# US 11,998,321 B2 · System and a method for automatically managing continuous glucose monitoring measurements indicative of glucose level in a bodily fluid

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- Number: US 11,998,321 B2
- Document ID: US11998321B2
- Status: Granted
- Kind: B2
- Application number: 16/422,789
- Filed: 2019-05-24
- Published: 2019-09-12
- Granted: 2024-06-04
- Earliest claimed: 2016-11-25
- Assignees: Roche Diabetes Care, Inc.
- Applicants: Roche Diabetes Care, Inc.
- Inventors: Christian Ringemann
- Web page: https://patentgrep.com/patent/US11998321B2

## CPC

- A61B 5/14532: {for measuring glucose, e.g. by tissue impedance measurement}
- A61B 5/0205: Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
- A61B 5/1118: {Determining activity level}
- A61B 5/7264: {Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems}
- A61B 5/742: {using visual displays (displays for heart-related electrical signals, e.g. ECG, A61B5/339)}
- A61M 5/1723: {using feedback of body parameters, e.g. blood sugar or pressure}
- G16H 20/13: delivered from dispensers
- G16H 20/17: delivered via infusion or injection
- G16H 20/60: relating to nutrition control, e.g. diets
- G16H 40/63: for local operation
- G16H 50/20: for computer-aided diagnosis, e.g. based on medical expert systems
- G16H 50/70: for mining of medical data, e.g. analysing previous cases of other patients
- A61B 5/0093: {Detecting, measuring or recording by applying one single type of energy and measuring its conversion into another type of energy}
- A61B 5/1112: {Global tracking of patients, e.g. by using GPS}
- A61B 5/14546: {for measuring analytes not otherwise provided for, e.g. ions, cytochromes}
- A61B 5/4839: {combined with drug delivery}
- A61B 5/6801: {specially adapted to be attached to or worn on the body surface}
- A61M 2230/201: Glucose concentration
- G16H 10/60: for patient-specific data, e.g. for electronic patient records
- G16H 50/30: for calculating health indices; for individual health risk assessment
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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)}
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## Abstract

The disclosure relates to a method and system for controlling glucose levels comprising receiving behavioral sensor measurements and analyte sensor measurements, determining a plurality of analyte profiles from continuous analyte sensor measurements; grouping the plurality of analyte profiles into clusters; assigning a selected behavioral parameter or a selected pattern of behavioral parameters to each analyte profile in a first cluster, and providing a treatment recommendation.

## Claims

### Claim 1

A method of managing glucose levels in a body fluid, comprising:
a) receiving continuous glucose measurements from a glucose sensor;
b) receiving behavioral measurements from one or more behavioral sensors and associating the behavioral measurements with one or more behavioral parameters;
c) dividing the continuous glucose measurements into a plurality of glucose profiles wherein each of the plurality of glucose profiles covers a different time interval;
d) grouping the plurality of glucose profiles into at least a first cluster and a second cluster different from the first cluster using a clustering parameter that comprises a clinically relevant parameter wherein the clinically relevant parameter is selected from the following group: parameters indicating one of hypoglycemia, nocturnal hypoglycemia, hyperglycemia, post-hypoglycemic hyperglycemia, and glucose variability;
e) assigning a selected one of the one or more behavioral parameters to a first subset of the plurality of glucose profiles but not to all of the plurality of glucose profiles and wherein each glucose profile in the first cluster is a member of the first subset, but less than all of the glucose profiles in the second cluster is a member of the first subset;
f) presenting the selected one of the one or more behavioral parameters and the first cluster; and
g) generating a treatment recommendation based upon an analysis of the results of step f) to prevent hyperglycemia wherein the treatment recommendation is an insulin bolus and administering the insulin bolus.

### Claim 2 (depends on 1)

The method according to claim 1, further comprising creating an ambulatory glucose profile for one of the first cluster and the second cluster; and
wherein the treatment recommendation and a recommended time for administering the treatment recommendation is derived from an analysis of the ambulatory glucose profile.

### Claim 3 (depends on 1)

The method according to claim 1, wherein the assigning of the selected one of the one or more behavioral parameters of step e) is performed before step d).

### Claim 4 (depends on 1)

The method according to claim 1, wherein:
the grouping in step d) comprises using a clustering parameter that comprises at least one of the one or more behavioral parameters; and
wherein the assigning of the selected one of the one or more behavioral parameters of step e) is performed before step d).

### Claim 5 (depends on 1)

The method according to claim 1, wherein the one or more behavioral sensors measure at least one of the following: heart rate data, body movement data, breathing rate data, breathing frequency data, GPS data, blood pressure data, and body temperature data.

### Claim 6 (depends on 1)

The method according to claim 1, further comprising creating an ambulatory glucose profile for at least one of the first cluster and the second cluster.

### Claim 7 (depends on 1)

The method according to claim 1, wherein step e) further comprises providing on a display the selected behavioral parameter and the first cluster.

### Claim 8 (depends on 1)

The method of claim 1, further comprising determining a first ambulatory glucose profile for the first cluster and a second ambulatory glucose profile for the second cluster and displaying the first and second ambulatory glucose profiles in a juxtaposed arrangement.

### Claim 9 (depends on 1)

The method of claim 1, wherein plurality of glucose profiles are grouped into a plurality of clusters that includes the first and second clusters and wherein each cluster of the plurality of clusters are classified according by an activity level occurring at a particular time of day.

### Claim 10 (depends on 1)

The method according to claim 1, wherein step e) is performed for a plurality of behavioral parameters and the selected one of the one or more behavioral parameters of step f) is a selected pattern of at least two behavioral parameters.

