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 @ 5:24 PM
Ignite Modification Date:
2025-12-24 @ 5:24 PM
NCT ID:
NCT02192450
Eligibility Criteria:
Inclusion Criteria:
* Type 1 diabetes \> 5 years
* One or more episodes of nocturnal severe hypoglycaemia during the preceding two years
* Treated with multiple dose insulin injection (\>2) or insulin pump. Both human insulin and insulin analogues are allowed
* Willingness to a once daily (OD) regimen concerning insulin degludec and insulin glargine
* Willingness to do self-monitoring of blood glucose (SMBG) and keep a diary
* Signed informed consent
Exclusion Criteria:
* History of primary and secondary adrenal insufficiency, growth hormone deficiency, or untreated myxoedema
* History of unstable angina or major cardiovascular events (myocardial infarction, coronary re-vascularisation, transient ischaemic attack, or stroke within the last three months)
* Heart failure, New York Heart Association (NYHA) class IV
* History of malignancy unless a disease-free period exceeding five years
* History of alcohol or drug abuse
* Treatment with glucose lowering agent(s) other than insulin
* Pregnant or lactating women
* Women of childbearing potential who are not using chemical (P-pills or gestagen depots) or mechanical (intra-uterine device) contraception
* Participation in another investigational drug study within the last 3 months
* Inability to understand the informed consent
* HbA1c \> 86 mmol/mol (10%)
* Shifting working hours
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02192450
Study Brief:
Protocol Section:
NCT02192450