US 11,950,903 B2Granted

Reporting of glycemic variability from continuous glucose monitoring

AssigneeSenseonics, Incorporated

InventorsJames Masciotti, Barbara Montgomery

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Abstract

In one aspect, a method of estimating an HbA1c level is provided. The method may include obtaining a first and second glucose measurement, adding the first and the second glucose measurements to a glucose measurement data set, and calculating an estimated HbA1c level using at least the glucose measurement data set. In another aspect, a method of calculating a range of an estimated HbA1c level is provided. The method may comprise at least calculating an estimated HbA1c level and a standard deviation of the estimated HbA1c level using a glucose measurement data set, and combining the estimated HbA1c level with the standard deviation of the estimated HbA1c level to acquire the range of the estimated HbA1c level. In another aspect, a glucose monitoring device may display glycemic variability of an individual.

Claims21

Dependent claims

An analyte monitoring method comprising:

using an analyte monitoring sensor of an analyte monitoring system to measure glucose levels of a patient, wherein using the analyte monitoring sensor of the analyte monitoring system to measure the glucose levels of the patient comprises using a fluorometer of the analyte monitoring sensor to measure the glucose levels of the patient, using the fluorometer of the analyte monitoring sensor to measure the glucose levels of the patient comprises using the fluorometer to measure parameters of fluorescence after and/or during excitation by a spectrum of light, and the measured parameters include an intensity and/or a wavelength distribution of emission spectrum of the fluorescence;
using the analyte monitoring sensor to communicate over a wireless communication link;
using an analyte monitoring device of the analyte monitoring system to obtain a first glucose measurement indicative of a first glucose level of the patient;
using the analyte monitoring device to obtain a second glucose measurement indicative of a second glucose level of the patient;
using the analyte monitoring device to add the first and the second glucose measurements to a glucose measurement data set;
using a processor of the analyte monitoring device to calculate an estimated HbA1c level using the glucose measurement data set, an association constant k2, and an association constant k3, wherein the association constant k2 represents a conversion of a pre-A1c to an HbA1c, and the association constant k3 represents a life span of the pre-A1c and the HbA1c;
and
using a display of the analyte monitoring device to display the estimated HbA1c level.

5 more elements

An analyte monitoring method comprising:

using an analyte monitoring sensor of an analyte monitoring system to measure glucose levels of a patient, wherein using the analyte monitoring sensor of the analyte monitoring system to measure the glucose levels of the patient comprises using a fluorometer of the analyte monitoring sensor to measure the glucose levels of the patient, using the fluorometer of the analyte monitoring sensor to measure the glucose levels of the patient comprises using the fluorometer to measure parameters of fluorescence after and/or during excitation by a spectrum of light, and the measured parameters include an intensity and/or a wavelength distribution of emission spectrum of the fluorescence;
using the analyte monitoring sensor to communicate over a wireless communication link;
using an analyte monitoring device of the analyte monitoring system to obtain a first glucose measurement indicative of a first glucose level of the patient;
using the analyte monitoring device to obtain a second glucose measurement indicative of a second glucose level of the patient;
using the analyte monitoring device to add the first and the second glucose measurements to a glucose measurement data set;
using a processor of the analyte monitoring device to calculate an estimated HbA1c level using the glucose measurement data set and the following formula:
[
H
⁢
b
⁢
A
1
⁢
c
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[
H
⁢
b
]
⁢
(
mmol
mol
)
=
[
G
⁢
L
⁢
U
]
⁢
(
t
)
*
(
k
1
⁢
k
2
k
-
1
+
k
2
⁢
(
e
-
k
3
⁢
t
-
e
-
(
k
3
+
k
-
1
+
k
2
)
⁢
t
)
)
where k1 is an association constant that represents a binding constant when a glucose attaches to a hemoglobin to form a pre-A1c, k−1 is an association constant that represents a dissociation constant when the glucose detaches from the hemoglobin, k2 is an association constant that represents a conversion of the pre-A1c to an HbA1c and k3 is an association constant that represents a life span of the pre-A1c and the HbA1c;
using the processor of the analyte monitoring device to calculate a standard deviation of the estimated HbA1c level using the glucose measurement data set;
using the processor of the analyte monitoring device to combine the estimated HbA1c level with the standard deviation of the estimated HbA1c level to acquire a range of the estimated HbA1c level;
and
using a display of the analyte monitoring device to display the range of the estimated HbA1c level.

79 more elements

Dependencies are inferred from the claim text.

Facts

Application: 16/191,913Filed 15 Nov 2018 · us provisional application
Priority: 15 Nov 2017
Published: US 2019/0142314 A116 May 2019
Granted: 9 Apr 2024
Term ends: Not estimatedThe source records don’t support an estimate.

Classification12 codes

A61B 5/14532
Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g.…: for…
A61B 5/0004
Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network: characterised by the type of…
A61B 5/7435
Using visual displays: displaying user selection data, e.g. icons in a graphical user interface
G16H 50/30
ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or…: for…