### Claim 11

A method of managing glucose levels in a body fluid, comprising:
a) receiving continuous glucose measurements from a glucose sensor;
b) receiving behavioral measurements from one or more behavioral sensors and associating the behavioral measurements with one or more behavioral parameters;
c) dividing the continuous glucose measurements into a plurality of glucose profiles wherein each of the plurality of glucose profiles covers a different time interval;
d) grouping the plurality of glucose profiles into at least a first cluster and a second cluster different from the first cluster using a clustering parameter that comprises a clinically relevant parameter wherein the clinically relevant parameter is selected from the following group: parameters indicating one of hypoglycemia, nocturnal hypoglycemia, hyperglycemia, post-hypoglycemic hyperglycemia, and glucose variability;
e) assigning a selected one of the one or more behavioral parameters to a first subset of the plurality of glucose profiles but not to all of the plurality of glucose profiles and wherein each glucose profile in the first cluster is a member of the first subset, but less than all of the glucose profiles in the second cluster is a member of the first subset;
f) presenting the selected one of the one or more behavioral parameters and the first cluster; and
g) generating a treatment recommendation based upon an analysis of the results of step f) to prevent hypoglycemia wherein the treatment recommendation is an ingestion of food and administering the ingestion of food.

### Claim 12

A method of managing glucose levels in a body fluid, comprising:
a) receiving continuous glucose measurements from a glucose sensor;
b) receiving behavioral measurements from one or more behavioral sensors and associating the behavioral measurements with one or more behavioral parameters;
c) dividing the continuous glucose measurements into a plurality of glucose profiles wherein each of the plurality of glucose profiles covers a different time interval;
d) grouping the plurality of glucose profiles into at least a first cluster and a second cluster different from the first cluster using a clustering parameter that comprises a level of similarity between the glucose profiles;
e) assigning a selected one of the one or more behavioral parameters to a first subset of the plurality of glucose profiles but not to all of the plurality of glucose profiles and wherein each glucose profile in the first cluster is a member of the first subset, but less than all of the glucose profiles in the second cluster is a member of the first subset;
f) presenting the selected one of the one or more behavioral parameters and the first cluster; and
g) creating an ambulatory glucose profile for at least one of the first cluster and the second cluster and generating a treatment option wherein the treatment option is determined based upon an analysis of the ambulatory glucose profile to prevent hyperglycemia wherein the treatment option is an insulin bolus and administering the insulin bolus.

### Claim 13 (depends on 12)

The method according to claim 12, wherein the assigning of the selected one of the one or more behavioral parameters of step e) is performed before step d).

### Claim 14 (depends on 12)

The method according to claim 12, wherein the treatment option further comprises a recommended time for administering the treatment option and the step of administering the insulin bolus occurs at the recommended time.

### Claim 15 (depends on 5)

The method according to claim 5, wherein step e) is performed for a plurality of behavioral parameters and the selected one of the one or more behavioral parameters of step f) is a selected pattern of at least two behavioral parameters.

### Claim 16

A method of managing glucose levels in a body fluid, comprising:
a) receiving continuous glucose measurements from a glucose sensor;
b) receiving behavioral measurements from one or more behavioral sensors and associating the behavioral measurements with one or more behavioral parameters;
c) dividing the continuous glucose measurements into a plurality of glucose profiles wherein each of the plurality of glucose profiles covers a different time interval;
d) grouping the plurality of glucose profiles into at least a first cluster and a second cluster different from the first cluster using a clustering parameter that comprises a level of similarity between the glucose profiles;
e) assigning a selected one of the one or more behavioral parameters to a first subset of the plurality of glucose profiles but not to all of the plurality of glucose profiles and wherein each glucose profile in the first cluster is a member of the first subset, but less than all of the glucose profiles in the second cluster is a member of the first subset;
f) presenting the selected one of the one or more behavioral parameters and the first cluster; and
g) creating an ambulatory glucose profile for at least one of the first cluster and the second cluster and generating a treatment option wherein the treatment option is determined based upon an analysis of the ambulatory glucose profile to prevent hypoglycemia wherein the treatment option is the consumption of food and administering the consumption of food.

### Claim 17

A glucose management system, comprising:
a medication delivery device; and
a processor configured to:
a) receive continuous glucose measurements measured with a glucose sensor;
b) receive behavioral measurements measured with one or more behavioral sensors, and associate the behavioral measurements with one or more behavioral parameters;
c) divide the continuous glucose measurements into a plurality of glucose profiles wherein each of the plurality of glucose profiles covers a different time interval;
d) group the plurality of glucose profiles into at least a first cluster and a second cluster different from the first cluster using i) a clustering parameter that comprises a level of similarity between the glucose profiles and/or ii) a clustering parameter that comprises a clinically relevant parameter wherein the clinically relevant parameter is selected from the following group: parameters indicating one of hypoglycemia, nocturnal hypoglycemia, hyperglycemia, post-hypoglycemic hyperglycemia, and glucose variability;
e) assign a selected one of the one or more behavioral parameters to each glucose profile in the first cluster, but less than all of the glucose profiles in the second cluster;
f) present the selected one of the one or more behavioral parameters and the first cluster; and
g) generate a treatment option and a recommended time for administering the treatment option wherein the treatment option and the recommended time are determined based upon an analysis of an ambulatory glucose profile determined for the first cluster and wherein the treatment option is an insulin bolus and the glucose management system is further configured to automatically administer the insulin bolus with the medication delivery device at the recommended time.

### Claim 18 (depends on 17)

The glucose management system according to claim 17, further comprising a display configured to display the selected behavioral parameter and the first cluster.