Diabetes mellitus type 2 MedDRA version: 20.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Sponsors
Medical University of Graz
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the acceptance of the GlucoTab@MobileCare system for glycaemic management in patients with type 2 diabetes receiving domiciliary nursing care ;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
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Number of BG values below individual glycaemic target range according to health status (plus time of day) • Number of blood glucose measurements per day • Insulin dose (Total daily dose (TDD), basal insulin dose, bolus insulin dose) • Number of insulin injections per day • Number of non-performed insulin injections per day • Type of start (according to algorithm OR as judged by physician) • Number of adverse events, device-related adverse events and serious adverse events • Differences between BG values entered in GlucoTab@MobileCare and BG values recorded by AccuChek® Guide • User satisfaction with the GlucoTab@MobileCare system regarding the user interface and the provided functionality • Other usability parameters like user workload and support of treatment workflow • Physician adherence to insulin starting dose suggestion (according to algorithm OR as judged by physician) • Nurse adherence to suggested basal-insulin adjustment/titration dose • Nurse adherence to suggested basal-insulin injection dose • Nurse adherence to suggested timing of adjustment/titration • Number of missed blood glucose measurements per day • Number of additionally performed blood glucose measurements per day • Adherence to suggested BG measurement frequency • Nurse adherence to suggested short-acting insulin injection dose • Patient/relative usability/practicability parameters as assessed by questionnaire at the end of trial • Nurse usability/practicability parameters as assessed by questionnaire before start and at the end of trial • Mean percentage of FBGs in the FBG target range according to health status calculated by all FBGs measured = 24 h | — |
Countries
Austria
Contacts
Public ContactSponsor contact
Medizinische Universität Graz
Outcome results
None listed