HK1188311A - Updatability of structured blood glucose tests on handheld diabetes management devices - Google Patents

Description

Updatability of structured blood glucose tests on handheld diabetes management devices

Technical Field

The present disclosure relates to handheld medical devices, and more particularly to handheld blood glucose (bG) management devices.

Background

The background description provided herein is for the purpose of generally presenting the context of the disclosure. Work of the presently named inventors, to the extent it is described in this background section, as well as aspects of the description that may not otherwise qualify as prior art at the time of filing, are neither expressly nor impliedly admitted as prior art against the present disclosure.

A diabetic condition (often referred to as diabetes) is a chronic condition in which a person has elevated blood glucose levels caused by a deficiency in the body's ability to produce and/or use insulin. There are three main types of diabetes. Type 1 diabetes usually affects children and young adults and can be autoimmune, genetic, and/or environmental. Type 2 diabetes accounts for 90-95% of the diabetic condition and is associated with obesity and physical inactivity. Gestational diabetes is a form of glucose intolerance diagnosed during pregnancy and usually heals naturally after delivery.

In 2009, at least 2 million people worldwide had diabetes according to the world health organization. In 2005, it was estimated that 110 million people died from diabetes. The incidence of diabetes is rapidly increasing and it is estimated that the number of deaths from diabetes doubles between 2005 and 2030. In the united states, nearly 2 thousand 4 million americans have diabetes, with an estimated 25% of the elderly aged 60 and older having diabetes. Central prediction of disease control and prevention: after 2000, 1 out of every 3 americans born will develop diabetes in their lifetime. The National Diabetes Information exchange center (National Diabetes Information Clearinghouse) estimates: diabetes costs in the united states alone at 1320 billion dollars per year. Without treatment, diabetes may lead to serious complications, such as heart disease, stroke, blindness, kidney failure, amputation, and death associated with pneumonia and influenza.

Management of diabetes is complicated by the fact that the level of blood glucose entering the bloodstream is dynamic. Changes in insulin in the bloodstream that control the transport of glucose out of the bloodstream also complicate diabetes management. Blood glucose levels are sensitive to diet and exercise, but may also be affected by sleep, stress, smoking, travel, illness, menses, and other psychological and lifestyle factors unique to each patient. The dynamic nature of blood glucose and insulin, as well as all other factors affecting blood glucose, often require that people with diabetes predict blood glucose levels. The administration of insulin and/or oral medication may be adjusted and timed to maintain blood glucose levels within an appropriate range throughout.

Management of diabetes is often highly invasive due to the need to consistently obtain reliable diagnostic information, follow prescribed therapy, and manage lifestyle on a daily basis. Diagnostic information (such as blood glucose levels) can be obtained from capillary blood samples using a lancing device (lancing device) and a test strip. Blood glucose levels are measured via a test strip using a handheld blood glucose meter. Interstitial glucose levels can be obtained from a continuous glucose sensor worn on the body.

A treatment regimen for the patient may be established based on one or more of the patient's blood glucose levels. The treatment regimen may include administration of insulin and/or oral medication. Insulin may be administered using a syringe, an ambulatory infusion pump, or a combination of both. In the case of insulin therapy, determining the amount of insulin to be injected at a given time may require prediction of dietary components (e.g., dietary components of fat, carbohydrates, and proteins). Determining the amount of insulin to be injected at a given time may also require consideration of the effects of exercise and physiological conditions. The management of lifestyle factors (such as weight, diet, and exercise) by a patient can significantly affect the type and effectiveness of treatment.

Management of diabetes involves a large amount of diagnostic data and descriptive data (descriptive data) obtained from: medical equipment, personal healthcare equipment, patient recorded information, healthcare professional test results, prescription medications, and recorded information. The medical devices include self-monitoring bG meters, continuous glucose monitors, portable insulin infusion pumps, diabetes analysis software, and diabetes device configuration software, each of which generates or manages, or both generates and manages, a large amount of diagnostic and explanatory data. The personal care device may include a weight scale and a blood pressure cuff. The information recorded by the patient may include information related to meals, exercise, and lifestyle. Health care professional biomarker data may include HbA1C, cholesterol, triglycerides, and glucose tolerance. The information recorded by the healthcare professional may include treatment and other patient specific information.

Currently, a health care professional can query a patient with diabetes to perform, for example, a three day blood glucose (bG) test. The three-day distribution (profile) bG structuring test involves: the patient checks his or her bG levels multiple times during each of three days, and handwriting the bG measurements with a chart. Preferably, the three-day distribution bG structuring test is performed under the following conditions: the patient examined his or her bG levels at seven different times during each of three days, and the seven different measurements were recorded daily. Seven different times at which the patient should measure and record his or her bG levels are: 1) before breakfast; 2) after breakfast; 3) before lunch; 4) after lunch; 5) before dinner; 6) after a night meal; and 7) bedtime. The patient should consume breakfast between measures 1 and 2, lunch between measures 3 and 4, and dinner between measures 5 and 6. Based on the results of this three-day distribution bG structured test, the health care professional can determine or adjust the insulin therapy for the patient. There is a need for: the handheld patient device aggregates, manipulates, manages, presents, and communicates diagnostic data and descriptive data from medical devices, personal care devices, patient recorded information, biomarker information, and recorded information in an efficient manner. This would enable the patient to improve his or her care and health, live an extended life and reduce the risk of complications from diabetes.

Disclosure of Invention

A handheld diabetes management device with improved updatability of entry, adherence, and exit criteria comprising: a blood glucose (bG) management engine, a memory, a display, and a processor module. The bG measurement engine measures a bG level in a blood sample of a user and generates sample data indicative of the bG level. The processor module is in communication with the bG measurement engine, the display, and the memory. The processor module selectively implements (execute) firmware stored in the non-modifiable portion of the memory to perform operations for implementing a structured bG test; selectively retrieving entry, adherence, and exit criteria stored in a modifiable portion of the memory for each individual bG sample expected to be input for the structured bG test; selectively retrieving entry, adherence, and exit criteria stored in a modifiable portion of the memory for a bG sample group expected for the structured bG test; and retrieving entry, adherence criteria, and exit criteria from the modifiable portion of the memory for the structured bG test.

