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 @ 6:27 PM
Ignite Modification Date:
2025-12-24 @ 6:27 PM
NCT ID:
NCT00615368
Eligibility Criteria:
Inclusion Criteria:
* Type 1 diabetes
* Hypoglycaemia unawareness
* 2 or more episodes of hypoglycaemia in the last 12 months
* Age \>18 år
* Duration of diabetes \> 5 år
* Weight \> 50 kg
* No pregnancy
* Informed consent
Exclusion Criteria:
* Pregnancy
* Heart failure (NYHA 2-4)
* Ischaemic heart disease
* Epilepsy
* Venous thromboembolic disease
* Thrombocytosis
* Beta receptor antagonists
* Disturbance of vision
* History of stroke
* History of erythropoietin treatment
* Plasma-creatinin \> 100 umol/l (male)or 88 umol/l (female)
* Plasma-haemoglobin \< 7,0 or \> 11 mmol/l at time of inclusion
* Operation with blood loss within the last 6 weeks
* Cancer
* Treated with ciclosporin
* Suspicion of non-compliance with protocol
* Conditions incompatible with participation - e.g. safety considerations.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00615368
Study Brief:
Protocol Section:
NCT00615368