DigiDiab Pilot Spain - Nursing Home and Domiciliary Nursing Care

Medical University of Graz

Status: Enrolling

Conditions: Type 2 Diabetes

Treatments: Device: GlucoTab; Other: Diabetes Treatment

Study type: Observational

Funder types: Other

Identifiers

NCT06605859

230206 EIT Health-nursing home

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

40 participants in 2 patient groups

GlucoTab Prospective Group

Treatment:

Device: GlucoTab

Retrospective Control Group

Treatment:

Other: Diabetes Treatment