DigiDiab Pilot Spain - Nursing Home and Domiciliary Nursing Care

Официальное название

An Open, Multicentre, Prospective, Non-interventional Study of the CE-marked Medical Device GlucoTab in Nursing Homes and Domiciliary Nursing Care, According to Intended Use Without Additional Invasive and Stressful Measures

Обзор

GlucoTab is a stand-alone software system to support healthcare professionals in the care of patients with diabetes mellitus or newly diagnosed hyperglycaemia who are treated with insulin and/or other glucose-lowering drugs or of patients only requiring glucose monitoring. It provides a therapy algorithm for subcutaneous basal insulin therapy of patients with type 2 diabetes, which will be used in this study.

Подробное описание

GlucoTab: The CE-marked medical device GlucoTab is a system designed to support healthcare personnel in managing insulin therapy for patients with diabetes.

In this study, only the GlucoTab algorithm supported basalinsulin therapy will be used, which is intended for patients with Type 2 diabetes in domiciliary nursing care and nursing homes requiring insulin therapy.

Вмешательства

• Устройство GlucoTab
  Insulin therapy will be started and adjusted according to the GlucoTab system with incorporated software algorithm. The goal of the basal-insulin algorithm is to maintain blood glucose within acceptable targets according to the predefined health status. For a limited time period after therapy start, three measurements per day are suggested by the algorithm to determine blood glucose. Insulin dosage titration will be performed according to the algorithm in GlucoTab under supervision of the nurse
• Другое Diabetes Treatment
  Diabetes Standard Care

Первичные конечные точки

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

Вторичные конечные точки (3)

• Usability [Срок оценки: at the end of the study, on average three months]
• Safety - number of hypoglycaemic events [Срок оценки: at the end of the study, on average three months]
• Efficacy - mean pre-breakfast blood glucose [Срок оценки: at the end of the study, on average three months]

Критерии участия

Критерии включения

• Elderly people, willing to be treated with a basal insulin therapy according to the GlucoTab system
• Informed consent obtained after being advised of the nature of the study
• Male or female aged ≥ 18 years
• Type 2 diabetes (treated with insulin therapy)
• Residents of participating nursing homes/domiciliary nursing care in the region of Camp de Tarragona (Spain).

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 would interfere with the trial or the safety of the patient

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Испания · 1 центр

• IDIAP Jordi Gol — Tarragona

Идентификаторы

NCT: NCT06605859 · 230206 EIT Health-nursing home

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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