A computer-readable storage medium of a handheld blood glucose (bG) management device that measures a bG level of a user and includes a touch screen display, wherein the computer-readable storage medium includes a modifiable portion and a non-modifiable portion. The modifiable portion includes adherence, exit, and entry criteria stored for performing the structured bG test. The non-modifiable portion includes the following firmware: the firmware, when executed by the processor of the handheld diabetes management device, causes the processor to perform the structured bG test involving: obtaining a measurement of the bG level of the user according to a predefined schedule (schedule); and selectively retrieving the adherence, exit and entry criteria from the modifiable portion.

A method of improving updatability of entry, adherence, and exit criteria stored in a memory of a handheld diabetes management device, the method comprising: providing the handheld diabetes management device with a blood glucose (bG) measurement engine that measures a bG level in a blood sample of a user and generates sample data indicative of the bG level; providing the handheld diabetes management device with the memory and a touch screen display; providing the handheld diabetes management device with a processor module in communication with the bG measurement engine, the touch screen display, and the memory; storing firmware executable by the processor module to perform operations for implementing a structured bG test in a non-modifiable portion of the memory; and storing the entry, adherence, and exit criteria in a modifiable portion of the memory.

Further areas of applicability of the present disclosure will become apparent from the detailed description provided hereinafter. It should be understood that the detailed description and specific examples are intended for purposes of illustration only and are not intended to limit the scope of the disclosure.

Drawings

The present disclosure will become more fully understood from the detailed description and the accompanying drawings, wherein:

FIG. 1 illustrates a patient and a health care professional, along with various devices that may be used to assist the patient in monitoring and controlling health;

FIG. 2 shows a patient with a Continuous Glucose Monitor (CGM), a portable durable insulin infusion pump, a portable non-durable insulin infusion pump, and a blood glucose (bG) management device;

FIG. 3 illustrates a diabetes care system that may be used with the system for managing diabetes;

FIG. 4 is a high level diagram of an example embodiment of a handheld diabetes management device;

FIG. 5 includes a functional block diagram of an example embodiment of a handheld diabetes management device; and

6-7 include flow diagrams that depict example methods of performing a structured bG test on a handheld diabetes management device.

Detailed Description

The following description is merely illustrative in nature and is in no way intended to limit the disclosure, its application, or uses. For purposes of clarity, the same reference numbers will be used in the drawings to identify similar elements. As used herein, at least one of the phrases A, B and C should be understood to mean the use of a non-exclusive logical or of logic (a or B or C). It should be understood that the steps within a method may be implemented in a different order without altering the principles of the present disclosure.

As used herein, the term "module" may refer to, be part of, or include the following: an Application Specific Integrated Circuit (ASIC); an electronic circuit; a combinational logic circuit; a Field Programmable Gate Array (FPGA); a processor (shared, dedicated, or group) that implements the code; other suitable components that provide the described functionality; or a combination of some or all of the above, such as in a system on a chip. The term module may include memory (shared, dedicated, or group) that stores code implemented by the processor.

As used above, the term code may include software, firmware, and/or microcode, and may refer to programs, routines, functions, classes, and/or objects. As used above, the term "shared" means that some or all code from multiple modules may be implemented using a single (shared) processor. Additionally, some or all code from multiple modules may be stored by a single (shared) memory. As used above, the term "group" means that some or all code from a single module may be implemented using a group of processors. Additionally, some or all code from a single module may be stored by using a memory bank.

The apparatus and methods described herein may be implemented by one or more computer programs executed by one or more processors. The computer program includes processor implementable instructions stored on a non-transitory tangible computer readable medium. The computer program may also include stored data. Examples of non-transitory tangible computer readable media include, but are not limited to, non-volatile memory, magnetic storage, and optical storage.

A handheld blood glucose (bG) management device includes a processor that implements firmware for operating the diabetes management device. The firmware is stored in a firmware module that is implemented in a non-modifiable portion of a memory of the diabetes management device. The firmware may be considered to be a routine implemented by the processor to operate the diabetes management device.

Typically, one or more approvals of the firmware are required before the diabetes management device (implementing the firmware) can be made publicly available. For example only, approval from one or more regulatory agencies (e.g., the food and drug administration) may be required before a diabetes management device is made available in an area of the world subject to regulatory authority's regulations. Prior to approving the firmware, a given regulatory body may require submission of a copy of the firmware, execution of one or more clinical trials to establish operability of the firmware, and/or satisfaction of one or more other requirements.

The firmware includes, among other things, subroutines for each different type of structured bG test that the diabetes management device is capable of performing. Each of the subroutines may be considered a sub-module of the firmware module. One or more groups of bG samples are expected to be input for each structured bG test. One or more individual bG samples are expected to be input for each group of bG samples.

Entry criteria, adherence criteria, and exit criteria are associated with each structured bG test. Test configuration data is also associated with each structured bG test. Entry criteria, adherence criteria, and exit criteria are also associated with each desired bG sample group and each desired bG sample. The test configuration data can include how many data samples are expected to be input, how many data samples are expected for each group of data samples, the interval (e.g., period) between successive data samples, the acceptable range or window for each data sample, and/or other suitable data for use in performing the structured bG test. Data collection for a structured bG test, for a group of bG samples, or for individual bG samples can begin when the associated entry criteria are satisfied. The structured bG test, the bG sample group, or the bG sample can be accepted as adhering to predetermined characteristics of the structured bG test, the bG sample group, or the bG sample when the associated adherence criteria are satisfied. Data collection for a structured bG test, a bG sample group, or a bG sample can end when the associated exit criteria are satisfied. Alternatively, data collection for a structured bG test, a bG sample group, or a bG sample can end when the associated adherence criteria are satisfied.

