Continuous analyte monitor data recording device operable in a blinded mode

• US 9,241,631 B2
• Filed: 10/26/2011
• Issued: 01/26/2016
• Est. Priority Date: 10/27/2010
• Status: Active Grant

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Valdes, Jorge, Price, David, Bowman, Leif N., Cote, Kristin
• Primary Examiner(s): Natnithithadha, Navin
• Assistant Examiner(s): MESSERSMITH, ERIC J
• Application Number:
  US13/282,182
• Publication Number:
  US 20120108934A1
• Time in Patent Office: 1,553 Days
• Field of Search: 600/345, 600/365
• US Class Current: 1/1
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• CPC Class Codes: A61B 5/0004 characterised by the type of physiological signal transmitted
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/0024 for multiple sensor units attached to the patient, e.g. using a body or personal area network
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/1427 Multiple blood sampling, e.g. at periodic or pre-established intervals
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/14735 comprising an immobilised reagent
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150267 Modular design or construction, i.e. subunits are assembled separately before being joined together or the device comprises interchangeable or detachable modules
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150854 long distance, e.g. between patient's home and doctor's office
• CPC Class Codes: A61B 5/150862 intermediate range, e.g. within room or building
• CPC Class Codes: A61B 5/15087 short range, e.g. between console and disposable using implanted devices A61B5/150877
• CPC Class Codes: A61B 5/150877 with implanted devices
• CPC Class Codes: A61B 5/150969 Low-profile devices which resemble patches or plasters, e.g. also allowing collection of blood samples for testing
• CPC Class Codes: A61B 5/15105 Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving devices
• CPC Class Codes: A61B 5/155 : Devices specially adapted for continuous or multiple sampling, e.g. at predetermined intervals devices loaded with multiple lancets simultaneously A61B5/15146
• CPC Class Codes: A61B 5/157 : Devices characterised by integrated means for measuring characteristics of blood
• 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 5/742 : using visual displays A61B5/339 takes precedence
• 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: G16H 40/67 : for remote operation
• CPC Class Codes: Y02A 90/10 : Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Abstract

A system is provided including a continuous analyte sensor that produces a data stream indicative of a host'"'"'s analyte concentration and a device that receives and records data from the data stream from the continuous analyte sensor. The data received from the continuous analyte sensor may be used to provide alarms to the user when the analyte concentration and/or the rate of change of analyte concentration, as measured by the continuous analyte sensor, is above or below a predetermined range. Data received from the continuous analyte sensor may also be used to prompt the diabetic or caregiver to take certain actions, such as to perform another single point blood glucose measurement. The device may provide for toggling between modes that allow or prevent the display of glucose concentration values associated with the continuous glucose sensor.

Claims

1. A system for monitoring glucose concentration, the system comprising:

a continuous glucose sensor, the continuous glucose sensor configured to continuously measure glucose a concentration of a host and output a data stream associated with the glucose concentration; and

a device configured to operatively connect with the continuous glucose sensor, the device comprising at least one processor configured to process the data stream from the continuous glucose sensor to generate real-time measured glucose concentration values and store the measure glucose concentration values in memory, and a user interface configured to display the measured glucose concentration values,

wherein the device is configured for toggling between an unblinded mode allowing for display of real-time glucose concentration values associated with the continuous glucose sensor on the user interface and a blinded mode preventing display of real-time glucose concentration values associated with the continuous glucose sensor on the user interface and

a network server configured to generate a computer-displayable performance report that includes a graphical representation of measured glucose concentration values over time, wherein the report graphically distinguishes glucose values measured during the unblinded mode from glucose values measured during the blinded mode identifies changes in sensor data over at least two different time periods, wherein a first time period of the at least two time periods is a time period when the device is in the blinded mode and wherein a second time period of the at least two time periods is a time period when the device is in the unblinded mode.

2. The system of claim 1, wherein the at least one processor is configured to determine when to trigger an alarm, wherein the determination of when to trigger the alarm is based at least in part on information associated with the processed data stream.

3. The system of claim 1, wherein the alarm is configured to warn a user of a pending hyperglycemic event or a pending hypoglycemic event.

4. The system of claim 1, wherein the at least one processor is configured to determine when to prompt a user to perform a single point glucose measurement, wherein the determination of when to prompt the user is based at least in part on information associated with the processed data stream.

5. The system of claim 1, wherein the continuous glucose sensor is an implantable device.

6. The system of claim 1, wherein the device further includes a single point glucose monitor configured to measure a glucose concentration in blood.

7. The system of claim 6, wherein the device further comprises a memory for recording at least one of the data stream from the continuous analyte sensor or measured glucose concentration values associated with the single point glucose monitor.

8. The system of claim 1, wherein the device is configured to download data from the continuous analyte sensor to networked storage, and wherein the computing device is a remote server.

9. The system of claim 1, wherein the device is configured to compare a first time period of glucose values measured while the device is in the blinded mode and to a second time period of glucose values measured while the device is in the unblinded mode and graphically indicate a result of the comparison in the performance report.

