# US 10,369,283 B2 · Systems and methods for managing glycemic variability

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- Number: US 10,369,283 B2
- Document ID: US10369283B2
- Status: Granted
- Kind: B2
- Application number: 14/065,847
- Filed: 2013-10-29
- Published: 2014-05-08
- Granted: 2019-08-06
- 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/US10369283B2

## 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 for improving glucose management for a patient by reducing glycemic variability, the method comprising:
receiving input indicative of one or more insulin infusion sites on the patient including one or more of a location on a body for the one or more insulin infusion sites and a duration of use of an insulin delivery device;
generating, using one or more continuous glucose sensors, continuous glucose sensor data indicative of a glucose concentration of the patient;
based on the continuous glucose sensor data, determining one or more glucose control metrics for each of the one or more insulin infusion sites;
comparing the determined one or more glucose control metrics to a predetermined threshold;
identifying, based on the comparing, a problem associated with at least one of the location or the duration of use of the insulin delivery device;
determining a suggestion for modifying a glucose management routine based on the identified problem;
outputting information to a user based on the determined one or more glucose control metrics for each of the one or more insulin infusion sites, the outputted information including the identified problem and the determined suggestion; and
controlling insulin delivery by the insulin delivery device to reduce glycemic variability using at least one of the identified problem or the determined suggestion for modifying the glucose management routine.

### Claim 2 (depends on 1)

The method of claim 1, further comprising prompting, using a user interface, for information indicative of the one or more of the location and the duration of use.

### Claim 3 (depends on 1)

The method of claim 1, wherein the one or more insulin infusion sites comprises a plurality of insulin infusion sites.

### Claim 4 (depends on 1)

The method of claim 1, further comprising determining a timeframe associated with use of at least one of the one or more insulin infusion sites based on the duration of use, wherein determining the one or more glucose control metrics is based on glucose sensor data indicative of the patient's glucose concentration within the timeframe.

### Claim 5 (depends on 1)

The method of claim 1, wherein outputting information comprises providing via a user interface an indication of glucose control associated with each of a plurality of different insulin infusion sites.

### Claim 6 (depends on 1)

The method of claim 1, wherein the one or more glucose control metrics is indicative of the patient's glucose control relative to a glucose target value or range over time.

### Claim 7

A system for improving glucose management for a patient by reducing glycemic variability, the system comprising:
one or more continuous glucose sensors configured to generate continuous glucose sensor data indicative of a glucose concentration of the patient;
at least one processor; and
at least one memory including code which when executed by the at least one processor provides operations comprising:
receiving input indicative of one or more insulin infusion sites on the patient and including one or more of a location on a body for the one or more insulin infusion sites and a duration of use of an insulin delivery device,
based on the continuous glucose sensor data, determining one or more glucose control metrics for each of the one or more insulin infusion sites,
comparing the determined one or more glucose control metrics to a predetermined threshold,
identifying, based on the comparing, a problem associated with at least one of the location or the duration of use of the insulin delivery device,
determining a suggestion for modifying a glucose management routine based on the identified problem,
outputting information to a user based on the determined one or more glucose control metrics for each of the one or more insulin infusion sites, the outputted information including the identified problem and the determined suggestion, and
controlling insulin delivery by the insulin delivery device to reduce glycemic variability using at least one of the identified problem or the determined suggestion for modifying the patient's glucose management routine data.

### Claim 8 (depends on 7)

The system of claim 7, wherein the operations further comprise prompting, using a user interface, for information indicative of the one or more of the location and the duration of use.

### Claim 9 (depends on 7)

The system of claim 7, wherein the one or more insulin infusion sites comprises a plurality of insulin infusion sites and where one or more glucose control metrics is determined for each of the plurality of insulin infusion sites.

### Claim 10 (depends on 7)

The system of claim 7, wherein the operations further comprise determining a timeframe associated with use of at least one of the one or more insulin infusion sites, wherein determining the one or more glucose control metrics is based on glucose sensor data within the timeframe.

### Claim 11 (depends on 7)

The system of claim 7, wherein outputting information comprises providing via a user interface of the system an indication of glucose control associated with each of a plurality of different insulininfusion sites.

### Claim 12 (depends on 7)

The system of claim 7, wherein the one or more glucose control metrics is indicative of the patient's glucose concentration over time relative to a glucose target value or range.

### Claim 13 (depends on 1)

The method of claim 1, wherein identifying the problem includes automatically detecting missed insulin administration by analyzing the continuous glucose sensor data.

### Claim 14 (depends on 1)

The method of claim 1, further comprising receiving a user-selection of meals from a list of meals available for selection and associating the continuous glucose sensor data to the user selection of meals, wherein: identifying the problem includes detecting one or meals associated with poor glucose control by analyzing the continuous glucose sensor data for glucose control patterns for the user-selection of meals.

### Claim 15 (depends on 14)

The method of claim 14, wherein determining the suggestion includes suggesting different timing or dosing for insulin infusion for the one or more meals associated with poor glucose control.

### Claim 16 (depends on 1)

The method of claim 1, wherein identifying the problem includes analyzing the continuous glucose sensor data to detect glucose control patterns for the location or the duration, and determining the suggestion includes determining a suggestion for a location change for insulin infusion or a duration change for using the insulin delivery device.

### Claim 17 (depends on 1)

The method of claim 1, wherein determining one or more glucose control metrics includes determining a glycemic variability index representing glucose variability over time.

### Claim 18 (depends on 17)

The method of claim 17, wherein determining the glycemic variability index includes determining a length of a line representing glucose concentration over time.

### Claim 19

A method for improving glucose management for a patient by reducing glycemic variability, the method comprising:
receiving input indicative of one or more insulin infusion sites on the patient, wherein the received input includes input indicative of a location on a body for the one or more insulin infusion sites, a duration of use of an insulin delivery device, or both the location on the body and the duration of use of the insulin delivery device;
generating, using one or more continuous glucose sensors, continuous glucose sensor data indicative of a glucose concentration of the patient;
for each of the one or more insulin infusion sites, determining a glucose variability index based on the continuous glucose sensor data;
comparing the glucose variability index to a predetermined threshold;
identifying, based on the comparing, a problem associated with at least one of the location or the duration of use of the insulin delivery device;
determining a suggestion for modifying a glucose management routine based on the identified problem; and
based on the glucose variability index for each of the one or more insulin infusion sites, outputting to a user the identified problem and the determined suggestion for use in reducing glycemic variability by modifying the glucose management routine including insulin delivery.

### Claim 20 (depends on 19)

The method of claim 19, further comprising controlling insulin delivery by an insulin delivery device using at least one of the identified problem or the determined suggestion.