Type 1 Diabetes Mellitus Clinical Trial
Official title:
Development of Algorithms for a Hypoglycemic Prevention Alarm
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.
After the run-in phase, there is a 21-night trial in which each night is randomly assigned
2:1 to have either the predictive low-glucose suspend (PLGS) system active (intervention
night) or inactive (control night).
Three predictive algorithm versions were studied sequentially during the study.
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