Study of VX-880 Infusion to Treat Adults With Type 1 Diabetes and Severe Low Blood Sugar Episodes Evaluating Safety, Tolerability, and Effectiveness in Participants Aged 18 to 65

What this Trial Is About

Researchers are studying VX-880 infusion to assess its safety, tolerability, and effectiveness in adults with Type 1 diabetes who have impaired awareness of low blood sugar and have experienced severe hypoglycemia. This study is a Phase 3 clinical trial focusing on treatment outcomes in this specific population. Participants will receive VX-880, a biological infusion delivered into the hepatic portal vein. The study does not include a comparison group and is designed as a single-group intervention. The treatment and follow-up period may last up to 5 years, with ongoing monitoring of insulin independence and severe hypoglycemic events. During the study, participants will be monitored for adverse events and changes in insulin use and blood sugar control, including glycosylated hemoglobin levels. Continuous glucose monitoring is required before and throughout the study. Researchers will evaluate safety and effectiveness over time, with key outcomes assessed up to one year after treatment and long-term follow-up extending to five years.

A Safety, Tolerability, and Efficacy Study of VX-880 in Participants With Type 1 Diabetes