Efficacy, Usability Study of the GlucoTab System for Glycaemic Management in Type 2 Diabetic Patients at General Wards

An Open, Single-centre, Non-controlled Study of Efficacy, Safety and Usability of the GlucoTab System for Glycaemic Management in Non-critically Ill Patients With Type 2 Diabetes at General Wards

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.

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