Type 2 Diabetes
Conditions
Brief summary
Objective: To investigate the performance (safety) of the GlucoTab system for glycaemic management in non-critically ill patients with type 2 diabetes at general wards.
Interventions
DEVICEGlucoTab System
Sponsors
Medical University of Graz
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 diet, oral agents, non-insulin injected anti-diabetic medicine, insulin therapy or any combination of the four) or newly diagnosed hyperglycaemia which requires s.c. insulin therapy
Exclusion criteria
* Type 1 diabetes, gestational diabetes * Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the patient * Pregnancy * Any mental condition rendering the patient incapable of giving his consent * Known or suspected allergy to insulin glargine or insulin aspart * Continuous parenteral nutrition * Participation in another trial which can influence the software algorithm
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean percentage of blood glucose measurements in the target range 70 to 140 mg/dl, as calculated by all premeal and bedtime glucose values measured ≥ 24 hours after start of therapy | duration of hospital stay (maximum three weeks) |
Secondary
| Measure | Time frame |
|---|---|
| Number of blood glucose measurements per day | duration of hospital stay (maximum three weeks) |
| Adherence to the insulin dose suggestion of the GlucoTab system | duration of hospital stay (maximum three weeks) |
| Mean daily blood glucose as calculated by premeal and bedtime blood glucose values: Overall and per treatment day | duration of hospital stay (maximum three weeks) |
Countries
Austria
Outcome results
None listed