# US 10,311,976 B2 · Bolus calculator with probabilistic carbohydrate measurements

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- Number: US 10,311,976 B2
- Document ID: US10311976B2
- Status: Granted
- Kind: B2
- Application number: 15/140,550
- Filed: 2016-04-28
- Published: 2017-11-02
- Granted: 2019-06-04
- Earliest claimed: 2016-04-28
- Assignees: Roche Diabetes Care, Inc.
- Applicants: Roche Diabetes Care, Inc.
- Inventors: David L. Duke
- Web page: https://patentgrep.com/patent/US10311976B2

## CPC

- G16H 20/10: relating to drugs or medications, e.g. for ensuring correct administration to patients
- G16H 20/17: delivered via infusion or injection
- G16H 20/60: relating to nutrition control, e.g. diets
- G16H 50/30: for calculating health indices; for individual health risk assessment
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## Abstract

Methods and devices involving using a bolus calculator to account for an uncertainty of a carbohydrate estimate to reduce a risk of hypoglycemia and a risk of hyperglycemia. More specifically, methods and devices using an algorithm executed by a processor of the bolus calculator and using a carbohydrate estimate and a measure defining the uncertainty of the carbohydrate estimate to determine the probability of hypoglycemia and hyperglycemia if the carbohydrate estimate is an overestimate or an underestimate, and subsequently providing recommendations and alerts to a user.

## Claims

### Claim 1

A method of using a bolus calculator to account for an uncertainty of a carbohydrate estimate to reduce a risk of hypoglycemia and a risk of hyperglycemia comprising:
providing the bolus calculator containing therewithin a processor that when activated executes an algorithm defining pre-set values for:
a first threshold percentage defining a probability of hypoglycemia (Phypo);
a second threshold percentage defining a probability of hyperglycemia (Phyper);
a hypoglycemia threshold (Thypo); and
a hyperglycemia threshold (Thyper); and
providing to the bolus calculator the carbohydrate estimate and a measure defining the uncertainty of the carbohydrate estimate (c);
activating the processor to execute the algorithm to use the pre-set values, the carbohydrate estimate and the measure defining the uncertainty of the carbohydrate estimate to:
determine the probability of hypoglycemia if the carbohydrate estimate has overestimated the carbohydrate content and therefore a standard meal insulin bolus has been overestimated and thus should be adjusted to reduce the risk of hypoglycemia: and
determine the probability of hyperglycemia if the carbohydrate estimate has underestimated the carbohydrate content and therefore the standard meal insulin bolus has been underestimated and thus should be adjusted to reduce the risk of hyperglycemia;
providing a recommendation to a user when the carbohydrate estimate has been overestimated to adjust a corresponding meal insulin bolus;
administering the adjusted corresponding meal insulin bolus through a therapy delivery device operatively coupled to the bolus calculator to the user such that the administered adjusted corresponding meal insulin bolus affects a blood glucose value of the user to reduce the risk of hypoglycemia; and
alerting the user when the carbohydrate estimate has been underestimated recommending a post-prandial glucose measurement.

### Claim 2 (depends on 1)

The method of claim 1 further comprising setting the threshold percentage defining the probability of hypoglycemia at about five percent, and setting the threshold percentage defining the probability of hyperglycemia at about seventy-five percent.

### Claim 3 (depends on 1)

The method of claim 1 further comprising setting the threshold percentage defining the probability of hypoglycemia at between about ten percent and twenty-five percent, and setting the threshold percentage defining the probability of hyperglycemia between about seventy percent to about eighty percent.

### Claim 4

A method of using a bolus calculator to account for an uncertainty of a carbohydrate estimate to reduce a risk of hypoglycemia and a risk of hyperglycemia comprising:
providing the bolus calculator containing therewithin a processor that when activated executes an algorithm defining pre-set values for:
a first threshold percentage defining a probability of hypoglycemia (Phypo);
a second threshold percentage defining a probability of hyperglycemia (Phyper);
a hypoglycemia threshold (Thypo); and
a hyperglycemia threshold (Thyper); and
providing to the bolus calculator the carbohydrate estimate (c) and a standard deviation (σc) defining the uncertainty of the carbohydrate estimate;
activating the processor to execute the algorithm;
determining the probability of hypoglycemia if the carbohydrate estimate has overestimated the carbohydrate content and therefore a standard meal insulin bolus has been overestimated and thus should be adjusted to reduce the risk of hypoglycemia by:
calculating the standard meal insulin bolus (Imeal) utilizing the carbohydrate estimate and a carbohydrate ratio of a user;
calculating, using the carbohydrate estimate, the standard deviation, and a parameter on a normal cumulative distribution, a first level (cPhypo) corresponding the threshold percentage defining the probability of hypoglycemia;
calculating a hypoglycemia-averse insulin bolus (Ihypo(x) %) using an insulin sensitivity factor of the user, the hypoglycemia threshold and the calculated first level;
comparing the standard meal insulin bolus with the hypoglycemia-averse insulin bolus;
selecting the minimum of the standard meal insulin bolus and the hypoglycemia-averse insulin bolus thereby accounting for the risk of hypoglycemia;
administering the selected minimum bolus through a therapy delivery device operatively coupled to the bolus calculator to the user such that the administered selected minimum bolus affects a blood glucose value of the user to reduce the risk of hypoglycemia; and
determining the probability of hyperglycemia if the carbohydrate estimate has underestimated the carbohydrate content and therefore the standard meal insulin bolus has been underestimated and thus should be adjusted to reduce the risk of hyperglycemia by:
calculating, using the carbohydrate estimate, the standard deviation, and a parameter on a normal cumulative distribution a second level, (cPhyper) corresponding to the threshold percentage defining the probability of hyperglycemia;
calculating, using the calculated second level, the user carbohydrate ratio, the user insulin sensitivity factor, and the target glucose level, a value representing a post-prandial glucose estimate;
comparing the value to the hyperglycemia threshold; and
providing an alert to the user instructing the user to take a post-prandial glucose measurement when the value is greater than the hyperglycemia threshold, thereby accounting for the risk of hyperglycemia.

