A single-centre, open-label, non-controlled trial of acceptance, usability, safety and efficacy of a tablet based workflow and decision support system with incorporated basal-insulin algorithm for glycaemic management in patients with type 2 diabetes receiving domiciliary nursing care
- Conditions
- E11Type 2 diabetes mellitus
- Registration Number
- DRKS00015059
- Lead Sponsor
- Medizinische Universität Graz, Universitätsklinik für Innere Medizin, Klinische Abteilung für Endokrinologie und Diabetologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 9
Informed consent obtained after being advised of the nature of the study;
Male or female aged = 18 years;
Type 2 diabetes (treated with insulin therapy);
Receiving domiciliary nursing care by the OERK Graz
Type 1 Diabetes;
Instable corticosteroid therapy;
Any disease or condition which the investigator feels would interfere with the trial or the safety of the patient;
Any mental condition rendering the patient incapable of giving his/her consent;
Intravenous insulin therapy;
Hyperglycaemic episodes (ketoacidosis, hyperosmolar state) if they require intravenous insulin therapy;
Gestational diabetes or pregnancy;
Known or suspected allergy to certain insulin types;
Terminally ill patients;
Total parenteral nutrition (TPN);
Participation in another trial which could influence the basal-insulin algorithm
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The percentage of actions the GlucoTab@MobileCare system supports either to capture BG values or provide insulin dose suggestions according to the algorithm.<br>When: after study has been completed all data will be evaluated.<br>The primary endpoint will be measured according to captured BG values the system supports and insulin dose suggestions according to the algorithm.<br>The endpoint will be measured by the captured BG values the system supports and insulin dose suggestions according to the algorithm.
- Secondary Outcome Measures
Name Time Method