# US 12,183,458 B2 · Systems, devices, and methods for analyte monitoring and benefits thereof

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- Number: US 12,183,458 B2
- Document ID: US12183458B2
- Status: Granted
- Kind: B2
- Application number: 17/329,101
- Filed: 2021-05-24
- Published: 2021-11-25
- Granted: 2024-12-31
- Earliest claimed: 2020-05-22
- Assignees: Abbott Diabetes Care Inc.
- Applicants: Abbott Diabetes Care Inc.
- Inventors: Yelena Nabutovsky; Matthew S. D. Kerr; Gregory J. Roberts; Jennifer M. Joseph
- Web page: https://patentgrep.com/patent/US12183458B2

## CPC

- G16H 10/20: for electronic clinical trials or questionnaires
- G16H 40/67: for remote operation
- A61B 5/14532: {for measuring glucose, e.g. by tissue impedance measurement}
- A61B 5/4839: {combined with drug delivery}
- A61B 5/742: {using visual displays (displays for heart-related electrical signals, e.g. ECG, A61B5/339)}
- G16H 20/17: delivered via infusion or injection
- A61B 5/002: {Monitoring the patient using a local or closed circuit, e.g. in a room or building (A61B5/0017 takes precedence)}
- 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}
- A61B 2560/0271: using a remote monitoring unit
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

A method of treatment of a type 2 diabetic patient includes selecting a type 2 diabetic patient having a predetermined comorbidity for treatment, initiating a continuous glucose monitor regimen for the selected type 2 diabetic patient, wherein after six months of initiation of the continuous glucose monitor regimen, a rate of hospitalization for a predetermined diagnostic category of the selected patient having the predetermined comorbidity is reduced by at least 12% relative to an average rate of hospitalization for the predetermined diagnostic category of selected patients having the predetermined comorbidity without the continuous glucose monitor regimen.

## Claims

### Claim 1

A system to establish and monitor an analyte monitor regimen of a user comprising:
a sensor control device comprising an analyte sensor coupled with sensor electronics, the sensor control device configured to transmit data indicative of an analyte level; and,
a reader device comprising a user interface, wireless communication circuitry configured to receive the data indicative of the analyte level and
one or more processors coupled with a memory, the memory configured to store instructions that, when executed by the one or more processors, cause the one or more processors to:
output, based on one or more instances of operation of the reader device over a predetermined period of time, at least one measurement of an analyte level on the user interface of the reader device, wherein the at least one measurement of the analyte level is a current analyte level during the one or more instances of the operation of the reader device;
determine a trending analyte level based on the current analyte level and historical analyte data stored in the memory;
output the trending analyte level on the user interface of the reader device;
update and store the historical analyte data in the memory to include the current analyte level;
receive, from the sensor control device, an updated current analyte level;
determine an updated trending analyte level based on the updated current analyte level and the updated historical analyte data stored in the memory;
output the updated trending analyte level on the user interface of the reader device;
quantify at least one of a total number of scans or views for a day or a marker to indicate that a scan or view had occurred at a particular time on the user interface of the reader device;
output a sensor usage indicator including the at least one of a total number of scans or views for a day or a marker to indicate that a scan or view had occurred at a particular time on the user interface of the reader device;
output a notification on the user interface of the reader device that indicates at least one of an alarm condition, the updated current analyte level measurement associated with the alarm condition, and the updated trending analyte level associated with the alarm condition;
determine a determined rate of hospitalization for a predetermined diagnostic category based on collected data of users without a continuous glucose monitoring and having a predetermined comorbidity; and
estimate a rate of hospitalization for the user in the predetermined diagnostic category and having the predetermined comorbidity, wherein the rate of hospitalization for the user is at least 12% less than the determined rate of hospitalization for the users without the continuous glucose monitoring and having the predetermined comorbidity;
wherein the analyte monitor regimen is configured to increase the instances of operation of the reader device and actionable engagement with the user interface.

### Claim 2 (depends on 1)

The system of claim 1, wherein the predetermined comorbidity is anemia.

### Claim 3 (depends on 2)

The system of claim 2, wherein the instructions further comprise causing the one or more processors to receive data about basal-bolus insulin therapy treatment of the user.

### Claim 4 (depends on 3)

The system of claim 3, wherein the predetermined period of time is six months and the predetermined diagnostic category is infectious and parasitic diseases, and the rate of hospitalization for the user is 51% less than the determined rate of hospitalization for infectious and parasitic diseases.

