Evaluating VX-880 for Type 1 Diabetes with Severe Hypoglycemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study assesses the safety, tolerability, and efficacy of VX-880 infusion in individuals with Type 1 diabetes who experience impaired awareness of hypoglycemia and have a history of severe hypoglycemic episodes. Participants must have been insulin-dependent for over five years and have documented severe hypoglycemia within the past year. The study will involve the use of continuous glucose monitoring to track participants' glucose levels throughout the trial. The goal is to determine if VX-880 can improve the management of their diabetes and reduce the risk of severe hypoglycemia.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* Clinical history of T1D with \>=5 years of duration of insulin dependence
* At least two episodes of documented severe hypoglycemia in the 12 months prior to enrollment
* Stable diabetic treatment
* Consistent use of continuous glucose monitor (CGM) for at least 3 months before Screening and willingness to use CGM for the duration of the study

Key Exclusion Criteria:

-Prior islet cell transplant, organ transplant, or cell therapy

Other protocol-defined Inclusion/Exclusion criteria may apply

Where it's running

• City of Hope
  Duarte, California, United States Recruiting
• University of California San Francisco
  San Francisco, California, United States Recruiting
• UHealth Diabetes Research Institute
  Miami, Florida, United States Recruiting
• University of Chicago
  Chicago, Illinois, United States Recruiting
• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting
• Hospital of the University of Pennsylvania
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Study coordinator: Medical Information
• Email: medicalinfo@vrtx.com
• Phone: 617-341-6777

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.