Intelligent therapy recommendation algorithm and method of using the same

1. A method of automatically making a therapy recommendation to adjust a stored insulin pump parameter, the method comprising the steps of:

obtaining a blood glucose value at the end of a time interval;

determining if an intervening event occurred during the time interval before the blood glucose value was obtained, wherein the intervening event includes at least one of a meal, a correction bolus, and an error code that changes the blood glucose value unrelated to the stored pump parameter and thereby interferes with recommending a change to the stored pump parameter;

recommending no change to the stored pump parameter based on the blood glucose value if the intervening event occurred during the time interval before the blood glucose value was obtained;

updating a recommended change to the stored pump parameter based on a previous recommended change to the stored pump parameter and the difference between the blood glucose value and a target blood glucose level if no intervening event occurred during the time interval;

comparing an absolute value of the updated recommended change to a predefined threshold value of the stored pump parameter, wherein the predefined threshold value is 0.05 or 0.1 U/h when the stored pump parameter is a basal rate, the predefined threshold value is 5 grams carbohydrates per unit of insulin when the stored pump parameter is a carbohydrate-to-insulin ratio (CR), and the predefined threshold value is 5 mg/dl for a Unit of insulin when the stored pump parameter is an insulin sensitivity factor (ISF);

making the therapy recommendation if the updated recommended change exceeds the threshold and the therapy recommendation is within safety parameters; and

displaying the therapy recommendation to adjust the stored pump parameter.

2. The method of claim 1 , wherein the blood glucose value is obtained by a continuous glucose monitor.

3. The method of claim 1 , wherein the pump parameter is a basal rate.

4. The method of claim 1 , wherein the pump parameter is a carbohydrate-to-insulin ratio (CM).

5. The method of claim 4 , wherein the step of updating a recommended change further comprises:

updating the recommended change for the CIR from a first postprandial blood glucose value;

updating the recommended change using a second postprandial blood glucose value if a second postprandial blood glucose value exists; and

repeating the updating step for any additional postprandial blood glucose values if they exist.

6. The method of claim 5 , wherein the time interval is a postprandial period after a meal, and the step of recommending no change to the stored pump parameter further comprises: skipping the first, second or any additional postprandial blood glucose value if the intervening event occurred during the time interval.

7. The method of claim 1 , wherein the pump parameter is an insulin sensitivity factor (ISF).

8. The method of claim 7 , wherein the step of updating a recommended change further comprises:

updating the recommended change for the ISF from a first post correction bolus blood glucose value;

updating the recommended change using a second postprandial blood glucose value if a second post correction bolus blood glucose value exists; and

repeating the updating step for any additional post correction bolus blood glucose values if they exist.

9. The method of claim 8 , wherein the time interval is a predetermined window of time after the correction bolus, and the step of recommending no change to the stored pump parameter further comprises: skipping the first, second, or any additional post correction bolus blood glucose value if the intervening event occurred during the time interval.

10. The method of claim 1 , wherein the step of confirming the therapy recommendation is within safety parameters comprises:

reviewing recent blood glucose history; and

using a moving standard deviation analysis on the recent blood glucose history to confirm the blood glucose value is relatively consistent with the blood glucose history.

11. The method of claim 10 , wherein the moving standard deviation analysis is only performed on a therapy recommendation that will lead to an increase in insulin.

12. The method of claim 1 , wherein the step of confirming the therapy recommendation is within safety parameters further comprises:

limiting the therapy recommendation to a particular maximum value.

13. The method of claim 1 , wherein the step of confirming the therapy recommendation is within safety parameters comprises:

limiting the pump parameter to an absolute maximum or absolute minimum.

14. The method of claim 1 , further comprising: resetting the recommended change when the recommended change exceeds the threshold.

15. A method of automatically making a therapy recommendation for adjusting a basal rate stored on an insulin pump, the method comprising the steps of:

obtaining a blood glucose value at the end of a time interval;

determining if an intervening event occurred during the time interval , wherein the intervening event changes the blood glucose value unrelated to the stored basal rate and thereby interferes with recommending a change to the stored basal rate;

recommending no change to the stored basal rate based on the blood glucose value if the intervening event occurred during the time interval;

updating a recommended change to the stored basal rate based on a previous day recommended change to the stored basal rate during that interval and the difference between the blood glucose value and a target blood glucose level if no intervening event occurred during the time interval;

comparing an absolute value of the updated recommended change to a predefined threshold value of the stored basal rate, wherein the predefined threshold value is 0.05 or 0.1 U/h;

making the therapy recommendation if the updated recommended change exceeds the threshold and the therapy recommendation is within safety parameters; and

displaying the therapy recommendation to adjust the stored basal rate.

16. The method of claim 15 , wherein the basal rate is an overnight basal rate.

17. The method of claim 15 , wherein the step of recommending no change to the stored basal rate further comprises: skipping the blood glucose value if the intervening event includes a meal or a correction bolus during the time interval before the blood glucose value was obtained.

18. The method of claim 15 , wherein the step of confirming the therapy recommendation is within safety parameters comprises:

reviewing recent blood glucose history; and

using a moving standard deviation analysis on the recent blood glucose history to confirm the blood glucose value is relatively consistent with the blood glucose history.