### Claim 5 (depends on 4)

The method of claim 4 further comprising coupling the bolus calculator with a physically separate memory such that the standard deviation is derived in part from the medical history of the user.

### Claim 6 (depends on 4)

The method of claim 4 further comprising a memory within the bolus calculator, wherein the standard deviation is derived in part from previous determinations of the user as to an ability to estimate carbohydrates.

### Claim 7 (depends on 4)

The method of claim 4 further comprising a memory, wherein the standard deviation is derived in part from previous tests provided to the user testing estimating carbohydrates.

### Claim 8 (depends on 4)

The method of claim 4 further comprising the user providing to the bolus calculator the carbohydrate estimate.

### Claim 9 (depends on 4)

The method of claim 4 further comprising querying the user, by the bolus calculator, of the certainty of the carbohydrate estimate provided by the user, and providing the user with options detailing the uncertainty that can be selected.

### Claim 10 (depends on 4)

The method of claim 4 further comprising providing, visually via the display, the alert to the user instructing the user to take the post-prandial glucose measurement.

### Claim 11 (depends on 4)

The method of claim 4 further comprising setting the threshold percentage defining the probability of hypoglycemia at about five percent, and setting the threshold percentage defining the probability of hyperglycemia at about seventy-five percent.

### Claim 12 (depends on 4)

The method of claim 4 further comprising setting the threshold percentage defining the probability of hypoglycemia at between about ten percent and twenty-five percent, and setting the threshold percentage defining the probability of hyperglycemia between about seventy percent to about eighty percent.

### Claim 13

A bolus calculator to account for an uncertainty of a carbohydrate estimate to reduce a risk of hypoglycemia and a risk of hyperglycemia comprising:
a processor that when activated is configured to execute an algorithm defining pre-set values for:
a first threshold percentage defining a probability of hypoglycemia (Phypo);
a second threshold percentage defining a probability of hyperglycemia (Phyper);
a hypoglycemia threshold (Thypo); and
a hyperglycemia threshold (Thyper); and
the processor is configured, upon receipt by the bolus calculator of the carbohydrate estimate and a standard deviation (σc) that defines the uncertainty of the carbohydrate estimate (c), to:
determine the probability of hypoglycemia if the carbohydrate estimate has overestimated the carbohydrate content and therefore a standard meal insulin bolus has been overestimated and thus should be adjusted to reduce the risk of hypoglycemia in which the processor:
calculate the standard meal insulin bolus (Imeal) utilizing the carbohydrate estimate and a carbohydrate ratio of a user;
calculate, using the carbohydrate estimate, the standard deviation, and a parameter on a normal cumulative distribution, a first level, (cPhypo) corresponding to the threshold percentage defining the probability of hypoglycemia;
calculate a hypoglycemia-averse insulin bolus (Ihypo(x) %) using an insulin sensitivity factor of the user, the hypoglycemia threshold and the calculated first level;
compare the standard meal insulin bolus with the hypoglycemia-averse insulin bolus;
selects the minimum of the standard meal insulin bolus and the hypoglycemia-averse insulin bolus thereby accounting for the risk of hypoglycemia;
administer the selected minimum bolus through a therapy delivery device operatively coupled to the bolus calculator to the user such that the administered selected minimum bolus affects a blood glucose value of the user to reduce the risk of hypoglycemia; and
determine the probability of hyperglycemia if the carbohydrate estimate has underestimated the carbohydrate content and therefore the standard meal insulin bolus has been underestimated and thus should be adjusted to reduce the risk of hyperglycemia in which the processor:
calculate, using the carbohydrate estimate, the standard deviation, and a parameter on a normal cumulative distribution, a second level, (cPhyper) corresponding to the threshold percentage defining the probability of hyperglycemia;
calculate, using the calculated second level, the user insulin sensitivity factor, and the target glucose level, a value representing a post-prandial glucose estimate;
compare the value to the hyperglycemia threshold; and
provide an alert to the user instructing the user to take a post-prandial glucose measurement when the value is greater than the hyperglycemia threshold, thereby accounting for the risk of hyperglycemia.

