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 @ 7:10 PM
Ignite Modification Date:
2025-12-24 @ 7:10 PM
NCT ID:
NCT02843503
Eligibility Criteria:
Inclusion Criteria:
* diagnosed with type 1 DM at least 6 months according to the WHO definition
* Body Mass Index (BMI) \<35 kg/m²
* willing and able to wear a CGM device for the duration of the study and undergo all study procedures
* HbA1c \<10%
* Signed informed consent form prior to study entry
Exclusion Criteria:
* patient is pregnant, or breast feeding during the period of the study.
* patient 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.
* patient requires regular use of acetaminophen (paracetamol) while participating in the study due to known negative impact on CGM performance.
* patient is actively enrolled in another clinical trial or took part in a study within 30 days.
* known adrenal gland problem, panhypopitutarism, gastroparesis, migraine, epilepsy or ischemic heart disease or other cardiovascular event in the year previous to study participation .
* inability of the patient to comply with all study procedures.
* inability of the patient to understand the patient information.
* patient donated blood in the last 3 months.
* has severe medical or psychological condition(s) or chronic conditions/infections that in the opinion of the investigator would compromise the patient's safety or successful participation in the study.
* is assessed by the investigators to have difficult intravenous (IV) access .
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02843503
Study Brief:
Protocol Section:
NCT02843503