10. A system for monitoring glucose concentration, the system comprising:

a continuous glucose sensor, the continuous glucose sensor configured to continuously measure glucose a concentration of a host and output a data stream associated with the measured glucose concentration; and

a device configured to operatively connect with the continuous glucose sensor, the device comprising at least one processor configured to process the data stream from the continuous glucose sensor and a display screen,

wherein the device is configured for toggling between an unblinded mode allowing for display of real-time glucose concentration values associated with the continuous glucose sensor on the display screen and a blinded mode preventing display of glucose concentration values associated with the continuous glucose sensor, and

wherein the device is further configured to generate and display a performance report that identifies a first time period of measured glucose values while the device is in the blinded mode and a second time period of measured glucose values while the device is in the unblinded mode, and provides a comparison of the first time period to the second time period.

11. The system of claim 10, wherein the device further includes a single point glucose monitor and wherein the display is configured to display glucose concentration values associated with the single point glucose monitor in both the unblended and blinded modes.

12. The system of claim 11, wherein the single point glucose monitor is configured to measure a glucose concentration in blood.

13. The system of claim 10, wherein the at least one processor is further configured to determine when to trigger an alarm, wherein the determination of when to trigger the alarm is based at least in part on information associated with the processed data stream.

14. The system of claim 10, wherein the alarm is configured to warn a user of a pending hyperglycemic event or a pending hypoglycemic event.

15. The system of claim 10, wherein the continuous glucose sensor is an implantable device.

16. The system of claim 10, wherein the device further comprises a memory for recording at least one of the data stream from the continuous analyte sensor or measured glucose concentration values associated with the single point glucose monitor.

17. A method for analyzing glucose concentration in a user, the method comprising:

receiving, from a continuous glucose sensor to a device, a data stream associated with a measured glucose concentration of a host;

processing the data stream;

recording in computer readable memory the data stream and/or information derived from or associated with the data stream;

determining when to trigger an alarm, wherein the determining of when to trigger the alarm is based at least in part on the data stream or information derived from or associated with the data stream;

toggling the device between an unblinded mode and a blinded mode;

initiating display on a display screen of the device real-time glucose concentration values associated with the continuous glucose sensor while the device is in the unblinded mode;

preventing initiation of display on the display screen of the device real-time glucose concentration values associated with the continuous glucose sensor while the device is in the blinded mode;

generating, using at least one processor, a performance report that displays measured glucose concentration values associated with the continuous glucose sensor over time, wherein the performance report visually distinguishes glucose concentration values measured while the device is in the blinded mode from glucose concentration values measured while the device is in the unblinded mode; and

displaying the performance report on a computer display.

18. A method for monitoring an analyte concentration in a user, the method comprising:

using a computing device, receiving, from a continuous analyte sensor, a data stream associated with the analyte concentration of the user;

processing the data stream;

recording the data stream in memory of the computing device;

preventing display of any information associated with the data stream on the computing device while the computing device is in a blinded mode;

enabling display of information associated with the data stream on the computing device while the computing device is in an unblinded mode;

triggering an alarm on the computing device based at least in part on information associated with the processed data stream; and

generating, using at least one processor, a performance report that identifies a first time period of glucose values measured while the computing device is in the blinded mode and compares the glucose values of the first time period to a second time period of glucose values measured while the computing device is in the unblinded mode.

19. The method of claim 18, wherein the analyte is glucose.

20. The method of claim 19, wherein the alarm comprises a prompt to a user to perform a single point glucose measurement.

21. The method of claim 19, wherein the alarm comprises a notification of a hypoglycemic or hyperglycemic event.

22. The method of claim 18, comprising transmitting the data stream or data derived from the data stream over a communication link to a computer network.

23. A system for continuous monitoring of an analyte concentration in a host, the system comprising:

a continuous analyte sensor;

a recording device configured to receive a data stream from the continuous analyte sensor representative of analyte concentration in the host, wherein the recording device is configurable to switch between a blinded mode that enables a restriction of host access to data from the continuous analyte sensor while still providing alarms to the host based on data from the continuous analyte sensor, and an unblinded mode that does not enable the restriction while still providing alarms to the host based on data from the continuous analyte sensor; and

a processing device configured to;

(i) identify a first time period of sensor data when the computing device is in the blinded mode and a second time period of sensor data when the computing device is in the unblinded mode, (ii) compare the first time period to the second time period, and (iii) generate a performance report that includes a graphical representation of a result of the comparison.

24. The system of claim 23, comprising a single point analyte monitor.

25. The system of claim 24, wherein the single point analyte monitor is integrated into the recording device.

26. The system of claim 25, wherein the recording device is configured to display analyte concentration values measured by the single point analyte monitor.

27. The system of claim 23, wherein the recording device is configured to transmit the data stream or data derived from the data stream over a communication link to a computer network.

28. The system of claim 23, wherein the continuous analyte sensor is configured to sense glucose concentration.

29. The system of claim 23, further comprising a computer display configured to display the performance report.

30. The system of claim 23, wherein the processor module is further configured to cause display of the performance report on a computing device.