Methods, devices, and systems for adjusting laboratory HBA1C values
Inventors
Xu, Yongjin • Dunn, Timothy C.
Assignees
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Publication Number
US-12699105-B2
Publication Date
2026-08-04
Expiration Date
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.
Core Innovation
The disclosed technology provides a kinetic model of red blood cell hemoglobin glycation, elimination, and generation. It derives physiological parameters including 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 a plurality of first glucose levels and a laboratory HbA1c level using a model that relies on cross-membrane glucose transport and glycation.
After the physiological parameters are determined, the approach measures a plurality of second glucose levels for the subject over a time period. Using the physiological parameters, the laboratory HbA1c, and the plurality of second glucose levels, the technology derives a calculated HbA1c (cHbA1c) level for the subject.
The method then performs an adjusted HbA1c calculation depending on availability of k_age during a data acquisition phase. During a data acquisition phase in which k_age is determined to not be available, the technology calculates an approximate version of an adjusted HbA1c (aHbA1c) based on the cHbA1c level, K, and a defined reference k (k_ref); after the data acquisition phase in which k_age is determined to be available, it calculates an actual version of the aHbA1c based on the cHbA1c level, k_age, and a defined reference k_age (k_refage).
Claims Coverage
The partial content provides three independent claims: a method claim, a system claim, and a hardware-instructions claim. Across these independent claims, the coverage centers on deriving red blood cell glycation-related physiological parameters from glucose levels and laboratory HbA1c using a cross-membrane glucose transport and glycation model, computing a calculated HbA1c and an adjusted HbA1c with an approximate-versus-actual k_age availability pathway, and using the adjusted HbA1c to treat the subject through administering and/or adjusting diabetes-related treatment parameters; multiple inventive features are present, with the core set shared across all three independents.
Red blood cell physiological parameter determination using cross-membrane glucose transport and glycation model
Determining at least one physiological parameter for a subject selected from 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 a plurality of first glucose levels and a laboratory HbA1c level using a model that relies on cross-membrane glucose transport and glycation.
Calculated HbA1c derivation from measured glucose levels plus physiological parameters and laboratory HbA1c
Measuring a plurality of second glucose levels for the subject over a time period and 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.
Approximate versus actual adjusted HbA1c calculation depending on k_age availability
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); 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_refage).
Treating the subject based on the approximate or actual adjusted HbA1c by administering and/or adjusting diabetes-related parameters
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.
System configuration with analyte sensor, processors, and stored instructions implementing HbA1c modeling and treatment
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 executable by the processors to determine the physiological parameter set, measure a plurality of second glucose levels over a time period, derive cHbA1c, compute an approximate or actual aHbA1c depending on k_age availability, and treat the subject.
Hardware instructions implementation of HbA1c modeling and treatment
One or more hardware storage devices that store instructions executable by one or more processors to determine the physiological parameter set, measure a plurality of second glucose levels over a time period, derive cHbA1c, compute an approximate or actual aHbA1c depending on k_age availability, and treat the subject.
Across the independent claims, the coverage is built around an RBC glucose-transport and glycation kinetic modeling approach that determines k_gly/k_gen/k_age/K from first glucose levels and laboratory HbA1c, then uses measured glucose levels to derive cHbA1c and compute an adjusted HbA1c. The aHbA1c is approximate when k_age is unavailable and actual when k_age is available, and the computed aHbA1c is then used as the basis for treating the subject through administering and/or adjusting insulin dosage and optionally glycation medication dosage, exercise regime, and/or meal intake.
Stated Advantages
Documented Applications
Not explicitly described in patent.
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