Systems and methods for managing glycemic variability

Patent metadata

Field	Value
Publication number	US-11600384-B2
Application number	US-201916445055-A
Country	US
Kind code	B2
Filing date	Jun 18, 2019
Priority date	Nov 7, 2012
Publication date	Mar 7, 2023
Grant date	Mar 7, 2023

Abstract

Methods and apparatus, including computer program products, are provided for processing analyte data. In some example implementations, a method may include generating glucose sensor data indicative of a host's glucose concentration using a glucose sensor; calculating a glycemic variability index (GVI) value based on the glucose sensor data; and providing output to a user responsive to the calculated glycemic variability index value. The GVI may be a ratio of a length of a line representative of the sensor data and an ideal length of the line. Related systems, methods, and articles of manufacture are also disclosed.

First claim

What is claimed is:

1. A computer-implemented method comprising:
receiving input indicative of one or more insulin infusion sites on a patient;
calculating one or more glucose control metrics for each of the one or more insulin infusion sites, the calculating based on continuous glucose sensor data indicative of a glucose concentration of the patient, the continuous glucose sensor data generated by one or more continuous glucose sensors, wherein the glucose control metrics comprise a glycemic variability index (GVI) value representative of the patient's glucose variability during a timeframe and a clinical relevance score representative of a clinical significance of the continuous glucose sensor data;
automatically outputting information for display on a user interface including the calculated GVI and clinical relevance score for each of the one or more insulin infusion sites; and
transmitting a signal for controlling insulin delivery to an insulin delivery device inserted into an optimal insulin infusion site of the one or more insulin infusion sites, wherein the optimal insulin infusion site is based on the glucose control metrics.

2. The method of claim 1 , further comprising prompting the user, using the user interface, for information indicative of one or more of a location of each of the one or more insulin infusion sites on a body of the patient and a duration of use of each of the one or more insulin infusion sites, wherein:
the receiving the input is in response to the prompting, and
the input indicative of the one or more insulin infusion sites comprises one or more of the location of each of the one or more insulin infusion sites on the body of the patient and the duration of use of each of the one or more insulin infusion sites.

3. The method of claim 1 , wherein the GVI is defined as being equal to L/L O , wherein L is a length of a line representative of the host's glucose concentration over the timeframe and Lo is a defined line length for the timeframe.

4. The method of claim 1 , wherein the one or more glucose control metrics further comprise a patient glycemic status (PGS), wherein the PGS is defined as being equal to GVI*MG*(1−PTIR)+Penalty, wherein MG is a mean glucose value associated with the glucose concentration of the host over the timeframe, PTIR is a percentage of time the glucose concentration of the host is within a defined range of glucose concentration values, and the Penalty is a non-linear hyperbolic function that asymptotes with a predetermined number of detected episodes of sever hypoglycemia within an amount of time, and wherein the information further comprises the PGS.

5. The method of claim 4 , wherein automatically outputting the information is responsive to calculating the PGS.

6. The method of claim 1 , wherein automatically outputting the information is responsive to calculating the GVI.

7. The method of claim 1 , further comprising triggering an alert through the user interface when the GVI exceeds a threshold, and wherein the alert comprises one or more of an audible alert, a visual alert, and a tactile alert.

8. The method of claim 1 , wherein automatically outputting the information is performed periodically based on the timeframe.

9. The method of claim 1 , wherein calculating the clinical relevance score comprises:
using a scoring map for converting the continuous glucose sensor data to the clinical relevance score, wherein a scale of the clinical relevance score is linear and a scale of the glucose sensor data is non-linear.

10. The method of claim 1 , wherein the outputted information comprises one or more of a numerical value for the clinical relevance score and a graph of numerical values for clinical relevance scores over time displayed on the user interface.

11. A system comprising:
at least one processor; and
at least one memory including code which when executed by the at least one processor causes the processor to perform a method, the method comprising:
receiving input indicative of one or more insulin infusion sites on a patient;
calculating one or more glucose control metrics for each of the one or more insulin infusion sites, the calculating based on continuous glucose sensor data indicative of the glucose concentration of the patient, the continuous glucose sensor data generated by one or more continuous glucose sensors, wherein the glucose control metrics comprise a glycemic variability index (GVI) value representative of the patient's glucose variability during a timeframe and a clinical relevance score representative of a clinical significance of the continuous glucose sensor data;
automatically outputting information for display on a user interface including the calculated GVI and the clinical relevance score for each of the one or more insulin infusion sites; and
transmitting a signal for controlling insulin delivery to an insulin delivery device inserted into an optimal insulin infusion site of the one or more insulin infusion sites, wherein the optimal insulin infusion site is based on the glucose control metrics.

12. The system of claim 11 , wherein the method further comprises:
prompting the user, using the user interface, for information indicative of one or more of a location of each of the one or more insulin infusion sites on the body of the patient and a duration of use of each of the one or more insulin infusion sites, wherein:
the receiving the input is in response to the prompting, and
the input indicative of the one or more insulin infusion sites comprises one or more of the location of each of the one or more insulin infusion sites on the body of the patient and the duration of use of each of the one or more insulin infusion sites.

13. The system of claim 11 , wherein the GVI is defined as being equal to L/L O , wherein L is a length of a line representative of the host's glucose concentration over the timeframe and Lo is a defined line length for the timeframe.

14. The system of claim 11 , wherein the one or more glucose control metrics further comprise a patient glycemic status (PGS), wherein the PGS is defined as being equal to GVI*MG*(1−PTIR)+Penalty, wherein MG is a mean glucose value associated with the glucose concentration of the host over the timeframe, PTIR is a percentage of time the glucose concentration of the host is within a defined range of glucose concentration values, and the Penalty is a non-linear hyperbolic function that asymptotes with a predetermined number of detected episodes of sever hypoglycemia within an amount of time, and wherein the information further comprises the PGS.

15. The system of claim 14 , wherein automatically outputting the information is responsive to calculating the PGS.

16. The system of claim 11 , wherein automatically outputting the information is responsive to calculating the GVI.

17. The system of claim 11 , further comprising triggering an alert through the user interface when the GVI exceeds a threshold, and wherein the alert comprises one or more of an audible alert, a visual alert, and a tactile alert.

18. The system of claim 11 , wherein automatically outputting the information is performed periodically based on the timeframe.

19. The system of claim 11 , wherein calculating the clinical relevance score comprises:
using a scoring map for converting the continuous glucose sensor data to the clinical relevance score, wherein a scale of the clinical relevance score is linear and a scale of the glucose sensor data is non-linear.

20. The system of claim 11 , wherein the outp

Assignees

• Dexcom Inc

Inventors

• Bhavaraju Naresh C
• Garcia Arturo
• Mayou Phil
• Peyser Thomas A
• Kamath Apurv Ullas
• Mahalingam Aarthi
• Sayer Kevin
• Hall Thomas
• Mensinger Michael Robert
• Hampapuram Hari
• Price David
• Valdes Jorge
• Kazalbash Murrad

Classifications

• G16H15/00

  ICT specially adapted for medical reports, e.g. generation or transmission thereof · CPC title

• G16H40/67 Primary

  for remote operation · CPC title

• G16H40/63

  for local operation · CPC title

• G16H20/17

  delivered via infusion or injection · CPC title

• G16H50/30

  for calculating health indices; for individual health risk assessment · CPC title