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 9,848,774 B2
• Filed: 08/31/2012
• Issued: 12/26/2017
• 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
• Primary Examiner(s): Gort, Elaine
• Assistant Examiner(s): Go, John P
• Application Number:
  US13/601,163
• Publication Number:
  US 20130030841A1
• Time in Patent Office: 1,943 Days
• Field of Search: 705 2, 705 3, 705 4
• 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 and insulin usage comprising:

storing testing data for a plurality of 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 according to their respective prescriptions for testing;

automatically, without user involvement, transmitting test results from a blood glucose meter to the repository in response to detection of an event selected from the group consisting of telephone activation if the blood glucose meter is built into or connected to a cellular telephone configured to communicate with the repository wirelessly, and selected motion activation of the blood glucose meter, 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;

storing, at the repository, prescription data indicating insulin allotted to patients according to their respective prescriptions for insulin;

automatically, without user involvement, transmitting to the repository delivery data relating to insulin delivered by an insulin delivery device in response to detection of complete insulin delivery;

analyzing, using the computer, the stored prescription data and the delivery data stored at the repository that corresponds to insulin delivered by the insulin delivery device over a selected period of time to determine if a prescribed patient supply of insulin requires replenishment; and

generating an output indicative of at least one of a number of the allotted test strips determined to be actually used or determined to remain unused, and an order for more insulin when the prescribed patient supply of insulin is determined to require replenishment.

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 indicate that a selected ratio of the number of test strips allotted to the patient remain unused.

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 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 1, wherein the repository stores meter calibration data for the blood glucose meter, and further comprising:

analyzing the test results and the meter calibration data stored in the repository 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 1, 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 at least one of an alert to the patient when any of the test strips are determined to be defective, and an alert advising a vendor to send the patient more test strips to replace the test strips determined to be defective.

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

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

transmitting, to the repository, delivery data relating to insulin that was delivered by the insulin delivery device to the patient and comprising device data.

12. The method of claim 11, wherein the insulin delivery device comprises an RFID tag configured to transmit an insulin delivery device identification number corresponding to the insulin delivery device and to store 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 device data; and

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

13. The method of claim 12, wherein the device data in the RFID tag 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.

14. The method of claim 12, further comprising transmitting, via the blood glucose meter, the delivery data to the repository substantially coincidentally with a blood glucose testing event.

15. The method of claim 12, further comprising transmitting, via the blood glucose meter, the delivery data to the repository via at least one of a cellular network and the internet.

16. The method of claim 12, 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.

17. The method of claim 12, further comprising transmitting the delivery data to the repository in response to the activating the RFID tag and detection of complete insulin delivery.

18. The method of claim 11, wherein the delivery data comprises multiple dose information.

19. The method of claim 12, 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 the RFID tag.

20. The method of claim 11, wherein the transmitting by the insulin delivery device 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.

21. The method of claim 12, further comprising automatically transmitting at least one of blood glucose test data and the delivery data to the repository 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.

22. The method as claimed in claim 1, further comprising at least one of

automatically refilling a 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, and

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.

23. The method as claimed in claim 22, wherein the automatically refilling comprises a vendor sending refills to the patient, and further comprising:

determining that a prescribed number of test results for the patient has not been received at the repository during a selected time period; and

transmitting a message to the vendor to send no more refills to the patient until the prescribed number of test results for the patient are received at the repository.

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

transmitting, to a third party payor, the determined number of test strips actually used by the patient; and

billing the third party payor on the basis of determined number of test strips that have actually been used.

25. The method as claimed in claim 1, further comprising determining compensation of a manufacturer of the test strips by at least one of a wholesaler and retailer that provide test strips to the respective patients for whom the testing data and the test results are stored in the repository, the determined compensation being at least wholesale acquisition cost (WAC) for the determined number of test strips that have actually been used by the respective patients.

26. The method as claimed in claim 25, further comprising determining a rebate for the third party payor that is less than the WAC and based on the determined number of test strips that have actually been used by the respective patients.

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

determining compensation of a manufacturer of the test strips by a wholesaler or retailer that provides test strips to the respective patients for whom the testing data and the test results are stored in the repository, the determined compensation of the manufacturer being for a selected number of test strips shipped to the wholesaler or retailer;

determining the reimbursement amount of the wholesaler or retailer by a third party payor to be for the selected number of test strips shipped to the wholesaler or retailer; and

determining a rebate for the third party payor in the amount of the reimbursement amount less compensation corresponding to the number of test strips determined to have actually been used by the respective patients based on their test results stored in the repository.

28. The method of claim 1, further comprising:

analyzing, for at least one selected patient, information in the repository comprising at least one of the testing data, the test results, the insulin delivery device data, and the data relating to the insulin delivered by the insulin delivery device, to generate real-time feedback for the patient;

transmitting the feedback to the blood glucose meter for display, the feedback comprising at least one of a calculated insulin dose, a prompt to medicate, and an indication of current blood glucose level relative to prescribed target values for blood glucose levels.

29. The method of claim 28, further comprising:

analyzing the information in the repository corresponding to a plurality of patients to generate a display screen indicating selected information for each of the plurality of patients comprising at least one of the test results for a selected time period, an average of the test results over a designated time period, and insulin dose compliance based on the data relating to the insulin delivered by the insulin delivery device; and

identifying the patients on the display screen whose information is above, below or within selected ranges using respective color coding or shading on the display screen.

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

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

automatically, without user involvement, transmitting test results from a blood glucose meter to the repository in response to detection an event selected from the group consisting of telephone activation if the blood glucose meter is built into or connected to a cellular telephone configured to communicate with the repository wirelessly, selected pressure activation of the blood glucose meter, and selected motion activation of the blood glucose meter, 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;

storing, at the repository, prescription data indicating insulin allotted to patients according to their respective prescriptions for insulin;

automatically, without user involvement, transmitting to the repository delivery data relating to insulin delivered by an insulin delivery device in response to detection of complete insulin delivery;

analyzing, using the computer, the stored prescription data and the delivery data stored at the repository that corresponds to insulin delivered by the insulin delivery device over a selected period of time to determine if a prescribed patient supply of insulin requires replenishment; and

generating an output indicative of at least one of the number of times the glucose sensor was determined to be used, and an order for more insulin when the prescribed patient supply of insulin is determined to require replenishment.

10. The method as claimed in claim 9, wherein the glucose sensor is an insertable continuous glucose monitor sensor, and further comprising automatically sending a new glucose sensor to the patient if the number of times the glucose sensor was actually used by the patient is determined to be a selected non-zero integer number.