Assessment of Blood Glucose Monitoring Systems

Leistungsbewertung Von Blutzuckermesssystemen im Methodenvergleich

System accuracy evaluation of different blood glucose monitoring systems with 3 lots of test strips per systems according to ISO 15197:2013

Inclusion Criteria:

• 18 years of age or older
• Male or female subjects with type 1 or type 2 diabetes or healthy subjects
• For BG adjustment people with type 1 diabetes

Exclusion Criteria:

• Severe acute illness that, in the opinion of the Investigator, might pose additional risk to the patient
• Chronic illness that, in the opinion of the Investigator, might pose additional risk to the patient
• Current condition that, in the opinion of the Investigator, doesn't enable subject to participate in the study
• For BG adjustment people with type 1 diabetes without CHD, condition after myocardial infarction, PAOD, cerebral events or hypoglycaemia unawareness
• Legal incompetence or limited legal competence
• Age < 18 years
• Dependency from the sponsor or the clinical investigator
• Mental incapacity or language barriers precluding adequate compliance with the study procedures