Patent Grant
9907508
The present invention pertains to apparatus and systems for diabetes management, and more specifically to such apparatus and systems as are operative to determined at a plurality of times whether and by how much to vary at least one of the one or more components of a patient's present insulin dosage regimen, and to provide the means for administering insulin doses.
Diabetes is a chronic disease resulting from deficient insulin secretion by the endocrine pancreas. About 7% of the general population in the Western Hemisphere suffers from diabetes. Of these persons, roughly 90% suffer from Type-2 diabetes while approximately 10% suffer from Type-1. In Type-1 diabetes, patients effectively surrender their endocrine pancreas to autoimmune distraction and so become dependent on daily insulin injections to control blood-glucose-levels. In Type-2 diabetes, on the other hand, the endocrine pancreas gradually fails to satisfy increased insulin demands, thus requiring the patient to compensate with a regime of oral medications or insulin therapy. In the case of either Type-1 or Type-2 diabetes, the failure to properly control glucose levels in the patient may lead to such complications as heart attacks, strokes, blindness, renal failure, and even premature death.
Insulin therapy is the mainstay of Type-1 diabetes management and one of the most widespread treatments in Type-2 diabetes, about 27% of the sufferers of which require insulin. Insulin administration is designed to imitate physiological insulin secretion by introducing two classes of insulin into the patient's body: Long-acting insulin, which fulfills basal metabolic needs; and short-acting insulin (also known as fast-acting insulin), which compensates for sharp elevations in blood-glucose-levels following patient meals. Orchestrating the process of dosing these two types of insulin, in whatever form (e.g., separately or as premixed insulin) involves numerous considerations.
First, patients measure their blood-glucose-levels (using some form of a glucose meter) on average about 3 to 4 times per day. The number of such measurements and the variations therebetween complicates the interpretation of these data, making it difficult to extrapolate trends therefrom that may be employed to better maintain the disease. Second, the complexity of human physiology continuously imposes changes in insulin needs for which frequent insulin dosage regimen adjustments are warranted. Presently, these considerations are handled by a patient's endocrinologist or other healthcare professional during clinic appointments. Unfortunately, these visits are relatively infrequent—occurring once every 3 to 6 months—and of short duration, so that the physician or other healthcare professional is typically only able to review the very latest patient medical data. In consequence, it has been shown that more than 60% of patients control their diabetes at sub-optimal levels, leading to unwanted complications from the disease.
Indeed, one of the major obstacles of diabetes management is the lack of availability of a patient's healthcare professional and the relative infrequency of clinic appointments. Studies have, in fact, established that more frequent insulin dosage regimen adjustments—e.g., every 1 to 2 weeks—improves diabetes control in most patients. Yet as the number of diabetes sufferers continues to expand, it is expected that the possibility of more frequent insulin dosage regimen adjustments via increased clinic visits will, in fact, decrease. And, unfortunately, conventional diabetes treatment solutions do not address this obstacle.
The device most commonly employed in diabetes management is the blood glucose meter. Such devices come in a variety of forms, although all are characterized by their ability to provide patients near instantaneous readings of their blood-glucose-levels. This additional information can be used to better identify dynamic trends in blood-glucose-levels. However, all conventional glucose meters are designed to be diagnostic tools rather than therapeutic ones. Therefore, by themselves, even state-of-the-art glucose meters do not lead to improved glycemic control.
One conventional solution to the treatment of diabetes is the insulin pump. Insulin pumps are devices that continuously infuse short acting insulin into a patient at a predetermined rate to cover both basal needs and meals. As with manual insulin administration therapy, a healthcare professional sets the pump with the patient's insulin dosage regimen during clinic visits. In addition to their considerable current expense, which prohibits their widespread use by patients with Type-2 diabetes, insulin pumps require frequent adjustment by the physician or other healthcare professional to compensate for the needs of individual patients based upon frequent blood-glucose-level measurements.
