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Recruiting NCT06605872

DigiDiab Pilot: Impact Study Hospital

— Observational Type 2 Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GlucoTab, Diabetes Treatment.
Who it may be relevant to
Registry conditions: Type 2 Diabetes. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

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.

Interventions

  • 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).
  • Other Diabetes Treatment
    Diabetes Standard Care

Primary outcome measures

  • Efficacy - mean percentage of blood glucose values in target range [Time frame: ≥ 24 hours after start of therapy by using the GlucoTab system four times daily]
Secondary outcome measures (3)
  • Usability - 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 [Time frame: from enrollment to the end of treatment with a maximum of 21 days]
  • Efficacy - mean daily blood glucose [Time frame: from enrollment to the end of treatment with a maximum of 21 days]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Spain · 1 center
  • Hospital Universitari Joan XXIII de Tarragona — Tarragona

Identifiers

NCT: NCT06605872 · 230206 EITHealth-hospital

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