All entry, adherence, and exit criteria may be written (encoded) into firmware in a firmware module (in a non-modifiable portion of memory). However, the requirement for regulatory approval of firmware may limit the ability to make modifications/updates to one or more entry, adherence, and/or exit criteria (if such modifications/updates are desired).

In an example diabetes management device of the present disclosure, entry, adherence, and exit criteria and test configuration data may be stored in a modifiable portion of memory. In this manner, test configuration data and/or entry, adherence, and/or exit criteria may be modified independently of firmware. Firmware subroutines stored in the non-modifiable portion of memory point to where the associated test configuration data and associated entry, adherence, and exit criteria are stored.

The separation of the storage of the test configuration data and the entry, adherence and exit criteria from the firmware module allows changes to the test configuration data and/or to the entry, adherence and/or exit criteria to be made independently of the firmware. Thus, another approval for the firmware may not be necessary because the firmware will not change when the test configuration data and/or the entry, adherence, and/or exit criteria are changed/updated. Not having to obtain another approval can provide significant and measurable cost savings (e.g., as compared to not having to perform another round of clinical testing). This may also enable earlier public availability of changes/updates to the trial configuration data and/or to the entry, adherence and/or exit criteria. Additionally, the same firmware may be distributed across diabetes management devices throughout the world, while test configuration data and/or entry, adherence, and exit criteria may be updated remotely, e.g., based on local standards.

Referring now to fig. 1, a patient 100 with diabetes and a healthcare professional 102 are shown in a clinical setting. People with diabetes may have metabolic syndrome, pre-diabetes, type 1 diabetes, type 2 diabetes, gestational diabetes, etc. Healthcare providers for diabetes are diverse and include nurses, nurses (nurses practioners), physicians, endocrinologists, and other providers, and are collectively referred to as healthcare professionals.

During a healthcare consultation, the patient 100 typically shares a variety of data with the healthcare professional 102, including blood glucose (bG) measurements, continuous glucose monitoring data, the amount and type of insulin taken, the amount of food and beverages consumed, exercise schedules, health status, and other lifestyle information. The health care professional 102 may obtain additional data for the patient 100, such as measurements of HbA1C, cholesterol levels, triglycerides, blood pressure, and body weight. These data can be recorded manually or electronically on a handheld diabetes management device 104 (e.g., a handheld bG monitor device), diabetes analysis software implemented on a Personal Computer (PC) 106, and/or a web-based diabetes analysis site. The healthcare professional 102 can analyze the patient data manually or electronically by using diabetes analysis software and/or a web-based diabetes analysis site. After analyzing the data and reviewing how well the patient 100 followed the previously prescribed therapy, the health care professional 102 can determine whether to modify the therapy prescribed for the patient 100.

Referring now to fig. 2, the patient 100 may use a Continuous Glucose Monitor (CGM) 200, a portable durable insulin infusion pump 202 or a portable non-durable insulin infusion pump 204 (collectively referred to as insulin pumps 202 or 204), and the diabetes management device 104. The CGM 200 may use a subcutaneous sensor to sense and monitor the amount of glucose in the blood of the patient 100. The CGM 200 transmits the bG measurement to the diabetes management device 104. The CGM 200 may also measure the insulin level in the blood of the patient 100 and transmit the measurement to the diabetes management device 104.

The diabetes manager 104 performs various tasks including measuring and recording bG measurements, determining the amount of insulin to be administered to the patient 100 via the insulin pump 202 or 204, receiving user input via a user interface, archiving data, performing structured bG tests, and the like. The diabetes management device 104 can transmit instructions to the insulin pump 202 or 204, and the insulin pump 202 or 204 selectively delivers insulin to the patient 100. Insulin may be delivered in the form of a meal bolus, a correction bolus, a basal dose, and the like.

Referring now to FIG. 3, a diabetes management system 300 is shown that can be used by the patient 100 and/or the health care professional 102. The system 300 may include one or more of the following devices: a diabetes management device 104, a CGM 200, an insulin pump 202 or 204, a mobile device 302, diabetes management software implemented on a computer 106, and one or more other healthcare devices 304. The diabetes management device 104 can be configured as a system "hub" and communicate with one or more of the other devices of the system 300. Alternatively, the insulin pump 204, the mobile device 302, or another suitable device may act as a system hub. Communication between the various devices in system 300 may be performed using a wireless interface (e.g., bluetooth) and/or a wired interface (e.g., USB). The communication protocols used by these devices may include protocols conforming to the IEEE 11073 standard as extended by using Guidelines provided by the Health Alliance Design Guidelines (Continua Health Alliance Design Guidelines). In addition, the patient 100 and the Health care professional 102 may exchange information using a Health care recording system (such as Microsoft Health vault and Google Health) system.

The diabetes management software running on the computer 106 may include an analyzer-configurator that stores configuration information for the devices of the system 300. For example only, the configurator has a database for storing configuration information of the diabetes management device 104 and other devices. The user may interface the configurator through a standard web-based or computer Graphical User Interface (GUI). The configurator selectively communicates the user-approved configuration to the devices of the system 300. The analyzer selectively retrieves data from the devices of the system 300, stores the data in a database, selectively analyzes the data, and outputs the analysis results through a standard web-based or computer GUI.

Referring now to FIG. 4, a high-level illustration of an example embodiment of the diabetes management device 104 is presented. The diabetes management device 104 includes, among other things, a housing 404, a user unit control switch (not shown in FIG. 4), a touch screen display 408, and a bG test strip port 420. The user unit control switches may include, for example, an ON/OFF switch, a volume switch, an alarm switch for bG testing and/or insulin administration, and/or one or more other switches or other types of control devices that a user may use to control the functions/operations of the diabetes management device 104.

The bG test strip 416 can be inserted into the bG test strip port 420. The bG test strip 416 can be inserted into the bG test strip port 420 by a user from a test strip drum (not shown) located within the diabetes management device 104 or in another suitable manner. The bG test strip 416 is shown inserted into the bG test strip port 420 in the example of FIG. 4, and the bG test strip 416 is shown separate from the bG test strip port 420 in the example of FIG. 5.

