Investigation of acceptance, usability, safety and efficacy of the GlucoTab@MobileCare system for type 2 diabetes in domiciliary nursing care
- Conditions
- Diabetes mellitus type 2MedDRA version: 20.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2018-000863-98-AT
- Lead Sponsor
- Medical University of Graz
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 10
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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
•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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Main Objective: To investigate the acceptance of the GlucoTab@MobileCare system for glycaemic management in patients with type 2 diabetes receiving domiciliary nursing care<br><br> ;Secondary Objective: To investigate usability, safety and efficacy parameters of the basal-insulin algorithm incorporated in the GlucoTab@MobileCare system for glycaemic management in patients with type 2 diabetes receiving domiciliary nursing care;Primary end point(s): The percentage of actions the system supports either to capture BG values or provide insulin dose suggestions according to the basal insulin algorithm.;Timepoint(s) of evaluation of this end point: Length of GlucoTab@MobileCare treatment
- Secondary Outcome Measures
Name Time Method