Methods, devices, and systems for adjusting laboratory HBA1C values
Physiological parameters that related to the kinetics of red blood cell hemoglobin glycation, red blood cell elimination, and red blood cell generation within the body of a subject can be used, for example, to calculate a more reliable calculated HbA1c (cHbA1c), adjusted HbA1c (aHbA1c), and/or a personalized target glucose range, among other things, for subject-personalized diagnoses, treatments, and/or monitoring protocols. Such physiological parameters may be determined using a model that considers cross-membrane glucose transport and glycation.
1 . A method comprising:
determining at least one physiological parameter for a subject selected from the group consisting of:
a red blood cell glycation rate constant (k gly ),
a red blood cell generation rate constant (k gen ),
a red blood cell elimination constant (k age ), and
an apparent glycation constant (K) based on (1) a plurality of first glucose levels and (2) a laboratory HbA1c level using a model that relies on cross-membrane glucose transport and glycation;
measuring a plurality of second glucose levels for the subject over a time period;
deriving a calculated HbA1c (cHbA1c) level for the subject based on the at least one physiological parameter, the laboratory HbA1c, and the plurality of second glucose levels;
performing at least one of:
during a data acquisition phase in which the k age is determined to not be available, calculating an approximate version of an adjusted HbA1c (aHbA1c) level for the subject based on the cHbA1c level, the K, and a defined reference k (k ref ); or
after the data acquisition phase in which the k age is determined to be available, calculating an actual version of the aHbA1c level for the subject based on the cHbA1c level, the k age , and a defined reference k age (k ref age ); and
treating the subject based on either the approximate version or the actual version of the aHbA1c level by administering and/or adjusting:
an insulin dosage,
a glycation medication dosage,
an exercise regime,
a meal intake, or
a combination thereof.
2 . The method of claim 1 , wherein measuring the plurality of second glucose levels comprises:
sampling a bodily fluid from the subject using an analyte sensor; and
measuring the plurality of second glucose levels with the analyte sensor.
3 . The method of claim 2 further comprising:
displaying the cHbA1c level on a display of a system comprising the analyte sensor.
4 . The method of claim 1 , wherein measuring the plurality of second glucose levels comprises:
sampling a bodily fluid from the subject over a time period using an analyte sensor of a closed-loop or hybrid closed-loop insulin pump system;
measuring the plurality of second glucose levels in the bodily fluid with the analyte sensor; and
administering, via the closed-loop or hybrid closed-loop insulin pump system, the insulin dosage based on either the approximate version or the actual version of aHbA1c.
5 . The method of claim 1 further comprising: treating the subject based on either the approximate version or the actual version of the aHbA1c level by administering and/or adjusting the insulin dosage.
6 . The method of claim 1 further comprising:
treating the subject based on the aHbA1c level by determining and/or administering a personalized treatment for subject triage, a personalized treatment for titration of diabetes medication, a personalized closed-loop or hybrid closed-loop control system, a personalized treatment using glycation medications, or a combination thereof.
7 . A system comprising:
an analyte sensor configured to measure a glucose level in a bodily fluid;
one or more processors; and
one or more hardware storage devices that store instructions that are executable by the one or more processors to cause the system to:
determine at least one physiological parameter for a subject selected from the group consisting of:
a red blood cell glycation rate constant (k gly ),
a red blood cell generation rate constant (k gen ),
a red blood cell elimination constant (k age ), and
an apparent glycation constant (K) based on (1) a plurality of first glucose levels and (2) a laboratory HbA1c level using a model that relies on cross-membrane glucose transport and glycation;
measure a plurality of second glucose levels for the subject over a time period;
derive a calculated HbA1c (cHbA1c) level for the subject based on the at least one physiological parameter, the laboratory HbA1c, and the plurality of second glucose levels;
perform at least one of:
during a data acquisition phase in which the k age is determined to not be available, calculate an approximate version of an adjusted HbA1c (aHbA1c) level for the subject based on the cHbA1c level, the K, and a defined reference k (k ref ); or
after the data acquisition phase in which the k age is determined to be available, calculating an actual version of the aHbA1c level for the subject based on the cHbA1c level, the k age , and a defined reference k age (k ref age ); and
treat the subject based on either the approximate version or the actual version of the aHbA1c level by administering and/or adjusting:
an insulin dosage,
a glycation medication dosage,
an exercise regime,
a meal intake, or
a combination thereof.
8 . The system of claim 7 , wherein measuring the plurality of second glucose levels comprises:
sampling a bodily fluid from the subject using the analyte sensor; and
measuring the plurality of second glucose levels with the analyte sensor.
9 . The system of claim 8 wherein the instructions, when executed by the one or more processors, further causes the system to:
display the cHbA1c level on a display.
10 . The system of claim 7 , wherein measuring the plurality of second glucose levels comprises:
sampling a bodily fluid from the subject over a time period using the analyte sensor, which is associated with a closed-loop or hybrid-closed loop insulin pump system;
measuring the plurality of second glucose levels in the bodily fluid with the analyte sensor; and
administering, via the closed-loop or hybrid closed-loop insulin pump system, the insulin dosage based on either the approximate version or the actual version of the aHbA1c.
11 . The system of claim 7 wherein the instructions, when executed by the one or more processors, further causes the system to:
treat the subject based on either the approximate version or the actual version of the aHbA1c level by administering and/or adjusting the insulin dosage.
12 . The system of claim 7 wherein the instructions, when executed by the one or more processors, further causes the system to:
treat the subject based on either the approximate version or the actual version of the aHbA1c level by determining and/or administering a personalized treatment for subject triage, a personalized treatment for titration of diabetes medication, a personalized closed-loop or hybrid-closed loop control system, a personalized treatment using glycation medications, or a combination thereof.
13 . One or more hardware storage devices that store instructions that are executable by one or more processors to cause the one or more processors to:
determine at least one physiological parameter for a subject selected from the group consisting of:
a red blood cell glycation rate constant (k gly ),
a red blood cell generation rate constant (k gen ),
a red blood cell elimination constant (k age ), and
an apparent glycation constant (K) based on (1) a plurality of first glucose levels and (2) a laboratory HbA1c level using a model that relies on cross-membrane glucose transport and glycation;
measure a plurality of second glucose levels for the subject over a time period;
derive a calculated HbA1c (cHbA1c) level for the subject based on the at least one physiological parameter, the laboratory HbA1c, and the plurality of second glucose levels;
perform at least one of:
during a data acquisition phase in which the k age is determined to not be available, calculate an approximate version of an adjusted HbA1c (aHbA1c) level for the subject based on the cHbA1c level, the K, and a defined reference k (k ref ); or
after the data acquisition phase in which the k age is determined to be available, calculate an actual version of the aHbA1c level for the subject based on the cHbA1c level, the k age , and a defined reference k age (k ref age ); and
treat the subject based on either the approximate version or the actual version of the aHbA1c level by administering and/or adjusting:
an insulin dosage,
a glycation medication dosage,
an exercise regime,
a meal intake, or
a combination thereof.
14 . The one or more hardware storage devices of claim 13 , wherein treating the subject is performed by administering and/or adjusting the insulin dosage.