Apparatus and methods for taking blood glucose measurements and recommending insulin doses

Inventors

Bielawa, Holly • Demetris, Carissa • Goebel, James • Morton, Carol Treat • Pomorski, Michelle • Puricelli, Thomas • Rodgers, Jim • Bashan, Eran • Hodish, Israel • Hindinger, John R.

Assignees

Hygieia Inc

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Publication Number

US-9341614-B2

Patent

Publication Date

2016-05-17

Expiration Date


Abstract

The present disclosure related to an apparatus that may be used for taking blood glucose measurements and providing individualized insulin dose recommendations wherein the apparatus is easy to use and facilitates improved diabetes control in patients. Also disclosed are related methods.

Core Innovation

The invention relates to an insulin-dose recommending blood glucose measurement apparatus that uses a test strip port, a processor, computer-readable memory, and a display screen to determine a patient’s current blood glucose level measurement from a sample of the patient’s blood on a test strip. The processor causes a successive display of information including the patient’s current blood glucose level measurement, an event associated with the current blood glucose level measurement, and a recommended insulin dose, and the apparatus presents these items in a user interface intended to support intuitive interaction and navigation.

The apparatus further causes a continuous and simultaneous display of indicia corresponding to at least the patient’s current blood glucose level measurement, the event associated with the current blood glucose level measurement, and the recommended insulin dosage, while simultaneously causing the successive information display. The continuously displayed indicia are positioned in alignment on the display screen with the position of the first button, and the successively displayed information is positioned in alignment with the second and third buttons.

A plurality of buttons enables a user to selectively cycle through the successive information displays using a first button and to selectively alter information displayed in one or more of the successive information displays using second and third buttons. The apparatus also supports automatic advancement of successive information displays after a predetermined period if button actuation does not occur, user override of the recommended insulin dose, and a safety feature that inhibits insulin recommendation at low glucose.

Claims Coverage

The independent claims cover an insulin-dose recommending apparatus with a test strip port, processor, display screen, and user-actuated cycling through successive displays, where continuous and simultaneous indicia are displayed in spatial alignment with button positions. Across the independent claims, the core inventive features total at least two principal categories: the successive/continuous display structure with spatial alignment, and button-driven cycling and altering of successive displays using buttons.

Test strip determined glucose measurement and successive display

Cause the successive display of information corresponding to a patient's current blood glucose level measurement as determined from a sample of the patient's blood provided on a test strip, an event associated with the said current blood glucose level measurement, and a recommended insulin dose.

Continuous simultaneous indicia aligned to button position

Cause the continuous and simultaneous display of indicia corresponding to at least the patient's current blood glucose level measurement, an event associated with said current blood glucose level measurement, and a recommended insulin dosage while simultaneously causing the display of said successive information; continuously displayed indicia corresponding to each of the successive information displays are positioned on the display screen in an alignment with the position of the first button, and the successively displayed information is positioned on the display screen in an alignment with the second and third buttons.

Button cycling and altering successive information displays

A plurality of buttons that may be user-activated operatively connected to the processor, including a first button operative to enable a user to selectively cycle through the successive information displays on the display screen, and second and third buttons operative to enable a user to selectively alter the information displayed in one or more of the successive information displays on the display screen.

Button cycling through successive information displays

At least one button operative to enable a user to selectively cycle through the successive information displays on the display screen.

Together, the independent claims define a test-strip-based apparatus that successively displays current blood glucose, an associated event, and a recommended insulin dose while continuously and simultaneously displaying indicia aligned with button positions, and that enables user cycling and altering of the successive information displays via user-actuated buttons.

Stated Advantages

Supports intuitive interaction and navigation.

Includes automatic advancement of successive information displays after a predetermined period if button actuation does not occur.

Allows user override of the recommended insulin dose.

Includes a safety feature that inhibits insulin recommendation at low glucose.

Describes human-factors proficiency targets for intended users, including a target that at least 85% of users become proficient after two uses and related performance thresholds.

Documented Applications

Insulin-dosing regimen-specific event tagging and dose computation using stored tables/software such as FAITH™.

Regimen contexts including basal-only, premixed, and basal-bolus with sliding scales and carbohydrate counting.

Default event selection by time of day.

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