RecruitingNCT06605872

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

Sponsor

Medical University of Graz

Enrollment

500 participants

Start Date

Apr 1, 2025

Study Type

OBSERVATIONAL

Conditions

Type 2 Diabetes

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the GlucoTab digital decision-support system for managing blood sugar levels in hospitalized patients. The system helps hospital staff determine the right insulin doses for patients with type 2 diabetes or high blood sugar during a hospital stay. **You may be eligible if...** - You have a confirmed history of type 2 diabetes, or your blood sugar is newly elevated and requires insulin injections during hospitalization - You are admitted to a surgical or internal medicine ward - You are expected to stay in hospital for at least 48 hours after enrolling - You can give informed consent **You may NOT be eligible if...** - You have type 1 diabetes - You require insulin through an IV drip or an insulin pump - You are pregnant or have gestational diabetes - You are allergic to insulin - You are receiving nutrition through an IV (total parenteral nutrition) - You are mentally unable to consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEGlucoTab

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).

OTHERDiabetes Treatment

Diabetes Standard Care

Locations(1)

Hospital Universitari Joan XXIII de Tarragona

Tarragona, Spain

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