At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Development of Algorithms for a Hypoglycemic Prevention Alarm
In Brief
A clinical study evaluating Predictive Low Glucose Suspend Algorithm ON and Predictive Low Glucose Suspend Algorithm OFF for Type 1 Diabetes Mellitus. Completed, enrolled 20 participants across 2 sites.
Detailed Summary
This research study, Development of Algorithms for a Hypoglycemic Prevention Alarm, is being conducted at Stanford University Medical Center and the University of Colorado Barbara Davis Center. It is paid for by the Juvenile Diabetes Research Foundation. The purpose of doing this research study is to understand the best way to stop an insulin infusion pump from delivering insulin to prevent a subject from having hypoglycemia. Nocturnal hypoglycemia is a common problem with type 1 diabetes. This is a pilot study to evaluate the safety of a system consisting of an insulin pump and continuous glucose monitor communicating wirelessly with a bedside computer running an algorithm that temporarily suspends insulin delivery when hypoglycemia is predicted in a home setting.
Study Details
Timeline
Interventions
The algorithm uses a Kalman filter-based model to predict whether the sensor glucose level will fall below 80 mg/dL within a given time period and suspends the insulin pump if this event is predicted.