Phase 12a Study of E-islet 01 Infusion for Adults With Type 1 Diabetes and Severe Hypoglycemia Evaluating Safety, Tolerability, and Effectiveness in People With Impaired Hypoglycemic Awareness

What this Trial Is About

Researchers are evaluating the safety, tolerability, and effectiveness of a treatment called E-islet 01 in adults with Type 1 Diabetes who have difficulty recognizing low blood sugar impaired awareness of hypoglycemia and experience severe low blood sugar events. This Phase 12a study aims to better understand how this biological treatment works for this specific group of participants. Participants will receive an infusion of Allogeneic Human E-islet E-islet 01 into the hepatic portal vein. The study will follow participants for up to five years to monitor safety and treatment effects. Key measures include the number of severe hypoglycemic events and changes in blood sugar control one year after infusion. During the study, participants will be closely monitored for adverse events and changes in blood sugar control, including measurements of glycated hemoglobin HbA1c and C-peptide levels. Other outcomes include time spent with blood sugar in range and insulin independence or reduction. Participants will perform self-blood glucose monitoring and be evaluated regularly to assess treatment response and safety over the full duration of the trial.

A Safety, Tolerability, and Efficacy Study of E-islet 01 in Participants With Type 1 Diabetes