CONTINUOUS ANALYTE MONITOR DATA RECORDING DEVICE OPERABLE IN A BLINDED MODE

• US 20140114157A1
• Filed: 12/30/2013
• Published: 04/24/2014
• 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
• Granted Patent: US 9,247,878 B2
• Time in Patent Office: Days
• US Class Current: 600/347
• 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 for monitoring analyte in a host, 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. In one embodiment, the device includes a single point analyte monitor, from which it obtains an analyte value, and is configured to display only single point analyte measurement values, and not any analyte measurement values associated with data received from the continuous analyte sensor. Instead, data received from the continuous analyte sensor is 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. In another embodiment, the device provides for toggling between two modes, with one mode that allows for display of glucose concentration values associated with the continuous glucose sensor and a second mode that prevents the display of glucose concentration values associated with the continuous glucose sensor.

Claims

1-10. -10. (canceled)

11. A method for monitoring a glucose concentration of a host using a continuous glucose sensor, comprising:

generating, using a continuous glucose sensor, a data stream indicative of a host'"'"'s glucose concentration;

processing the data stream to determine a real-time glucose concentration value of the host;

recording, using a mobile computing device, the data stream and/or information derived from or associated with the data stream;

triggering, using the mobile computing device, a real-time alarm, wherein the determining of when to trigger the alarm is based at least in part on the determined real-time glucose concentration; and

determining, using the computing device, when to prompt a user to perform a single point glucose measurement, wherein the determining of when to perform the single point glucose measurement is based at least in part on the data stream or information derived from or associated with the processed data stream,

wherein display of glucose concentration values based on the data stream is prevented by the computing device.

12. The method of claim 11, further comprising transferring data from a single point glucose monitor to the computing device.

13. The method of claim 11, further comprising performing retrospective analysis on the data stream using the computing device.

14. The method of claim 11, further comprising initiating a first mode wherein display of glucose concentration values based on the data stream is prevented by the computing device, and initiating a second mode wherein display of glucose concentration values based on the data stream is allowed by the computing device.

15. A method for monitoring a glucose concentration in a user using a mobile computing device, the method comprising:

receiving, from a continuous glucose sensor, a data stream indicative of a host'"'"'s glucose concentration;

processing the data stream;

recording the data stream without displaying any information associated with the data stream on the computing device;

triggering a user-perceptible alarm on the computing device based at least in part on information associated with the processed data stream;

prompting a user to enter calibration information using the computing device; and

accepting user input indicative of calibration information.

16. The method of claim 15, wherein the calibration information is a single point glucose measurement.

17. The method of claim 15, wherein the alarm comprises a notification of a hypoglycemic or hyperglycemic event.

18. The method of claim 15, further comprising transmitting the data stream or data derived from the data stream over a communication link to a computer network.

19. A device for monitoring a glucose concentration of a host measured by a continuous glucose sensor, the device comprising:

one or more processors;

non-transitory computer-readable instructions that, when executed by the one or more processors, cause the device to;

receive, from a continuous glucose sensor, a data stream indicative of a host'"'"'s glucose concentration;

process the data stream to determine a real-time glucose concentration value of the host;

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

trigger a real-time alarm, wherein the determining of when to trigger the alarm is based at least in part on the determined real-time glucose concentration; and

determine when to prompt a user to perform a single point glucose measurement, wherein the determining of when to perform the single point glucose measurement is based at least in part on the data stream or information derived from or associated with the processed data stream,

wherein the device is configured to prevent display of glucose concentration values based on the data stream.

20. The device of claim 19, wherein the non-transitory computer-readable instructions, when executed by the one or more processors, are further configured to cause the device to perform retrospective analysis on the data stream using the computing device.

21. The device of claim 19, wherein the non-transitory computer-readable instructions, when executed by the one or more processors, are further configured to cause the device to initiate a first mode that prevents the device from displaying glucose concentration values based on the data stream, and initiate a second mode that allows the device to display glucose concentration values based on the data stream.

22. A system for monitoring a glucose concentration of a host, the system comprising:

a continuous glucose sensor; and

a mobile device configured to;

receive, from the continuous glucose sensor, a data stream indicative of a host'"'"'s glucose concentration,

process the data stream,

record the data stream without displaying any information associated with the data stream on the computing device,

trigger a user-perceptible alarm on the computing device based at least in part on information associated with the processed data stream,

prompt a user to enter calibration information using the computing device, and

accept user input indicative of calibration information.

23. The system of claim 22, wherein the calibration information is a single point glucose measurement.

24. The system of claim 22, wherein the alarm comprises a notification of a hypoglycemic or hyperglycemic event.

25. The system of claim 22, wherein the device is further configured to transmit the data stream or data derived from the data stream over a communication link to a computer network.