Continuous analyte monitor data recording device operable in a blinded mode

• US 9,247,878 B2
• Filed: 12/30/2013
• Issued: 02/02/2016
• 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:
  US14/144,371
• Publication Number:
  US 20140114157A1
• Time in Patent Office: 764 Days
• Field of Search: 600/347, 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 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. 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 during a first time period and a second time period;

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

initiating, using the mobile computing device, a first mode wherein display of the real-time glucose concentration values based on the data stream is disabled by the computing device but triggering the hypoglycemia event alarm is enabled by the mobile computing device;

initiating a second mode, using the mobile computing device, wherein both display of glucose concentration values based on the data stream and triggering the hypoglycemia event alarm are enabled by the mobile computing device; and

generating and displaying on a computer display a performance report that user-perceptively distinguishes glucose concentration values associated with the data stream generated during the first time period from glucose concentration values associated with the data stream generated during the second time period, wherein the first time period is when the mobile computing device is in the first mode and wherein the second time period when the mobile computing device is in the second mode.

2. The method of claim 1, further comprising transferring data from a single point glucose monitor to the computing device.

3. The method of claim 1, further comprising performing retrospective analysis on the data stream using the computing device.

4. 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 while in a blinded mode;

recording the data stream without displaying any information associated with the data stream on the computing device while in an unblinded mode;

triggering a user-perceptible hypoglycemia event alarm on the computing device based at least in part on a comparison of information associated with the processed data stream with a predetermined hypoglycemia threshold;

calculating a change in glucose concentration values from a first time period and a second time period, wherein the first time period of the two time periods is a time period when the computing device is in the blinded mode and wherein the second time period of two time periods is a time period when the computing device is in the unblinded mode; and

generating and displaying a performance report that includes a representation of a result of the calculation so to provide to a user an indication of a difference in glucose values while in the blinded mode from the unblinded mode.

5. The method of claim 4, further comprising prompting a user to enter calibration information using the computing device and accepting user input indicative of calibration information.

6. The method of claim 5, wherein the calibration information is a single point glucose measurement.

7. The method of claim 4, further comprising transmitting the data stream or data derived from the data stream over a communication link to a computer network.

8. A system for monitoring a glucose concentration of a host measured b a continuous glucose sensor, the system comprising:

one or more processors;

non-transitory computer-readable instructions that, when executed by the one or more processors, cause the system 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 values of the host;

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

trigger a hypoglycemia event alarm, wherein the determining of when to trigger the alarm is based at least in part on a comparison of the determined real-time glucose concentration with a predetermined hypoglycemia threshold;

initiate a first mode that prevents the device from displaying on a display screen of the device real-time glucose concentration values based on the data stream but allows triggering the hypoglycemia event alarm;

initiate a second mode that allows the device to display real-time glucose concentration values on the display screen of the device based on the data stream and allows triggering the hypoglycemia event alarm;

identify one or more changes in information derived from the data stream from a first predefined time period to a second, different predefined time period, wherein the first time period is a time period when the device is in the blinded mode and wherein the second time period is a time period when the device is in the unblinded mode;

generate a performance report that includes a representation of a result of the identifying; and

display on a computer display the performance report.

9. The device of claim 8, 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.

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

a mobile computing device configured to;

receive a data stream indicative of a host'"'"'s glucose concentration generated by one or more a continuous glucose sensors over a time period while the mobile device is in a blinded mode and a different time period while the mobile device is in an unblinded mode,

process the data stream to generate real-time glucose values,

record the data stream and the real-time glucose values,

initiate a blinded mode that prevents the mobile device from displaying a display screen of the device real-time glucose concentration values based on the data stream but allows triggering the by hypoglycemia event alarm, and

initiate a second mode that allows the mobile device to display real-time glucose concentration values on the display screen of the device based on the data stream and allows trigger the hypoglycemia event alarm; and

a computer configured to generate and display a performance report that graphically represents information derived from the data stream generated while in the blinded mode differently from information derived from the data stream generated while in the unblinded mode.

11. The system of claim 10, wherein the performance report further identifies changes in information derived from the data stream generated while in the blinded mode from changes in information derived from the data stream generated while in the unblinded mode.

12. The system of claim 11, wherein the information derived from the data stream generated while in the blinded mode is glucose values measured during the first time period and the information derived from the data stream generated while in the blinded mode is glucose values measured during the second time period.

13. The system of claim 10, wherein the mobile device is further configured to trigger a user-perceptible hypoglycemia event alarm on based at least in part on a comparison of a real-time glucose value of the generated real-time glucose values with a predetermined hypoglycemia threshold regardless of whether the device is in the blinded mode or the unblinded mode.

14. The system of claim 10, further comprising prompting a user to enter calibration information using the computing device and accepting user input indicative of calibration information.

15. The system of claim 14, wherein the calibration information is a single point glucose measurement.

16. The system of claim 10, 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.