Purpose of the FORWARD Study

The purpose of the FORWARD Study is to evaluate the safety, tolerability, and effectiveness of an investigational islet cell infusion in individuals with type 1 diabetes with severe low blood sugar (hypoglycemia) and impaired hypoglycemic awareness. The goal of this investigational infusion is to provide replacement cells for the ones that have been lost or do not work properly in people with diabetes. The therapy is considered investigational, which means it is not approved as a marketed product by Health Canada, the United States Food and Drug Administration (FDA), the European Medicines Agency (EMA), or any other regulatory (government) authority.

Who May Qualify

Eligible participants must meet the following key criteria:

  • Male or female between the ages of 18 and 65 (inclusive)
  • Diagnosed with type 1 diabetes
  • Severe hypoglycemia, meaning you have required assistance from somebody else to recover from low blood sugar
  • Blood type of A or AB
  • Do not have significant active infection or chronic infection such as hepatitis B or C, HIV, tuberculosis, invasive aspergillus, histoplasmosis, or coccidioidomycosis within the past year
  • Do not have 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 last three months (unless CGM is not available as standard of care)
  • Willing and able to comply with the study instructions

There are additional eligibility requirements, which the study doctor will discuss with those interested in participating.

Study Participation

The investigational infusion of islet cells will occur up to 60 days after the screening visit. Prior to a planned investigational islet cell infusion, you will be admitted to the hospital for approximately three days and will remain in the hospital for approximately four more days after the infusion for safety monitoring. There may be a second investigational infusion if you are enrolled in the first part of the study. The follow-up period is approximately five years following your final investigational infusion. After these initial five years, you may be asked to participate in a separate long-term follow-up study.

During the study:

  • You will need to attend follow-up visits monthly after the investigational infusion for the first year and about every three months after for approximately five years. You and your study doctor may choose to have some of the study visits at your home with a home health nurse.
  • You will receive several medicines before, during, and after the investigational infusion of the islet cells and will be asked to take medicines for the entire duration of the study.
  • You must wear the study CGM which will be provided to you at no cost.

For Families and Caregivers

If your loved one is living with type 1 diabetes, share this website with them today, or talk to their doctor for more information.

About the Investigational Infusion Process

See if you may qualify