System and method for mitigating risk in automated medicament dosing

• US 10,864,322 B2
• Filed: 12/20/2017
• Issued: 12/15/2020
• Est. Priority Date: 09/06/2013
• Status: Active Grant

• Current Assignee: Tandem Diabetes Care Incorporated
• Original Assignee: Tandem Diabetes Care Incorporated
• Inventors: Saint, Sean, Rosinko, Michael
• Primary Examiner(s): Stiles, Amber R
• Application Number:
  US15/848,163
• Publication Number:
  US 20180110921A1
• Time in Patent Office: 1,091 Days
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2209/01 Remote controllers for specific apparatus
• 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 20/17 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: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 50/70 for mining of medical data, e.g. analysing previous cases of other patients

Abstract

A portable infusion pump can communicate with glucose monitor, such as a continuous glucose monitor (CGM), to receive continuous feedback relating to a user'"'"'s blood glucose level during insulin or other medicament therapy and can automatically deliver insulin to a user when the CGM data indicates a need for additional insulin. Due to potential unreliability in the correlation of the CGM data to the user'"'"'s actual blood glucose level, risk mitigation can be employed to limit the amount of extra insulin that can be delivered by the pump in response to the CGM data.

Claims

1. A portable infusion system, comprising:

a delivery mechanism adapted to facilitate delivery of a medicament to a user;

a memory adapted to store parameters relating to the delivery of the medicament;

a communications device adapted to receive information from a continuous glucose monitor;

a processor functionally linked to the delivery mechanism, the memory and the communications device, the processor configured to;

obtain the information from the continuous glucose monitor;

store in a memory a threshold relating to predicted accuracy of the continuous glucose monitor after which automatic adjustment of the delivery of the medicament based on the information from the continuous glucose monitor is not permitted;

monitor the information received from the continuous glucose monitor;

determine that the threshold has been reached;

disable automatic adjustment of the delivery of the medicament based on the information from the continuous glucose monitor if it is determined that the threshold has been reached.

2. The portable infusion system of claim 1, wherein the threshold is set as an amount of time that has elapsed since a most recent calibration of the continuous glucose monitor.

3. The portable infusion system of claim 2, wherein the processor is configured to determine that the continuous glucose monitor has been calibrated and re-enable automatic adjustment after determining that the continuous glucose monitor has been calibrated.

4. The portable infusion system of claim 3, wherein the processor automatically re-enables automatic adjustment after determining that the continuous glucose monitor has been calibrated.

5. The portable infusion system of claim 2, wherein the amount of time is 12 hours.

6. The portable infusion system of claim 1, wherein the threshold is set as a maximum predicted error of the continuous glucose monitor.

7. The portable infusion system of claim 1, wherein the threshold is set as a maximum difference between a blood glucose level at a most recent calibration of the continuous glucose monitor and a current estimated blood glucose level of the continuous glucose monitor.

8. The portable infusion system of claim 1, wherein the processor is a part of an ambulatory infusion pump that includes the delivery mechanism.

9. The portable infusion system of claim 1, wherein the processor is further configured to provide a notification on a user interface that automatic adjustment of the delivery of the medicament has been disabled.

10. The portable infusion system of claim 9, wherein the user interface is part of an ambulatory infusion pump that includes the delivery mechanism.

11. A portable infusion system, comprising:

a delivery mechanism adapted to facilitate delivery of a medicament to a user;

a memory adapted to store parameters relating to the delivery of the medicament;

a communications device adapted to receive information from a continuous glucose monitor;

a processor functionally linked to the delivery mechanism, the memory and the communications device, the processor configured to;

obtain the information from the continuous glucose monitor;

enable automated dosing during which at least some delivery of the medicament to the user is automatically adjusted based on the information from the continuous glucose monitor;

store a predetermined time limit for automated dosing, the predetermined time limit determined based on a predicted reliability of the information from the continuous glucose monitor;

disable automated dosing upon determining that the predetermined time limit has been reached.

12. The portable infusion system of claim 11, wherein the predetermined time limit is based on a time since a most recent calibration of the continuous glucose monitor.

13. The portable infusion system of claim 12, further comprising:

receiving an indication that the continuous glucose monitor has been calibrated; and

resetting the predetermined time limit after receiving the indication that the continuous glucose monitor has been calibrated.

14. The portable infusion system of claim 12, wherein the processor is configured to determine that the continuous glucose monitor has been calibrated and re-enable automated dosing after determining that the continuous glucose monitor has been calibrated.

15. The portable infusion system of claim 14, wherein the processor automatically re-enables automated dosing after determining that the continuous glucose monitor has been calibrated.

16. The portable infusion system of claim 11, wherein the processor is a part of an ambulatory infusion pump that includes the delivery mechanism.

17. The portable infusion system of claim 11, wherein the processor is further configured to provide a notification on a user interface that automated dosing has been disabled.

18. The portable infusion system of claim 17, wherein the user interface is part of an ambulatory infusion pump that includes the delivery mechanism.