### Claim 14 (depends on 13)

The bolus calculator of claim 13 further comprising a physically separate memory coupled to the bolus calculator such that the standard deviation is derived in part from the medical history of the user stored in the memory.

### Claim 15 (depends on 13)

The bolus calculator of claim 13 wherein the bolus calculator contains a memory therewithin such that the standard deviation is derived in part from previous determinations of the user as to an ability to estimate carbohydrates which have been previously stored in the memory.

### Claim 16 (depends on 13)

The bolus calculator of claim 13 wherein the bolus calculator is coupled to a memory such that the standard deviation is derived in part from previous tests provided to the user testing estimating carbohydrates which have been previously stored in the memory.

### Claim 17 (depends on 13)

The bolus calculator of claim 13 wherein the bolus calculator is configured to query the user, to ask for the carbohydrate estimate.

### Claim 18 (depends on 13)

The bolus calculator of claim 13 wherein the bolus calculator is configured to query the user, to ask of the certainty of the carbohydrate estimate provided by the user, and provide the user with options detailing the uncertainty that can be selected via buttons on a display of the bolus calculator.

### Claim 19 (depends on 13)

The bolus calculator of claim 13 wherein the processor is configured to provide, visually via the display, the alert to the user which instructs the user to take the post-prandial glucose measurement.

### Claim 20 (depends on 13)

The bolus calculator of claim 13 wherein the processor is configured to set the threshold percentage defining the probability of hypoglycemia at about five percent, and set the threshold percentage defining the probability of hyperglycemia at about seventy-five percent.

### Claim 21

An improved graphical user interface (GUI) display of a bolus calculator with a memory and a processor to execute one or more programs stored in the memory to account for an uncertainty of a carbohydrate estimate to reduce a risk of hypoglycemia and a risk of hyperglycemia, the improved GUI display operatively coupled to the processor, the improved GUI display comprising:
a probability of hypoglycemia when the carbohydrate estimate has overestimated the carbohydrate content and therefore a standard meal insulin bolus has been overestimated and thus should be adjusted to reduce the risk of hypoglycemia, and the bolus adjustment;
a probability of hyperglycemia when the carbohydrate estimate has underestimated the carbohydrate content and therefore the standard meal insulin bolus has been underestimated and thus should be adjusted to reduce the risk of hyperglycemia, and an alert to take a post-prandial glucose measurement; and
wherein the processor when activated is configured to execute an algorithm defining pre-set values for:
a first threshold percentage defining the probability of hypoglycemia (Phypo);
a second threshold percentage defining the probability of hyperglycemia (Phyper);
a hypoglycemia threshold (Thypo); and
a hyperglycemia threshold (Thyper); and
the processor is configured, upon receipt by the bolus calculator of the carbohydrate estimate and a standard deviation (σc) that defines the uncertainty of the carbohydrate estimate (c), to:
determine the probability of hypoglycemia if the carbohydrate estimate has overestimated the carbohydrate content and therefore a standard meal insulin bolus has been overestimated and thus should be adjusted to reduce the risk of hypoglycemia in which the processor:
calculate the standard meal insulin bolus (Imeal) utilizing the carbohydrate estimate and a carbohydrate ratio of a user;
calculate, using the carbohydrate estimate, the standard deviation, and a parameter on a normal cumulative distribution, a first level, (cPhypo) corresponding to the threshold percentage defining the probability of hypoglycemia;
calculate a hypoglycemia-averse insulin bolus (Ihypo(x) %) using an insulin sensitivity factor of the user, the hypoglycemia threshold and the calculated first level;
compare the standard meal insulin bolus with the hypoglycemia-averse insulin bolus;
select the minimum of the standard meal insulin bolus and the hypoglycemia-averse insulin bolus thereby accounting for the risk of hypoglycemia; and
determine the probability of hyperglycemia if the carbohydrate estimate has underestimated the carbohydrate content and therefore the standard meal insulin bolus has been underestimated and thus should be adjusted to reduce the risk of hyperglycemia in which the processor:
calculate, using the carbohydrate estimate, the standard deviation, and a parameter on a normal cumulative distribution, a second level, (cPhyper) corresponding to the threshold percentage defining the probability of hyperglycemia;
calculate, using the calculated second level, the user insulin sensitivity factor, and the target glucose level, a value representing a post-prandial glucose estimate;
compare the value to the hyperglycemia threshold; and
provide an alert to the user instructing the user to take a post-prandial glucose measurement when the value is greater than the hyperglycemia threshold, thereby accounting for the risk of hyperglycemia.