Patent Application
20130035563
The invention relates to a system for managing diabetes by analyzing blood glucose levels and other patient information to formulate queries, advice and educational materials displayed on a portable device carried by the patient.
Complications of diabetes are serious and include kidney failure (requiring dialysis or transplant), blindness, heart disease and limb amputation. Adequate control of diabetes leads to lower risk of complications.
Modem approaches to managing diabetes primarily rely upon dietary and lifestyle management, often combined with regular ongoing blood glucose level monitoring. Diet management allows control and awareness of the types of nutrients entering the digestive system, and hence allows indirectly, significant control over changes in blood glucose levels. Blood glucose monitoring allows verification of these, and closer control, especially important since some symptoms of diabetes are not easy for the patient to notice without actual measurement.
Every patient has different reactions to diet, exercise, and drugs administered. Patients also have different complications or potential complications associated with their disease, often including one or more of: Elevated blood pressure; compromised thyroid function; circulatory abnormalities, stroke; cardiovascular disease; infection; eye health issues including cataracts; and kidney disease. Thus, diabetes management is optimally an individualized management plan, which is continuously updated and revised as patient data relating to diet, exercise, blood glucose, and drug administration changes.
Effective diabetes management therefore requires adhering to a fairly strict diet, exercise, glucose testing, and drug (including insulin) administration regimen. But non-adherence to the regimen is commonplace. Kutz S M: Adherence to diabetes regimens: empirical status and clinical applications. Diabetes Ethic 16:50-56, 1990; Johnson S B: Methodological issues in diabetes research: measuring adherence. Diabetes Care 15:1658-67, 1992: McNabb W L: Adherence in diabetes: can we define it and can we measure it? Diabetes Care 20:215-18, 1997; Weissberg-Benchell J, Glasgow A M, Tynan W D, Wirtz P. Turek J. Ward J: Adolescent diabetes management and mismanagement. Diabetes Care 18:77-82, 1995. Was to educate patients and increase patient awareness about the importance of strict regimen adherence can have a significant beneficial impact on patient outcomes. Where that educational effort is coupled with close monitoring and advice on glucose testing, diet, exercise and drug administration, the patient outcomes can be improved further.
What is needed is an integrated system of education, monitoring and advising on glucose testing, diet, exercise and drug administration, all in a portable and convenient, form for the patient, to maximize system utilization and thus effective disease management.
The most convenient form for integrating a system of education, monitoring and advising on glucose testing, diet, exercise and drug administration is a device which is lightweight and portable (and easily carried by the patient) and which is capable of:
In the case where the device's computing power or access to full patient information is limited, the device is preferably linked wirelessly to a server that performs some or all of the analysis described above. In the case of employing a server, the glucose test results are transmitted to the server, and the device receives the results of the server's analysis in the form of queries, advice and educational messages. A wireless link to the device also provides the ability for feedback, advice and/or intervention from appropriately experienced health care workers, as necessary and appropriate.
The internal programs on the device and/or available through the wireless link should also permit patient inquiries about when to administer insulin or other drugs, when and what to eat, and whether to increase or decrease exertion level. Preferably, the internal programs on the device provide responses to some patient inquiries, and some advice for the patient, including taking emergency actions. That way, even if the server is not available, the device can do much of the important monitoring and feedback to maintain patient health. Other transmission systems besides the wireless link which allow the patient to transmit and receive the relevant data and advice from the server could also be used.
The device preferably also includes the ability to test ketone levels and record the results, track quantity and timing of food consumption, and a pedometer or accelerometer to track patient exertion and total calories expended in exercise.
Among the notifications to the patient (which can be included in the device internal programs) is one for tracking use of and recording the number of glucose test strips and/or ketone test strips on hand—with a notification to the patient to re-order from a supplier when the available supply of test strips begins to run low. The supplier can also be notified to automatically query the patient if an order is needed when the tracking of strips indicates the supply of test strips is low. Notification of the supplier would be through the wireless link. Similarly, the server is preferably notified to automatically query the patient if an order is needed when the tracking of strips indicates the supply of test strips is low. This automatic tracking, notification and query serves to monitor patient compliance with the glucose/ketone testing regimen, and to ensure that strips are not over-ordered and/or ordered a significant time before there is a need.
In management of diabetes, maintaining an appropriate blood glucose level is key to avoiding or minimizing negative outcomes. Tracking and recording of blood glucose levels over a period of time allows one to determine how various factors (including meal content, meal timing, insulin dosage and injection schedule, exercise intensity, duration and frequency) affect blood glucose levels. Thus, the internal programs on the device preferably also allow patients to record blood glucose levels over time, along with factors including those listed which can affect blood glucose levels, and then further allow the patient to see averages, highs, lows, or other analysis of the blood glucose level monitoring over time, so that the patient can optimize such factors in view of their effect on blood glucose. Having such functions on the device itself allows the patients to view such analysis of blood glucose monitoring over time, even where the wireless link to the server is not available. More preferably, all such analysis are also transmitted to the server, where detailed information about the patient's profile and preferences can be considered along with the analysis as well as other factors, and advice and recommendations based on all the information and analysis can be provided to the patient. Similarly, all such analysis sent to the server are preferably also sent to or available to the healthcare team so that they can provide added input, educational materials or intervention (if needed). All such analysis are also preferably sent automatically to other parties involved in the patient's care, including the patient's personal physician(s).
