Performance Study to Test the GlucoMen®Day System Using Intravascular and Subcutaneous Microdialysis in Subjects With Type 1 Diabetes

Inclusion criteria

• Informed consent obtained after being advised of the nature of the study
• Male or female aged 18 - 75 years (both inclusive)
• Type 1 diabetes treated with multiple daily insulin injection or continuous subcutaneous insulin infusion for 12 months
• Body mass index 20.0 - 29.5 kg/m² (both inclusive)
• HbA1c < 86.0mmol/mol

Exclusion criteria

• Female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods.
• Skin pathology or condition prohibiting needle insertion as judged by the investigator.
• History of bleeding disorder.
• History of heparin-induced thrombocytopenia (HIT)
• Current participation in another clinical study.
• Significant acute or chronic illness that might interfere with subject safety or integrity of results as judged by the investigator.
• Lipodystrophy
• Current treatment with systemic (oral or i.v.) corticosteroids or any anticoagulation medication.
• Blood donation or blood loss of more than 500 mL within 12 weeks prior to the study day.
• Known hypersensitivity to Fondaparinux sodium (Arixtra®).
• Significant history of alcoholism or drug abuse or a positive result in urine drug/alcohol screen.

Study day exclusion criteria:

• Non-fasting (i.e. consumption of food or beverages, other than water, later than 22:00 hours the evening before the visit) except if slight intake of rapidly absorbable carbohydrates has been necessary in order to prevent hypoglycaemia.
• Positive result of alcohol breath test.