A Safety, Tolerability, and Efficacy Study of VC-02™ Combination Product in Subjects With Type 1 Diabetes Mellitus and Hypoglycemia Unawareness

Inclusion Criteria: * Men and non-pregnant women * Diagnosis of T1DM for a minimum of five (5) years * Hypoglycemia unawareness or significant glycemic lability * Stable diabetic treatment * Willingness to use a continuous glucose meter * Acceptable candidate for implantation Exclusion Criteria: * History of islet cell, kidney, and/or pancreas transplant. * Six (6) or more severe, unexplained hypoglycemic events within six (6) months of enrollment * Uncontrolled or untreated thyroid disease or adrenal insufficiency * Diabetic complications such as severe kidney disease or renal dysfunction, proliferative retinopathy, diabetic foot ulcers, amputations attributable to diabetes, and/or severe peripheral neuropathy * Non-compliance with current anti-diabetic regimen * Detectable stimulated serum C-peptide during screening period assessment.