# US 2016/0354543 A1 · Multivariable artificial pancreas method and system

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- Number: US 2016/0354543 A1
- Document ID: US20160354543A1
- Status: Published application
- Kind: A1
- Application number: 15/171,355
- Filed: 2016-06-02
- Published: 2016-12-08
- Earliest claimed: 2015-06-02
- Assignees: Illinois Institute of Technology
- Inventors: Ali Cinar; Kamuran TURKSOY; Iman HAJIZADEH
- Web page: https://patentgrep.com/patent/US20160354543A1

## CPC

- A61M 5/1723: {using feedback of body parameters, e.g. blood sugar or pressure}
- A61B 5/14532: {for measuring glucose, e.g. by tissue impedance measurement}
- 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}
- A61M 5/142: Pressure infusion, e.g. using pumps
- G16H 40/63: for local operation
- G16Z 99/00: Subject matter not provided for in other main groups of this subclass
- A61B 5/14503: {invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors (A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence)}
- A61B 2560/0276: Determining malfunction
- A61M 2005/14208: {with a programmable infusion control system, characterised by the infusion program}
- A61M 2205/3523: using telemetric means
- A61M 2205/50: with microprocessors or computers
- A61M 2230/201: Glucose concentration
- 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)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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

Methods and modules for using physiological (biometric) variables to advance the state of the artificial pancreas. The method and system includes one or more modules for recursive model identification, hypoglycemia early alert and alarm, adaptive control, hyperglycemia early alert and alarm, plasma insulin concentration estimation, assessment of physical activity (e.g., presence, type, duration, expected effects on insulin sensitivity and GC), detection of acute stress and assessment of its impact on insulin sensitivity, detection of sleep and its stages and assessment of sleep stages on GC, sensor fault detection and diagnosis, software and controller performance evaluation and adjustment and/or pump fault detection and diagnosis.

## Claims

### Claim 1

A method for monitoring and/or treating glucose levels of a patient with diabetes, the method comprising:
automatically monitoring a glucose concentration level in the patient with a continuous glucose monitor worn by the patient to obtain a measured glucose level;
automatically monitoring physiological variables of the patient using at least one physiological sensor Worn, by the patient to obtain measured physiological variables;
automatically determining a physiological state of the patient from the measured physiological variables; and
automatically estimating a future glucose level of the patient as a function of the measured glucose level, at least one of the measured physiological variables, and the determined physiological state of the patient.

### Claim 2 (depends on 1)

The method according to claim 1, further comprising:
automatically determining a. change between at least two measured, glucose levels that exceeds a predetermined value; and
automatically comparing the change in the measured glucose level to any change in physiological state to determine a cause of the change in the measured glucose level.

### Claim 3 (depends on 1)

The method according to claim 1, wherein the physiological state is selected, from sleep, physical activity, stress, or combinations thereof.

### Claim 4 (depends on 3)

The method according to claim 3, wherein the at least one physiological sensor worn by the patient measures physiological variables selected from a combination of movement, skin temperature, dissipated heat from, the body, galvanic skin response, heart rate, ECG, respiration rate, posture, or body position.

### Claim 5 (depends on 1)

The method according to claim 1, wherein automatically determining a physiological state of the patient comprises automatically matching the measured physiological variables to one of a plurality of predetermined classified physiological states.

### Claim 6 (depends on 1)

The method according to claim 1, further comprising automatically predicting and alarming the patient of a predicted future low blood glucose concentration and automatically determining and suggesting responsive measures including carbohydrate consumption to prevent low blood glucose concentration.

### Claim 7 (depends on 1)

The method according to claim 1, further comprising automatically detecting food consumption and/or a rapid glucose level increase without manual input by the patient.

### Claim 8 (depends on 1)

The method according to claim 1, wherein the physiological state is physical activity and further comprising automatically determining an intensity and/or duration of the exercise.

### Claim 9 (depends on 1)

The method according to claim 1, wherein the physiological state is acute stress

### Claim 10 (depends on 1)

The method according to claim 1, wherein the physiological state is sleep and further comprising automatically determining a sleep pattern and stage of sleep for the patient.

### Claim 11 (depends on 1)

The method according to claim 1, further comprising automatically monitoring for and determining a faulty or missing measurement information transmitted by the continuous glucose monitor or the physiological sensors.

### Claim 12

A device for monitoring and/or treating patient glucose levels, the device comprising:
a continuous glucose monitor adapted to measure a glucose level of a patient; a physiological status monitoring system worn by the patient and adapted to measure at least one physiological variable of the patient; and
an automatic controller in communication with the glucose monitor and the physiological status monitoring system, the controller including: a prediction module adapted to automatically predict a future glucose level using data measured by the glucose monitor system and the physiological monitoring system, and a physiological classification module adapted to automatically determine a physiological state of the patient from the measured at least one physiological variable.

### Claim 13 (depends on 12)

The device according to claim 12, wherein the prediction module comprises an algorithm for predicting future glucose concentration values at or between 5 to 60 minutes into the future.

### Claim 14 (depends on 12)

The device according to claim 12, wherein each of the prediction module and the physiological classification module comprise a recursively updated stable multivariate time-series model.

### Claim 15 (depends on 12)

The device according to claim 12, further comprising a hypoglycemia detection module and alarm.

### Claim 16 (depends on 12)

The device according to claim 12, further comprising a meal detection module adapted to detect food consumption and to compute a bolus insulin amount without manual input by the patient.

### Claim 17 (depends on 12)

The device according to claim 12, further comprising an estimator adapted to estimate a future plasma glucose concentration and/or a future plasma, insulin concentration.

### Claim 18 (depends on 12)

The device according to claim 12, wherein the physiological classification module detects and classifies the physiological state as a function of activity intensity and duration, body position, heart rate, respiration pattern, or a combination thereof.

### Claim 19 (depends on 12)

The device according to claim 12, wherein the physiological classification module is adapted to detect and/or classify a physiological state selected from physical activity, stress, sleep, or combinations thereof.

### Claim 20 (depends on 12)

The device according to claim 12, further comprising an insulin pump in combination with the controller, wherein the controller controls an insulin infusion as a function of the predicted future glucose level.

### Claim 21 (depends on 12)

The device according to claim 12, further comprising a fault detection and diagnosis module to monitor in real time sensors, an insulin pump, and modules of the device for malfunctions.