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:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-25 @ 4:05 AM
NCT ID:
NCT03987802
Eligibility Criteria:
Inclusion Criteria:
* Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
* Male or female, age equal to or above 18 years at the time of signing the informed consent.
* Patients diagnosed with diabetes mellitus.
* Patients scheduled to start treatment with Fiasp® based on the clinical judgement of their treating physician.
Exclusion Criteria:
* Known or suspected hypersensitivity to study product(s) or related products.
* Patients on or likely to use insulin pump therapy during the study period
* Previous participation in this study. Participation is defined as having given signed informed consent.
* Mental incapacity, unwillingness or language barriers hindering adequate understanding or cooperation.
* Participation in any clinical study of an approved or non-approved investigational medicinal product within 1 month before treatment start.
* Any disorder which in the opinion of the treating physician may jeopardise the patient's safety or compliance with the protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03987802
Study Brief:
Protocol Section:
NCT03987802