Reduction of Nocturnal Hypoglycemia and Hyperglycemia in the Home Using Predictive Algorithms

Objective: to gain experience with in-home use of a modified algorithm that will dose insulin to minimize projected hyperglycemia overnight in addition to suspending the pump if hypoglycemia is projected overnight and to obtain feasibility, safety, and initial efficacy data. Study Design: randomized controlled trial, with randomization on a night level within subject. Major Eligibility Criteria: clinical diagnosis of type 1 diabetes, daily insulin therapy for at least one year and an insulin infusion pump for at least 6 months; 15.0 to \180 mg/dl, 10.0 mmol/L) overnight. Major Safety Outcomes: CGM measures of hypo- and hyperglycemia, including morning blood glucose and mean overnight sensor glucose; adverse events including severe hypoglycemia and diabetic ketoacidosis.