# US 11,304,664 B2 · System and method to manage diabetes based on glucose median, glucose variability, and hypoglycemic risk

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- Number: US 11,304,664 B2
- Document ID: US11304664B2
- Status: Granted
- Kind: B2
- Application number: 17/122,970
- Filed: 2020-12-15
- Published: 2021-08-19
- Granted: 2022-04-19
- Earliest claimed: 2013-03-15
- Assignees: Abbott Diabetes Care Inc.
- Applicants: Abbott Diabetes Care Inc.
- Inventors: Erwin S. Budiman; Gary A. Hayter; Kenneth J. Doniger; Timothy C. Dunn; Nathan C. Crouther; Glenn Berman; Howard A. Wolpert
- Web page: https://patentgrep.com/patent/US11304664B2

## CPC

- 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 5/14532: {for measuring glucose, e.g. by tissue impedance measurement}
- A61B 5/4848: {Monitoring or testing the effects of treatment, e.g. of medication}
- A61B 5/7282: {Event detection, e.g. detecting unique waveforms indicative of a medical condition (cough events A61B5/0823; seizures A61B5/4094; sleep apnoea A61B5/4818)}
- A61B 5/742: {using visual displays (displays for heart-related electrical signals, e.g. ECG, A61B5/339)}
- G01N 33/66: involving blood sugars, e.g. galactose
- G16H 20/10: relating to drugs or medications, e.g. for ensuring correct administration to patients
- G16H 50/30: for calculating health indices; for individual health risk assessment
- G16Z 99/00: Subject matter not provided for in other main groups of this subclass
- A61B 5/4836: {Diagnosis combined with treatment in closed-loop systems or methods (A61B5/0036 takes precedence)}
- A61B 5/746: {Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms}
- G16H 15/00: ICT specially adapted for medical reports, e.g. generation or transmission thereof
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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)
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16Z: INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS, NOT OTHERWISE PROVIDED FOR

## Abstract

A system and method provides a glucose report for determining glycemic risk based on an ambulatory glucose profile of glucose data over a time period, a glucose control assessment based on median and variability of glucose, and indicators of high glucose variability. Time of day periods are shown at which glucose levels can be seen. A median glucose goal and a low glucose line provide coupled with glucose variability provide a view into effects that raising or lowering the median goal would have. Likelihood of low glucose, median glucose compared to goal, and variability of glucose below median provide probabilities based on glucose data. Patterns can be seen and provide guidance for treatment.

## Claims

### Claim 1

A method for determining glycemic risk of a patient during pregnancy using a continuous glucose monitor, the method comprising:
continuously collecting glucose measurements of the patient via a sensor of the continuous glucose monitor, wherein the glucose measurements are indicative of an interstitial glucose level;
communicating the glucose measurements collected by the continuous glucose monitor to a processor of a computing device;
determining a hypoglycemia risk level based on a comparison of the glucose measurements collected by the continuous glucose monitor to a baseline threshold, wherein the baseline threshold is based on a number and a magnitude of glucose measurements below a predetermined minimum glucose concentration;
receiving, by the computing device, an indication that the patient is pregnant;
in response to receiving the indication that the patient is pregnant, adjusting the baseline threshold to an adjusted threshold that requires one or both of lower magnitude glucose measurements below the predetermined minimum glucose concentration or a greater number of glucose measurements below the predetermined minimum glucose concentration in comparison to the number and/or the magnitude of glucose measurements below the predetermined minimum glucose concentration of the baseline threshold in order to increase the hypoglycemia risk level; and
displaying on a display of the computing device a visual representation of the hypoglycemia risk level, wherein the hypoglycemia risk level comprises one of high, moderate or low risk.

### Claim 2 (depends on 1)

The method of claim 1, wherein adjusting the baseline threshold to the adjusted threshold further comprises decreasing the predetermined minimum glucose concentration.

### Claim 3 (depends on 1)

The method of claim 1, wherein the predetermined minimum glucose concentration is 70 mg/dL.

### Claim 4 (depends on 1)

The method of claim 1, further comprising determining the hypoglycemia risk level during a plurality of time periods in one day, and displaying the hypoglycemia risk level for each of the plurality of time periods.

### Claim 5 (depends on 1)

The method of claim 1, wherein determining the hypoglycemia risk level is performed by a remote computing device.

### Claim 6 (depends on 1)

The method of claim 1, further comprising communicating the collected glucose measurements to a healthcare provider.

### Claim 7 (depends on 1)

The method of claim 1, further comprising displaying a recommendation of an intervention based on the collected glucose measurements.

### Claim 8 (depends on 1)

The method of claim 1, further comprising displaying a report comprising a plot of the collected glucose measurements over time.

### Claim 9 (depends on 8)

The method of claim 8, wherein the plot of the collected glucose measurements over time comprises an ambulatory glucose profile.

### Claim 10

A system for determining glycemic risk of a patient during pregnancy, the system comprising:
a continuous glucose monitor configured to collect glucose measurements of the patient, the continuous glucose monitor comprising a glucose sensor configured to sense an interstitial glucose level; and
a computing device in communication with the continuous glucose monitor, the computing device comprising a display, a processor, and a non-volatile memory coupled with the processor, the memory storing a glucose data processing program that, when executed by the processor, causes the processor to:
determine a hypoglycemia risk level based on a comparison of the glucose measurements to a baseline threshold, wherein the baseline threshold is based on a a number and a magnitude of glucose measurements below a predetermined minimum glucose concentration,
receive an indication that the patient is pregnant,
in response to the received indication that the patient is pregnant, adjust the baseline threshold to an adjusted threshold that requires one or both of lower magnitude glucose measurements below the predetermined minimum glucose concentration or a greater number of glucose measurements below the predetermined minimum glucose concentration in comparison to the number and/or the magnitude of glucose measurements below the predetermined minimum glucose concentration of the baseline threshold in order to increase the hypoglycemia risk level, and
visually present on the display the hypoglycemia risk level.

### Claim 11 (depends on 10)

The system of claim 10, wherein the computing device comprises a smartphone.

### Claim 12 (depends on 10)

The system of claim 10, wherein the computing device comprises a laptop computer.

### Claim 13 (depends on 10)

The system of claim 10, wherein the predetermined minimum glucose concentration is 70 mg/dL.

### Claim 14 (depends on 10)

The system of claim 10, wherein the display is further configured to display a report comprising a plot of the glucose measurements over time.