Hybrid Closed Loop Insulin Delivery System in Hypoglycemia

Inclusion Criteria: * Male and female subjects age 25 to 70 years. * Subjects who are able to provide written informed consent and to comply with the procedures of the study protocol. * Clinical history compatible with type 1 diabetes with disease onset \< 40 years of age and insulin dependent for \> 10 years. * Absent C-peptide (\< 0.3 ng/ml). * Involvement in intensive diabetes management defined as the use of basal-bolus insulin analog delivery by multi-dose injection (MDI) or continuous subcutaneous insulin infusion (CSII) together with self-monitoring of blood glucose values more than 3 times daily with or without continuous glucose monitoring (CGM) under the direction of an endocrinologist, diabetologist, or diabetes nurse practitioner with at least 3 clinical evaluations during the previous 12 months. * Hypoglycemia unawareness manifested by a Clarke score of 4 or more AND at least 1 of the following: HYPO score greater than or equal to the 90th percentile (1047); OR marked glycemic lability defined by a glycemic lability index (LI) score greater than or equal to the 90th percentile (433 mmol/l2/h•wk-1); OR a composite of a HYPO score greater than or equal to the 75th percentile (423) and a LI greater than or equal to the 75th percentile (329) (Senior et al., 2015). * Documented \> 5% time spent in the hypoglycemic range (glucose \< 60 mg/dl) by 7 day real- time or blinded CGM; at least one episode of hypoglycemic during the 7 days must occur overnight. Exclusion Cri…