Feasibility Study Assessing the Ability of an Insulin Pump-controlling Algorithm to Minimize Hypoglycemia

Feasibility Study Assessing the Ability of an Insulin Pump-controlling Algorithm to Minimize Hypoglycemia

Feasibility Study Assessing the Ability of an Insulin Pump-controlling Algorithm to Minimize Hypoglycemia in Patients With Type 1 Diabetes in a Clinical Research Setting

This study will be conducted in a Clinical Research Center (CRC) setting and recruiting type 1 diabetes that are currently using an insulin pump.

This study is a non-randomized, uncontrolled feasibility study that looks to enroll people with type 1 diabetes who are currently using an insulin pump. During the subject's participation, the study staff will closely monitor the study subject in a clinical research center environment for approximately 30 hours, while controller algorithm determined insulin doses are delivered by an insulin pump, and utilizing continuous glucose monitoring results.

This study is a non-randomized feasibility study enrolling type 1 diabetics who are currently using an insulin pump. Participating Investigators will closely monitor the study subject in a clinical research center environment for approximately 30 hours, while controller algorithm determined insulin doses are delivered by an insulin pump, and utilizing continuous glucose monitoring results.

Evaluate the performance of the System while the subject is under close medical supervision in the Clinical Research Center (CRC) setting

Evaluating the ability of the system to predict a fall or rise in glucose values below or above a low glucose threshold, and take the corresponding appropriate action of reducing or suspending insulin delivery in order to keep the subject's glucose above this threshold, or resuming insulin delivery at the current basal rate upon the increase of glucose above this threshold. Ability of the system to issue timely and accurate warnings.

Understand the System's ability to safely keep the subject glucose levels within designated threshold. The subject and the device will be continuously monitored by the Principle Investigator and Algorithm Engineer to ensure proper function of the device and subject safety. All Adverse Events will be captured on the CRF.

Inclusion Criteria: Age 21-65 years Type 1 diabetes mellitus for at least one year Currently using an insulin infusion pump for at least the past 6 months Exclusion Criteria: Pregnancy History of Diabetic Ketoacidosis (DKA) in the past six months History of severe hypoglycemia (Seizure, unconsciousness) in the past 6 months

Finan DA, Dassau E, Breton MD, Patek SD, McCann TW Jr, Kovatchev BP, Doyle FJ 3rd, Levy BL, Venugopalan R. Sensitivity of the Predictive Hypoglycemia Minimizer System to the Algorithm Aggressiveness Factor. J Diabetes Sci Technol. 2015 Jun 30;10(1):104-10. doi: 10.1177/1932296815593292.