Title
An Online Failure Detection Method of the Glucose Sensor-Insulin Pump System: Improved Overnight Safety of Type-1 Diabetic Subjects
Abstract
Sensors for real-time continuous glucose monitoring (CGM) and pumps for continuous subcutaneous insulin infusion (CSII) have opened new scenarios for Type-1 diabetes treatment. However, occasional failures of either CGM or CSII may expose diabetic patients to possibly severe risks, especially overnight (e.g., inappropriate insulin administration). In this contribution, we present a method to detect in real time such failures by simultaneously using CGM and CSII data streams and a black-box model of the glucose-insulin system. First, an individualized state-space model of the glucose-insulin system is identified offline from CGM and CSII data collected during a previous monitoring. Then, this model, CGM and CSII real-time data streams are used online to obtain predictions of future glucose concentrations together with their confidence intervals by exploiting a Kalman filtering approach. If glucose values measured by the CGM sensor are not consistent with the predictions, a failure alert is generated in order to mitigate the risks for patient safety. The method is tested on 100 virtual patients created by using the UVA/Padova Type-1 diabetic simulator. Three different types of failures have been simulated: spike in the CGM profile, loss of sensitivity of glucose sensor, and failure in the pump delivery of insulin. Results show that, in all cases, the method is able to correctly generate alerts, with a very limited number of false negatives and a number of false positives, on average, lower than 10%. The use of the method in three subjects supports the simulation results, demonstrating that the accuracy of the method in generating alerts in presence of failures of the CGM sensor-CSII pump system can significantly improve safety of Type-1 diabetic patients overnight.
Year
DOI
Venue
2013
10.1109/TBME.2012.2227256
Biomedical Engineering, IEEE Transactions
Keywords
Field
DocType
Kalman filters,alarm systems,biomedical equipment,chemical sensors,diseases,medical control systems,medical signal detection,patient care,CGM data streams,CGM failure,CGM profile spike,CSII data streams,CSII failure,Kalman filtering approach,Type-1 diabetes treatment,Type-1 diabetic subjects,confidence intervals,continuous glucose monitoring,continuous subcutaneous insulin infusion,failure alert,future glucose concentration prediction,glucose sensor sensitivity loss,glucose sensor-insulin pump system,glucose-insulin system black box model,individualized state space model,insulin pump delivery failure,online failure detection method,patient safety risks,real time CGM sensors,Continuous glucose monitoring (CGM),Kalman filter,diabetes,parameter estimation
Biomedical engineering,Blood Glucose Self-Monitoring,Continuous glucose monitoring,Computer science,Equipment Failure Analysis,Artificial intelligence,Confidence interval,Diabetes mellitus,Computer vision,Emergency medicine,Insulin pump,Insulin,False positive paradox
Journal
Volume
Issue
ISSN
60
2
0018-9294
Citations 
PageRank 
References 
7
1.14
4
Authors
4
Name
Order
Citations
PageRank
Andrea Facchinetti115228.83
Simone Del Favero26715.81
Giovanni Sparacino327652.52
Claudio Cobelli4658113.31