### Claim 5 (depends on 3)

The system of claim 3, wherein the predetermined period of time is six months and the predetermined diagnostic category is respiratory diseases, and the rate of hospitalization for the user is 38% less than the determined rate of hospitalization for respiratory diseases.

### Claim 6 (depends on 3)

The system of claim 3, wherein the predetermined period of time is six months and the predetermined diagnostic category is kidney and urinary tract diseases, and the first rate of hospitalization for the user is 57% less than the determined rate of hospitalization for kidney and urinary tract diseases.

### Claim 7 (depends on 3)

The system of claim 3, wherein the predetermined period of time is six months and the predetermined diagnostic category is hepatobiliary and pancreatic diseases, and the rate of hospitalization for the user is 55% less than the determined rate of hospitalization for hepatobiliary and pancreatic diseases.

### Claim 8 (depends on 2)

The system of claim 2, wherein the instructions further comprise causing the one or more processors to receive data about non-multiple daily insulin injection therapy treatment of the user.

### Claim 9 (depends on 8)

The system of claim 8, wherein the predetermined period of time is six months and the predetermined diagnostic category is infectious and parasitic diseases, and the rate of hospitalization for the user is 48% less than the determined rate of hospitalization for infectious and parasitic diseases.

### Claim 10 (depends on 8)

The system of claim 8, wherein the predetermined period of time is six months and the predetermined diagnostic category is respiratory diseases, and the rate of hospitalization for the user is 59% less than the determined rate of hospitalization for respiratory diseases.

### Claim 11 (depends on 8)

The system of claim 8, wherein the predetermined period of time is six months and the predetermined diagnostic category is kidney and urinary tract diseases, and the first rate of hospitalization for the user is 51% less than the determined rate of hospitalization for kidney and urinary tract diseases.

### Claim 12 (depends on 8)

The system of claim 8, wherein the predetermined period of time is six months and the predetermined diagnostic category is hepatobiliary and pancreatic diseases, and the rate of hospitalization for the user is 44% less than the determined rate of hospitalization for hepatobiliary and pancreatic diseases.

### Claim 13 (depends on 2)

The system of claim 2, wherein the predetermined period of time is six months and the predetermined diagnostic category is infectious and parasitic diseases, and the rate of hospitalization for the user is 33% less than the determined rate of hospitalization for infectious and parasitic diseases.

### Claim 14 (depends on 1)

The system of claim 1, wherein the instructions further comprise causing the one or more processors to receive data about basal-bolus insulin therapy treatment of the user.

### Claim 15 (depends on 14)

The system of claim 14, wherein the predetermined period of time is six months and the predetermined comorbidity is a fluid and electrolyte disorder, and the rate of hospitalization for infectious and parasitic diseases for the user is 59% less than the determined rate of hospitalization for infectious and parasitic diseases.

### Claim 16 (depends on 14)

The system of claim 14, wherein the predetermined period of time is six months and the predetermined comorbidity is a valvular disorder, and the rate of hospitalization for infectious and parasitic diseases for the user is 58% less than the determined rate of hospitalization for infectious and parasitic diseases.

### Claim 17 (depends on 14)

The system of claim 14, wherein the predetermined period of time is six months and the predetermined comorbidity is liver disease, and the rate of hospitalization for infectious and parasitic diseases for the user is 50% less than the determined rate of hospitalization for infectious and parasitic diseases.

### Claim 18 (depends on 1)

The system of claim 1, wherein the instructions further comprise causing the one or more processors to receive data about non-multiple daily insulin injection therapy treatment of the user.

### Claim 19 (depends on 18)

The system of claim 18, wherein the predetermined period of time is six months and the predetermined comorbidity is a fluid or electrolyte disorder, and the first rate of hospitalization for infectious and parasitic diseases for the user is 68% less than the determined rate of hospitalization for infectious and parasitic diseases.

### Claim 20 (depends on 18)

The system of claim 18, wherein the predetermined period of time is six months and the predetermined comorbidity is a valvular disorder, and the rate of hospitalization for infectious and parasitic diseases for the user is 53% less than the determined rate of hospitalization for infectious and parasitic diseases.

### Claim 21 (depends on 18)

The system of claim 18, wherein the predetermined period of time is six months and the predetermined comorbidity is liver disease, and the rate of hospitalization for infectious and parasitic diseases for the user is 54% less than the determined rate of hospitalization for infectious and parasitic diseases.
