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-10624577-B2
Publication Date
2020-04-21
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 disclosure describes systems, devices, and methods for diagnosing and treating glycemic imbalance in a patient by using blood glucose detections obtained from blood samples at a plurality of times. Each blood glucose-level detection is tagged with an identifier reflective of when the blood sample was obtained, and a glycemic state is determined using at least the blood glucose detections. The glycemic state is compared to a desired glycemic range to diagnose glycemic imbalance when the glycemic state is outside the desired glycemic range.
The treatment includes adjusting at least one component of a present insulin dosage regimen to stay within the desired glycemic range while dampening or preventing unstable oscillations. The insulin dosage regimen components include long-acting insulin component and short-acting insulin component parameters such as carbohydrate ratio and plasma glucose correction factor, and the regimen is adjusted to manage the patient toward durable glycemic balance.
The disclosure further emphasizes mechanisms for dampening unstable oscillations, including periodic updates and asynchronous safety updates associated with severe hypoglycemia, tagging glucose readings by time and event categories, and algorithmic detection of hypoglycemic episodes. Oscillation damping mechanisms include intermittent adjustments, limiting consecutive dosage increments, and off intervals between adjustment directions, with additional statistical checks including a normal-distribution check via a third moment.
Claims Coverage
The partial content includes one independent claim for diagnosing and treating glycemic imbalance and dependent claims that refine the inventive concept. Across the claim set, the coverage centers on time-tagging blood glucose measurements, comparing a determined glycemic state to a desired glycemic range, and adjusting insulin regimen components to stay in range while dampening or preventing unstable oscillations until an insulin component is lowered to a predetermined level.
Time-tagging blood glucose detections at a plurality of times
Obtaining blood samples at a plurality of times; detecting blood glucose levels and tagging each blood glucose-level detection with an identifier reflective of when the blood sample was obtained.
Glycemic state determination and desired glycemic range comparison
Determining a glycemic state of the patient using at least the blood glucose detections; diagnosing glycemic imbalance by comparing the glycemic state to a desired glycemic range and determining that the glycemic state is outside the desired glycemic range.
Adjusting insulin dosage regimen components to dampen unstable oscillations
Adjusting at least one component of a present insulin dosage regimen to stay within the desired glycemic range and dampen or prevent unstable oscillations; performing the method until at least one component required to stay within the desired glycemic range is lowered to a predetermined level.
Intermittent adjustment value for oscillation dampening
Dampening or preventing unstable oscillations by adjusting with an intermittent value.
Directional constraint using current increase less than previous decrease
Dampening or preventing unstable oscillations by ensuring that an increase in the insulin dosage regimen is less than a previous decrease in the regimen.
Desired glycemic range bound
The desired glycemic range is between 85 mg/dL and 200 mg/dL.
Adjustment based on total daily insulin
Adjusting at least one component of a present insulin dosage regimen by calculating the patient's total daily insulin amount.
Consecutive dosage increment rule with off period
Determining how much to adjust while applying a consecutive dosage increment rule that sets an off period if more than a desired number of increments occurs.
Overall claim coverage protects a diagnosis-and-treatment method that time-tags blood glucose detections, determines a glycemic state, diagnoses imbalance via comparison to a desired glycemic range, and adjusts components of a present insulin dosage regimen to remain within range while dampening unstable oscillations until an insulin component is lowered to a predetermined level. Dependent claims further narrow the glycemic range, specify intermittent and directional oscillation-dampening behavior, and constrain adjustment magnitude via total daily insulin and a consecutive-increment rule with off periods.
Stated Advantages
Improved A1C.
Reduced hypoglycemia rate and/or reduced hypoglycemia frequency.
Management toward durable glycemic balance by alleviating glycemic imbalance while dampening or preventing unstable oscillations.
Documented Applications
Diagnosing and treating glycemic imbalance in a human patient using time-tagged blood glucose detections and adjusting a present insulin dosage regimen to achieve and maintain durable glycemic balance.
Clinical management of insulin dosage over months or years with insulin requirement changes and A1C improvement while reducing hypoglycemia rate or frequency.
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