Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2025-12-24 @ 11:55 PM
NCT ID:
NCT01709851
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01709851
Study Brief:
Protocol Section:
NCT01709851