DigiDiab Pilot: Impact Study Hospital

Medical University of Graz500 enrolled

Overview

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.

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

500

Conditions

Type 2 Diabetes

Interventions

GlucoTabDEVICE

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).

Diabetes TreatmentOTHER

Diabetes Standard Care

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hospital Universitari Joan XXIII de Tarragona

Tarragona, Spain

RECRUITING

Outcomes

Primary Outcomes

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)

Time frame: ≥ 24 hours after start of therapy by using the GlucoTab system four times daily

Secondary Outcomes

Usability - adherence to suggestions of the GlucoTab system

adherence to suggestions of the GlucoTab system

Time frame: 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

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

Efficacy - mean daily blood glucose

mean daily blood glucose

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

Central Contacts

Lichtenegger

CONTACT

+4331638572766 katharina.lichtenegger@medunigraz.at

Data from ClinicalTrials.gov

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