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Clinical Trials in Spain / NCT06605859
Recruiting Observational

DigiDiab Pilot Spain - Nursing Home and Domiciliary Nursing Care

NCT06605859 · tracked via the Priya Life Science Spain tracker
Phase
Observational
Started
2025-04-08
Last updated
2025-08-03

Condition(s) studied

Type 2 Diabetes

Investigational drug(s) / intervention(s)

GlucoTabDiabetes Treatment

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 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.

Diabetes Treatment: Diabetes Standard Care

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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). Exclusion Criteria: * 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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
IDIAP Jordi Gol Tarragona Spain Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06605859 on ClinicalTrials.gov ↗ ← All trials in Spain