System and Methods for Improved Diabetes Data Management and Use Employing Wireless Connectivity Between Patients and Healthcare Providers and Repository of Diabetes Management Information

• US 20130030841A1
• Filed: 08/31/2012
• Published: 01/31/2013
• Est. Priority Date: 03/23/2006
• Status: Active Grant

• Current Assignee: Embecta Corporation
• Original Assignee: Becton, Dickinson & Co
• Inventors: Bergstrom, Chris, Butterbrodt, Jay, Fiedler, Alan W., Ginsberg, Barry, Gordon, Tim H., Upham, Paul
• Granted Patent: US 9,848,774 B2
• Time in Patent Office: Days
• US Class Current: 705/3
• CPC Class Codes: A61B 2560/0271 using a remote monitoring unit
• CPC Class Codes: A61B 2560/0456 Apparatus provided with a docking unit
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61M 2205/3561 local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/3576 with non implanted data transmission devices, e.g. using external transmitter or receiver
• CPC Class Codes: A61M 2205/6018 providing set-up signals for the apparatus configuration
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 15/00 ICT specially adapted for medical reports, e.g. generation or transmission thereof
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 20/30 relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
• CPC Class Codes: G16H 20/60 relating to nutrition control, e.g. diets
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 80/00 ICT specially adapted for facilitating communication between medical practitioners or patients, e.g. for collaborative diagnosis, therapy or health monitoring
• CPC Class Codes: Y10T 436/144444 Glucose

Abstract

Methods, devices and a system for disease management are provided that employ diagnostic testing devices (e.g., blood glucose meters) and medication delivery devices (e.g., insulin delivery devices) for providing data to a repository in real-time and automatically. Repository data can be analyzed to determine such information as actual test strip use, patient health parameters to outside prescribed ranges, testing and medication delivery compliance, patient profiles or stakeholders to receive promotional items or incentives, and so on. Connected meters and medication delivery devices and repository data analysis are also employed to associate a diagnostic test to a mealtime based on timing of a therapeutic intervention performed by an individual.

Claims

1. A computer-implemented method of determining test strip usage comprising:

storing testing data for patients in a repository, the testing data comprising for respective patients at least one of the number of recommended tests per day and the number of test strips allotted to the patient via one of a supplier and an insurer;

automatically transmitting test results from a blood glucose meter to the repository, the test results comprising measured glucose level;

analyzing, using the computer, the testing data and the test results stored in the repository for at least a selected one of the patients to determine at least one of the number of test strips actually used by the patient within a selected time period and the number of allotted test strips that are unused within a selected time period; and

generating an output indicative of a number of the test strips determined to be actually used or determined to remain unused.

2. The method as claimed in claim 1, further comprising automatically generating a refill prescription for test strips if the number of test strips actually used by the patient is determined to be a selected ratio of the number of test strips allotted to the patient.

3. The method as claimed in claim 1, further comprising generating an estimate of when the patient is going to be out of test strips and automatically sending more test strips to the patient when a selected number of test strips allotted to the patient are determined to remain unused.

4. The method as claimed in claim 1, further comprising billing at least one of an insurer and healthcare payor for test strips based on the number of test strips determined to be actually used by the patient.

5. The method as claimed in claim 1, further comprising:

analyzing the testing data and the test results stored in the repository to identify selected ones of the patients having at least one of selected testing practices based on their compliance with executing their corresponding number of recommended tests per day and selected glucose levels based on their corresponding test results; and

transmitting at least one of a promotion, educational information and an incentive to the selected ones of the patients.

6. The method as claimed in claim 5, wherein the transmitting further comprises:

analyzing the testing data and the test results stored in the repository to identify selected ones of the patients having at least one of selected health profiles based on their corresponding test results; and

selling advertising to vendors for transmission to the selected ones of the patients as potential consumers for new diabetes management products.

7. The method as claimed in claim 5, wherein the repository stores meter calibration data for the blood glucose meter, and further comprising:

analyzing the test results and the meter calibration data to determine whether the blood glucose meter is malfunctioning; and

transmitting an alert when the blood glucose meter is determined to be malfunctioning.

