Type 2 Diabetes
Conditions
Keywords
GlucoTab, Type 2 diabetes
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.
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
Sponsors
Medical University of Graz
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy - mean percentage of blood glucose values in target range | ≥ 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
| Measure | Time frame | Description |
|---|---|---|
| Usability - adherence to suggestions of the GlucoTab system | from enrollment to the end of treatment with a maximum of 21 days | adherence to suggestions of the GlucoTab system |
| Safety - number of hypoglycaemic events | from enrollment to the end of treatment with a maximum of 21 days | Safety is assessed by the number of hypoglycaemic events |
| Efficacy - mean daily blood glucose | from enrollment to the end of treatment with a maximum of 21 days | mean daily blood glucose |
Countries
Spain
Contacts
Primary ContactLichtenegger
Outcome results
None listed