# US 12,014,821 B2 · Systems and methods for managing glycemic variability

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- Number: US 12,014,821 B2
- Document ID: US12014821B2
- Status: Granted
- Kind: B2
- Application number: 18/163,255
- Filed: 2023-02-01
- Published: 2023-06-01
- Granted: 2024-06-18
- Earliest claimed: 2012-11-07
- Assignees: DexCom, Inc.
- Applicants: Dexcom, Inc.
- Inventors: Naresh C. Bhavaraju; Arturo Garcia; Phil Mayou; Thomas A. Peyser; Apurv Ullas Kamath; Aarthi Mahalingam; Kevin Sayer; Thomas Hall; Michael Robert Mensinger; Hari Hampapuram; David Price; Jorge Valdes; Murrad Kazalbash
- Web page: https://patentgrep.com/patent/US12014821B2

## CPC

- G16H 40/67: for remote operation
- A61M 5/142: Pressure infusion, e.g. using pumps
- A61M 5/1723: {using feedback of body parameters, e.g. blood sugar or pressure}
- G01N 33/49: Blood {(chemical methods for determining blood cell populations G01N33/5094; chemical analysis of blood groups or blood types G01N33/80)}
- G16H 15/00: ICT specially adapted for medical reports, e.g. generation or transmission thereof
- G16H 20/17: delivered via infusion or injection
- G16H 40/63: for local operation
- G16H 50/00: ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
- 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
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## 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.

## Claims

### Claim 1

A computer-implemented method comprising:
receiving glucose measurements of a host over a timeframe from at least one continuous glucose sensor;
calculating one or more glucose control metrics indicative of a glycemic variability of the host based on the glucose measurements, the one or more glucose control metrics comprising a Patient Glycemic Status (PGS) index value; and
transmitting a signal to an insulin delivery device for controlling insulin delivery to the host based on the calculated one or more glucose control metrics.

### Claim 2 (depends on 1)

The method of claim 1, wherein the PGS index value indicates an overall glycemic status of the host within the timeframe.

### Claim 3 (depends on 1)

The method of claim 1, wherein the PGS index value is defined as being equal to GVI*MG*(1−PTIR), wherein:
GVI is defined as GVI=L/Lo, wherein L is a length of a line representative of the glucose measurements of the host over the timeframe and Lo is an ideal line length for the timeframe;
MG is a mean glucose value associated with the glucose measurements of the host over the timeframe; and
PTIR is a percentage of time during the timeframe during which the glucose measurements of the host are within a defined range of glucose concentration values.

### Claim 4 (depends on 1)

The method of claim 1, wherein the PGS index value is defined as being equal to GVI*MG*(1−PTIR)+Penalty, wherein:
GVI is defined as GVI=L/Lo, wherein L is a length of a line representative of the glucose measurements of the host over the timeframe and Lo is an ideal line length for the timeframe;
MG is a mean glucose value associated with the glucose measurements of the host over the timeframe;
PTIR is a percentage of time during the timeframe during which the glucose measurements of the host are 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.

### Claim 5 (depends on 1)

The method of claim 1, further comprising:
outputting an alert to a user based on the calculated one or more glucose control metrics, the alert comprising the PGS index value.

### Claim 6 (depends on 5)

The method of claim 5, further comprising:
comparing the PGS index value to one or more predetermined thresholds for the host, wherein outputting the alert to the user is responsive to the comparison of the PGS index value to the one or more predetermined thresholds.

### Claim 7 (depends on 5)

The method of claim 5, wherein the alert comprises one or more of an audible alert, a visual alert, and a tactile alert.

### Claim 8 (depends on 1)

The method of claim 1, wherein the one or more glucose control metrics are calculated retrospectively.

