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GlucoTab is a stand-alone software system to support healthcare professionals in the care of patients with diabetes mellitus or newly diagnosed hyperglycaemia who are treated with insulin and/or other glucose-lowering drugs or of patients only requiring glucose monitoring.
It provides a therapy algorithm for subcutaneous basal insulin therapy of patients with type 2 diabetes, which will be used in this study.
GlucoTab: The CE-marked medical device GlucoTab is a system designed to support healthcare personnel in managing insulin therapy for patients with diabetes.
In this study, only the GlucoTab algorithm supported basalinsulin therapy will be used, which is intended for patients with Type 2 diabetes in domiciliary nursing care and nursing homes requiring insulin therapy.
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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. The goal of the basal-insulin algorithm is to maintain blood glucose within acceptable targets according to the predefined health status. For a limited time period after therapy start, three measurements per day are suggested by the algorithm to determine blood glucose. Insulin dosage titration will be performed according to the algorithm in GlucoTab under supervision of the nurses of the nursing homes/domiciliary nursing care. Correctional bolus insulin will be administered at defined time-points according to BG targets in the predefined health status. Nurses and nursing assistants will be trained in the use of the GlucoTab. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy - mean percentage of fasting blood glucose in target range | Efficacy is assessed by evaluating the Mean percentage of Fasting Blood Glucose in the target range 80 - 180 mg/dl | ≥ 24 hours after start of the therapy by using the GlucoTab system |
| Measure | Description | Time Frame |
|---|---|---|
| Usability | adherence to dose suggestions of the GlucoTab system | at the end of the study, on average three months |
| Safety - number of hypoglycaemic events | Safety is assessed by evaluating the number of hypoglycaemic events |
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Inclusion Criteria:
Exclusion Criteria:
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Non-critically ill patients with type 2 diabetes in the participating nursing homes/domiciliary nursing care who require s.c. insulin therapy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lichtenegger | Contact | +4331638572766 | katharina.lichtenegger@medunigraz.at |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IDIAP Jordi Gol | 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 |
|
| at the end of the study, on average three months |
| Efficacy - mean pre-breakfast blood glucose | mean pre-breakfast blood glucose | at the end of the study, on average three months |
| D004700 | Endocrine System Diseases |