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Идёт набор NCT07317102

Omnipod-5 A French Prospective Multicentric Study in Real World (Optimal-B)

— Наблюдательное Diabetes Type 1 Diabetes Diabetes Mellitus

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: Omnipod 5.
Кому может быть актуально
Состояния в реестре: Diabetes, Type 1 Diabetes, Diabetes Mellitus. Базовые параметры: от 2 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
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The purpose of this postmarket clinical investigation is to evaluate the levels of glycemic control, quality of life, and satisfaction, as well as the patient experience, and acute diabetes complication rates provided by the Omnipod 5 Automated Insulin Delivery System (referred to as the Omnipod 5 System) in a real-world setting.

Подробное описание

Twelve-month, real-world, non-interventional, prospective follow-up of adult and pediatric patients aged more than 2 years old, prescribed the commercially available FreeStyle Libre 2 Plus configuration of the Omnipod 5 Automated Insulin Delivery System in France.

OPTIMAL-B study (Omnipod 5 - A French Prospective Multicentric Study in Real World), aims to provide the requisite real-world data on the glycemic control, quality of life, safety, and device usage profiles of users of the Omnipod 5 System during the 12 months after starting using Omnipod 5 in automated mode.

Вмешательства

  • Устройство Omnipod 5
    The Omnipod 5 Automated Insulin Delivery System (Omnipod 5 System) is a tubeless insulin pump with a mono-hormonal insulin delivery system designed to deliver U-100 insulin subcutaneously for the management of type 1 diabetes in people aged 2 years and older who require insulin. The Omnipod 5 System is intended to function as an automated insulin delivery system when used with compatible Continuous Glucose Monitoring (CGM) systems.

Первичные конечные точки

  • Change in the percentage of time in the 70 - 180 mg/dL range [Срок оценки: Change in percentage of time in specified range between Baseline and 12-months following first initiation of automated mode]
Вторичные конечные точки (12)
  • Percentage of time in the 70 - 180 mg/dL range [Срок оценки: Up to 12-months following first initiation of automated mode]
  • Percentage of time in the 70 - 140 mg/dL range [Срок оценки: Up to 12-months following first initiation of automated mode]
  • Percentage of time below 54 mg/dL [Срок оценки: Up to 12-months following first initiation of automated mode]
  • Percentage of time below 70 mg/dL [Срок оценки: Up to 12-months following first initiation of automated mode]
  • Percentage of time above 180 mg/dL [Срок оценки: Up to 12-months following first initiation of automated mode]
  • Percentage of time above 250 mg/dL [Срок оценки: Up to 12-months following first initiation of automated mode]
  • Glucose Management Indicator (GMI) [Срок оценки: Up to 12-months following first initiation of automated mode]
  • Glycemic Risk Index (GRI) [Срок оценки: Up to 12-months following first initiation of automated mode]
  • Coefficient of variation (CV) [Срок оценки: Up to 12-months following first initiation of automated mode]
  • Mean glucose [Срок оценки: Up to 12-months following first initiation of automated mode]
  • HbA1c Level (if available) [Срок оценки: Up to 12-months following first initiation of automated mode]
  • Percentage of patients with ≥ 70% [Срок оценки: Up to 12-months following first initiation of automated mode]

Критерии участия

Критерии включения

  • Patient with T1D aged ≥ 2 years.
  • Patient prescribed, less than a year ago, a commercially available confi guration of the Omnipod 5 System using a FreeStyle Libre 2 Plus sensor.
  • Patient has never used the Omnipod 5 System prior to inclusion.
  • Patient has not objected to the use of their personal data for this study.
  • Patient or legal guardian has an email address and mobile phone number.
  • Patient (and legal guardians if the patient is a minor) is able to understand study information and Non-Opposition form.
  • Patient (and legal guardians if the patient is a minor) is able to understand and complete questionnaires in French.
  • Patient is covered by the local social security system

Критерии исключения

  • Patient is currently pregnant.
  • Patient presents an allergy to the materials of the Omnipod 5 System (patch, cannula, CGM).
  • Patient is unable to be followed by the same investigation site for the duration of the study or is unwilling or unable to maintain contact with the healthcare professional.
  • Patient is already participating in a clinical trial or in another study precluding their participation in other studies.
  • Adult under guardianship, curatorship or tutorship.
  • Adult otherwise deprived of liberty.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 24 центра
  • CHU Angers — Angers
  • CHU Besançon - Hôpital de Jean Minjoz — Besançon
  • APHP Hopital Avicenne — Bobigny
  • CHU Bordeaux - Hôpital Pellegrin — Bordeaux
  • CHU Bordeaux - Hôpital St-André — Bordeaux
  • CHU Brest - Hôpital de la Cavale Blanche — Brest
  • Hôpital Femme Mère Enfant — Bron
  • Centre Hospitalier Sud Francilien — Corbeil-Essonnes
  • … и ещё 16 центров

Идентификаторы

NCT: NCT07317102 · Optimal-B

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