# US 12,009,102 B2 · Automated system for monitoring a patient's blood sugar

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- Number: US 12,009,102 B2
- Document ID: US12009102B2
- Status: Granted
- Kind: B2
- Application number: 17/055,097
- Filed: 2019-05-03
- Published: 2021-09-02
- Granted: 2024-06-11
- Earliest claimed: 2018-05-22
- Assignees: Commissariat A L'energie Atomique Et Aux Energies Alternatives
- Applicants: Commissariat à l'Énergie Atomique et aux Énergies Alternatives
- Inventors: Romain Blanc; Eléonore Maeva Doron; Hector-Manuel Romero Ugalde
- Web page: https://patentgrep.com/patent/US12009102B2

## CPC

- G16H 50/30: for calculating health indices; for individual health risk assessment
- A61B 5/14532: {for measuring glucose, e.g. by tissue impedance measurement}
- A61B 5/1495: Calibrating or testing of in-vivo probes
- A61B 5/4839: {combined with drug delivery}
- A61M 5/1723: {using feedback of body parameters, e.g. blood sugar or pressure}
- G05B 13/048: {using a predictor}
- G16H 10/60: for patient-specific data, e.g. for electronic patient records
- G16H 20/17: delivered via infusion or injection
- G16H 40/40: for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
- G16H 40/67: for remote 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
- A61M 2205/702: automatically during use
- A61M 2230/201: Glucose concentration
- G16H 20/60: relating to nutrition control, e.g. diets
- 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)
- 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)}
- G05B: CONTROL OR REGULATING SYSTEMS IN GENERAL; FUNCTIONAL ELEMENTS OF SUCH SYSTEMS; MONITORING OR TESTING ARRANGEMENTS FOR SUCH SYSTEMS OR ELEMENTS (systems for controlling or regulating non-electric variables G05D; systems for regulating electric or magnetic variables G05F; control devices or systems insofar as characterised by mechanical features only G05G)

## Abstract

An automated system for controlling a patient's blood glucose, including a blood glucose sensor and a processing and control unit, wherein the processing and control unit is configured to calculate, from a first mathematical model fCR specific to the patient and taking into account a single blood glucose value Gr measured by the sensor, a factor CR representative of the patient's insulin sensitivity.

## Claims

### Claim 1

An automated system for controlling a patient's blood glucose, comprising a blood glucose sensor and a processing and control unit, wherein the blood glucose sensor is configured to measure a blood glucose value (Gr) of the patient, and wherein the processing and control unit is configured to:
determine, based on a history of blood glucose values measured by the blood glucose sensor, a history of insulin injected to the patient, and a history of carbohydrate ingestion by the patient, a plurality of real insulin sensitivity factor (CRr) values for a plurality of events identified for the patient over a past observation period, wherein each event of the plurality of events corresponds to a continuous time range from an initial time (tinit) to a final time (tfinal) during which the insulin sensitivity factor (CRr) is isolated,
calibrate a first mathematical model (fCR) based on the plurality of real insulin sensitivity factor (CRr) values, the calibrating comprising determining the first mathematical model (fCR) by regression from the plurality of real insulin sensitivity factor (CRr) values; and
calculate, from the first mathematical model (fCR) and taking into account the blood glucose value (Gr) measured by the blood glucose sensor, a factor (CR) representative of an insulin sensitivity of the patient.

### Claim 2 (depends on 1)

The system according to claim 1, further comprising an insulin injection device, wherein the processing and control unit is configured to control the insulin injection device by taking into account the factor (CR) representative of the insulin sensitivity of the patient.

### Claim 3 (depends on 2)

The system according to claim 2, wherein the processing and control unit is configured to predict, from a second mathematical model, a future trend of the patient's blood glucose over a prediction period, and to control the insulin injection device by taking the prediction into account.

### Claim 4 (depends on 1)

The system according to claim 1, wherein the first mathematical model is a function of equation
CR=fCR(Gr)=a×Grb+c
where a, b, and c are parameters specific to the patient.

### Claim 5 (depends on 1)

The system according to claim 1, wherein the continuous time range complies with the following criteria:
the initial time (tinit) is in a hyperglycemia phase, that is, a phase where the patient's blood glucose is greater than a predetermined threshold;
a correction bolus, that is, an additional insulin dose has been delivered to the patient after a beginning of the hyperglycemia phase and before the initial time (tinit), to limit a duration of the hyperglycemia phase;
the patient's blood glucose continuously decreases between the initial time (tinit) and the final time (tfinal);
no carbohydrate ingestion by the patient has occurred between a time (tinit−Tj) and the final time (tfinal), wherein the time (tinit−Tj) is the initial time (tinit) minus a predetermined fasting duration (Tj).

### Claim 6 (depends on 1)

The system according to claim 1, wherein the processing and control unit is configured to, during an initial phase (Tpop) of use of the system prior to calibrating the first mathematical model, use a non-personalized generic mathematical model (fCR-pop) to calculate the factor (CR) representative of the insulin sensitivity of the patient.

### Claim 7 (depends on 6)

The system according to claim 6, wherein the processing and control unit is configured to, during an intermediate phase (Thyb) of use of the system, subsequent to the initial phase (Tpop) and prior to calibrating the first mathematical model, use a partially personalized mathematical model (fCR-hyb) to calculate the factor (CR) representative of the insulin sensitivity of the patient.

### Claim 8 (depends on 7)

The system according to claim 7, wherein the partially personalized mathematical model is defined by equation:
fCR-hyb(Gr)=k×fCR-pop(Gr)
where k is a factor specific to the patient defined according to the following formula:
k
=
TDD
m
⁢
o
⁢
y
a
⁢
1
×
B
⁢
W
where BW designates a weight of the patient, TDDmoy designates an average daily insulin dose injected to the patient over the initial phase (Tpop), and a1 is a constant factor in a range from 0.5 to 0.9.

### Claim 9 (depends on 1)

The system according to claim 1, wherein the processing and control unit is configured to, after calibrating the first mathematical model (fCR), implement a plurality of successive steps of re-calibration of the first mathematical model to take into account new data of blood glucose measured by the blood glucose sensor, of insulin injected to the patient, and of carbohydrate ingestion by the patient.

### Claim 10 (depends on 1)

The system according to claim 1, further comprising an insulin injection device, wherein the processing and control unit is configured to regulate insulin delivered to the patient based on the determined factor JCR) representative of the insulin sensitivity of the patient, wherein the regulating comprises controlling the insulin injection device.