An even more recent solution to diabetes treatment seeks to combine an insulin pump and near-continuous glucose monitoring in an effort to create, in effect, an artificial pancreas regulating a patient's blood-glucose-level with infusions of short-acting insulin. According to this solution, real-time patient information is employed to match insulin dosing to the patient's dynamic insulin needs irrespective of any underlying physician-prescribed treatment plan. While such systems address present dosing requirements, they are entirely reactive and not instantaneously effective. In consequence of these drawbacks, such combined systems are not always effective at controlling blood glucose levels. For instance, such combined units cannot forecast unplanned activities, such as exercise, that may excessively lower a patient's blood-glucose level. And when the hypoglycemic condition is detected, the delay in the effectiveness of the insulin occasioned not only by the nature of conventional synthetic insulin but also the sub-dermal delivery of that insulin by conventional pumps results in inefficient correction of the hypoglycemic event.
While the foregoing solutions are beneficial in the management and even treatment of diabetes in some patients, or at least hold the promise of being so, there continues to exist the need for an apparatus that is easy to use so as to facilitate improved diabetes control in patients.
The present invention comprehends an apparatus and system for diabetes management. In one embodiment, the inventive apparatus comprises a body which houses:
In one embodiment, the apparatus may be for single-use only, meaning that the quantity of insulin cannot be replenished upon exhaustion thereof.
In another embodiment, the apparatus is for multiple-use and the quantity of insulin is therefore able to be replenished. According to this embodiment, the quantity of insulin may be contained in a cartridge that is selectively removable from the housing so as to be replaceable upon exhaustion of the quantity of insulin therein.
In one embodiment, the body may further house a test strip port for receiving a test strip. Per this embodiment, the processor is operative to determine a patient's current blood glucose level measurement from a sample of the patient's blood provided on a test strip. Also per this embodiment, the display may, optionally, be operative to display a patient's current blood glucose level measurement.
According to one feature of the invention, means may be provided for communicating data from the memory to a remote device for remote storage. Such means are particularly, though not exclusively, suited to employment of the apparatus for single-use only, according to which data stored in the apparatus may be remotely stored, including, for example, for later transfer to a second, like apparatus.
Per another feature, means may be provided communicating data from the memory of the apparatus directly to a second, like apparatus for diabetes management. Such means are particularly, though not exclusively, suited to employment of the apparatus for single-use only.
Per yet another feature of the invention, the apparatus may further comprise means for preventing a patient from administering an injection when there is an insufficient quantity of insulin remaining in the apparatus.
The present invention further comprehends a system for diabetes management, comprising:
In one embodiment, the apparatus may be for single-use only. Accordingly, the quantity of insulin cannot be replenished.
In another embodiment, the apparatus is for multiple-use and the quantity of insulin is therefore able to be replenished. According to this embodiment, the quantity of insulin may be contained in a cartridge that is selectively removable from the housing so as to be replaceable upon exhaustion of the quantity of insulin therein.
According to one feature of the invention, the body further houses a test strip port for receiving a test strip, and the processor of the apparatus is operative to determine the patient's current blood glucose level measurement from a sample of the patient's blood provided on a test strip, and wherein further the means for communicating between the device and the apparatus are further operative for communicating the patient's blood glucose measurement between the apparatus and the device.
Per yet another feature of the invention, the apparatus may further comprise means for preventing a patient from administering an injection when there is an insufficient quantity of insulin remaining in the apparatus.
For a better understanding of the invention, and to show more clearly how it may be carried into effect according to one or more embodiments thereof, reference will now be made, by way of example, to the accompanying drawings, showing exemplary embodiments of the present invention and in which:
As required, detailed embodiments of the present invention are disclosed herein. However, it is to be understood that the disclosed embodiment is merely exemplary of the invention that may be embodied in various and alternative forms. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a representative basis for teaching one skilled in the art to variously employ the present invention.
The accompanying drawings are not necessarily to scale, and some features may be exaggerated or minimized to show details of particular components or elements.
