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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Efficacy - mean percentage of blood glucose values in target range
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
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 Outcomes
- Usability - adherence to suggestions of the GlucoTab system(from enrollment to the end of treatment with a maximum of 21 days)
- Safety - number of hypoglycaemic events(from enrollment to the end of treatment with a maximum of 21 days)
- Efficacy - mean daily blood glucose(from enrollment to the end of treatment with a maximum of 21 days)