DIABETES CARE KIT THAT IS PRECONFIGURED TO ESTABLISH A SECURE BIDIRECTIONAL COMMUNICATION LINK BETWEEN A BLOOD GLUCOSE METER AND INSULIN PUMP

• US 20120093315A1
• Filed: 12/22/2010
• Published: 04/19/2012
• Est. Priority Date: 10/15/2010
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Nierzwick, Mark, Pash, Phillip E., Tenbarge, James Duane
• Granted Patent: US 8,401,194 B2
• Time in Patent Office: Days
• US Class Current: 380/270
• 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: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: H04L 63/061 for key exchange, e.g. in peer-to-peer networks cryptographic mechanisms or cryptographic arrangements for key agreement H04L9/0838
• CPC Class Codes: H04L 63/0869 for achieving mutual authentication cryptographic mechanisms or cryptographic arrangements for mutual authentication H04L9/3273
• CPC Class Codes: H04W 12/06 Authentication
• CPC Class Codes: H04W 12/50 Secure pairing of devices

Abstract

A diabetes care kit for providing diagnostics and therapy that is preconfigured to reduce initial setup by a user. The kit can include a handheld diabetes managing device and insulin pump. The handheld diabetes managing device and insulin pump can each be preloaded with an encryption key such that the handheld diabetes managing device and the insulin pump are paired and a secure bidirectional communication link exists between the handheld diabetes managing device and the insulin pump.

Claims

1. A diabetes care kit for providing diagnostics and therapy that is preconfigured to reduce initial setup by a user, comprising:

a handheld diabetes managing device including;

a blood glucose meter configured to determine a blood glucose level of a user,

a first processor coupled to the blood glucose meter and configured to generate an insulin pump command based on the blood glucose level,

a first memory coupled to the processor and preloaded with an encryption key,

a first communication module coupled to the processor and first memory and configured to generate an encrypted communication message based on the insulin pump command and the encryption key, and

a first antenna coupled to the first communication module and configured to transmit the encrypted communication message; and

an insulin pump including;

an insulin dosing module configured to dispense insulin based on an insulin dose command,

a second processor coupled to the insulin dosing module and configured to generate the insulin dose command based on the insulin pump command,

a second memory coupled to the second processor and preloaded with the encryption key,

a second communication module coupled to the second processor and the second memory and configured to decode the encrypted communication message based on the encryption key to obtain the insulin pump command, and

a second antenna coupled to the second communication module and configured to receive the encrypted communication message,

wherein the handheld diabetes managing device and the insulin pump are paired such that a secure bidirectional communication link exists between the handheld diabetes managing device and the insulin pump.

2. The kit of claim 1, wherein the handheld diabetes managing device further comprises a first pairing application implemented as computer executable instructions in the first memory and the insulin pump further comprises a second pairing application implemented as computer executable instructions in the second memory, the first pairing application being configured to execute a pairing procedure at the handheld diabetes managing device and the second pairing application being configured to execute the pairing procedure at the insulin pump, the pairing procedure pairing the handheld diabetes managing device and the insulin pump and including:

at the insulin pump, outputting a pump identification signal that contains a pump identification code that uniquely identifies the insulin pump;

at the handheld diabetes managing device, receiving the pump identification signal;

at the handheld diabetes managing device, obtaining the pump identification code from the pump identification signal;

at the handheld diabetes managing device, displaying the pump identification code on a diabetes managing device display;

at the insulin pump, displaying the pump identification code on an insulin pump display;

at the handheld diabetes managing device, receiving an insulin pump selection input that selects the pump identification code corresponding to the insulin pump;

at the handheld diabetes managing device, generating a first verification string;

at the insulin pump, generating a second verification string;

at the handheld diabetes managing device, displaying the first verification string on the diabetes managing device display;

at the insulin pump, displaying the second verification string on the insulin pump display;

at the handheld diabetes managing device, receiving a first confirmation input corresponding to the first verification string matching the second verification string;

at the insulin pump, receiving a second confirmation input corresponding to the first verification string matching the second verification string; and

establishing a secure bidirectional communication link between the handheld diabetes managing device and the insulin pump based on the receipt of the first confirmation input by the handheld diabetes managing device and the receipt of the second confirmation input by the insulin pump.

3. The kit of claim 2, wherein the pairing procedure further comprises:

at the handheld diabetes managing device, generating a test communication message;

at the handheld diabetes managing device, generating an encrypted test communication message by encrypting the test communication message with the encryption key;

at the handheld diabetes managing device, outputting the encrypted test communication message;

at the insulin pump, receiving the encrypted test communication message;

at the insulin pump, decoding the encrypted test communication message with the encryption key to obtain the test communication message; and

at the insulin pump, confirming receipt of the test communication message by the insulin pump.

