DigiDiab Pilot: Impact Study Hospital

NCT06605872 | Recruiting

• 1 other identifier: 230206 EITHealth-hospital
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes

Keywords

GlucoTab; Type 2 diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Usability - 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

  from enrollment to the end of treatment with a maximum of 21 days

• Efficacy - mean daily blood glucose

  from enrollment to the end of treatment with a maximum of 21 days

Study Arms (2)

GlucoTab Prospective Group

Device: GlucoTab

Retrospective control group

Other: Diabetes Treatment

Interventions

GlucoTab DEVICE

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).

GlucoTab Prospective Group

Diabetes Treatment OTHER

Diabetes Standard Care

Retrospective control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• informed consent obtained after being advised of the nature of the study
• admission to either surgical or internal medicine ward
• an expected length of hospital stay for at least 48 hours after enrolment

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Hospital Universitari Joan XXIII de Tarragona

Tarragona, Spain

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Lichtenegger

CONTACT

+4331638572766; katharina.lichtenegger@medunigraz.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: September 20, 2024
• Study Start: April 1, 2025
• Primary Completion: September 15, 2025
• Study Completion: October 31, 2025
• Last Updated: August 1, 2025

Record last verified: 2025-07

Locations

ES (1)