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US 12,699,105 B2Granted
Methods, devices, and systems for adjusting laboratory HBA1C values
AssigneeAbbot Diabetes Care Inc.
InventorsYongjin Xu, Timothy C. Dunn
Life of this patent
Estimating the term…
Abstract
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.
Claims14
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 (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) 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 kage 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 (kref);
- or
- after the data acquisition phase in which the kage is determined to be available, calculating an actual version of the aHbA1c level for the subject based on the cHbA1c level, the kage, and a defined reference kage (krefage);
- 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.
15 more elements
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 (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) 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 kage 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 (kref);
- or
- after the data acquisition phase in which the kage is determined to be available, calculating an actual version of the aHbA1c level for the subject based on the cHbA1c level, the kage, and a defined reference kage (krefage);
- 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.
19 more elements
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 (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) 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 kage 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 (kref);
- or
- after the data acquisition phase in which the kage is determined to be available, calculate an actual version of the aHbA1c level for the subject based on the cHbA1c level, the kage, and a defined reference kage (krefage);
- 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.
15 more elements
Dependencies are inferred from the claim text.