Systems, devices, and methods for alleviating glucotoxicity and restoring pancreatic beta-cell function in advanced diabetes mellitus
Inventors
Assignees
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Publication Number
US-11723592-B2
Publication Date
2023-08-15
Expiration Date
Abstract
Systems, methods and/or devices for treating diabetes mellitus by alleviating glucotoxicity and restoring pancreatic beta-cell function, comprising at least a first memory for storing data inputs corresponding at least to one or more components in a patient's present insulin dosage regimen, and data inputs corresponding at least to the patient's blood-glucose-level measurements determined at a plurality of times, and a processor operatively connected to the at least first memory. The processor is programmed at least to determine from the data inputs corresponding to the patient's blood-glucose-level measurements determined at a plurality of times whether and by how much to vary at least one of the components of the patient's present insulin dosage regimen. Also disclosed are systems, methods, and/or devices for alleviating glucotoxicity and restoring pancreatic beta-cell function, comprising establishing the patient's current glycemic state relative to a desired glycemic range and determining from at least one of a plurality of the data corresponding to the patient's blood glucose-level measurements whether and by how much to adjust at least one of the components in the patient's present insulin dosage regimen.
Core Innovation
The disclosed invention provides a method for treating diabetes mellitus by alleviating glucotoxicity and/or restoring pancreatic beta-cell function in a patient. The method stores one or more components of the patient's insulin dosage regimen and repeatedly draws blood samples at a plurality of times to ascertain blood glucose-level measurements. Each measurement is tagged with an identifier reflective of when the measurement was obtained, and the patient's current glycemic state is established relative to a desired glycemic range.
The method determines whether there have been an excessive number of hypoglycemic events over a predefined period of time, and varies at least one component of the patient's present insulin dosage regimen in response to such a determination. It also determines whether and by how much to adjust at least one component to stay within the desired glycemic range and administer the lowest insulin dosage, including increasing, decreasing, or pausing the dosage regimen to dampen or prevent unstable oscillations.
The overall objective is an improved glycemic composite index, together with restoration of beta-cell function which reduces exogenous insulin reliance. The method performs the steps until the insulin dosage regimen required to stay within the desired glycemic range is lowered to a predetermined level, and the apparatus and system repeatedly tag measurements, calculate deviations from the desired glycemic range, adjust insulin dosage regimen components, and determine the variation needed to maintain glucose within a predefined range over time.
Claims Coverage
The independent claims cover four aspects: a method, an apparatus, and a system that iteratively monitor time-tagged blood glucose measurements relative to a desired glycemic range and repeatedly adjust insulin dosage regimen components to alleviate glucotoxicity and/or restore pancreatic beta-cell function, continuing until the regimen is lowered to a predetermined level.
Iterative diabetes treatment to alleviate glucotoxicity and/or restore beta-cell function
A method for treating diabetes mellitus by alleviating glucotoxicity and/or restoring pancreatic beta-cell function, storing insulin dosage regimen components, drawing blood samples at a plurality of times, ascertaining blood glucose-level measurements, tagging each measurement with an identifier reflective of when obtained, establishing current glycemic state relative to a desired glycemic range, and determining excessive hypoglycemic events over a predefined period of time to vary at least one regimen component accordingly.
Lowest-insulin adjustment using glycemic range with hypoglycemia and A1C weighing
Determining whether and by how much to adjust at least one component of the patient's present insulin dosage regimen to stay within the desired glycemic range and administer the lowest insulin dosage, adjusting the regimen by increasing, decreasing, or pausing to dampen or prevent unstable oscillations, wherein the adjustment weighs both A1C percentage and the number of hypoglycemic events within the predefined period of time to achieve an improved glycemic composite index and restoration of beta-cell function.
Iterative timer-based deviation-to-adjustment loop
An apparatus comprising a timer and a processor programmed to tag blood glucose-level measurements with an identifier reflective of when obtained, calculate deviation of obtained measurements from a desired glycemic range, adjust at least one insulin dosage regimen component in response to a determination that the most recent measurement was not within the desired glycemic range, reinitiate the timer after the determination, and repeatedly tag, calculate deviation, adjust, and determine regimen variation until the insulin dosage regimen required to stay within the desired glycemic range is lowered to a predetermined level.
System that repeatedly tags deviations and determines variation until regimen is lowered
A system including memory and processor configured to initiate a timer, increment the timer based on passage of time and/or receipt of blood glucose-level measurements, tag measurements with an identifier reflective of when obtained, calculate deviation from a desired glycemic range, adjust at least one insulin dosage regimen component when the most recent measurement was not within the desired glycemic range with timer reinitiation, determine at the end of the time period whether and by how much to vary at least one component to maintain glucose within a predefined range with timer reinitiation, and repeatedly increment the timer, tag measurements, calculate deviation, adjust components, and determine variation until the regimen is lowered to a predetermined level.
Across the independent claims, the core coverage is an iterative control framework that uses time-tagged blood glucose-level measurements to establish a glycemic state relative to a desired glycemic range, calculates deviation, detects excessive hypoglycemic events, and adjusts one or more components of the insulin dosage regimen, including increasing, decreasing, or pausing to dampen oscillations, until the regimen needed to stay within range is lowered to a predetermined level while weighing A1C and hypoglycemic event count to improve a glycemic composite index and restore beta-cell function.
Stated Advantages
Alleviating glucotoxicity and/or restoring pancreatic beta-cell function
Administering the lowest insulin dosage while staying within the desired glycemic range
Improved glycemic composite index by weighing A1C percentage and the number of hypoglycemic events
Restoration of beta-cell function which reduces exogenous insulin reliance
Dampening or preventing unstable oscillations
Documented Applications
Not explicitly described in patent.
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