US 12,042,276 B2Granted

Methods, devices, and systems for physiological parameter analysis

AssigneeAbbott Diabetes Care Inc.

InventorsYongjin Xu, Timothy C. Dunn, Gary Hayter

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Abstract

Methods, devices, and systems may use a kinetic model to determine physiological parameters related to the kinetics of red blood cell glycation, elimination, and generation. Such physiological parameters can be used, for example, to determine a more reliable calculated HbA1c. In another example, a method may comprise: receiving a plurality of glucose levels over a time period; receiving a glycated hemoglobin (HbA1c) level corresponding to an end of the time period; determining at least one physiological parameter selected from the group consisting of: a red blood cell glycation rate constant (kgly), a red blood cell generation rate constant (kgen), a red blood cell elimination constant (kage), and an apparent glycation constant (K), based on (1) the plurality of glucose levels and (2) the HbA1c level; and adjusting a glucose level target based on the at least one physiological parameter.

Claims20

Dependent claims

A system for determining at least one glucose level target comprising:

an analyte sensor configured to measure a glucose level in a bodily fluid of a subject;
and
a monitoring device comprising:
one or more processors;
and
a memory operatively coupled to the one or more processors storing instructions which, when executed by the one or more processors, causes the one or more processors to:
receive a first plurality of glucose levels in the bodily fluid over a first plurality of time periods (ti=t1 . . . tz) from the analyte sensor, where i=1 for a first time period of the plurality of time periods and i=z for a last time period of the plurality of time periods;
receive a first glycated hemoglobin (HbA1c) level for the subject corresponding to an end of the last time period of the first plurality of time periods;
determine, based on (1) the first plurality of glucose levels and (2) the first HbA1c level, a red blood cell glycation rate constant kgly using Equation A:
EA=[G]/((kage/kgly)+[G]) Equation A
where EA is the first HbA1c, [G] is an average glucose level over the first plurality of time periods based on the first plurality of glucose levels, and kage is a constant, estimated, or calculated red blood cell elimination constant;
adjust at least one glucose level target based on the determined red blood cell glycation rate constant (kgly), wherein the at least one glucose level target is a personalized lower glucose limit (GL) based on Equation B:
GL=(LGL*kglyref)/kglysub Equation B
where kglyref is a red blood cell location constant (kgly) for a normal person, kglysub is the determined red blood cell gylcation rate constant (kgly), and where LGL is an accepted normal lower glucose limit;
and
a delivery system configured to receive the at least one glucose level target and treat the subject based on the at least one glucose level target, wherein treating the subject comprises administering and/or adjusting based on the at least one glucose level target:
an insulin dosage, a glycation-medication dosage, or a combination thereof.

14 more elements

A method for determining at least one glucose level target comprising:

receiving a first plurality of glucose levels for a subject over a first plurality of time periods (ti=t1 . . . tz), where i=1 for a first time period of the plurality of time periods and i=z for a last time period of the plurality of time periods;
receiving a first glycated hemoglobin (HbA1c) level for the subject corresponding to an end of the last time period of the first plurality of time periods;
determining, based on (1) the first plurality of glucose levels and (2) the first HbA1c level, a red blood cell glycation rate constant (kgly) using Equation A:
E
⁢
A
=
[
G
]
/
(
(
k
a
⁢
g
⁢
e
k
g
⁢
l
⁢
y
)
+
[
G
]
)
Equation
⁢
A
where EA is the first HbA1c, [G] is an average glucose level over the first plurality of time periods based on the first plurality of glucose levels, and kage is a constant, estimated, or calculated red blood cell elimination constant;
and
adjusting at least one glucose level target based on the determined red blood cell glycation rate constant (kgly), wherein the at least one glucose level target is a personalized lower glucose limit (GL) based on Equation B:
GL=(LGL*kglyref)/kglysub Equation B
where kglyref is a red blood cell glycation rate constant (kgly) for a normal person, kglysub is the determined red blood cell glycation constant (kgly), and where LGL is an accepted normal lower glucose limit;
and
treating the subject based on the at least one glucose level target, wherein treating the subject comprises administering and/or adjusting based on the at least one glucose level target:
an insulin dosage, a glycation-medication dosage, an exercise regime, a meal intake, or a combination thereof.

39 more elements

A system for determining at least one glucose level target comprising:

