Summary:
A clinical trial for people with type 1 diabetes (T1D) with severe low blood sugar (hypoglycemia) and impaired hypoglycemic awareness.
Study Purpose:
The purpose of this study is to evaluate the safety, tolerability, and effectiveness of an investigational islet cell infusion, called VX-880, in individuals with T1D with severe low blood sugar (hypoglycemia) and impaired hypoglycemic awareness. The goal of this infusion is to provide replacement cells for the ones that have been lost or don’t work properly in people with diabetes. The first infusion of the islet cells will occur up to 90 days after the screening visit, but it may happen sooner. There may be a second infusion for participants enrolled in the first part of the study. The follow-up period is approximately five years following a participant’s final infusion.
If you qualify for this clinical research study, you will receive all study-related medications and procedures at no cost. You and your study doctor may choose to have some of the study visits at your home with a home health nurse, allowing for a reduced number of times that you must travel to the study site. You may also be compensated financially for your study-related time and reimbursed for travel.
Eligibility Criteria:
Key inclusion criteria for this study:
- Male or female between the ages of 18 and 65 (inclusive)
- Diagnosed with T1D with documented severe hypoglycemia and impaired hypoglycemic awareness
- Blood type A or AB
- No significant active infection or chronic infection such as hepatitis B or C, HIV, tuberculosis, invasive aspergillus, histoplasmosis, or coccidioidomycosis within the past year
- No advanced complications associated with diabetes including untreated proliferative retinopathy, skin ulcers, or amputations attributable to diabetes
- Consistent use of a continuous glucose monitor (CGM) for the past three months
- Willing and able to comply with the study instructions
Other protocol-defined inclusion and exclusion criteria may apply.