Control-to-range failsafes

• US 10,332,632 B2
• Filed: 06/01/2016
• Issued: 06/25/2019
• Est. Priority Date: 06/01/2016
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Duke, David L., Ringemann, Christian, Manohar, Chinmay Uday
• Primary Examiner(s): Gray, Phillip A
• Application Number:
  US15/170,425
• Publication Number:
  US 20170348482A1
• Time in Patent Office: 1,119 Days
• Field of Search: 604500-504
• 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 2205/3303 Using a biosensor
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• 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 40/67 for remote operation
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems

Abstract

Methods and systems are disclosed for determining a basal rate adjustment of insulin in a continuous glucose monitoring system of a person with diabetes. A method may include receiving, by at least one computing device, a signal representative of at least one glucose measurement and detecting, by the at least one computing device, a glucose state of the person based on the signal, the detected glucose state including a glucose level of the person and a rate of change of the glucose level. The method may also include calculating, by the at least one computing device, an adjustment to a basal rate of a therapy delivery device based on a control-to-range algorithm and at least one failsafe constraint to account for changes in the insulin sensitivity of the person with diabetes or inaccurate glucose measurement.

Claims

1. A method of determining a basal rate adjustment of insulin in a continuous glucose monitoring system of a person with diabetes, the method comprising:

receiving, by at least one computing device, a signal representative of at least one glucose measurement;

detecting, by the at least one computing device, a glucose state of the person based on the signal, the detected glucose state including a glucose level of the person and a rate of change of the glucose level;

calculating, by the at least one computing device, an adjustment to a basal rate of a therapy delivery device based on a control-to-range algorithm and at least one failsafe constraint to account for changes in the insulin sensitivity of the person with diabetes or inaccurate glucose measurement, wherein the therapy delivery device has a nominal basal rate representing an unadjusted basal rate set for the person with diabetes;

wherein the failsafe constraint is calculated in accordance with a method selected from the group consisting of;

(a) calculating bolus recommendations with a bolus calculator, the computing device comprising the bolus calculator, and

treating increases in the basal rate as a bolus and inputting the bolus into the bolus calculator if the increase is greater than a threshold representing a predetermined multiple of the nominal basal rate;

(b) determining if the basal rate is at or below a threshold value, and

limiting the control-to-range algorithm to increasing the basal rate to a limiting nominal basal rate for a specified period of time if the basal rate is at or below the threshold value;

(c) limiting the amount that the control-to-range algorithm may increase a basal rate multiplier during each evaluation period to a maximum basal multiplier delta;

(d) determining the sum of basal rate increases over a defined time span,

determining if the sum of basal rate increases is greater than the insulin equivalent of a predetermined allocation of rescue carbohydrates, and

limiting the basal rate increase if the sum of basal rate increases is greater than the insulin equivalent;

(e) determining if the basal rate remains above 1.1×

the nominal basal rate for a predetermined period of time,

alerting the person with diabetes to test their blood sugar and input the tested blood sugar into the continuous glucose monitoring system as an input blood sugar measurement, and

accessing agreement between the input blood sugar measurement and the detected glucose level of the person with diabetes within a predetermined metric of quality, wherein if the at least one computing device determines the input blood sugar measurement and the detected glucose level of the person with diabetes are not in agreement within the predetermined metric of quality, the control-to-range algorithm is turned off or the aggressiveness is reduced until the sensor in the continuous glucose monitoring system is replaced or the sensor is recalibrated and confirmed to be accurate; and

(f) combinations thereof.

2. The method of claim 1, further comprising displaying to a user, on a graphical user interface, graphical data representative of the calculated adjustment to the basal rate.

3. The method of claim 1, further comprising transmitting a control signal to instruct the therapy delivery device to adjust the basal rate based on the calculated adjustment.

4. The method of claim 3, wherein the therapy delivery device includes an insulin pump for delivering insulin to the person with diabetes, and the therapy delivery device is in communication with the at least one computing device for receiving the calculated adjustment of the basal rate.

