: From enrollment to 3 months

The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): number of glucose excursions >200 mg/dL
From enrollment to 3 months
The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): estimated HbA1c (eA1c)
Временное ограничение: From enrollment to 3 months

The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): estimated HbA1c (eA1c)
From enrollment to 3 months
The variability of CGM parameters according to physical activity (percentage of daytime activity) : Variation in the number of steps
Временное ограничение: From enrollment to 3 months and 6 months

The variability of CGM parameters according to physical activity (percentage of daytime activity), Variation in the number of steps
From enrollment to 3 months and 6 months
The variability of CGM parameters according to body composition (body fat percentage)
Временное ограничение: From enrollment to 3 months and 6 months

The variability of CGM parameters according to body composition (body fat percentage) : body fat in kg
From enrollment to 3 months and 6 months
The variability of CGM parameters according to body composition
Временное ограничение: From enrollment to 3 months and 6 months

The variability of CGM parameters according to body composition (lean mass percentage) : body fat in kg
From enrollment to 3 months and 6 months
The variability of CGM parameters according to body composition (fat mass percentage in the dominant arm)
Временное ограничение: From enrollment to 3 months and 6 months

The variability of CGM parameters according to body composition (fat mass percentage in the dominant arm) : body fat in kg
From enrollment to 3 months and 6 months
The variability of CGM parameters according to body composition (fat mass percentage in the non-dominant arm) : body fat in kg
Временное ограничение: From enrollment to 3 months and 6 months

The variability of CGM parameters according to body composition (fat mass percentage in the non-dominant arm) : body fat in kg
From enrollment to 3 months and 6 months
The variability of CGM parameters according to nutritional intake : Daily nutritional intake (kcal)
Временное ограничение: From enrollment to 3 months and 6 months

The variability of CGM parameters according to nutritional intake : Daily nutritional intake (kcal)
From enrollment to 3 months and 6 months
The variability of CGM parameters according to nutritional intake : carbohydrates (kg)
Временное ограничение: From enrollment to 3 months ans 6 months

The variability of CGM parameters according to nutritional intake : carbohydrates (kg)
From enrollment to 3 months ans 6 months
The variability of CGM parameters according to nutritional intake : fats (kg)
Временное ограничение: From enrollment to 3 months and 6 months

The variability of CGM parameters according to nutritional intake : fats (kg)
From enrollment to 3 months and 6 months
The variability of CGM parameters according to nutritional intake : proteins (kg)
Временное ограничение: From enrollment to 3 months and 6 months

The variability of CGM parameters according to nutritional intake : proteins (kg)
From enrollment to 3 months and 6 months

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Hospices Civils de Lyon

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Оцененный)

1 ноября 2026 г.

Первичное завершение (Оцененный)

1 февраля 2028 г.

Завершение исследования (Оцененный)

1 мая 2028 г.

Даты регистрации исследования

Первый отправленный

21 сентября 2026 г.

Впервые представлено, что соответствует критериям контроля качества

25 сентября 2026 г.

Первый опубликованный (Действительный)

1 октября 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

1 октября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

25 сентября 2026 г.

Последняя проверка

1 сентября 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • 69HCL25_1040
  • 2026-A00194-47 (Другой идентификатор: ID-RCB)

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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