METHOD TO IMPROVE SAFETY MONITORING IN TYPE-1 DIABETIC PATIENTS BY DETECTING IN REAL-TIME FAILURES OF THE GLUCOSE

• US 20130231543A1
• Filed: 03/05/2013
• Published: 09/05/2013
• Est. Priority Date: 03/05/2012
• Status: Abandoned Application

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Facchinetti, Andrea, Sparacino, Giovanni, Cobelli, Claudio, Del Favero, Simone
• Application Number:
  US13/785,384
• Publication Number:
  US 20130231543A1
• Time in Patent Office: Days
• US Class Current: 600/365
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/725 using specific filters therefor, e.g. Kalman or adaptive filters A61B5/316 take precedence
• CPC Class Codes: A61B 5/7282 Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: A61B 5/7405 using sound
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 5/743 Displaying an image simultaneously with additional graphical information, e.g. symbols, charts, function plots
• CPC Class Codes: A61B 5/7455 characterised by tactile indication, e.g. vibration or electrical stimulation
• CPC Class Codes: A61B 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B
• CPC Class Codes: A61M 2202/0468 non-physiological
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 5/14 Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass

Abstract

A device for monitoring a diabetic patient includes continuous glucose monitoring system that is configured to generate glucose data indicative of the patient'"'"'s actual glucose level. An continuous subcutaneous insulin infusion pump is configured to inject insulin into the patient and that is configured to generate insulin data regarding when and how much insulin has been injected into the patient. A processor, programmed with a discrete-time reiterative filter, calculates a predicted glucose level corresponding to a predicted glucose level currently expected to be sensed by the continuous glucose monitoring system, based on the insulin data and the glucose data over time and is also programed to generate an alert when the actual glucose level is different from the predicted glucose level by a predetermined amount. An alert generating device is coupled to the processor and is configured to generate an aesthetically-sensible event corresponding to the generation of the alert.

Claims

1. A device for monitoring a diabetic patient, comprising:

(a) a continuous glucose monitoring system that is configured to generate glucose data indicative of the patient'"'"'s actual glucose level;

(b) a continuous subcutaneous insulin infusion pump that is configured to inject insulin into the patient and that is configured to generate insulin data regarding when and how much insulin has been injected into the patient;

(c) a processor, in data communication with the continuous glucose monitoring system and the insulin pump, that is programmed with a discrete-time reiterative filter configured to calculate a predicted glucose level corresponding to a predicted glucose level currently expected to be sensed by the continuous glucose monitoring system, based on the insulin data and the glucose data over time and that is programed to generate an alert when the actual glucose level is different from the predicted glucose level by a predetermined amount; and

(d) an alert generating device coupled to the processor and configured to generate an aesthetically-sensible event corresponding to the generation of the alert.

2. The device of claim 1, wherein the discrete-time reiterative filter includes a Kalman filter predictor that is configured to calculate the predicted glucose level.

3. The device of claim 1, wherein the alert generating device comprises a sound generating device.

4. The device of claim 1, wherein the alert generating device comprises a light generating device.

5. The device of claim 1, wherein the alert generating device comprises a vibration generating device.

6. In a glucose monitoring system for monitoring a diabetic patient that includes a continuous glucose monitoring system that is configured to generate glucose data indicative of the patient'"'"'s actual glucose level and an insulin pump that is configured to inject insulin into the patient and that is configured to generate insulin data regarding when and how much insulin has been injected into the patient, the improvement comprising:

a processor, in data communication with the continuous glucose monitoring system and the insulin pump, that is programmed with a failure detection module to calculate a predicted glucose level based on the insulin data and the glucose data over time and that is programed to generate an alert when the actual glucose level is different from the predicted glucose level by a predetermined amount.

7. The glucose monitoring system of claim 6, wherein the insulin pump comprises a continuous subcutaneous insulin infusion pump.

8. The glucose monitoring system of claim 6, wherein the failure prediction module includes a discrete-time Kalman filter predictor that is configured to calculate the predicted glucose level.

9. The glucose monitoring system of claim 6, wherein the alert comprises an audible alarm.

10. The glucose monitoring system of claim 6, wherein the alert comprises a visual notification.

11. The glucose monitoring system of claim 6, wherein the alert comprises a vibration.

12. A method of monitoring a diabetic patient, employing a processor coupled to a tangible computer-readable memory, comprising the steps of:

(a) receiving glucose data, from a continuous glucose monitoring system, indicative of the patient'"'"'s actual glucose level;

(b) receiving insulin data, from an insulin pump, indicative of when and how much insulin has been injected into the patient.

(c) generating a predicted glucose level based on the glucose data and the insulin data;

(d) comparing the actual glucose level to the predicted glucose level; and

(e) generating an alert when the actual glucose level is different from the predicted glucose level by a predetermined amount.

13. The method of claim 12, wherein the insulin pump comprises a continuous subcutaneous insulin infusion pump.

14. The method of claim 12, wherein the step of generating a predicted glucose level employs a discrete-time Kalman filter predictor that is configured to calculate the predicted glucose level.

15. The method of claim 12, wherein the alert comprises an audible alarm.

16. The method of claim 12, wherein the alert comprises a visual notification.

17. The method of claim 12, wherein the alert comprises a vibration.