https://pittplusme.org/study/2581

VX22-264-101 - Type 1 Diabetes Treatment Study

STUDY BASICS

Do you have Type 1 Diabetes? Are you 18-65 years old? You may be eligible for a research study to determine whether the VX-264 implant can improve glucose control. Compensation is provided.

STUDY PURPOSE

VX-264 is comprised of cells to control blood sugars and a device that contains those cells. The combination product comprises VX-264 together with a container that holds the device and the tools used to surgically implant the device. The overall purpose of this study is to test whether VX-264 can be implanted via a surgical procedure in the abdominal wall of participants with Type 1 Diabetes (T1D), and stay in place safely and tolerably, and to determine whether the study product can improve glucose control. VX-264 is considered investigational, which means it is not approved as a marketed product by the U.S. Food and Drug Administration (or any other government authority).

COULD THIS STUDY BE RIGHT FOR YOU?

Eligible participants:

Are ages 18-65
Have Type 1 Diabetes
Are in the compatible blood groups (A or AB)

WHAT PARTICIPANTS CAN EXPECT

There will be about 34 visits over a 5-year period, with a 3-day inpatient hospital stay to receive the VX-264 study product via implantation surgery. We will follow you for a total of 5 years, and you will be asked to enroll in a long-term follow-up study.

At each study visit, the study doctor or site staff will check your health, the effects of the study product, and to see if you can continue in the study. Some visits may be via telemedicine (in-home video conference) or as in-home nursing visits. You will be asked to complete blood glucose monitoring, surveys, and questionnaires, to help us monitor your health.

We will perform the following procedures at various visits (multiple exams may be performed during the same visit):