A Trial to Compare Automated Lyumjev Delivery With Carbohydrate Counting, Qualitative Meal-size Estimation, and Meal Detection in Type 1 Diabetes

Conditions de participation

• Sexe:

  ALL

• Âges admissibles:

  18 and up

Critères de participation

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.