User selectable options 424 may be displayed on portions of the display 408. The selectable options 424 may include a menu option 428, a single insulin option 432, a carbohydrate option 436, and an event option 440. Additionally or alternatively, one or more other user-selectable options may be available. The user can access the device menu of the diabetes management device 104 by selecting the menu option 428. The user may enter various insulin (and/or other medication) information (e.g., amount, insulin type, etc.) by selecting the bolus insulin option 432. The user may enter various carbohydrate intake information (e.g., amounts) by selecting carbohydrate option 436. The user may also enter other food intake information (e.g., protein content, fat content, etc.) by selecting carbohydrate option 436. The user may enter various event-related information (e.g., meals, exercises, stress periods, etc.) that may affect the user's bG measurements by selecting the event option 440.

Although the display 408 is described herein as a touch screen display, the diabetes management device 104 may include another suitable form of display (e.g., an LED, etc.). If a touch screen display is not used, the user control switches may include specific buttons or controls by which the user can select various options and enter the indicia needed to select, enter, and execute the "structured bG test". The "structured bG test" can also be referred to as a "focus test".

The above description is a broad description of the diabetes management device 104. In practice, the diabetes management device 104 may include additional controls, input ports, output ports, etc., as may be desired, to further enhance its utility and use with other components and devices (e.g., computers, infusion pumps, cell phones, etc.). The description of the diabetes management device 104 should not be viewed as limiting the construction of the diabetes management device 104 or limiting the features and capabilities of the diabetes management device 104.

Referring now to FIG. 5, a functional block diagram of the diabetes management device 104 is presented. The diabetes management device 104 can include a processor module (e.g., a microprocessor-based subsystem) 504 that can receive information from the bG measurement engine 508. The bG measurement engine 508 can be located near the bG test strip port 420.

The bG measurement engine 508 reads (measures) the bG test strip 416. The bG measurement engine 508 can include a code key module 512 that includes pre-calibration data for determining bG levels from the bG test strip 416. The bG measurement engine 508 generates bG sample data 516 based on its reading of the bG test strip 416. Among other things, the bG sample data 516 includes data indicative of the bG level of the blood sample on the bG test strip 416. The processor module 504 can also receive bG sample data from other sources, such as via the CGM 200, the display 408, and/or another suitable source. The processor module 504 may receive user input data via, for example, the display 408 and/or one or more other suitable sources.

The bG measurement engine 508 can also generate bG sample data 516 to indicate the date and time that the bG test strip 416 was read. In other words, the bG measurement engine 508 can include a timestamp with the bG sample data 516. In various embodiments, the processor module 504 can selectively time stamp the bG sample data 516, and can time stamp user input data and other data as they are received.

The clock 518 may provide the date and time. The user may configure the current date and time and the clock 518 tracks the current date and time thereafter. In various embodiments, the current date and time may be obtained from the computer 106 (e.g., synchronized with the computer 106). The bG measurement engine 508 communicates the bG sample data 516 to the processor module 504.

The processor module 504 communicates with a database 520 for storing bG sample data, user input data, and other data. For example only, the processor module 504 can store each piece of bG sample data received in the database 520. The processor module 504 is also in communication with the display 408 and one or more interfaces 524. Each of the interfaces 524 can provide an interface between the diabetes management device 104 and an external device, such as the computer 106, the insulin pump 202 or 204, the CGM 200, the mobile device 302, the other healthcare device 304, and/or one or more other suitable external devices.

The processor module 504 is also in communication with an alarm generation module 528. The alert generation module 528 may generate one or more alerts when prompted by the processor module 504. For example only, the alert generation module 528 can generate an audible alert, a tactile (e.g., vibration) alert, and/or a visual alert. An alert can be used, such as prompting a user to enter data for the structured bG test during a time window around the acceptance time. The acceptance time may be a default time or set by the user, for example.

The processor module 504 is also in communication with a memory 532. For example only, the memory 532 may be a NAND-type flash memory or another suitable type of memory. Although not shown in the example of fig. 5, in various embodiments, database 520 may be implemented within memory 532.

In an example embodiment, the structure of memory 532 may be considered modular, where the modules of memory 532 each include a particular type of data. For example only, the memory 532 may include a firmware module 536 and a structured bG test module 540 as shown in the example of FIG. 5. The memory 532 may also include one or more other modules.

The firmware of the diabetes management device 104 is stored in the firmware module 536. Where memory 532 is a NAND-type flash memory or another type of rewritable memory, firmware module 536 is partitioned from the rest of memory 532 and firmware module 536 is otherwise made non-modifiable (e.g., read-only). In this manner, the firmware cannot be updated, rewritten, or otherwise modified via user input to the diabetes management device 104 or via other means. In various embodiments, firmware module 536 may be implemented separately from memory 532, such as within Read Only Memory (ROM) or another suitable type of memory as shown in phantom at 542. However, in all embodiments, firmware module 536 is not modifiable, or firmware module 536 is made non-modifiable.

The processor module 504 selectively implements one or more portions of the firmware to perform various functions of the diabetes management device 104. For example only, the processor module 504 can implement the portion of firmware corresponding to the structured bG test when execution of the structured bG test is initiated. For example only, the user, a health care professional, or the device itself can initiate the performance of the structured bG test. Although not specifically stated, the actions performed by the processor module 504 described below can be performed when the firmware is implemented for the structured bG test.

The processor module 504 can create a table in the database 520 with one or more entries for each bG sample and group of bG samples expected to be input for the structured bG test. The processor module 504 can selectively trigger the generation of one or more alarms and/or cause the display 408 to display one or more reminders indicating that user input or a bG sample is desired for the structured bG test. The processor module 504 can limit the number of structured bG tests performed on the diabetes management device 104 at a given time to 1.

