DigiDiab Pilot: Impact Study Hospital

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

GlucoTab is an innovative workflow and decision support tool for standardised diabetes management by healthcare professionals which provides automated and personalised dosage recommendations for different insulin therapy regimens.

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Device: GlucoTab; Other: Diabetes Treatment

Detailed Description

GlucoTab has already been tested in several clinical trials in Austria and has consecutively obtained the CE-mark that is valid throughout European countries.

The current study aims to further develop, implement and evaluate GlucoTab in different European pilot regions. For this reason, GlucoTab will be translated in different languages and tested in Sweden, Denmark, and Spain.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Lichtenegger; Phone Number: +4331638572766; Email: katharina.lichtenegger@medunigraz.at

Study Locations

• Spain
  • Tarragona, Spain
    • Recruiting
    • Hospital Universitari Joan Xxiii de Tarragona
    • Contact: Teresa Maria Auguet; Phone Number: +34 977 295 800; Email: mariateresa.auguet@urv.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants are non-critically ill patients with type 2 diabetes at general hospital wards who require s.c. insulin therapy during hospital stay

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
GlucoTab Prospective Group	Device: GlucoTab; Insulin therapy will be started and adjusted according to the GlucoTab system with incorporated software algorithm. Insulin therapy prescription for the next 24 hours is suggested once daily by the GlucoTab system taking previous insulin doses, glucose readings, patient age, renal function and insulin sensitivity into account. The goal of the algorithm is to maintain fasting and premeal glucose concentrations between 100-140 mg/dl, (5.6 to 7.8 mmol/l).
Retrospective control group	Other: Diabetes Treatment; Diabetes Standard Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy - mean percentage of blood glucose values in target range	Efficacy is assessed by measuring the mean percentage of blood glucose values in the target range 100 to 140 mg/dl (5.6 to 7.8 mmol/l)	≥ 24 hours after start of therapy by using the GlucoTab system four times daily

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability - adherence to suggestions of the GlucoTab system	adherence to suggestions of the GlucoTab system	from enrollment to the end of treatment with a maximum of 21 days
Safety - number of hypoglycaemic events	Safety is assessed by the number of hypoglycaemic events	from enrollment to the end of treatment with a maximum of 21 days
Efficacy - mean daily blood glucose	mean daily blood glucose	from enrollment to the end of treatment with a maximum of 21 days

Collaborators and Investigators

• Sponsor: Medical University of Graz

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2025
• Primary Completion (Estimated): September 15, 2025
• Study Completion (Estimated): October 31, 2025

Study Registration Dates

• First Submitted: September 18, 2024
• First Submitted That Met QC Criteria: September 18, 2024
• First Posted (Actual): September 20, 2024

Study Record Updates

• Last Update Posted (Actual): August 1, 2025
• Last Update Submitted That Met QC Criteria: July 29, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Type 2 diabetes; GlucoTab
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 230206 EITHealth-hospital

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No