# US 2019/0317104 A1 · System and method for dynamically calibrating and measuring analyte concentration in diabetes management monitors

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- Number: US 2019/0317104 A1
- Document ID: US20190317104A1
- Status: Published application
- Kind: A1
- Application number: 16/455,307
- Filed: 2019-06-27
- Published: 2019-10-17
- Earliest claimed: 2013-12-27
- Assignees: Becton, Dickinson and Company
- Applicants: Becton, Dickinson and Company
- Inventors: Paul Edney; Ling Zheng; James Petisce
- Web page: https://patentgrep.com/patent/US20190317104A1

## CPC

- G01N 33/66: involving blood sugars, e.g. galactose
- A61B 5/0071: {by measuring fluorescence emission}
- A61B 5/14532: {for measuring glucose, e.g. by tissue impedance measurement}
- A61B 5/1455: using optical sensors, e.g. spectral photometrical oximeters
- A61B 5/1459: invasive, e.g. introduced into the body by a catheter
- A61B 5/1495: Calibrating or testing of in-vivo probes
- A61M 5/1723: {using feedback of body parameters, e.g. blood sugar or pressure}
- A61B 5/14507: {specially adapted for measuring characteristics of body fluids other than blood (devices for taking samples of body liquids A61B10/0045)}
- A61B 5/4839: {combined with drug delivery}
- A61B 2560/0223: of calibration, e.g. protocols for calibrating sensors
- 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)
- 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)}

## Abstract

An optical analyte sensor and diabetes management system is provided. The sensor preferably includes a hydrogel matrix for receiving a sample containing an analyte at unknown concentration, a light emitter for emitting light at a stimulation frequency, a light receiver for receiving a fluorescence signal at a first isosbestic frequency, and at a second frequency, for measuring an intensity of the fluorescence signal and the first and second frequencies. A processor determines a concentration of the analyte based on the respective intensities.

## Claims

### Claim 1

A diabetes management system comprising an optical analyte sensor and an insulin infusion device, wherein the optical analyte sensor comprises:
a matrix for receiving a sample containing the analyte at an unknown concentration;
a light emitter for emitting light at a stimulation frequency upon the sample;
a light receiver for receiving a fluorescence signal at a first isosbestic frequency, and at a second frequency, and for measuring an intensity of the fluorescence signal at the first and second frequencies;
a processor for determining a concentration of the analyte based on the respective intensities measured at the first and second frequencies; and
wherein the analyte sensor further comprises a transceiver for transmitting a signal to the insulin infusion device.

### Claim 2 (depends on 1)

The diabetes management system of claim 1, wherein the processor further determines an insulin requirement and wherein the signal transmitted to the insulin infusion device comprises an insulin requirement based on the determined insulin requirement.

### Claim 3 (depends on 1)

The diabetes management system of claim 1, wherein the sensor is an in-vitro sensor.

### Claim 4 (depends on 1)

The diabetes management system of claim 1, wherein the sensor is an in-vivo sensor.

### Claim 5 (depends on 1)

The diabetes management system of claim 1, wherein the sensor is a continuous sensor.

### Claim 6 (depends on 1)

The diabetes management system of claim 1, wherein the analyte is glucose.

### Claim 7 (depends on 1)

The diabetes management system of claim 1, wherein the analyte is hemoglobin HbA1c.

### Claim 8 (depends on 1)

The diabetes management system of claim 1, wherein the analyte is glycated albumin.

### Claim 9

An optical analyte sensor comprising:
a matrix for receiving a sample containing the analyte at an unknown concentration;
a light emitter for emitting light at a stimulation frequency upon the sample;
a light receiver for receiving a fluorescence signal at a first isosbestic frequency, and at a second frequency, and for measuring an intensity of the fluorescence signal at the first and second frequencies;
a processor for determining a concentration of the analyte based on the respective intensities measured at the first and second frequencies; wherein said processor further determines a sensor drift based on previous intensity measurements and corrects the determined concentration based on the determined sensor drift.

### Claim 10 (depends on 9)

The optical analyte sensor of claim 9, further comprising a transceiver for transmitting signals indicative of determine analyte concentration to a remote device.

### Claim 11 (depends on 10)

The optical analyte sensor of claim 10, wherein the remote device is a smartphone.

### Claim 12 (depends on 10)

The optical analyte sensor of claim 10, wherein the transceiver transmits signals to a remote storage device.

### Claim 13 (depends on 9)

The optical analyte sensor of claim 9, wherein the optical sensor comprises an energy source and is adapted for at least one day of continuous use.

### Claim 14 (depends on 9)

The optical analyte sensor of claim 9, wherein the optical sensor is used in the subcutaneous space of a host.

### Claim 15 (depends on 9)

The optical analyte sensor of claim 9, wherein the optical sensor is used in the intradermal space of a host.

### Claim 16 (depends on 9)

The optical analyte sensor of claim 9, wherein the optical sensor is used in the supradermal space of a host.

### Claim 17 (depends on 9)

The optical analyte sensor of claim 9, wherein the optical sensor is used in the intravascular space of a host.

### Claim 18 (depends on 9)

The optical analyte sensor of claim 9, wherein the optical sensor is used in a bodily fluid.

### Claim 19 (depends on 9)

The optical analyte sensor of claim 9, wherein the optical analyte sensor is an in-vitro sensor.