As used herein, the term “insulin dose” means and refers to the quantity of insulin taken on any single occasion, while the term “insulin dosage regimen” refers to and means the set of instructions (typically defined by the patient's physician or other healthcare professional) defining when and how much insulin to take in a given period of time and/or under certain conditions. One conventional insulin dosage regimen comprises several components, including a long-acting insulin dosage component, a plasma glucose correction factor component, and a carbohydrate ratio component. Thus, for instance, an exemplary insulin dosage regimen for a patient might be as follows: 25 units of long acting insulin at bedtime; 1 unit of fast-acting insulin for every 10 grams of ingested carbohydrates; and 1 unit of fast-acting insulin for every 20 mg/dL by which a patient's blood glucose reading exceeds 120 mg/dL. In the context of this disclosure, a “current” insulin dose equates to the number of insulin units the patient needs to administer on the basis of the latest blood-glucose-level measurement and his or her prevailing insulin dosage regimen.
Referring now to the drawings, wherein like numerals refer to like or corresponding parts throughout the several views, the present invention is generally characterized as an apparatus 10 for diabetes management, the apparatus comprising a body 11 which houses:
The data inputs corresponding at least to one or more components in a patient's present insulin dosage regimen and the patient's blood-glucose-level measurements determined at a plurality of times stored in the at least first memory may, by way of non-limiting example, comprise those data inputs described in the inventions as set forth in US Published Applications 20090253970 and 20090253973, the disclosures of which published patent applications are incorporated herein by reference in their entireties. Relatedly, operation of the processor to at least determine from the data inputs whether and by how much to vary at least one of the one or more components of the patient's present insulin dosage regimen may, by way of non-limiting example, correspond to operation of the inventions as set out in the aforesaid US Published Applications 20090253970 and 20090253973. As explained more fully therein, the operation of the exemplary embodiments of those inventions is characterized by the determination of whether and by how much to vary one or more components of a patient's insulin dosage regimen based upon the determined efficacy of that regimen in view of blood glucose level measurements recorded as of the time of the determination. As a non-limiting example, determination of whether and by how much to vary a patient's present insulin dosage regimen is undertaken both on the basis of evaluations conducted at predefined time intervals (every 7 days, for example) as well as asynchronously to such intervals. The asynchronous determinations will evaluate the patient's blood-glucose-level data for safety each time a new blood-glucose-level measurement is received to determine whether any urgent action, including any urgent variation to the patient's present insulin dosage, is necessary. More particularly, each time a new patient blood glucose-level measurement is received into the memory it is accessed by the processor and sorted and tagged according to the time of day the measurement was received and whether or not it is associated with a certain event, e.g., pre-breakfast, bedtime, nighttime, etc. Once so sorted and tagged, the new and/or previously recorded blood-glucose-level measurements are subjected to evaluation for the need to update on the basis of the passage of a predefined period of time measured by a counter, as well as the need to update asynchronously for safety. For instance, a very low blood glucose measurement representing a severe hypoglycemic event or the accumulation of several low measurements in the past few days may lead to an update in the patient's insulin dosage regimen, while an update to that regimen may otherwise be warranted if a predefined period of time (e.g., 7 days) has elapsed since the patient's insulin dosage regimen was last updated. If an excessive number of such hypoglycemic events is not indicated, then the algorithm queries whether or not it is time to update the patient's insulin dosage regimen irrespective of the non-occurrence of hypoglycemic events, and based instead upon the passage of a predefined interval of time (e.g., 7 days) since the need to update the patient's insulin dosage regimen was last assessed. If such an update is not indicated, i.e., because an insufficient time interval has passed, then no action is taken with respect to the patient's insulin dosage and the algorithm ends until the next blood glucose-level measurement data are input.
Where, as in the embodiment of
Power to operate the apparatus, including the display and processor, may be provided by one or more batteries (not shown) disposed in the body 11. These one or more batteries may be rechargeable or single-use, replaceable or irreplaceable.
The means for effecting delivery of a portion of the quantity of insulin may take the form of a plunger 15 operative in known fashion to dispense a portion of insulin through the needle 14 upon actuation of the plunger. Such means are found in conventional insulin pens. Of course, any other means employed to dispense insulin in conventional insulin pens may be substituted.
