DigiDiab Pilot — GlucoTab use in hospitals

An Open, Multicentre, Prospective, Non-interventional Study of the CE-marked Medical Device GlucoTab, According to Intended Use Without Additional Invasive and Stressful Measures With a Matched Retrospective Control Group

This pilot will test whether GlucoTab, a computer tool that gives automated, personalized insulin dose suggestions, helps hospital patients with type 2 diabetes or new-onset high blood sugar who need subcutaneous insulin.

Quick facts

• Study type: Observational
• Enrollment: 500 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Medical University of Graz (other)
• Locations: 1 site (Tarragona)
• Trial ID: NCT06605872 on ClinicalTrials.gov

What this trial studies

GlucoTab is a workflow and decision-support tool that provides automated, individualized insulin dosing recommendations for inpatient care. This observational pilot will implement translated versions of GlucoTab in European hospital wards and collect data on glucose control, insulin dosing, safety events, and clinician workflow. Participants are hospitalized adults with type 2 diabetes or new-onset hyperglycaemia who require subcutaneous insulin and are expected to stay at least 48 hours. The project builds on prior Austrian trials and CE marking to refine the tool across pilot regions including Spain, Sweden, and Denmark while monitoring feasibility and outcomes.

Who should consider this trial

Good fit: Adults admitted to participating surgical or internal medicine wards with type 2 diabetes or new-onset hyperglycaemia who will require subcutaneous insulin, can give informed consent, and are expected to stay at least 48 hours are ideal candidates.

Not a fit: Patients with type 1 diabetes, those receiving intravenous insulin or continuous subcutaneous insulin infusion, patients on total parenteral nutrition, pregnant patients, those with known insulin allergy, or those unable to consent are excluded and would not benefit from participation.

Why it matters

Potential benefit: If successful, GlucoTab could make inpatient insulin dosing more consistent and safer, reducing episodes of very high or very low blood sugar.

How similar studies have performed: GlucoTab has been tested in several clinical trials in Austria and has obtained a CE mark, indicating prior feasibility and regulatory acceptance in Europe.

Eligibility criteria

Inclusion Criteria:

* informed consent obtained after being advised of the nature of the study
* a documented history of type 2 diabetes prior to inclusion or new-onset hyperglycaemia which requires s.c. insulin therapy during hospital stay
* admission to either surgical or internal medicine ward
* an expected length of hospital stay for at least 48 hours after enrolment

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 or treating physician would interfere with the trial or the safety of the patient

Inclusion and exclusion criteria will be the same as above for the retrospective CG with the exception of:

* period of time will be from September 2022 to September 2023
* no informed consent will be obtained from the retrospective CG

Where this trial is running

Tarragona

• Hospital Universitari Joan XXIII de Tarragona — Tarragona, Spain (RECRUITING)

Study contacts

• Study coordinator: Lichtenegger

Conditions: Type 2 Diabetes, GlucoTab, Type 2 diabetes