All of the entry, adherence, and exit criteria used in implementing the structured bG test are stored in the structured bG test module 540. Test configuration data used in implementing the structured bG test is also stored in the structured bG test module 540. Importantly, unlike the firmware stored in the firmware module 536, the structured bG test module 540 is modifiable and remotely updateable. For example only, one or more entry, adherence, and/or exit criteria and/or test configuration data may be updated or otherwise modified remotely via software implemented on computer 106 or in another suitable manner. This is advantageous as it allows for easy future modifications of such criteria and/or trial configuration data in cases where such modifications should be required, preferred, etc. Additional significant advantages are: since the firmware module 536 is not modifiable, future modifications to the entry, adherence, and/or exit criteria and/or the test configuration data will not trigger the need for another regulatory approval process by the manufacturer of the diabetes management device 104.

The firmware portion of the processor module 504 that is implemented to perform a given structured bG test points to the associated test configuration data, entry, adherence, and exit criteria stored in the structured bG test module 540. The processor module 504 selectively retrieves the associated test configuration data and the associated entry, adherence, and exit criteria from the structured bG test module 540. As needed during the implementation of the structured bG test, or in another suitable manner, the processor module 504 can retrieve all of the test configuration data associated with the structured bG test and the entry, adherence, and exit criteria when initiating the execution of the structured bG test. The processor module 504 can retrieve entry, adherence, and exit criteria for each desired bG sample, for each desired bG sample group (i.e., sample group), and for the structured bG test. For example only, the test configuration data may include data relating to: a plurality of data samples expected to be input for the structured bG test; a plurality of data sample sets for a bG structured test; a desired interval (e.g., period) between successive data samples; the period over which the structured bG test is to be performed (e.g., the number of days); an acceptance time range or window for each data sample; and/or other suitable data.

The entry criteria for the expected (individual) bG sample includes one or more criteria used in determining whether to begin expecting receipt of bG sample data. For example only, the entry criteria can include a time (of date) after which the bG sample is expected to be entered. For example only, if a given bG sample is expected on a given date between time X and time Y, the entry criteria for the bG sample can include that date and time X. Additionally or alternatively, the entry criteria for a bG sample can include one or more other suitable criteria, such as user input data, whether user input data has been received, whether user input data exhibits a predetermined characteristic, whether an earlier input satisfies its associated adherence criteria, and so forth.

The adherence criteria for the received bG sample includes one or more criteria used in determining whether to accept or reject the bG sample. In other words, the adherence criteria for the received bG sample include criteria used in determining whether the bG sample data is acceptable for consideration in making the medical determination. For example only, if a bG sample is expected on a given date between time X and time Y, the adherence criteria for the bG sample can include the date and a time window defined by time X and time Y. Accepted bG samples can be labeled for consideration in making medical determinations. The rejected bG samples can determine whether the exit criteria for the bG sample groups and/or the structured bG test are satisfied.

The processor module 504 selectively accepts or rejects the received bG sample based on a comparison of one or more characteristics of the bG sample data with associated adherence criteria. For example only, the processor module 504 can mark the received bG sample as accepted when the associated adherence criteria are satisfied. Conversely, the processor module 504 can mark a bG sample as rejected when the received bG sample does not satisfy the associated adherence criteria.

The exit criteria for the expected bG samples include one or more criteria used in determining whether to stop expecting input to the expected bG samples. For example only, the exit criteria of a bG sample can include satisfaction of the adherence criteria associated with the bG sample, satisfaction of the exit criteria of a bG sample group of which the desired bG sample is a part, and/or satisfaction of the exit criteria of the structured bG test. Additionally or alternatively, the exit criteria for the desired bG sample can include an end time and date. For example only, if a bG sample is expected on a given date between time X and time Y, the exit criteria for the bG sample can include the date and time Y. The exit criteria can also include whether a previous bG sample satisfies its adherence criteria and/or one or more other suitable exit criteria.

When the exit criteria for a bG sample are satisfied and the satisfaction is not due to the associated adherence criteria being satisfied, the processor module 504 can selectively mark the expected bG sample of the structured bG test as having been lost (or otherwise not received) in the database 520. For example only, if a bG sample is expected on a given date between time X and time Y, the processor module 504 can mark the bG sample as having been lost in the database 520 when the bG sample is not received and time Y elapses.

The entry criteria for the desired bG sample group include using one or more criteria in determining whether to begin expecting bG samples for the bG sample group to be input. For example only, the entry criteria can include a time (of a date) after which one or more bG samples of the bG sample group are expected to be input. For example only, if it is desired to enter bG sample(s) for a bG sample group that begins on a given date, the entry criteria for the given sample group can include that date. Additionally or alternatively, the entry criteria for the desired set of samples may include one or more other suitable criteria.

The adherence criteria for the desired bG sample group include one or more criteria used in determining whether to accept or reject the bG sample group (which includes accepted bG samples of the bG sample group). In other words, the adherence criteria for the bG sample groups include criteria used in determining whether the bG samples of the bG sample groups as a whole are acceptable for consideration in making the medical determination. For example only, the adherence criteria for the desired sample group can include a threshold number of accepted bG samples. For example only, if X bG samples are expected to be input for a given bG sample group and Y of the X bG samples are expected to be accepted, Y can be the adherence criteria for the bG sample group. X and Y are integers, and Y is greater than 0 and less than or equal to X. Additionally or alternatively, the adherence criteria for the desired bG sample group can include one or more other suitable criteria.

The processor module 504 selectively accepts or rejects bG sample groups based on a comparison of one or more characteristics of the bG sample groups to associated adherence criteria. For example only, the processor module 504 can mark the bG sample group as accepted when the associated adherence criteria are satisfied.

