Diabetes mellitus type 2 MedDRA version: 19.1 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: Male or female aged = 65 years Planned minimum stay of 1 week Insulin planned as inpatient and/or discharge therapy Type 2 diabetes (treated with diet, oral agents, non-insulin injected anti-diabetic medicine, insulin therapy or any combination of the four) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80
Exclusion criteria
Exclusion criteria: Instable corticosteroid therapy (>5 mg per day) Known or suspected allergy to insulin glargine/ glulisine Parenteral nutrition
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To investigate usability, safety and further efficacy parameters of the new basal-insulin algorithm (decision support) and the computerized physician-based documentation (no decision support) incorporated in the GlucoTab system for glycaemic management in patients with type 2 diabetes at acute geriatric care wards;Main Objective: To compare efficacy of the basal-insulin algorithm (decision support) with computerized documentation (without decision support) incorporated in the GlucoTab system for glycaemic management in patients with type 2 diabetes at acute geriatric care wards;Primary end point(s): Mean percentage of FBGs in the FBG target range according to health status calculated by all FBGs measured = 24 hours after start of therapy;Timepoint(s) of evaluation of this end point: Lenght of GlucoTab treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Number of episodes below individual glycaemic target range according to health status (plus time of day) • Number of blood glucose measurements per day • Insulin dose (TDD of basal vs. bolus vs. premixed insulin) • Number of insulin injections per day • Number of non-performed insulin injections per day • Insulin starting dose • Insulin end-dose • Type of start (according to known dose/ according to new calculation OR as judged by physician) T • Number of falls • Number of adverse events, device-related adverse events and serious adverse events • Adherence to insulin starting dose suggestion (known dose/ new calculation) • Adherence to suggested long-acting insulin titration dose • Adherence to suggested long-acting insulin injection dose • Adherence to suggested time point 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 • Adherence to suggested therapy change/end of algorithm • Adherence to suggested short-acting insulin injection dose • User satisfaction with the GlucoTab system regarding the user interface and the provided functionality/ Other usability parameters like user workload and support of treatment workflow • Medical prescription available • Number of Log-Ins • Number of therapy adaptations/changes • Number of MD consultation by nurses • Mean pre-breakfast blood glucose, mean pre-lunch blood glucose, mean pre-dinner blood glucose, mean bedtime blood glucose: overall and per treatment day | — |
Countries
Austria
Contacts
Public ContactPrincipal Investigator
Geriatrische Gesundheitszentren der Stadt Graz
Outcome results
None listed