The goal of this study is to assess the functionality of an integrated predictive low glucose suspend system designed to minimize the incidence and duration of hypoglycemia by suspending insulin delivery if hypoglycemia is projected.
This protocol is designed to test the functionality of a predictive low glucose suspend system under supervised conditions where basal insulin rates are manually increased until a system generated suspension occurs. The study will collect data that will be used for planning a pivotal study, and the study data are intended to be used to support a Premarket Approval (PMA) application.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
10
To assess the functionality of a predictive low glucose suspend (PLGS) system that uses Continuous Glucose Monitoring (CGM) values to suspend basal insulin delivery when hypoglycemia is predicted as well as resume basal insulin delivery once Continuous Glucose Monitoring (CGM) values begin to increase.
Stanford University
Palo Alto, California, United States
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, United States
Suspension of Insulin Delivery
To test functionality of the system
Time frame: 8 hours between 9pm and 5am
Restoration of insulin delivery
To test functionality of the system
Time frame: 8 hours between 9pm and 5am
Agreement between algorithm-recommended pump action
To test functionality of the system
Time frame: 8 hours between 9pm and 5am
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