The exit criteria for a bG sample group include one or more criteria used in determining that the expectation of receipt of an expected bG sample of the bG sample group should end. For example only, the exit criteria for a bG sample group can include satisfaction of the adherence criteria associated with the bG sample group and/or satisfaction of the exit criteria for the structured bG test. Additionally or alternatively, the exit criteria for a bG sample group can include an end date and time of the sample group. For example only, if all of the bG samples of a bG sample group are expected to be input before a given date, the exit criteria for the bG sample group can include the given date. Additionally or alternatively, the exit criteria for the bG sample group can include a threshold number of bG samples lost or rejected. For example only, if X bG samples are expected for a bG sample group and Y of the X bG samples is the maximum number of expected bG samples that may be lost or rejected, Y may be exit criteria for the bG sample group. X and Y are integers, and are also greater than or equal to 0 and less than or equal to X. Additionally or alternatively, the exit criteria for a bG sample group can include one or more other suitable criteria.

The entry criteria for the structured bG test include one or more criteria used in determining whether to begin executing the structured bG test. For example only, the entry criteria for the structured bG test can include a time (of a date) after which the structured bG test is to be started. Additionally or alternatively, the entry criteria for the structured bG test can include a threshold age of the user, a threshold range of HbA1c of the user, a threshold length of time the user has suffered from diabetes, a specified type of diabetes diagnosed for the user, a threshold Body Mass Index (BMI) of the user, and/or a threshold fasting blood glucose level. Additionally or alternatively, the entry criteria for the structured bG test can include one or more other suitable criteria.

The adherence criteria for the structured bG test include one or more criteria used in determining whether to accept or reject all bG data received for the structured bG test. In other words, the adherence criteria for the structured bG test include criteria used in determining whether the accepted bG sample set, as a whole, is acceptable for consideration in making the medical determination. For example only, the adherence criteria for the structured bG test can include a threshold number of accepted bG sample groups. For example only, if X bG sample groups are expected for the structured bG test and Y of the X bG sample groups are the minimum number of bG sample groups to be accepted, then Y can be the adherence criteria for the structured bG test. X and Y are integers, and Y is greater than 0 and less than or equal to X. Additionally or alternatively, the adherence criteria for the structured bG test can include one or more other suitable criteria.

The processor module 504 selectively accepts or rejects the input sample data for the structured bG test based on one or more characteristics of the bG sample group or the bG samples and the associated adherence criteria. For example only, the processor module 504 can mark the structured bG test as accepted when the associated adherence criteria are satisfied.

The exit criteria for the structured bG test include one or more criteria used in determining that the expectation of receipt of a bG sample of the structured bG test should end. For example only, the exit criteria of the structured bG test can include satisfaction of the adherence criteria associated with the structured bG test. Additionally or alternatively, the exit criteria for the structured bG test can include an end date (and possibly a time) of the structured bG test. For example only, if all samples of the structured bG test are expected to be entered before a given date, the exit criteria for the structured bG test can include the date. Additionally or alternatively, the exit criteria for the structured bG test can include a threshold number of missing and rejected bG samples and/or a threshold number of rejected bG sample groups. For example only, if X bG samples are expected for a sample group, and if Y of the X bG samples are the maximum number of expected bG samples that can be lost or rejected, Y can be exit criteria for the structured bG test. X and Y are integers, and Y is greater than or equal to 0 and less than or equal to X. For another example only, if X bG sample groups are expected for the structured bG test and Y of the X bG sample groups are the maximum number of bG sample groups that can be rejected, Y can be exit criteria for the structured bG test. X and Y are integers, and Y is greater than or equal to 0 and less than or equal to X. Additionally or alternatively, the exit criteria for a bG sample group can include one or more other suitable criteria.

Additional information regarding adherence, exit and entry criteria may be found in paragraphs [0048] and [0092] - [0116] of commonly assigned U.S. patent application No. 12/643,338, filed on 21.12.12.2009 and entitled "Structured Testing Method for Diagnostic or Therapy Support of a Patient with a viral Disease and Devices theroof. Additional information regarding adherence, exit and entry criteria may also be found in sections [0087] - [0112] of commonly assigned U.S. patent application Ser. No. 12/643,415, filed 21.12.2009 and entitled "Management Method and System for Implementation, Execution, Data Collection, and Data Analysis of a Structured Collection Procedure on a Collection Device". The above patent application including the above mentioned paragraphs is incorporated by reference.

6-7, an example method that the processor module 504 can implement in implementing the firmware for a given structured bG test is presented. Control may begin at operation 604, and at operation 604, implementation of a subroutine of firmware for the structured bG test may begin. The subroutines and firmware are stored in a non-modifiable portion of the memory of the diabetes management device 104.

At operation 608, the entry criteria for the structured bG test can be retrieved from the modifiable portion of the memory of the diabetes management device 104. At operation 612, a determination can be made as to whether the entry criteria for the structured bG test are satisfied. If true, operation 616 may be performed; if false, operation 608 may be returned to. At operation 616, the adherence criteria for the structured bG test can be retrieved from the modifiable portion of memory.

At 620, a determination can be made as to whether the adherence criteria for the structured bG test are satisfied. If true, at operation 624, the structured bG test can be accepted and execution of the structured bG test can be exited. If false, operation 628 may be performed. At operation 628, exit criteria for the structured bG test can be retrieved from the modifiable portion of memory. At operation 632, a determination can be made as to whether the exit criteria for the structured bG test are satisfied. If true, at operation 636, the structured bG test can be rejected and execution of the structured bG test can be exited. If false, operation 640 may be performed.

At operation 640, entry criteria for the bG sample group can be retrieved from the modifiable portion of memory. At operation 644, a determination may be made whether the entry criteria for the bG sample group are satisfied. If true, operation 648 can be performed; if false, operation 628 can be returned to. At operation 648, the adherence criteria for the bG sample group can be retrieved from the modifiable portion of memory. At operation 652, a determination may be made whether the adherence criteria for the bG sample group are satisfied. If true, the bG sample group can be accepted at operation 656 and an operation 672 can be performed, which is discussed in detail below. If false, operation 660 may be performed.