In order to control the portion of the quantity of insulin delivered to the patient via the needle 14, metering means are provided. In one form, such metering means may comprise any mechanism employed in conventional insulin pens, for instance, to ensure that actuation of the plunger 15 effectuates delivery of only a defined portion of insulin. According to such construction of the apparatus, unlimited actuation of the plunger 15 dispenses a predefined portion of insulin via the needle 14. The metering means preferably, though not necessarily, include a dial or other mechanism the selective movement of which would limit actuation of the plunger 15 in predefined increments corresponding to predefined measurements of insulin. A display 16 provided on the apparatus 10 indicates the current setting of the metering means so that the patient can know how much insulin will be dispensed upon actuation of the plunger 15. Of course, such display may be provided on the display screen 12 in the alternative. Thus, by actuation of the metering means, a patient can, as desired, modify the apparatus so that actuation of the plunger will dispense a portion of the quantity of insulin corresponding to a recommended insulin dose corresponding to the processor's determination of a recommended insulin dosage regimen (which may be the patient's existing regimen or a regimen modified according to the algorithm employed by the processor).
In an alternative embodiment, the delivery means may comprise an electro-mechanical device disposed in the body 11 and operative to automatically effect delivery of a portion of the quantity of insulin via the needle 14 upon actuation of one of a plurality of single-purpose or multi-function buttons 17 provided on the apparatus. Further according to this embodiment, the metering means are likewise automatic. Once a recommended insulin dosage regimen has been determined by the processor (whether that regimen is an existing or modified regimen), the electro-mechanical device is automatically adjusted by the processor so that the subsequent actuation of the delivery means (such as, for instance, via on ore more of the buttons 17) delivers to the patient a dose of insulin corresponding to a recommended current insulin dose, determined by the processor, that may be displayed on the display screen 12.
According to a still further embodiment, the delivery means may comprise the manually actuated plunger heretofore described, while the metering means may be an electro-mechanical device the operation of which is automatically effected by the processor. In this fashion, the amount of insulin dispensed by a patient's manual actuation of the plunger would automatically correspond to the recommended current insulin dose that may be displayed on the display screen 12.
As shown in
Alternatively, the apparatus 10′ may, as shown in
Needle 14 is preferably, though not necessarily, removably connected to the body 11 so as to be disposable following use and thereafter replaceable with a sanitary needle. Such removable connection, typical of conventional insulin pens, may be accomplished in any conventional fashion.
According to any of the foregoing, it is further contemplated that the apparatus 10, 10′ may include means for preventing a patient from administering an injection when there is no or an insufficient amount of insulin remaining in the apparatus. Such means may take the form of a visual warning, provided for instance on the display 12, 12′. Alternatively, or in addition, the apparatus may be programmed to physically prevent operation of the delivery means. Such may comprise an electro-mechanical device (which may be the same as or separate from those described in connection with the delivery and/or metering means), the operation of which is effected by the processor, which precludes actuation of the delivery means when it is determined by the processor (for instance, by calculation from the known initial quantity of insulin provided, the number of times the delivery means are actuated, and the dose/portion of insulin delivered each time the delivery means are actuated) that an insufficient amount of insulin remains to deliver a recommended dose of insulin or another, predefined dose.
Optionally, the apparatus 10 may, as shown in
Display screen 12 may, by way of non-limiting example, comprise an LCD screen, the apparatus being programmed, according to convention, to display thereon such information displays as described herein (e.g., a recommended insulin dose corresponding to the processor-determined insulin dosage regimen). Where the apparatus 10 is operative to determine blood glucose level measurements, and further includes data entry means such as the buttons 17 herein described to permit the patient and/or other user's to input data corresponding at least to one or more components in a patient's present insulin dosage regimen and data inputs related to the patient's blood glucose measurements, the display screen 12 may be operative so as to display information displays corresponding to at least the following:
a patient's current blood glucose level measurement;
an event associated with the said current blood glucose level measurement;
a measurement for the number of carbohydrates associated with the said event; and
a recommended insulin dose corresponding to the processor-determined insulin dosage regimen.
