Идёт набор NCT06605872

DigiDiab Pilot: Impact Study Hospital

— Наблюдательное Type 2 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: GlucoTab, Diabetes Treatment.
Кому может быть актуально: Состояния в реестре: Type 2 Diabetes. Базовые параметры: от 18 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: Испания
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

An Open, Multicentre, Prospective, Non-interventional Study of the CE-marked Medical Device GlucoTab, According to Intended Use Without Additional Invasive and Stressful Measures With a Matched Retrospective Control Group

Обзор

GlucoTab is an innovative workflow and decision support tool for standardised diabetes management by healthcare professionals which provides automated and personalised dosage recommendations for different insulin therapy regimens.

Подробное описание

GlucoTab has already been tested in several clinical trials in Austria and has consecutively obtained the CE-mark that is valid throughout European countries.

The current study aims to further develop, implement and evaluate GlucoTab in different European pilot regions. For this reason, GlucoTab will be translated in different languages and tested in Sweden, Denmark, and Spain.

Вмешательства

Устройство GlucoTab
Insulin therapy will be started and adjusted according to the GlucoTab system with incorporated software algorithm. Insulin therapy prescription for the next 24 hours is suggested once daily by the GlucoTab system taking previous insulin doses, glucose readings, patient age, renal function and insulin sensitivity into account. The goal of the algorithm is to maintain fasting and premeal glucose concentrations between 100-140 mg/dl, (5.6 to 7.8 mmol/l).
Другое Diabetes Treatment
Diabetes Standard Care

Первичные конечные точки

Efficacy - mean percentage of blood glucose values in target range [Срок оценки: ≥ 24 hours after start of therapy by using the GlucoTab system four times daily]

Вторичные конечные точки (3)

Usability - adherence to suggestions of the GlucoTab system [Срок оценки: from enrollment to the end of treatment with a maximum of 21 days]
Safety - number of hypoglycaemic events [Срок оценки: from enrollment to the end of treatment with a maximum of 21 days]
Efficacy - mean daily blood glucose [Срок оценки: from enrollment to the end of treatment with a maximum of 21 days]

Критерии участия

Критерии включения

informed consent obtained after being advised of the nature of the study
a documented history of type 2 diabetes prior to inclusion or new-onset hyperglycaemia which requires s.c. insulin therapy during hospital stay
admission to either surgical or internal medicine ward
an expected length of hospital stay for at least 48 hours after enrolment

Критерии исключения

type 1 diabetes mellitus
intravenous insulin therapy
hyperglycaemic episodes (ketoacidosis, hyperosmolar state) if they require intravenous insulin therapy
continuous subcutaneous insulin infusion
gestational diabetes or pregnancy
known or suspected allergy to insulin
total parenteral nutrition
any mental condition rendering the patient incapable of giving his/her consent
any disease or condition which according to the investigator or treating physician would interfere with the trial or the safety of the patient

Inclusion and exclusion criteria will be the same as above for the retrospective CG with the exception of: