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 @ 6:29 PM
Ignite Modification Date:
2025-12-24 @ 6:29 PM
NCT ID:
NCT02614768
Eligibility Criteria:
Inclusion Criteria:
* Informed consent obtained after being advised of the nature of the study
* Male or female aged ≥18 years
* Type 1 diabetes for at least 6 months according to the World Health Organization (WHO) definition
* Treatment with multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII) for at least 3 months
* Body Mass Index (BMI) \< 35 kg/m²
* Willing and able to wear 5 CGM devices for the duration of the study and undergo all study procedures.
* HbA1c ≤ 86 mmol/mol
Exclusion Criteria:
* Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject
* Female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods
* Any mental condition rendering the subject incapable of giving his consent
* Subject is using a medication that significantly impacts glucose metabolism (oral steroids) except if stable for at least the last three months and expected to remain stable for the study duration
* Subject may not use acetaminophen (paracetamol) while participating in the study
* Has severe medical or psychological condition(s) or chronic conditions/infections that in the opinion of the Investigator would compromise the subject's safety or successful participation in the study.
* Subject is actively enrolled in another clinical trial
* Known adrenal gland problem, pancreatic tumour, or insulinoma
* Inability of the subject to comply with all study procedures
* Inability of the subject to understand the patient information.
* Subject donated blood in the last 3 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02614768
Study Brief:
Protocol Section:
NCT02614768