Table 1.

Inclusion and exclusion criteria

Inclusion criteria
Men and non-pregnant women
Diagnosis of T1D for a minimum of 5 years
Hypoglycemia unawareness (Clarke score) or significant glycemic lability
Stable diabetic treatment
Willingness to use a continuous glucose meter
Acceptable candidate for surgical implantation
Exclusion criteria
History of islet cell, kidney, and/or pancreas transplant
Six or more severe, unexplained hypoglycemic events within 6 months of enrollment
Uncontrolled or untreated thyroid disease or adrenal insufficiency
Diabetic complications such as severe kidney disease or renal dysfunction, proliferative retinopathy, foot ulcers, amputations, and/or severe peripheral neuropathy
Detectable stimulated serum C-peptide during the screening perioda

^aC-peptide was assessed at two separate screening visits.