Optionally, the display screen 12 may further be operative to successively display a summary screen displaying simultaneously information corresponding to that provided on each of two or more of the foregoing information displays, including: a patient's current blood glucose level measurement, an event associated with the said current blood glucose level measurement, a measurement for the number of carbohydrates associated with the said event, and the recommended insulin dose.
According to the foregoing embodiment of the invention, the patient and/or other user is able to enter, in addition to, for instance, such other data as corresponds to one or more components in a patient's present insulin dosage regimen, data related to a particular blood glucose level measurement as determined by the processor from a sample of the patient's blood. These data include, for instance and without limitation, an appropriate event (e.g., breakfast, lunch, dinner) associated with a current blood glucose measurement as displayed on display 12, as well as the number of carbohydrates associated with the event.
Optionally, the apparatus 10 is programmed to enable a patient and/or other user to selectively override, such as by using one or more of the plurality of buttons 17, a recommended current insulin dose displayed on the display screen 12. To the extent that the metering means are automatically adjusted to effect delivery of the recommended insulin dose, it is contemplated that the metering means would be further adjusted in response to any change in the recommended current insulin dose made by the patient and/or other user.
Referring next to
In similar fashion, it is further contemplated that the apparatus of the present invention (especially, although again not exclusively, where fashioned for single-use) include means to communicate with like apparatus via a communication cable, wirelessly, or any other conventional communication means. This may be necessary, for instance, to transfer the patient's present insulin dosage regimen data, as well as historical blood-glucose-level measurement data from the apparatus 10′ the insulin supply of which is exhausted to a second, unspent apparatus. It will be appreciated that while such utility may be particularly desired where the apparatus 10′ is of “single-use” design, it may also be desired in order to transfer such data as is stored in a first apparatus to a second, like apparatus upon, or prior to, failure of the first.
Referring next to
According to this embodiment, data corresponding to the patient's insulin dosage regimen and the patient's blood-glucose-level measurements are stored in the memory of the device 100′, the processor of which is operative to access these data and determine at least whether and by how much to vary at least one of the one or more components of the patient's present insulin dosage regimen. Upon completion of this determination, information corresponding to at least a recommended current insulin dose may be transferred to the apparatus 10″ to be displayed on display 12 to be acted upon in any manner as heretofore described.
Per this embodiment of the invention, the data corresponding to the patient's insulin dosage regimen may be input on one or more occasions by the patient's physician or other healthcare professional. The patient's blood-glucose-level measurements may be transferred to the memory of the device 100′ via a separate blood glucose meter or, to the extent that such functionality is provided in the apparatus 10″ according to the embodiment as described herein, may be provided directly from the apparatus 10″.
Referring next to
The foregoing description of the exemplary embodiment of the invention has been presented for purposes of illustration and description. It is not intended to be exhaustive of, or to limit, the invention to the precise form disclosed, and modification and variations are possible in light of the above teachings or may be acquired from practice of the invention. The embodiment shown and described in order to explain the principles of the invention and its practical application to enable one skilled in the art to utilize the invention in various embodiments and with various modifications as are suited to the particular application contemplated. Accordingly, all such modifications and embodiments are intended to be included within the scope of the invention. Other substitutions, modifications, changes and omissions may be made in the design, operating conditions, and arrangement of the exemplary embodiments without departing from the spirit of the present invention.
This application is a continuation of U.S. application Ser. No. 13/128,358, filed Jul. 21, 2011, which is the National Phase application of International Application No. PCT/AU2009/063989, filed 11 Nov. 2009, which designates the United States and was published in English, which claims priority to U.S. provisional application No. 61/113,252, filed 11 Nov. 2008, and U.S. provisional application No. 61/257,886, filed 4 Nov. 2009. Each of these applications, in their entirety, are incorporated herein by reference.
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| Number | Date | Country | |
|---|---|---|---|
| 20150164415 A1 | Jun 2015 | US |
| Number | Date | Country | |
|---|---|---|---|
| 61257886 | Nov 2009 | US | |
| 61113252 | Nov 2008 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 13128358 | US | |
| Child | 14631525 | US |