### Claim 9

A system comprising:
at least one processor; and
at least one memory including code which when executed by the at least one processor provides operations comprising:
receiving glucose measurements of a host over a timeframe from at least one continuous glucose sensor;
calculating one or more glucose control metrics indicative of a glycemic variability of the host based on the glucose measurements, the one or more glucose control metrics comprising a Patient Glycemic Status (PGS) index value; and
transmitting a signal to an insulin delivery device for controlling insulin delivery to the host based on the calculated one or more glucose control metrics.

### Claim 10 (depends on 9)

The system of claim 9, wherein the PGS index value indicates an overall glycemic status of the host within the timeframe.

### Claim 11 (depends on 9)

The system of claim 9, wherein the PGS index value is defined as being equal to GVI*MG*(1−PTIR), wherein:
GVI is defined as GVI-L/Lo, wherein L is a length of a line representative of the glucose measurements of the host over the timeframe and Lo is an ideal line length for the timeframe;
MG is a mean glucose value associated with the glucose measurements of the host over the timeframe; and
PTIR is a percentage of time during the timeframe during which the glucose measurements of the host are within a defined range of glucose concentration values.

### Claim 12 (depends on 9)

The system of claim 9, wherein the PGS index value is defined as being equal to GVI*MG*(1−PTIR)+Penalty, wherein:
GVI is defined as GVI=L/Lo, wherein L is a length of a line representative of the glucose measurements of the host over the timeframe and Lo is an ideal line length for the timeframe;
MG is a mean glucose value associated with the glucose measurements of the host over the timeframe;
PTIR is a percentage of time during the timeframe during which the glucose measurements of the host are 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.

### Claim 13 (depends on 9)

The system of claim 9, further comprising:
outputting an alert to a user based on the calculated one or more glucose control metrics, the alert comprising the PGS index value.

### Claim 14 (depends on 13)

The system of claim 13, further comprising:
comparing the PGS index value to one or more predetermined thresholds for the host, wherein outputting the alert to the user is responsive to the comparison of the PGS index value to the one or more predetermined thresholds.

### Claim 15 (depends on 13)

The system of claim 13, wherein the alert comprises one or more of an audible alert, a visual alert, and a tactile alert.

### Claim 16 (depends on 9)

The system of claim 9, wherein the one or more glucose control metrics are calculated retrospectively.

### Claim 17

A non-transitory computer readable medium comprising instructions, that when executed by a computing device, cause the computing device to perform a method for monitoring a glucose concentration level of a host using one or more continuous glucose sensors, the method comprising:
receiving glucose measurements of a host over a timeframe from at least one continuous glucose sensor;
calculating one or more glucose control metrics indicative of a glycemic variability of the host based on the glucose measurements, the one or more glucose control metrics comprising a Patient Glycemic Status (PGS) index value; and
transmitting a signal to an insulin delivery device for controlling insulin delivery to the host based on the calculated one or more glucose control metrics.

### Claim 18 (depends on 17)

The non-transitory computer readable medium of claim 17, wherein the PGS index value indicates an overall glycemic status of the host within the timeframe.

### Claim 19 (depends on 17)

The non-transitory computer readable medium of claim 17, wherein the PGS index value is defined as being equal to GVI*MG*(1−PTIR), wherein:
GVI is defined as GVI=L/Lo, wherein L is a length of a line representative of the glucose measurements of the host over the timeframe and Lo is an ideal line length for the timeframe;
MG is a mean glucose value associated with the glucose measurements of the host over the timeframe; and
PTIR is a percentage of time during the timeframe during which the glucose measurements of the host are within a defined range of glucose concentration values.

### Claim 20 (depends on 17)

The non-transitory computer readable medium of claim 17, wherein the PGS index value is defined as being equal to GVI*MG*(1−PTIR)+Penalty, wherein:
GVI is defined as GVI=L/Lo, wherein L is a length of a line representative of the glucose measurements of the host over the timeframe and Lo is an ideal line length for the timeframe;
MG is a mean glucose value associated with the glucose measurements of the host over the timeframe;
PTIR is a percentage of time during the timeframe during which the glucose measurements of the host are 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.