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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GlucoTab Prospective Group |
| ||
| Retrospective control group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GlucoTab | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy - mean percentage of blood glucose values in target range | 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) | ≥ 24 hours after start of therapy by using the GlucoTab system four times daily |
| Measure | Description | Time Frame |
|---|---|---|
| Usability - adherence to suggestions of the GlucoTab system | 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 |
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Inclusion Criteria:
Exclusion Criteria:
Inclusion and exclusion criteria will be the same as above for the retrospective CG with the exception of:
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Participants are non-critically ill patients with type 2 diabetes at general hospital wards who require s.c. insulin therapy during hospital stay
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lichtenegger | Contact | +4331638572766 | katharina.lichtenegger@medunigraz.at |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Joan XXIII de Tarragona | Recruiting | Tarragona | Spain |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
| Diabetes Treatment | Other | Diabetes Standard Care |
|
Safety is assessed by the number of hypoglycaemic events
| from enrollment to the end of treatment with a maximum of 21 days |
| Efficacy - mean daily blood glucose | mean daily blood glucose | from enrollment to the end of treatment with a maximum of 21 days |
| D004700 | Endocrine System Diseases |