BASAL RATE TESTING USING FREQUENT BLOOD GLUCOSE INPUT

• US 20170000943A1
• Filed: 09/15/2016
• Published: 01/05/2017
• Est. Priority Date: 03/13/2007
• Status: Active Grant

• Current Assignee: Tandem Diabetes Care Incorporated
• Original Assignee: Tandem Diabetes Care Incorporated
• Inventors: Savard, Thomas Alan, Blomquist, Michael L.
• Granted Patent: US 11,291,763 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2005/14292 Computer-based infusion planning or simulation of spatio-temporal infusate distribution
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2230/005 Parameter used as control input for the apparatus
• 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: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 40/63 for local operation

Abstract

An apparatus comprising a user interface configured to generate an electrical signal to start a basal insulin rate test when prompted by a user, an input configured to receive sampled blood glucose data of a patient that is obtained during a specified time duration, including a time duration during delivery of insulin according to a specified basal insulin rate pattern, and a controller communicatively coupled to the input and the user interface. The controller includes an insulin calculation module configured for determining at least one of an amount of basal insulin over-delivered and an amount of basal insulin under-delivered during the basal insulin rate test in trying to meet a target blood glucose baseline. Other devices and methods are disclosed.

Claims

1. An apparatus comprising:

a user interface configured to generate an electrical signal to start a basal insulin rate test when prompted by a user;

an input configured to receive sampled blood glucose data of a patient that is obtained during a specified time duration, including a time duration when insulin is delivered according to a specified basal insulin rate pattern; and

a controller communicatively coupled to the input and the user interface, the controller including an insulin calculation module, wherein the insulin calculation module is configured to determine at least one of an amount of basal insulin over-delivered and an amount of basal insulin under-delivered during the basal insulin rate test in trying to meet a target blood glucose baseline.

2. The apparatus of claim 1, wherein the insulin calculation module is configured to determine the over-delivered amount and the under-delivered amount using a correction factor of the patient and a variance of a blood glucose level from the target blood glucose baseline.

3. The apparatus of claim 2, wherein the insulin calculation module is configured to determine the over-delivered amount and the under-delivered amount using an adjusted correction factor of the patient.

4. The apparatus of claim 2, wherein the insulin calculation module is configured to determine a recommended change, if any, to the basal insulin rate pattern.

5. The apparatus of claim 4, wherein the recommended change precedes any actual time of over-delivery or under-delivery by a time duration that compensates for a lag time associated with subcutaneous insulin delivery.

6. The apparatus of claim 4, wherein the user interface includes a display operatively coupled to the controller, and wherein the controller is configured to display at least one user instruction for the basal insulin rate test.

7. The apparatus of claim 6, wherein the controller is configured to display a recommended change to a basal insulin rate pattern.

8. The apparatus of claim 4, including:

a pump mechanism configured to deliver insulin according to the specified basal insulin rate pattern; and

a memory to store at least one basal insulin rate pattern, wherein the pump mechanism and the memory are operatively coupled to the controller.

9. The apparatus of claim 8, including a blood glucose monitor communicatively coupled to the input.

10. The apparatus of claim 9, wherein the blood glucose monitor is a continuous blood glucose monitor configured to automatically collect the sampled blood glucose data.

11. The apparatus of claim 10, including:

a display operatively coupled to the controller, and

wherein the controller is configured to prompt the user, via the display, to begin a blood glucose measurement using the blood glucose monitor.

12. The apparatus of claim 8, wherein the user interface and the input are configured to receive the sampled blood glucose data entered manually by the user.

13. The apparatus of claim 12, including:

a display operatively coupled to the controller, wherein the controller is configured to display user instructions for the basal rate test, including periodically prompting the user to enter a blood glucose value.

14. The apparatus of claim 8, wherein the insulin calculation module is configured to determine an amount of active insulin in the patient and to cancel the basal insulin rate test if the active insulin amount is above a specified threshold insulin amount.

15. The apparatus of claim 8, wherein the controller is configured to determine whether an insulin bolus dose is delivered and to cancel the basal insulin rate test if it determines that an insulin bolus dose is delivered during the basal insulin rate test.

16. The apparatus of claim 8, including a real time clock coupled to the controller, wherein the controller is configured to vary a basal rate of insulin delivery by a time of day according to the basal rate pattern.

17. The apparatus of claim 4, wherein the input is a first input and the apparatus further includes:

a blood glucose sensor circuit operatively coupled to the first input, the blood glucose sensor circuit configured to produce a blood glucose signal representative of a blood glucose level of the patient and provide the sampled blood glucose data to the first input;

a second input communicatively coupled to the controller, wherein the second input is configured to receive information related to insulin delivery according to the basal rate pattern, and

wherein the insulin calculation module is configured to determine at least one of the amount of basal insulin over-delivered and the amount of basal insulin under-delivered using the insulin delivery information and the sampled blood glucose data.

18. The apparatus of claim 17, including a communication port communicatively coupled to the second input, the communication port to receive the information related to insulin delivery.

19. The apparatus of claim 18, wherein the controller is configured to communicate a recommended change to the basal rate pattern through the communication port.

20. The apparatus of claim 17, wherein the user interface and the second input are configured to receive the information related to insulin delivery that is entered manually by the user.