System and methods for improved diabetes data management and use employing wireless connectivity between patients and healthcare providers and repository of diabetes management information

Patent metadata

Field	Value
Publication number	US-9848774-B2
Application number	US-201213601163-A
Country	US
Kind code	B2
Filing date	Aug 31, 2012
Priority date	Mar 23, 2006
Publication date	Dec 26, 2017
Grant date	Dec 26, 2017

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.

First claim

What is claimed is:

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.

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.

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

Assignees

• Bergstrom Chris
• Butterbrodt Jay
• Fiedler Alan W
• Ginsberg Barry
• Gordon Tim H
• Upham Paul
• Becton Dickinson Co

Inventors

• Bergstrom Chris
• Butterbrodt Jay
• Fiedler Alan W
• Ginsberg Barry
• Gordon Tim H
• Upham Paul

Classifications

• A61M2205/3561

  local, e.g. within room or hospital · CPC title

• G16H40/63

  for local operation · CPC title

• A61M2205/3569

  sublocal, e.g. between console and disposable · CPC title

• G16H15/00

  ICT specially adapted for medical reports, e.g. generation or transmission thereof · CPC title

• A61B2560/0456

  Apparatus provided with a docking unit · CPC title