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Идёт набор NCT06144554

Post Market Registry for the Omnipod 5 System in Children and Adults With Type 1 Diabetes

— Наблюдательное Type 1 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: Omnipod 5.
Кому может быть актуально
Состояния в реестре: Type 1 Diabetes. 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
США
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

Post Market Registry to Collect Real-World Safety and Effectiveness Data for the Omnipod 5 System in Children and Adults With Type 1 Diabetes

Обзор

This is a decentralized observational clinical registry to collect real-world evidence related to the safety and effectiveness of the Omnipod 5 system in children and adults with Type 1 Diabetes.

Подробное описание

This is a decentralized observational clinical registry to collect real-world evidence related to the safety and effectiveness of the Omnipod 5 system in children and adults with Type 1 Diabetes.

A minimum of 2,200 Type 1 participants will be recruited to ensure a minimum of 1,650 participants completing 12 months of follow-up. The minimum number of completed participants is as follows:

* 150 participants aged 2-5 * 300 participants aged 6-13 * 300 participants aged 14-17 * 900 participants aged 18+

In addition to the enrollment targets above, a minimum of 1100 Omnipod-naïve users, 880 pump-naïve users, and 110 CGM-naïve users will be recruited.

Participants are expected to be followed for 12 months.

Вмешательства

  • Устройство Omnipod 5
    The Omnipod 5 System consists of a tubeless insulin Pod and the Omnipod® 5 App, installed on a designated Controller or compatible Android smartphone. The Omnipod 5 System works with the Dexcom G6® Continuous Glucose Monitoring System to continuously adapt and automatically deliver insulin according to personal needs. Every two weeks while on the Omnipod 5 system, participants will receive a push notification to complete assessments including any severe hypoglycemia or diabetic ketoacidosis eve

Первичные конечные точки

  • Incidence rate of severe hypoglycemia [Срок оценки: From baseline to study completion, up to 12 months.]
  • Incidence rate of DKA [Срок оценки: From baseline to study completion, up to 12 months.]
  • A1c at 3, 6, 9 and 12 months [Срок оценки: Comparing the change in A1c at baseline compared to at 3, 6, 9 and 12 months]
  • Percentage of time < 54 mg/dL [Срок оценки: From baseline to study completion, up to 12 months]
  • Percentage of time < 70 mg/dL [Срок оценки: From baseline to study completion, up to 12 months]
  • Percentage of time > 180 mg/dL [Срок оценки: From baseline to study completion, up to 12 months]
  • Percentage of time > 250 mg/dL [Срок оценки: From baseline to study completion, up to 12 months]
  • Percentage of time in range 70-180 mg/dL [Срок оценки: From baseline to study completion, up to 12 months]
  • Mean Glucose mg/dL [Срок оценки: From baseline to study completion, up to 12 months]
  • Standard deviation of glucose mg/dL [Срок оценки: From baseline to study completion, about 12 months]

Критерии участия

Критерии включения

  • Self-reported type 1 diabetes
  • Prescribed, obtained, and have been using the Omnipod 5 System for no more than two weeks or plan to start using the system within the next two weeks
  • Willing to use only the following types of U-100 insulin during the study: Humalog U-100, Novolog, or Admelog
  • Able to read and speak English or Spanish (when available) fluently and reside full time in the United States
  • Willing to collect A1C samples using a provided home kit and send the samples to the registry specific core laboratory at baseline and 3, 6, 9 and 12 months
  • Willing and able to complete registry assessments every two weeks
  • Willing and able to complete registry outcome questionnaires at baseline, 6 months and end of study (or at withdrawal)
  • Is not currently pregnant or planning to become pregnant in the next 12 months and is using a reliable form of birth control
  • Access to internet via phone, tablet and/or computer to use the registry online platform
  • Willing to provide CGM and insulin delivery data collected prior to using the Omnipod 5 System, if available (participants will not be excluded if data is not provided)
  • Willing and able to provide informed consent (or assent) and/or has a parent/guardian willing and able to provide informed consent as applicable

Критерии исключения

  • Diagnosed with sickle cell anemia and/or hemoglobinopathy
  • Planned blood transfusions over the course of the study or has received a blood transfusion within 3 months prior to starting on Omnipod 5
  • Adults that are unable to provide informed consent

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

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • Circuit Clinical — Buffalo

Идентификаторы

NCT: NCT06144554 · Post-Market Registry

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