Glycemic health metric determination and application

• US 9,445,757 B2
• Filed: 12/15/2011
• Issued: 09/20/2016
• Est. Priority Date: 12/29/2010
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Desborough, Lane, Palerm, Cesar C.
• Primary Examiner(s): Riggs, II, Larry D
• Application Number:
  US13/326,890
• Publication Number:
  US 20120172694A1
• Time in Patent Office: 1,741 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• 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: A61B 5/6849 in combination with a needle set
• CPC Class Codes: A61B 5/7225 Details of analog processing, e.g. isolation amplifier, gain or sensitivity adjustment, filtering, baseline or drift compensation A61B5/30, A61B5/316 take precedence; transformers for specific applications H01F38/00; amplifiers H03F
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: A61B 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment

Abstract

Disclosed are methods, apparatuses, etc. for determination and application of a unidimensional metric for assessing a patient'"'"'s glycemic health. In one particular implementation, a computed metric may be used to balance short-term and long-term risks associated with a particular therapy. In another implementation, a computed unidimensional metric may be used to balance risks of hyperglycemia and hypoglycemia.

Claims

1. A method using one or more indicators of glycemic health in a patient to balance one or more of hypoglycemic or hyperglycemic tendencies for the patient, the method comprising:

at a special purpose computing apparatus, computing a profile of a blood glucose concentration of the patient based, at least in part, on observations of the blood glucose concentration collected at a blood glucose monitoring device;

applying a cost or loss function to the computed profile to compute a metric for balancing short-term and long-term risks associated with a therapy, the metric representative of the glycemic health of the patient, the cost or loss function being based, at least in part, on a log-square metric, wherein the metric is also based, at least in part, on a parameter selected to balance one or more Spearman rank coefficients with one or more hypoglycemic-based metrics and one or more hyperglycemic-based metrics; and

altering an insulin therapy applied to the patient by an infusion device, the altered insulin therapy determined based, at least in part, on the computed metric, wherein the altered insulin therapy is also based, at least in part, on a target blood glucose concentration level or target blood glucose range that has been adjusted upward or downward based, at least in part, on an indication by the computed metric of whether the patient is tending towards hypoglycemia or tending towards hyperglycemia.

2. The method of claim 1, wherein the metric comprises a unidimensional metric.

3. The method of claim 1, wherein altering the insulin therapy comprises adjusting the target blood glucose level or the target blood glucose range of the patient upward based, at least in part, on the indication by the computed metric that the patient is tending towards hypoglycemia, or adjusting the target blood glucose level or the target blood glucose range of the patient downward based, at least in part, on the indication by the computed metric that the patient is tending towards hyperglycemia.

4. The method of claim 1, wherein the blood glucose concentration profile comprises an estimated probability distribution function.

5. The method of claim 1, wherein the blood glucose concentration profile comprises a histogram of blood glucose concentration measurements.

6. The method of claim 1, wherein the blood glucose concentration profile comprises blood glucose concentration measurements.

7. The method of claim 1, wherein the computed metric comprises a bi-dimensional metric, and further comprising:

applying a first portion of the loss or cost function to the blood glucose concentration profile to derive a hyperglycemia component of the computed metric; and

applying a second portion of the loss or cost function to the blood glucose concentration to derive a hypoglycemia component of the computed metric.

8. The method of claim 1, wherein the log-square metric has the form

9. The method of claim 1, and further comprising:

defining the blood glucose concentration profile for a recurring period;

computing the metric based, at least in part, the recurring period; and

altering the insulin therapy for the recurring period in the future based, at least in part, on the computed metric, the altered insulin therapy comprising adjusting the target blood glucose level or the target blood glucose range upward responsive to a determination that the patient is tending towards hypoglycemia for the recurring period.

10. The method of claim 9, wherein the recurring period comprises a time of day.

11. The method of claim 9, wherein the recurring period comprises a day of week.

12. The method of claim 9, wherein the defining the blood glucose concentration profile for a recurring period further comprises computing the profile for the recurring period based on observations of the blood glucose concentration collected only during the recurring period.

13. The method of claim 1, wherein altering the insulin therapy applied to the patient further comprises affecting a closed-loop insulin delivery system based, at least in part, on the computed metric.

14. The method of claim 13, wherein affecting the closed-loop insulin delivery system further comprises affecting a periodic command based, at least in part, on the computed metric.

15. The method of claim 1, and further comprising triggering an alarm in response to the computed metric.

16. An article for using one or more indicators of glycemic health in a patient to balance one or more of hypoglycemic or hyperglycemic tendencies for the patient, the article comprising:

a non-transitory storage medium comprising machine-readable instructions stored thereon which are executable by a special purpose computing apparatus to;

compute a profile of a blood glucose concentration of a patient based, at least in part, on observations of the blood glucose concentration collected at a blood glucose monitoring device;

apply a cost or loss function to the computed profile to compute a metric for balancing short-term and long-term risks associated with a therapy, the metric representative of a glycemic health of the patient, the cost or loss function being based, at least in part, on a log-square metric, wherein the metric is also based, at least in part, on a parameter selected to balance one or more Spearman rank coefficients with one or more hypoglycemic-based metrics and one or more hyperglycemic-based metrics; and

alter an insulin therapy applied to the patient by an infusion device, the altered insulin therapy to be determined based, at least in part, on the computed metric, wherein the altered insulin therapy is also to be based, at least in part, on a target blood glucose concentration level or target blood glucose range to be adjusted upward or downward based, at least in part, on an indication by the computed metric of whether the patient is tending towards hypoglycemia or tending towards hyperglycemia.

17. The article of claim 16, wherein the instructions are executable by the special purpose computing apparatus to alter the insulin therapy by generating commands in an infusion system comprising the infusion device.

18. An apparatus for using one or more indicators of glycemic health in a patient to balance one or more of hypoglycemic or hyperglycemic tendencies for the patient, the apparatus comprising:

means for computing a profile of a blood glucose concentration of a patient based, at least in part, on observations of the blood glucose concentration;

means for applying a cost or loss function to the computed profile to compute a metric for balancing short-term and long-term risks associated with a therapy, the metric representative of a glycemic health of the patient, the cost or loss function being based, at least in part, on a log-square metric, wherein the metric is also based, at least in part, on a parameter selected to balance one or more Spearman rank coefficients with one or more hypoglycemic-based metrics and one or more hyperglycemic-based metrics; and

means for altering an insulin therapy applied to the patient by an infusion device, the altered insulin therapy determined based, at least in part, on the computed metric, wherein the altered insulin therapy is also based, at least in part, on a target blood glucose concentration level or target blood glucose range that has been adjusted upward or downward based, at least in part, on an indication by the computed metric of whether the patient is trending towards hypoglycemia or trending towards hyperglycemia.