DigiDiab Pilot: Impact Study Hospital

Not yet recruiting

• Conditions: Type 2 Diabetes
• Interventions: Device: GlucoTab; Other: Diabetes Treatment

• Registration Number: NCT06605872
• Lead Sponsor: Medical University of Graz

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.

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-18
• Study First Submitted QC: 2024-09-18
• Last Update Submitted: 2024-09-18
• Study First Posted: 2024-09-20
• Last Update Posted: 2024-09-20
• Study Start: 2024-11-01
• Primary Completion: 2025-09-15
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
GlucoTab Prospective Group	GlucoTab	-
Retrospective control group	Diabetes Treatment	-

Primary Outcome Measures

Name	Time	Method
Efficacy	≥ 24 hours after start of therapy by using the GlucoTab system four times daily	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)

Secondary Outcome Measures

Name	Time	Method
Usability	from enrollment to the end of treatment with a maximum of 21 days	adherence to suggestions of the GlucoTab system
Safety	from enrollment to the end of treatment with a maximum of 21 days	Safety is assessed by the number of hypoglycaemic events
Efficacy	from enrollment to the end of treatment with a maximum of 21 days	mean daily blood glucose