At operation 660, exit criteria for the bG sample group can be retrieved from the modifiable portion of memory. At operation 664, a determination may be made as to whether the exit criteria for the bG sample group are satisfied. If true, the bG sample group can be rejected at 668 and operation 672 can be performed. If false, operation 704 of FIG. 7 may be performed. At operation 672, a determination can be made as to whether another bG sample group is expected for the structured bG test. If true, then at operation 676, the next bG sample group can be continued, and operation 628 can be returned to. If false, operation 616 may be returned to.

Referring now to FIG. 7, at operation 704, entry criteria for a desired bG sample can be retrieved from a modifiable portion of memory. At operation 708, a determination can be made as to whether the entry criteria for the bG sample are satisfied. If true, operation 712 may be performed; if false, operation 628 can be returned to. At operation 712, a determination can be made as to whether the desired bG sample has been entered. If true, operation 716 may be performed; if false, operation 732 may be performed, which is discussed further below.

At operation 716, the adherence criteria for the bG sample can be retrieved from the modifiable portion of memory. At operation 720, a determination can be made as to whether the adherence criteria for the bG sample are satisfied. If true, the bG sample can be accepted at operation 724 and operation 732 can be performed; if false, the bG sample may be accepted at operation 728 and operation 732 may be performed. At operation 732, exit criteria for the bG sample can be retrieved from the modifiable portion of memory.

At operation 736, a determination can be made as to whether the exit criteria for the bG sample are satisfied. If true, the bG sample can be marked as having been lost at operation 740 and operation 744 can be performed; if false, operation 628 can be returned to. At operation 744, a determination can be made as to whether another bG sample is expected for the group of bG samples. If true, then at operation 748 the next bG sample can be continued and operation 628 can be returned to; if false, operation 648 may be returned to.

A handheld diabetes management device with improved updatability of entry, adherence, and exit criteria comprising: a blood glucose (bG) management engine, a memory, a display, and a processor module. The bG measurement engine measures a bG level in a blood sample of a user and generates sample data indicative of the bG level. The processor module is in communication with the bG measurement engine, the display, and the memory. The processor module selectively implements firmware stored in the non-modifiable portion of the memory to perform operations for implementing a structured bG test; selectively retrieving entry, adherence, and exit criteria stored in a modifiable portion of the memory for individual bG samples expected to be input for the structured bG test; selectively retrieving entry, adherence, and exit criteria stored in a modifiable portion of the memory for a bG sample group expected for the structured bG test; and retrieving entry, adherence criteria, and exit criteria from the modifiable portion of the memory for the structured bG test.

In other features, the processor module of the handheld diabetes management device initiates data collection for the structured bG test when the entry criteria for the structured bG test are satisfied.

In still other features, the processor module of the handheld diabetes management device ends data collection for the structured bG test when the adherence criteria or the exit criteria for the structured bG test are satisfied.

In further features, the processor module of the handheld diabetes management device marks the data stored for the structured bG test as accepted when the adherence criteria for the structured bG test are satisfied.

In still further features, the processor module of the handheld diabetes management device initiates data collection for a bG sample group when entry criteria for the bG sample group are satisfied.

In other features, the processor module of the handheld diabetes management device ends data collection for a bG sample group of the structured bG test when one of the adherence criteria and the exit criteria for the bG sample group are satisfied.

In still other features, the non-modifiable portion of the firmware is partitioned from other portions of the memory and marked as non-modifiable.

In further features, the non-modifiable portion of memory is implemented in a first memory module, the modifiable portion of memory is implemented in a second memory module, and the first memory module and the second memory module are separate memory modules.

In still further features, the diabetes management system comprises: the handheld diabetes management device of claim 1; and a computer remote from the handheld diabetes management device. The computer selectively updates at least one of entry, adherence, and exit criteria.

Another handheld diabetes management device with improved updatability of entry, adherence, and exit criteria includes: a blood glucose (bG) management engine, a memory, a display, and a processor module. The bG measurement engine measures a bG level in a blood sample of a user and generates sample data indicative of the bG level. The processor module is in communication with the bG measurement engine, the display, and the memory. The processor module selectively implements firmware stored in the non-modifiable portion of the memory for performing operations for implementing a structured bG test and selectively retrieves entry, adherence, and exit criteria stored in the modifiable portion of the memory for the structured bG test.

In other features, the processor module initiates data collection for the structured bG test when entry criteria are satisfied.

In still other features, the processor module ends data collection for the structured bG test when adherence criteria or exit criteria for the structured bG test are satisfied.

In further features, the non-modifiable portion of the firmware is partitioned from other portions of the memory and marked as non-modifiable.

In still further features, the non-modifiable portion of memory is implemented in a first memory module, the modifiable portion of memory is implemented in a second memory module, and the first memory module and the second memory module are separate memory modules.

A computer-readable storage medium of a handheld blood glucose (bG) management device that measures a bG level of a user and includes a touch screen display, wherein the computer-readable storage medium includes a modifiable portion and a non-modifiable portion. The modifiable portion includes adherence, exit, and entry criteria stored for performing the structured bG test. The non-modifiable portion includes the following firmware: the firmware, when executed by the processor of the handheld diabetes management device, causes the processor to perform the structured bG test involving: obtaining measurements of the bG levels of the user according to a predefined schedule; and selectively retrieving the adherence, exit and entry criteria from the modifiable portion.

A method of improving updatability of entry, adherence, and exit criteria stored in a memory of a handheld diabetes management device, the method comprising: providing the handheld diabetes management device with a blood glucose (bG) measurement engine that measures a bG level in a blood sample of a user and generates sample data indicative of the bG level; providing the handheld diabetes management device with the memory and a touch screen display; providing the handheld diabetes management device with a processor module in communication with the bG measurement engine, the touch screen display, and the memory; storing firmware executable by the processor module to perform operations for implementing a structured bG test in a non-modifiable portion of the memory; and storing the entry, adherence, and exit criteria in a modifiable portion of the memory.

