DigiDiab Pilot Spain — basal insulin support for nursing home and home-care residents
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
Medical University of Graz · NCT06605859
This project will try the GlucoTab software algorithm to help nurses manage basal insulin for adults with type 2 diabetes living in nursing homes or receiving domiciliary care in Tarragona, Spain.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of Graz (other) |
| Locations | 1 site (Tarragona) |
| Trial ID | NCT06605859 on ClinicalTrials.gov |
What this trial studies
GlucoTab is a CE-marked medical device that provides an algorithm to guide subcutaneous basal insulin therapy for people with type 2 diabetes. In this observational pilot, only the GlucoTab basal-insulin algorithm will be used to support nursing staff in participating nursing homes and domiciliary care settings. Nurses will apply the algorithm's dosing recommendations while patients are monitored for glucose control and safety outcomes such as hypoglycaemia. Data on insulin dosing, glucose values, and adverse events will be collected to describe feasibility and safety in this care environment.
Who should consider this trial
Good fit: Adults (≥18) with type 2 diabetes treated with insulin who are residents of participating nursing homes or receiving domiciliary nursing care in the Camp de Tarragona region and able to give informed consent.
Not a fit: People with type 1 diabetes, those on intravenous insulin or insulin pumps, pregnant women, patients requiring total parenteral nutrition, or those unable to consent are not expected to benefit from this intervention.
Why it matters
Potential benefit: If successful, the algorithm could help nurses deliver more consistent and safer basal insulin dosing, potentially improving glucose control and reducing hypoglycaemia for residents.
How similar studies have performed: The GlucoTab system is CE-marked and has been used in clinical settings, but applying its basal-insulin algorithm specifically in nursing-home and domiciliary care is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Tarragona
- IDIAP Jordi Gol — Tarragona, Spain (RECRUITING)
Study contacts
- Study coordinator: Lichtenegger
- Email: katharina.lichtenegger@medunigraz.at
- Phone: +4331638572766
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Type 2 Diabetes, GlucoTab