RecruitingNCT06605859

DigiDiab Pilot Spain - Nursing Home and Domiciliary Nursing Care

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

Sponsor

Medical University of Graz

Enrollment

40 participants

Start Date

Apr 8, 2025

Study Type

OBSERVATIONAL

Conditions

Type 2 Diabetes

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a digital blood sugar management system called GlucoTab in elderly people with type 2 diabetes who live in nursing homes or receive home nursing care in the Tarragona region of Spain. The system helps nurses make safer and more consistent insulin dosing decisions. **You may be eligible if...** - You are 18 years or older (study focuses on elderly residents) - You have type 2 diabetes treated with insulin - You are a resident of a participating nursing home or receive domiciliary (home-based) nursing care in the Camp de Tarragona region of Spain - You are willing to use the GlucoTab insulin management system - You can give informed consent **You may NOT be eligible if...** - You have type 1 diabetes - You require intravenous insulin - You have had a severe high blood sugar crisis requiring IV insulin - You use an insulin pump - You are pregnant or have gestational diabetes - You are known to be allergic to insulin Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEGlucoTab

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 nurses of the nursing homes/domiciliary nursing care. Correctional bolus insulin will be administered at defined time-points according to BG targets in the predefined health status. Nurses and nursing assistants will be trained in the use of the GlucoTab.

OTHERDiabetes Treatment

Diabetes Standard Care

Locations(1)

IDIAP Jordi Gol

Tarragona, Spain

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