Medical Device and Method for Glycemic Control

• US 20120116196A1
• Filed: 02/03/2010
• Published: 05/10/2012
• Est. Priority Date: 02/04/2009
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: Tubb, Andrew
• Granted Patent: US 11,166,650 B2
• Time in Patent Office: Days
• US Class Current: 600/365
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 20/17 delivered via infusion or injection

Abstract

A medical device and method for determining a dose of insulin to be administered for glycemic control is provided, wherein the dose is stepwise adapted, comprising determining a blood glucose value, receiving glycemic event information in respect to a predetermined glycemic event, wherein the predetermined glycemic event occurred within a predetermined time interval, receiving a previously adapted dose value stored in a storage unit, and setting an alert based on at least the blood glucose value, the glycemic event information and the previously adapted dose, wherein the alert indicates that the blood glucose value and the predetermined glycemic event are not in a specified relation to the previously adapted dose value.

Claims

1. A method for determining a dose of insulin to be administered for glycemic control, wherein the dose is stepwise adapted, the method comprising the steps of:

determining a blood glucose value,

receiving glycemic event information in respect to a predetermined glycemic event, wherein the predetermined glycemic event occurred within a predetermined time interval,

receiving a previously adapted dose value stored in a storage unit, and

setting an alert based on at least the blood glucose value, the glycemic event information and the previously adapted dose, wherein the alert indicates that the blood glucose value and the predetermined glycemic event are not in a specified relation to the previously adapted dose value.

2. The method according to claim 1, further comprising the step of defining the specified relation between the blood glucose value and the predetermined glycemic event and the previously adapted dose value by providing at least one specific blood glucose value range and at least one specific predetermined glycemic event, both corresponding to at least one specific dose value.

3. The method according to claim 1, further comprising the step of stopping to further increase the dose, wherein the stopping of the further increase of the dose is triggered by the alert, and wherein a predetermined user input is needed to deactivate the stopping of the further increase of the dose.

4. The method according to claim 1, further comprising the step of creating retest information, wherein the creating of the retest information is triggered by the alert and the retest information is for initiating a retest of the blood glucose value within a predetermined time.

5. The method according to claim 1, further comprising the step of displaying a message on a display indicating that the alert occurred, wherein the message comprises at least predefined safety instructions.

6. The method according to claim 5, wherein the retest information is displayed on the display for prompting a user to retest the blood glucose value within the predetermined time.

7. The method according to claim 1, further comprising the step of sending an additional message to a predetermined destination, wherein the sending of the additional message is triggered by the alert, and wherein the additional message comprises at least information indicating that the blood glucose value and the predetermined glycemic event are not in a specified relation to the previously adapted dose value.

8. A device for determining a dose of insulin to be administered for glycemic control, the device comprising:

a blood glucose determining unit adapted to determine a blood glucose value,

a storage unit adapted to store a previously adapted dose value,

a receiving unit arranged to receive a glycemic event information in respect to a predetermined glycemic event within a predetermined time interval and for receiving the previously adapted dose value stored in a storage unit,

adapting means arranged to stepwise adapting the dose according to the output of the receiving unit and the determining unit, and

an alert unit adapted to set an alert based on at least the blood glucose value, the glycemic event information and the previously adapted dose, wherein the alert unit is adapted to create the alert indicating that the blood glucose value and the predetermined glycemic event are not in a specified relation to the previously adapted dose value.

9. The device according to claim 8, further comprising a user interface adapted to receive instructions for defining the specified relation between the blood glucose value and the predetermined glycemic event and the previously adapted dose value by providing at least one specific blood glucose value range and at least one specific predetermined glycemic event both corresponding to at least one specific dose value, wherein the storage unit is further adapted to store the at least one specific blood glucose value range and the at least one specific predetermined glycemic event.

10. The device according to claim 8, further comprising a determining unit arranged to determine to stop the further increase of the dose based on the alert and arranged to receive a predetermined user input via the user interface for deactivating the stopping of the further increase of the dose.

11. The device according to claim 8, further comprising a message generation unit arranged to create retest information, wherein message generation unit is arranged to receive an alert signal from the alert unit and to generate the retest information for initiating a retest of the blood glucose value within a predetermined time.

12. The device according to claim 8, further comprising a display unit arranged to display a message indicating that the alert occurred, wherein the message generation unit is further arranged to create a message comprising at least predefined safety instructions.

13. The device according to claim 12, wherein the display unit is further arranged to display the retest information for prompting a user to retest the blood glucose value within the predetermined time.

14. The device according to claim 11, wherein the message generation unit further comprises a communication interface adapted to transmit an additional message to a predetermined destination, wherein the communication interface is arranged to transmit the additional message triggered by the alert, and wherein the message generation unit is further arranged to create the additional message comprising at least information indicating that the blood glucose value and the predetermined glycemic event are not in a specified relation to the previously adapted dose value.

15. A computer program for determining a dose of insulin to be administered for glycemic control, wherein the dose is stepwise adapted, the computer program comprising:

code for receiving a blood glucose value;

code for receiving glycemic event information in respect to a predetermined glycemic event, wherein the predetermined glycemic event occurred within a predetermined time interval;

code for receiving a previously adapted dose value stored in a storage unit; and

code for setting an alert based on at least the blood glucose value, the glycemic event information and the previously adapted dose, wherein the alert indicates that the blood glucose value and the predetermined glycemic event are not in a specified relation to the previously adapted dose value.

16. A computer program product comprising a computer-readable medium bearing computer program code embodied therein for use with a computer, wherein the computer program code comprises the computer program according to claim 15.