Diabetes, Type I Clinical Trial
Official title:
Closing the Loop Between Glucose Sensor and Insulin Pump-developing an Algorithm
An open interventional data collection study in order to build a database to close the loop
between glucose sensor and insulin pump.
background: The ultimate goal in diabetes treatment is to develop an autonomous insulin
delivery system (artificial pancreas) capable of continuous glucose sensing, thereby
mimicking the physiologic function of the islet beta cells and freeing the patient from the
need for constant calculations of daily insulin and carbohydrates. Several prototypes of
closed-loop system have been developed in recent years, based on different types of control
algorithms, to establish the connection between the sensor and the insulin pump. Current
research in the formulation of this type of subcutaneous closed-loop system still faces
major challenges, therefore, there is a need for further study and evaluation.
Objectives:
1. To evaluate the lag time of the effect of subcutaneous insulin infusion on blood
glucose levels by using continuous glucose sensor
2. To measure the insulin sensitivity as expressed by changes in blood glucose levels
after s.c insulin infusion .
3. To evaluate real time sensor calibration algorithms based on the measured lag times
4. Collecting clinical data in order to develop and evaluate mathematical models which
will serve a base to simulators.
5. Developing and accessing advanced learning and control algorithms as a step towards
developing an artificial pancreas
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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