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 @ 3:51 PM
Ignite Modification Date:
2025-12-24 @ 3:51 PM
NCT ID:
NCT04449692
Eligibility Criteria:
Inclusion Criteria:
* Age 18-64 years
* Duration of T1D ≥ 3 years
* Use of CSII or MDI therapy for ≥ 6 months
* Current use of Novorapid (change from another fast-acting insulin to Novorapid prior to study initiation is allowed)
* HbA1c ≤ 8.0%
* Regular use of carbohydrate counting in the judgement of the investigator
Exclusion Criteria:
* Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start
* History of allergy or intolerance to glucagon or glucagon-like products
* Patients with pheochromocytoma
* Clinically significant ECG abnormalities
* Females who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (sterilization, intrauterine device, contraceptive pill, patch or injection)
* Inability to understand the individual information and to give informed consent
* Current participation in another clinical trial that, in the judgment of the principle investigator, will compromise the results of the study or the safety of the subject
* Other concomitant medical or psychological condition that, according to the investigator's assessment, makes the individual unsuitable for study participation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT04449692
Study Brief:
Protocol Section:
NCT04449692