8. The method as claimed in claim 5, wherein the testing data further comprises at least one of date of test strip manufacture, test strip expiration date, lot number, calibration data, manufacturer identification, and logistic information comprising distribution country or region, and further comprising:

analyzing the test results and the testing data stored in the repository to determine whether any of the test strips are defective;

transmitting an alert when any of the test strips are determined to be defective.

11. The method as claimed in claim 1 or 9, further comprising:

storing insulin delivery device data at an insulin delivery device, the insulin delivery device data comprising insulin-type delivered via the insulin delivery device, the an insulin delivery device comprising at least one of a syringe, a microneedle, a pump and an insulin pen configured to deliver insulin; and

transmitting data relating to insulin delivered by the insulin delivery device to the repository.

12. The method of claim 11, further comprising:

storing patient prescription data for insulin at the repository; and

analyzing the stored patient prescription data and the stored insulin delivery device data corresponding to data collected by the insulin delivery device data over a selected period of time to determine if a patient supply of insulin requires replenishment.

13. The method of claim 11, wherein the insulin delivery device comprises an RFID tag for transmitting an insulin delivery device identification number corresponding to the insulin delivery device and for storing the insulin delivery device data, and further comprising:

activating the RFID tag via an RFID reader in a blood glucose meter to collect at least the insulin delivery device data; and

wirelessly communicating data to the repository relating to insulin delivered by the insulin delivery device automatically and substantially in real-time without user involvement in response to the activating.

14. The method of claim 13, wherein the insulin delivery device data comprises at least one of insulin-type delivered via the insulin delivery device, dosage, time stamp of delivery, and an identifier for at least one of the insulin delivery device, the blood glucose meter and the patient.

15. The method of claim 13, further comprising transmitting, via the blood glucose meter, the data relating to insulin delivered by the insulin delivery device to the repository substantially coincidentally with a blood glucose testing event.

16. The method of claim 13, further comprising transmitting, via the blood glucose meter, the data relating to insulin delivered by the insulin delivery device to the repository via at least one of a cellular network and the internet.

17. The method of claim 13, further comprising:

storing at the repository insulin delivery device identification numbers that uniquely identify corresponding insulin delivery devices; and

tracking via the repository the usage of respective ones of the insulin delivery devices.

18. The method of claim 13, further comprising transmitting the data relating to insulin delivered by the insulin deliver device to the repository in response to the activating and detection of complete insulin delivery.

19. The method of claim 11, wherein the data relating to insulin delivered by the insulin delivery device comprises multiple dose information.

20. The method of claim 13, further comprising:

storing multiple dose information at the insulin delivery device; and

transmitting the multiple dose information to the repository in response to the activating.

21. The method of claim 11, wherein transmitting comprises scanning available wireless frequencies and selecting a protocol based on optimal transmission qualities of a scanned frequency to communicate with the repository using at least one of a plurality of wireless protocols.

22. The method of claim 13, further comprising automatically transmitting at least one of blood glucose test data and the data related to insulin delivered by the insulin delivery device based on detection of at least one of the activating via the RFID reader, test strip reading, blood glucose measurement, detected motion, telephone activation when the blood glucose meter is connected to a cellular telephone, pressure activation, activation based on time, completion of insulin delivery, and repository instruction.

9. A computer-implemented method of determining glucose sensor usage comprising:

storing testing data for patients in a repository, the testing data comprising for respective patients at least the number of recommended tests per day;

automatically transmitting test results from a blood glucose meter to the repository, the test results comprising measured glucose level;

analyzing, using the computer, the testing data and the test results stored in the repository for at least a selected one of the patients to determine the number of times a glucose sensor was actually used by the patient within a selected time period; and

generating an output indicative of the number of times the glucose sensor was determined to be used.

10. The method as claimed in claim 9, further comprising automatically sending a new glucose sensor to the patient if the number of times a glucose sensor was actually used by the patient is determined to be a selected ratio of the number of recommended tests per day over the selected time period.