In other features, storing the entry, adherence, and exit criteria comprises: storing entry, adherence, and exit criteria stored for each individual bG sample expected to be input when implementing the structured bG test in a modifiable portion of the memory; storing entry, adherence, and exit criteria for groups of individual bG samples expected when implementing the structured bG test; and storing entry, adherence criteria, and exit criteria for the structured bG test in a modifiable portion of the memory.

In still other features, the method further comprises: partitioning the non-modifiable portion of the firmware from other portions of the memory; and marking the firmware as non-modifiable.

The broad teachings of the disclosure can be implemented in a variety of forms. Therefore, while this disclosure includes particular examples, the true scope of the disclosure should not be so limited since other modifications will become apparent to the skilled practitioner upon a study of the drawings, the specification, and the following claims.

Claims (18)

1. A handheld diabetes management device with improved updatability of entry, adherence, and exit criteria, wherein the handheld diabetes management device comprises:

-a blood glucose bG measurement engine that measures a bG level in a blood sample of a user and generates sample data indicative of the bG level;

-a memory;

-a display; and

-a processor module in communication with the bG measurement engine, the display, and the memory, the processor module performing the operations of:

-selectively implementing firmware stored in a non-modifiable portion of the memory to perform operations for implementing a structured bG test;

-selectively retrieving entry, adherence, and exit criteria stored in a modifiable portion of the memory for each individual bG sample expected to be input for the structured bG test;

-selectively retrieving entry, adherence, and exit criteria stored in a modifiable portion of the memory for a bG sample group expected for the structured bG test; and

-retrieving entry, adherence criteria, and exit criteria from the modifiable portion of the memory for the structured bG test.

2. The handheld diabetes management device of claim 1 or 2 wherein the processor module initiates data collection for the structured bG test when the entry criteria for the structured bG test are met.

3. The handheld diabetes management device of claim 1 wherein the processor module ends data collection for the structured bG test when adherence criteria or exit criteria for the structured bG test are met.

4. The handheld diabetes management device of claim 3 wherein the processor module marks data stored for the structured bG test as accepted when the adherence criteria for the structured bG test are satisfied.

5. The handheld diabetes management device of at least one of the preceding claims wherein the processor module initiates data collection for a bG sample group when entry criteria for the bG sample group are met.

6. The handheld diabetes management device of at least one of the preceding claims wherein the processor module ends data collection for a bG sample group of the structured bG test when one of adherence criteria and exit criteria for the bG sample group are met.

7. The handheld diabetes management device of at least one of the preceding claims wherein the non-modifiable portion of the firmware is partitioned from other portions of the memory and marked as non-modifiable.

8. The handheld diabetes management device of at least one of the preceding claims wherein the non-modifiable portion of memory is implemented in a first memory module,

wherein the modifiable part of the memory is implemented in the second memory module, and

wherein the first storage module and the second storage module are separate storage modules.

9. A diabetes management system, comprising:

-a handheld diabetes management device according to at least one of the preceding claims; and

a computer remote from the handheld diabetes management device and selectively updating at least one of entry, adherence, and exit criteria.

10. A handheld diabetes management device with improved updatability of entry, adherence, and exit criteria, wherein the handheld diabetes management device comprises:

a blood glucose bG measurement engine that measures a bG level in a blood sample of a user and generates a bG sample data indicative of the bG level,

-a memory;

-a touch screen display; and

a processor module in communication with the bG measurement engine, the memory, and the touch screen display, the processor module selectively implementing firmware stored in the non-modifiable portion of the memory for performing operations for implementing a structured bG test, and the processor module selectively retrieving entry, adherence, and exit criteria stored in the modifiable portion of the memory for the structured bG test.

11. The handheld diabetes management device of claim 10 wherein the processor module initiates data collection for the structured bG test when entry criteria are met.

12. The handheld diabetes management device of claim 10 or 11 wherein the processor module ends data collection for the structured bG test when adherence criteria or exit criteria for the structured bG test are met.

13. The handheld diabetes management device of at least one of claims 10 to 12 wherein the non-modifiable portion of the firmware is partitioned from other portions of the memory and marked as non-modifiable.

14. The handheld diabetes management device of at least one of claims 10 to 13 wherein the non-modifiable portion of memory is implemented in a first memory module,

wherein the modifiable part of the memory is implemented in the second memory module, and

wherein the first storage module and the second storage module are separate storage modules.

15. A computer-readable storage medium of a handheld blood glucose bG management device that measures a bG level of a user and includes a touch screen display, wherein the computer-readable storage medium comprises:

-a modifiable portion comprising stored adherence, exit, and entry criteria for performing the structured bG test; and

-a non-modifiable portion comprising the following firmware: the firmware, when executed by the processor of the handheld diabetes management device, causes the processor to perform the structured bG test involving: obtaining measurements of the bG levels of the user according to a predefined schedule; and selectively retrieving the adherence, exit and entry criteria from the modifiable portion.

16. A method of improving updatability of entry, adherence, and exit criteria stored in a memory of a handheld diabetes management device, the method comprising:

-providing the handheld diabetes management device with a blood glucose bG measurement engine that measures bG levels in a blood sample of a user and generates sample data indicative of the bG levels;

-providing the handheld diabetes management device with the memory and a touch screen display;

-providing the handheld diabetes management device with a processor module in communication with the bG measurement engine, the touch screen display, and the memory;

-storing firmware executable by the processor module to perform operations for implementing a structured bG test in a non-modifiable portion of the memory; and

-storing the entry, adherence and exit criteria in a modifiable part of the memory.

17. The method of claim 16, wherein storing the entry, adherence, and exit criteria comprises:

-storing entry, adherence, and exit criteria stored for each individual bG sample expected to be input when implementing the structured bG test in a modifiable portion of the memory;

-storing entry, adherence, and exit criteria for groups of individual bG samples expected when implementing the structured bG test; and

-storing entry, adherence criteria, and exit criteria for the structured bG test in a modifiable portion of the memory.

18. The method of claim 16 or 17, further comprising:

-segmenting non-modifiable portions of the firmware from other portions of the memory; and

-marking the firmware as non-modifiable.