EARLY FEASIBILITY STUDY: SAFETY AND EFFICACY OF PHOTON INFUSION SET

Обзор

Study 1: The purpose of this study is to evaluate safety and efficacy of Photon infusion sets (PIS) with new PFAS-free cannula (catheter) in adult patients with Type 1 diabetes for up to 10 days and 6 hours. This is a 1-center, prospective, open-label, 1-arm study with type 1 patients with diabetes on 780G insulin pump therapy with Guardian™ 4 Continuous Glucose Monitoring (CGM). All subjects will be instructed to change infusion sets every 246 hours (10 days \& 6 hours) or at set failure. Each subject is required to wear the CGM device continuously. After completing 2 sets, the subjects have an optional office visit to download pump and CGM data and will continue to additional two wears. At day 40 or after using 4 completed wears of infusion sets (Note: early infusion set failure with wear time of \<6 hours due to insertion failure will be reported, yet not accounted as completed wear), the patients will return to a visit, download pump and CGM data, and end the study. Photon infusion sets with 6-mm and 9-mm cannula length will be supplied for this study, with selection based on subjects' needs and doctor's recommendation. Subjects will change insulin reservoirs at least every 7 days (the labelled wear duration of the Extended reservoir). The infusion set(s) or reservoir(s) can be replaced independent of each other. The date and time of each infusion set insertion will be recorded in a Daily Log (Diary) which will include the causes of early removal, if occurs. Study 2: If Study 1 is successful, the same study designed as illustrated in Figure 1 may be performed on the current on-market Extended infusion set (EIS) for comparison of clinical performance with the PIS, using the same cohort of pump users.

Вмешательства

• Устройство PIS
  All subjects will be instructed to change the investigational infusion sets (PIS) every 246 hours (10 days \& 6 hours) or at set failure. Each subject is required to wear the CGM device continuously. defined as any one of the following: After completing 2 sets, the subjects have an optional office visit to download pump and CGM data and will continue to additional two wears. At day 40 or after using 4 completed wears of infusion sets (Note: early infusion set failure with wear time of \<6 hours

Первичные конечные точки

• Primary Effectiveness Endpoint [Срок оценки: 12 months]

Критерии участия

Критерии включения

• Clinical diagnosis of type 1 diabetes for at least one year
• Using a MiniMed™ 780G Insulin pump with Guardian sensor
• Age 18 to 80 years
• Hemoglobin A1c level less than or equal to 10%
• Not currently known to be pregnant, nor planning pregnancy during the study.
• Willingness to follow the protocol and sign the informed consent

Критерии исключения

• A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol.
• Pregnant or lactating females
• Subject has Glycosylated hemoglobin (HbA1c)< 10 % at time of screening.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06684561 · Sheba-24-1530-AT-CTIL

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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