Some advice to the patient is preferably provided from the internal programs on the device (without the need for transmission and input from the server or health care team). Such advice includes the basic advice for diabetes management, including, e.g., “administer _mg of insulin now” or “eat now.” This advice can be provided based on the results from the patient glucose testing, the timing from the last food intake and the patient's perception of their condition. This advice can also take the form of education so the patient can make an informed decision on what actions, if any, should be undertaken. In one embodiment, a portable device includes “generic” messages, stored in the device memory—allowing immediate display of some messages for the patient even if a wireless link is not available (particularly, where prompt action by the patient is needed, such as injecting insulin or eating). These generic messages preferably involve generalized education and patient direction, in response to particular circumstances, feelings, or test results the patient requests information about. For example, these messages can discuss dangers of low or high blood glucose, dangers of high ketone levels, health risks for diabetics, foods to avoid, wound care, and other such information.
In addition to generic messages, specific and personalized messages can be generated from the device memory as well, or specific and personalized messages can be generated from a central server (and accessed by the link on the portable device carried by the patient), where the central server receives, stores and analyzes information about test results and patient status, immediate past and over time, and also stores and analyzes information relating to other factors in the patient profile. These specific personalized messages are generated in response to constantly-changing patient-related information, including blood glucose, ketone levels, meal content and timing, and patient exertion level, and in consideration of the patient's personal health profile—including patient preferences and limitations. The personalized messages are in a form suitable for viewing by the patient, and may often include specific directives and commands, e.g., “stop exercise.” Simultaneously with the specific directives and commands, the system can automatically send a new generic or educational message regarding dangers and health risks the patient may be likely to encounter based on their status. For example, if the patient's blood glucose returned to a normal level after being elevated, the generic message would change from one relating to the dangers of elevated blood glucose, to one regarding steps to maintain blood glucose near the optimal level. And if the blood glucose drops too low, the generic message would change to the dangers of low blood sugar.
As noted, the patient's personal health profile is considered in generating the specific and personalized messages for the patient. The personal health profile is generated when the patient first subscribes and enters the system, and then is iteratively and interactively updated in view of changes to e.g., general health status, progression or improvement of glucose intolerance as well as of any other diseases or conditions, exertion limitations, and food and exercise preferences. Both the profile and the selected messages get progressively personalized to the patient's need, as the database of patient information grows and patient reactions and preferences are monitored. See application Ser. No. 12/693,849, incorporated by reference.
The invention includes the methods of monitoring and advising, as well as a business based on the monitoring and advising, which generates revenues by having patients subscribe to the system and use it. The invention also includes a computer/microprocessor capable of generating and/or displaying the queries and advice to the patient and other information including the ordering of more test strips. The invention also includes a computer/microprocessor capable of interacting with a server or health care team and displaying queries and advice from the server or health care team. The invention also includes a pedometer or accelerometer with the portable device carried by the patient to measure the exercise intensity, calories expended, and duration. A preferred accelerometer is described and claimed in U.S. Pat. No. 8,066,640, incorporated by reference.
Analysis of ketone testing (as shown in
Other analytes or metabolites related to management of diabetes include cholesterol, LDL, and others. These can also be tested conventionally and the results of the tests transmitted for recording and analysis at a central location.
Actuating the Team icon can display sub-icons for sending (over a wireless link) the results of testing, or the results from Trends, to the patient's personal physician, other's in the patient's health care team (such as the personal health care coach), or to elsewhere as indicated by the patient (i.e., to his email, family or to his social media).
Actuating the Messages icon allows one to display messages from physicians, the server or others on the health care team, that are personalized to the patient. The patient can also respond to messages in this function.
Referring to
At the time of testing, the results can also be associated with the patient's subjective state (“FeelTag”)—as patient's are often perceptive to significant changes in their blood glucose and this input can be used effectively in forming a recommendation. Further questions displayed about the patient's state can include whether the patient is any of: “Light headed, stressed, after exercise, ate extra food, increased medication, missed medication” and/or other input relevant to forming, a recommendation on food intake or insulin administration.
Following analysis and display of the blood glucose level, the level is automatically stored in the device memory, e.g., in a SD memory card, and queued to submit to the server. The information entered in response to the Meal tagging and Feel tagging screens is also stored, for later analysis.
If the blood glucose is above a threshold (e.g., 250 mg/dl), the display should preferably advise the patient to do a ketone test. The ketone test may also display on timed intervals, or if it is more than two hours since a meal, or if the patient is feeling unwell. If the patient is feeling fine and recently ate, then a message can be displayed stating, e.g., “glucose slightly high—exercise or drink water”; or, “glucose slightly low—drink some fruit juice.” Blood glucose tends to be low in the morning. Similarly, a slight increase in ketone level above normal might prompt a message to drink water to address it.