5. The method of claim 1, wherein for failsafe constraint (a) the increase in the basal rate is converted into a bolus for input into the bolus calculator by the at least one computing device in accordance with

I_corr=(TBR−

100%)*BR*TBR_duration

where I_corr is the correction bolus, TBR is a temporary basal rate, BR is the nominal basal rate, and TBR_duration is the duration of the TBR.

6. The method of claim 1, wherein the threshold is 1.3×

the nominal basal rate.

7. The method of claim 1, wherein for failsafe constraint (b) the threshold value is 0.2×

the nominal basal rate.

8. The method of claim 1, wherein for failsafe constraint (b) the threshold value is zero.

9. The method of claim 1, wherein for failsafe constraint (b) the limiting nominal basal rate is 1.1×

the nominal basal rate.

10. The method of claim 1, wherein for failsafe constraint (b) the specified period of time is 2 hours.

11. The method of claim 10, wherein a basal multiplier of the nominal basal rate is limited based on the current basal rate and a person with diabetes'"'"' insulin sensitivity factor.

12. The method of claim 11, wherein the limit of the multiplier of the nominal basal rate is determined by the at least one computing device in accordance with

13. The method of claim 1, wherein for failsafe constraint (c) the maximum basal multiplier delta is 0.5×

the nominal basal rate.

14. The method of claim 1, wherein for failsafe constraint (e) the predetermined metric of quality is agreement within +/−

20%.

15. The method of claim 1, wherein for failsafe constraint (b) if the basal rate is reduced to 0% of the nominal basal rate for 2 detecting cycles of the glucose state, the basal rate is prevented from rising above 1.1×

the nominal basal rate for 120 minutes.

16. A blood glucose management device configured to determine a basal rate adjustment in a continuous glucose monitoring system of a person with diabetes, the device comprising:

a non-transitory computer-readable medium storing executable instructions; and

at least one processing device configured to execute the executable instructions such that, when executed by the at least one processing device, the executable instructions cause the at least one processing device to;

receive a signal representative of at least one glucose measurement;

detect a glucose state of the person based on the signal, the detected glucose state including a glucose level of the person and a rate of change of the glucose level; and

calculate an adjustment to a basal rate of a therapy delivery device based on a control-to-range algorithm and at least one failsafe constraint to account for changes in the insulin sensitivity of the person with diabetes or inaccurate glucose measurement, wherein the therapy delivery device has a nominal basal rate representing an unadjusted basal rate set for the person with diabetes;

wherein the failsafe constraint is calculated in accordance with a method selected from the group consisting of;

(a) calculating bolus recommendations with a bolus calculator, the computing device comprising the bolus calculator, and

treating increases in the basal rate as a bolus and inputting the bolus into the bolus calculator if the increase is greater than a threshold representing a predetermined multiple of the nominal basal rate;

(b) determining if the basal rate is at or below a threshold value, and

limiting the control-to-range algorithm to increasing the basal rate to a limiting nominal basal rate for a specified period of time if the basal rate is at or below the threshold value;

(c) limiting the amount that the control-to-range algorithm may increase a basal rate multiplier during each evaluation period to a maximum basal multiplier delta;

(d) determining the sum of basal rate increases over a defined time span,

determining if the sum of basal rate increases is greater than the insulin equivalent of a predetermined allocation of rescue carbohydrates, and

limiting the basal rate increase if the sum of basal rate increases is greater than the insulin equivalent;

(e) determining if the basal rate remains above 1.1×

the nominal basal rate for a predetermined period of time,

alerting the person with diabetes to test their blood sugar and input the tested blood sugar into the continuous glucose monitoring system as an input blood sugar measurement, and

accessing agreement between the input blood sugar measurement and the detected glucose level of the person with diabetes within a predetermined metric of quality, wherein if the at least one computing device determines the input blood sugar measurement and the detected glucose level of the person with diabetes are not in agreement within the predetermined metric of quality, the control-to-range algorithm is turned off or the aggressiveness is reduced until the sensor in the continuous glucose monitoring system is replaced or the sensor is recalibrated and confirmed to be accurate; and

(f) combinations thereof.