Method and system to derive glycemic patterns from clustering of glucose data

• US 9,504,412 B2
• Filed: 09/17/2012
• Issued: 11/29/2016
• Est. Priority Date: 09/17/2012
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Schaible, Thomas
• Primary Examiner(s): Natnithithadha, Navin
• Application Number:
  US13/621,499
• Publication Number:
  US 20140081103A1
• Time in Patent Office: 1,534 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1477 non-invasive
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• 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 5/150022 for capillary blood or interstitial fluid
• 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 5/155 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 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/7455 characterised by tactile indication, e.g. vibration or electrical stimulation
• 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: C12Q 1/006 for glucose
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52
• CPC Class Codes: G01N 27/3273 Devices therefor, e.g. test element readers, circuitry details not specific to biochemical electrodes G01N33/4875
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems

Abstract

Described are methods and systems for determining clusters of glucose data that can be utilized to provide insights to the person with diabetes, such as, for example, when a certain number of measurements during a predetermined time period is less than a predetermined threshold so that the subject is notified that the number of glucose measurements is less than optimum for management of diabetes.

Claims

1. A method for managing diabetes of a user with at least a glucose monitor and an infusion pump which are coupled to a controller, the method comprising the steps of:

conducting a plurality of glucose measurements over time with the at least one glucose monitor;

collating, using the controller, the plurality of glucose measurements into clusters for a predetermined time period;

in the event that the clusters indicate gaps in the glucose measurements during the predetermined time period, annunciating, using the controller, such gaps to the user;

in the event that the clusters indicate that the clusters are converging towards a certain range of glucose values, annunciating, using the controller, that the clusters are trending towards such range;

or

in the event that the clusters indicate three different ranges of glucose values for the predetermined time period including a high range, a mid-range, and a low range, comparing, using the controller, an upper boundary of the mid-range to an upper boundary of a predetermined ideal range, comparing, using the controller, a lower boundary of the mid-range to a lower boundary of the predetermined ideal range, and annunciating, using the controller, to the user whether the mid-range is outside the predetermined ideal range of a glucose range that is intermediate in value between 180 mg/dL and the boundary.

2. The method of claim 1, in which the annunciating of gaps comprises informing the user whenever at least a cluster in which a number (N) of glucose measurements of each cluster is divided into a total number of days (D) on which the glucose measurements were taken in a specific time interval of a day (SID) and the result (N/D) divided into the specific time interval in a day (SID) is less than a predetermined threshold.

3. The method of claim 2, in which the specific time interval in a day comprises at least one of an overnight interval from about 10 PM to about 6 AM;

a day interval from about 6 AM to about 5 PM;

or a night interval from about 5 PM to about 10 PM.

4. The method of claim 3, in which the predetermined threshold for the night interval comprises about 0.17 tests per hour-day.

5. The method of claim 3, in which the predetermined threshold for the day interval comprises about 0.095 tests per hour-day.

6. The method of claim 3, in which the message comprises a suggestion of which specific time interval to obtain more glucose measurements.

7. A system for management of diabetes of a subject, the system comprising:

at least one glucose monitor that is configured to measure a glucose concentration based on an enzymatic reaction with physiological fluid in a biosensor that provides an electrical signal representative of the glucose concentration; and

a controller in communication with at least one glucose monitor, the controller being configured to receive or transmit glucose data representative of glucose levels measured by the glucose monitor over a predetermined time period to determine plural clusters of glucose data with respect to glucose levels and the predetermined time so that the glucose levels with reference to a predetermined time period are correlated to each other in a cluster due to their similarity as compared to glucose levels in other clusters; and

wherein the controller annunciates a message whenever at least a cluster in which a number (N) of glucose measurements of each cluster is divided into a total number of days (D) on which the glucose measurements were taken in a specific time interval of a day (SID) and the result (N/D) divided into the specific time interval in a day (SID) is less than a predetermined threshold so that the subject is notified that the number of glucose measurements taken within the specific time interval of the day (SID) over the total number of days is less than optimum for management of diabetes.

8. The system of claim 7, in which the specific time interval in a day comprises at least one of an overnight interval from about 10 PM to about 6 AM;

a day interval from about 6 AM to about 5 PM;

or a night interval from about 5 PM to about 10 PM.

9. The system of claim 8, in which the predetermined threshold for the night interval comprises about 0.17 tests per hour-day.

10. The system of claim 8, in which the predetermined threshold for the day interval comprises about 0.095 tests per hour-day.

11. The system of claim 8, in which the message comprises a suggestion of which specific time interval to obtain more glucose measurements.