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 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 12:00 AM
NCT ID:
NCT06021158
Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of type 1 diabetes for at least 12 months. The diagnosis of type 1 diabetes is based on the investigator's judgment per local and international guideline criteria.
* Insulin pump use for at least 3 months.
* Individuals of childbearing potential must agree to use a highly effective method of birth control.
* Willing to switch to Lyumjev insulin for the duration of the study.
Exclusion Criteria:
* Use of oral antihyperglycemic agents within 2 weeks of admission (SGLT2i, metformin…); 1 month for GLP1-RA.
* Use of glucocorticoids (except low, stable doses and inhaled steroids).
* Use of hydroxyurea.
* Planned or ongoing pregnancy.
* Breastfeeding.
* Diabetic ketoacidosis and/or severe hypoglycemia episode (defined as requiring the assistance of another person, due to altered consciousness, to administer carbohydrates, glucagon, or other resuscitative actions) within one month of admission.
* Clinically significant retinopathy, nephropathy, or neuropathy as judged by the investigator.
* Recent (\<6 months) acute macrovascular event e.g., acute coronary syndrome or cardiac surgery.
* Known hypersensitivity to the study drug or its excipients.
* Other serious medical illness likely to interfere with study participation or with the ability to complete the trial, as judged by the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06021158
Study Brief:
Protocol Section:
NCT06021158