4. The kit of claim 3, wherein the handheld diabetes managing device further comprises a first message confirmation application implemented as computer executable instructions in the first memory and the insulin pump further comprises a second confirmation message application implemented as computer executable instructions in the second memory, wherein:

the second message confirmation application is configured to execute a third procedure at the insulin pump for confirming receipt of the test communication message at the insulin pump, the third procedure including;

generating a test communication received message,

generating an encrypted test communication received message by encrypting the test communication received message with the encryption key, and

outputting the encrypted test communication received message; and

the first message confirmation application is configured to execute a fourth procedure at the handheld diabetes managing device for confirming receipt of the test communication message at the insulin pump, the fourth procedure including;

receiving the encrypted test communication received message, and

decoding the encrypted test communication received message with the encryption key.

5. The kit of claim 2, wherein the handheld diabetes managing device and the insulin pump are configured to communicate by transmitting messages that are encrypted based on the encryption key.

6. The kit of claim 2, wherein the encryption key is an RSA public key.

7. The kit of claim 2, wherein the encryption key is a Twofish cipher key.

8. The kit of claim 2, wherein the first memory is preloaded with the encryption key during manufacture of the handheld diabetes managing device.

9. The kit of claim 2, wherein the second memory is preloaded with the encryption key during manufacture of the insulin pump.

10. The kit of claim 1, wherein the first memory is preloaded with the encryption key during manufacture of the handheld diabetes managing device.

11. The kit of claim 1, wherein the second memory is preloaded with the encryption key during manufacture of the insulin pump.

12. A method of manufacturing a diabetes care kit for providing diagnostics and therapy that is preconfigured to reduce initial setup by a user, comprising:

providing a handheld diabetes managing device, the handheld diabetes managing device including;

a blood glucose meter configured to determine a blood glucose level of a patient,

a first processor coupled to the blood glucose meter and configured to generate an insulin pump command based on the blood glucose level,

a first memory coupled to the first processor,

a first communication module coupled to the first processor and first memory and configured to generate an encrypted communication message based on the insulin pump command, and

a first antenna coupled to the first communication module and configured to transmit the encrypted communication message;

providing an insulin pump, the insulin pump including;

an insulin dosing module configured to dispense insulin to the patient based on an insulin dose command,

a second processor coupled to the insulin dosing module and configured to generate the insulin dose command based on the insulin pump command,

a second memory coupled to the second processor,

a second communication module coupled to the second processor and the second memory and configured to decode the encrypted communication message to obtain the insulin pump command, and

a second antenna coupled to the second communication module and configured to receive the encrypted communication message;

loading an encryption key in the first and second memory, the encryption key being utilized to generate the encrypted communication message at the handheld diabetes managing device and to decode the encrypted communication message at the insulin pump; and

establishing a secure bidirectional communication link between the handheld diabetes managing device and the insulin pump by pairing the handheld diabetes managing device with the insulin pump.

13. The method of claim 12, wherein establishing the secure bidirectional communication link between the handheld diabetes managing device comprises:

at a transmitting device, generating a test communication message, the transmitting device being one of the handheld diabetes managing device and the insulin pump;

at the transmitting device, generating an encrypted test communication message by encrypting the test communication message with the encryption key;

at the transmitting device, outputting the encrypted test communication message;

at a receiving device, receiving the encrypted test communication message, the receiving device being the other one of the diabetes managing device and the insulin pump;

at the receiving device, decoding the encrypted test communication message with the encryption key to obtain the test communication message; and

confirming receipt of the test communication message by the receiving device.

14. The method of claim 13, wherein confirming receipt of the test communication message by the receiving device comprises:

at the receiving device, generating a test communication received message;

at the receiving device, generating an encrypted test communication received message by encrypting the test communication received message with the encryption key;

at the receiving device, outputting the encrypted test communication received message;

at the transmitting device, receiving the encrypted test communication received message; and

at the transmitting device, decoding the encrypted test communication received message with the encryption key.

15. The method of claim 14, wherein the first memory is loaded with the encryption key during manufacture of the handheld diabetes managing device.

16. The method of claim 14, wherein the second memory is loaded with the encryption key during manufacture of the insulin pump.

17. The method of claim 14, wherein the encryption key is an RSA public key.

18. The method of claim 14, wherein the encryption key is a Twofish cipher key.

19. The method of claim 12, wherein the first memory is loaded with the encryption key during manufacture of the handheld diabetes managing device.

20. The method of claim 12, wherein the second memory is loaded with the encryption key during manufacture of the insulin pump.