Clinical trial NCT06605872: DigiDiab Pilot: Impact Study Hospital
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Type 2 Diabetes
Keywords: GlucoTab
Type 2 diabetes
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2024-09-20
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

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

Primary outcomes:
measure: Efficacy
timeFrame: ≥ 24 hours after start of therapy by using the GlucoTab system four times daily
Secondary outcomes:
measure: Usability
timeFrame: from enrollment to the end of treatment with a maximum of 21 days
measure: Safety
timeFrame: from enrollment to the end of treatment with a maximum of 21 days
measure: Efficacy
timeFrame: from enrollment to the end of treatment with a maximum of 21 days
Other outcomes:
Locations:
Study officials:
References: