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Набор скоро начнётся NCT06838819

CGM in Icodextrin PD

— Наблюдательное Diabetes Mellitus (Diagnosis) End Stage Renal Disease (ESRD) Dialysis Continuous Glucose Monitoring

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: Continuous glucose monitoring system.
Кому может быть актуально
Состояния в реестре: Diabetes Mellitus (Diagnosis), End Stage Renal Disease (ESRD), Dialysis, Continuous Glucose Monitoring. Базовые параметры: 18 лет — 75 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
Гонконг
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

Evaluation of Accuracy of Medtronic Simplera™ CGM in Patients on Icodextrin-containing Peritoneal Dialysis Regimens

Обзор

Assessment of performance (precision and accuracy) of Simplera™ CGM as compared with a gold standard reference laboratory method (YSI glucose) in diabetes patients on peritoneal dialysis with icodextrin

Вмешательства

  • Устройство Continuous glucose monitoring system
    Medtronic Simplera™

Первичные конечные точки

  • Mean absolute relative difference (MARD) [Срок оценки: 5 minutes]
Вторичные конечные точки (8)
  • Median absolute relative difference (MedARD) [Срок оценки: 5 minutes]
  • Consensus Error grid analysis [Срок оценки: 5 minutes]
  • Percent accuracy [Срок оценки: 5 minutes]
  • Hypoglycemia detection rates [Срок оценки: 15 minutes]
  • Hyperglycemia detection rates [Срок оценки: 15 minutes]
  • User satisfaction [Срок оценки: 2 weeks]
  • Correlation between CGM metrics, HbA1c and fructosamine [Срок оценки: 2 weeks]
  • Correlation between CGM metrics and SMBG [Срок оценки: 2 weeks]

Критерии участия

Критерии включения

  • Type 1 or 2 diabetes mellitus for at least 3 months
  • On continuous ambulatory peritoneal dialysis (CAPD) or APD for at least 2 months
  • On icodextrin PD solutions for at least 1 month or planned for switching to icodextrin PD solutions within 3 months of screening
  • Male or female age ≥ 18 years old and ≤ 75 year old.
  • Women who are not pregnant, lactating or planning a pregnancy during their participation in the clinical study.
  • Willingness, ability and commitment to comply with the testing, procedure and follow-up outlined in this protocol including (but not limited to) frequency of clinic visits and use of pre-specified glucose monitoring devices.
  • Willingness to abstain from swimming during their participation in the measurement phase.
  • In the opinion of the investigator, absence of any physical limitations, addictive diseases, or underlying medical conditions (including mental health) that may preclude the patient from being a good study candidate.
  • Written informed consent to participate in the study provided by the patient.

Критерии исключения

  • Poorly controlled diabetes mellitus with HbA1c>11%
  • Peritonitis within 1 month of screening
  • Planned for switching to hemodialysis or living donor transplant in the future 1 month
  • Currently pregnant, as demonstrated by a positive pregnancy test at screening for women of reproductive potential
  • Any active acute or chronic disease or condition that, in the opinion of the investigator, might interfere with the performance of this study.
  • Any active acute or chronic infectious disease that, in the opinion of the investigator, would pose an excessive risk to study staff.
  • Current use or recent exposure to any medication that in the opinion of the investigator could have an influence on the patient's ability to participate in this study or on the performance of the test device.
  • Extensive skin changes/diseases that preclude wearing the required number of devices on normal skin at the proposed application sites (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis).
  • Have a known allergy to medical-grade adhesives, or known hypersensitivity to any of the products used in the study.
  • Blood donation of more than 500 ml within the last three months
  • Currently participating in another investigational study protocol where the testing or results may interfere with study compliance, diagnostic results, or data collection.
  • Has a MRI scan, CT scan, or diathermy scheduled during the proposed study participation.
  • An identified protected vulnerable patient (including but not limited to those in detention, or a prisoner).
  • Women of reproductive potential who are unwilling to adopt contraceptive measures during the study period
  • Patients with history of pacemaker and prosthesis implantation.
  • Continuous use of real-time CGM for personal diabetes management in the three months prior to screening (sensor use >80% of time)

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Гонконг · 1 центр
  • Department of Medicine and Therapeutics, The Chinese University of Hong Kong — Гонконг

Идентификаторы

NCT: NCT06838819 · IcoSimplera

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