Systems, methods and devices for achieving glycemic balance

Inventors

Bashan, Eran • Hodish, Israel

Assignees

Hygieia Inc

Interested in licensing this patent?

MTEC can help explore whether this patent might be available for licensing for your application.

Publication Number

US-10736562-B2

Patent

Publication Date

2020-08-11

Expiration Date


Abstract

Systems, methods and/or devices for optimizing a patient's insulin dosage regimen over time, 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 one or more components in the patient's present insulin dosage regimen. Also disclosed are systems, methods and/or devices for treating a patient's diabetes by providing treatment guidance, wherein the patient's current glycemic state is determined relative to a desired balance point; 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 vary at least one of the one or more components in the patient's present insulin dosage regimen to get closer to the patient's desired balance point; wherein the desired balance point is the patient's lowest blood glucose-level within a predetermined range achievable before increasing the frequency of hypoglycemic events above a predetermined threshold.

Core Innovation

The invention provides systems, methods, and devices for treating a patient's diabetes by storing one or more components of the patient's insulin dosage regimen and using data corresponding to blood glucose-level measurements determined at a plurality of times. The method tags each blood glucose-level measurement with an identifier reflective of when or why the reading was obtained.

A processor determines the patient's current glycemic state relative to a desired balance point. The desired balance point is defined as the patient's lowest blood glucose-level within a predetermined range achievable before increasing the frequency of hypoglycemic events above a predetermined threshold.

From at least one of the plurality of blood glucose-level measurements, the processor determines whether and by how much to vary at least one of the one or more components in the patient's present insulin dosage regimen to get closer to the desired balance point. The method outputs an instruction to decrease administration when the number of hypoglycemic events exceeds a predetermined threshold or when the patient's blood glucose level is below a first threshold blood glucose level, and to increase administration when the number of hypoglycemic events is below the predetermined threshold and the patient's blood glucose level is above a second threshold blood glucose level.

The method administers the one or more components in accordance with the outputted instruction. Additional refinements include selecting time-related identifiers such as Breakfast, Lunch, Dinner, Bedtime, Nighttime, and Other, and defining the nature of hypoglycemic-event thresholds using severe event definitions and evaluation scoping by identifier.

Claims Coverage

Independent claim clm-00001 is a method claim. It includes eight inventive features focused on regimen-component storage, time-tagged blood-glucose measurements, glycemic-state comparison to a desired balance point, instruction logic for decreasing or increasing regimen components based on hypoglycemic-event frequency and glucose thresholds, and administering the regimen components according to the instruction.

Storing insulin dosage regimen components

The method stores one or more components of the patient's insulin dosage regimen.

Time-stamped blood glucose-level measurement data with identifiers

The method obtains data corresponding to the patient's blood glucose-level measurements determined at a plurality of times and tags each measurement with an identifier reflective of when or why the reading was obtained.

Determining glycemic state relative to a desired balance point

The method determines the patient's current glycemic state relative to a desired balance point.

Desired balance point as lowest achievable blood glucose before hypoglycemia frequency increases

The desired balance point is defined as the patient's lowest blood glucose-level within a predetermined range achievable before increasing the frequency of hypoglycemic events above the predetermined threshold.

Instruction logic to vary regimen components to get closer to the balance point

From at least one of the plurality of blood glucose-level data, the method determines whether and by how much to vary at least one regimen component in the patient's present insulin dosage regimen to get closer to the desired balance point.

Decrease/increase administration based on hypoglycemic-event count and glucose thresholds

The method outputs an instruction to decrease administration if the number of hypoglycemic events exceeds a predetermined threshold or if the patient's blood glucose level is below a first threshold blood glucose level, and outputs an instruction to increase administration if the number of hypoglycemic events is below the predetermined threshold and the patient's blood glucose level is above a second threshold blood glucose level.

Administering regimen components according to the outputted instruction

The method administers at least one of the one or more components of the patient's insulin dosage regimen in accordance with the outputted instruction.

Predetermined hypoglycemic-event threshold values per year

The predetermined threshold of hypoglycemic events is 50, 60, 70, 75, 80, 85, 90, 100, 110, or 120 events/year.

Across the independent claim, the inventive coverage centers on using stored insulin regimen components together with plurality time-tagged blood glucose-level measurements to determine current glycemic state relative to a desired balance point, then outputting decrease/increase instructions for varying regimen components based on hypoglycemic-event frequency relative to a predetermined threshold and blood glucose-level threshold comparisons, followed by administering according to the instruction.

Stated Advantages

Moves the patient's insulin dosage regimen closer to a desired balance point defined as the lowest achievable blood glucose-level within a predetermined range before hypoglycemic-event frequency increases above a predetermined threshold.

Decreases insulin administration when hypoglycemic-event frequency exceeds a predetermined threshold or when blood glucose is below a first threshold, and increases administration when hypoglycemic-event frequency is below the predetermined threshold and blood glucose is above a second threshold.

Documented Applications

No documented applications found

JOIN OUR MAILING LIST

Stay Connected with MTEC

Keep up with active and upcoming solicitations, MTEC news and other valuable information.