an analyte sensor configured to measure a glucose level in a bodily fluid of a subject;
a monitoring device comprising:
one or more processors;
and
a memory operatively coupled to the one or more processors storing instructions which, when executed by the one or more processors, causes the one or more processors to:
receive a first plurality of glucose levels in the bodily fluid over a first plurality of time periods (ti=t1 . . . tz) from the analyte sensor, where i=1 for a first time period of the plurality of time periods and i=z for a last time period of the plurality of time periods;
receive a first glycated hemoglobin (HbA1c) level for the subject corresponding to an end of a last time period of the first plurality of time periods;
determine, based on (1) the first plurality of glucose levels and (2) the first HbA1c level, an apparent glycation constant (K) using Equation A:
HbA
⁢
1
⁢
c
z
=
(
(
K
*
k
age
)
[
G
z
]
k
age
+
(
K
*
k
age
)
[
G
z
]
)
⁢
(
1
-
e
-
(
(
K
*
k
age
)
[
G
z
]
+
k
age
)
⁢
t
z
)
+
∑
i
=
1
z
-
1
[
(
(
K
*
k
age
)
[
G
i
]
k
age
+
(
K
*
k
age
)
[
G
i
]
)
⁢
(
1
-
e
-
(
(
K
*
k
age
)
[
G
i
]
+
k
age
)
⁢
t
i
)
⁢
∏
j
=
i
+
1
z
e
-
(
(
K
*
k
age
)
[
G
j
]
+
k
age
)
⁢
t
j
]
Equation
⁢
A
where kage is a red blood cell elimination constant and is an estimated value in Equation A, HbA1c, is the first HbA1c level, where [Gz] is an average glucose level over the last time period of the first plurality of time periods, where [Gi] is an average glucose level over a corresponding time period of the first plurality of time periods, where [Gj] is an average glucose level over a corresponding time period of the first plurality of time periods, where ti is a length of time interval of each time period in the first plurality of time periods;
adjust at least one glucose level target based on the determined apparent glycation constant (K), wherein the at least one glucose level target is selected from the group consisting of a personalized lower glucose limit (GU) based on Equation B and a personalized target glucose average (GT) based on Equation C:
GU=AU/(K(1−AU)) Equation B
where AU is an accepted normal HbA1c upper limit,
GT=AT/(K(1−AT)) Equation C
where AT is a target HbA1c level;
and
a delivery system configured to receive the at least one glucose level target and treat the subject based on the at least one glucose level target, wherein treating the subject comprises administering and/or adjusting based on the at least one glucose level target:
an insulin dosage, a glycation-medication dosage, or a combination thereof.

162 more elements

A method for determining at least one glucose level target comprising:

receiving a first plurality of glucose levels for a subject over a first plurality of time periods (ti=t1 . . . tz), where i=1 for a first time period of the plurality of time periods and i=z for a last time period of the plurality of time periods;
receiving a first glycated hemoglobin (HbA1c) level for the subject corresponding to an end of the last time period of the first plurality of time periods;
determining, based on (1) the first plurality of glucose levels and (2) the first HbA1c level, a red blood cell glycation rate constant (kgly) using Equation A:
HbA
⁢
1
⁢
c
z
=
(
(
K
*
k
age
)
[
G
z
]
k
age
+
(
K
*
k
age
)
[
G
z
]
)
⁢
(
1
-
e
-
(
(
K
*
k
age
)
[
G
z
]
+
k
age
)
⁢
t
z
)
+
∑
i
=
1
z
-
1
[
(
(
K
*
k
age
)
[
G
i
]
k
age
+
(
K
*
k
age
)
[
G
i
]
)
⁢
(
1
-
e
-
(
(
K
*
k
age
)
[
G
i
]
+
k
age
)
⁢
t
i
)
⁢
∑
j
=
i
+
1
z
⁢
e
-
(
(
K
*
k
age
)
[
G
j
]
+
k
age
)
⁢
t
j
]
Equation
⁢
A
where kage is a red blood cell elimination constant and is an estimated value in Equation A, HbA1c, is the first HbA1c level, where [Gz] is an average glucose level over the last time period of the first plurality of time periods, where [Gi] is an average glucose level over a corresponding time period of the first plurality of time periods, where [Gj] is an average glucose level over a corresponding time period of the first plurality of time periods, where ti is a length of time interval of each time period in the first plurality of time periods;
adjusting at least one glucose level target based on the determined apparent glycation constant (K), wherein the at least one glucose level target is selected from the group consisting of a personalized upper glucose limit (GU) based on Equation B and a personalized-target glucose average (GT) based on Equation C:
GU=AU/(K(1−AU)) Equation B
where AU is an accepted normal HbA1c upper limit,
GT=AT/(K(1−AT)) Equation C
where AT is a target HbA1c level;
and
treating the subject based on the at least one glucose level target, wherein treating the subject comprises administering and/or adjusting based on the at least one glucose level target:
an insulin dosage, a glycation-medication dosage, or a combination thereof.

158 more elements

Dependencies are inferred from the claim text.

Facts

Application: 17/883,518Filed 8 Aug 2022 · continuation
Priority: 21 Feb 2017
Published: US 2023/0024262 A126 Jan 2023
Granted: 23 Jul 2024
Term ends: Not estimatedThe source records don’t support an estimate.

Classification23 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 5/14503
Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g.…:…
A61B 5/14865
Using enzyme electrodes, e.g. with immobilised oxidase: invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors

Family

Application62/461,739Us provisional application · filed 21 Feb 2017
Application62/623,134Us provisional application · filed 29 Jan 2018
Application15/901,354Parent of this continuation · filed 21 Feb 2018
US 2023/0024262 A1Pre-grant publication · published 26 Jan 2023
US 11,406,293 B2Parent of this continuation
US 2018/0235524 A1Published application
US 12,042,276 B2This patent

From the US filing history. Foreign family members aren’t listed.