Feasibility Study Assessing The Ability Of An Insulin Pump-Controlling Algorithm To Minimize Hypoglycemia And Hyperglycemia In Patients With Type 1 Diabetes In A Clinical Research Setting

• To evaluate the performance of the System while the subject is under close medical supervision in the Clinical Research Center (CRC) setting. [ Time Frame: End of Study - in approximately 5 months from first subject enrolled ] [ Designated as safety issue: Yes ]
  Measuring the response of the investigational device, including insulin delivery dosing changes in response to glucose changes. Also, the ability of the system to mitigate Hypoglycemia.
  
  

• Safety Evaluation [ Time Frame: End of Study - in approximately 5 months from first subject enrolled ] [ Designated as safety issue: Yes ]

  Measuring the following:

  • the number and type of adverse events, including Adverse device effects, Serious Adverse Events, Unanticipated Adverse Device Effects, device malfunctions
  • Resulting glucose data from 24 hour clinical research center visit
  
  

Device: Hypoglycemia-Hyperglycemia Minimizer System
Hypoglycemia-Hyperglycemia Minimizer System, consisting of an subcutaneous insulin infusion pump, subcutaneous continuous glucose monitoring system, and a controller algorithm

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 24 hours, while controller algorithm determined insulin doses are delivered by an insulin pump, and utilizing continuous glucose monitoring results.

Total subject participation approximately 1 week for screening to completion. This includes approximately 24 hours usage of the investigation device in the clinical research center under close medical supervision.