The results of ketone testing and blood glucose, and patient input, are queued to submit to the server, analyzed and an appropriate message is generated advising the patient; including one or more of eat, begin exercise, stop exercise, administer medication. As noted, glucose and ketone test strips used are tracked and a message to reorder is generated when they become low. If a pedometer is part of the device, then the exercise (walking) by the patient can be logged and stored, along with blood glucose and ketone levels. Any or all of these parameters can be displayed on the device in a format showing changes over specified periods, so that the effect on blood glucose (and ketone levels) of changes in diet, exercise and medication can be tracked. See
Another feature of the system can be to track patient preferences, especially those relating to diet and exercise. The tracking of favorites and their updating, analyses and recommendations based on them, is normally is a more data-intensive function, and is based on information gathered from the patient at an initial interview and input into a central server. Accordingly, the tracking, updating, analyses and recommendations based on favorites is normally performed by the server, following transmission of real-time information on glucose or other metabolite levels from the patient to the server. The recommendations for eating can be highly specific and personalized: e.g., eat X calories of carbohydrates selected from “your favorites”: mashed potatoes and pinto beans. Eat X calories of lean protein, selected from “your favorites”: shrimp and egg whites. Similarly, recommendations for exercise can include recommendations for exercise duration and exertion level. A heart rate monitor could also be integrated into the system to automatically input the heart rate during exercise, and this input can also trigger advice from the patient device, and/or from the central server (“heart rate in proper zone” “stop exercising, heart rate too high”).
An example of personalized advice based on a patient's original profile would be that if someone is so obese that they cannot walk, then “start walking” would not be a transmitted command in response to test results showing that the patient has elevated blood glucose. The patient's preferences for particular foods, and the patient's food dislikes, along with their preferences for exercise type, exertion level, and timing, are also entered initially, and then updated as desired. All these parameters are considered in determining recommendations, educational messages, and directives to the patient.
Following transmission of each recommendation or directive, the patient's reaction to the recommended course of action, particularly the patient's blood glucose level, is recorded for analysis and monitoring. The patient's other reactions including subjective reactions, such as general well-being, lethargy, light-headedness, nausea, and headache, and other, is also recorded or analysis and monitoring. All this information may be applied in analysis and determination of further recommendations and/or further education for the patient.
Administering insulin or oral hypoglycemic agents—e.g., exenatide, liraglutide and pramlintide—can be among the specific recommendations for a patient. Administration of insulin analogues, including those which mimic real beta cell insulin (e.g., lispro, asport and glulisine), and those which are steadily absorbed after injection instead of having a ‘peak’ followed by a more or less rapid decline in insulin action (e.g. Insulin detemir and Insulin glargine), can also be recommended. The recommendation could also be for one or a combination of rapid-acting, short-acting, intermediate-acting and or long-acting insulin or insulin analogues.
Also suitable for recommending to a patient is administering Metformin (including Metformin in combination with other oral diabetic medications).
Other products suitable for recommendation for administration to the patient include:
Thiazolidinediones, also known as “glitazones,” rosiglitazone (Avandia) and pioglitazone (Actos);
Sulfonylureas, tolbutamide (Orinase™); acetohexamide (Dymelor™), tolazamide (Tolinase™); chlorpropamide (Diabinese™); glipizide (Glucotrol™); glyburide or glabenclamide (Diabeta™, Micronase™, Glynase™); glimepiride (Amaryl™); gliclazide (Diamicron™); glycopyramide; gliquidone;
Meglitinides, repaglinide (Prandin™), nateglinide (Starlix™)
Alpha-glucosidase inhibitors including miglitol (Glyset™), acarbose (Precose/Glucobay™), and voglibose;
Glucagon-like peptide (GLP) agonists including Exenatide, Liraglutide, and Taspoglutide Dipeptidyl peptidase-4 inhibitors including Evildagliptin (Galvus™); sitagliptin (Januvia™); saxagliptin (Onglyza™); linagliptin (Tradjenta™); allogliptin; septagliptin
pramlimide or other amylin agonists; and
cinnamon; chromium supplements; vanadyl sulfate; and thiamine.
The system can also track non-diabetes related medications for the patient, and send reminders to take those medications at appropriate times. This feature is particularly useful for patients with high blood pressure, heart disease, and other chronic conditions requiring regular administration of medication. The system can also record and monitor any adverse or other reactions to such medications, and send educational messages about drug interactions, or send messages to a health-care worker to intervene and provide advice to the patient.
The recording and personalization of food preferences and dislikes is a feature particularly likely to have positive impact on Type II diabetes patients. These patients are often overweight or obese and may have limited understanding of how to make positive dietary adjustment. The may not appreciate the high sugar content in most pre-packaged drinks and foods. Consuming such items may cause significant adverse reactions.
In many cases, the diabetes is eliminated or ameliorated if the patient can return to a closer to normal weight/bodyfat percentage. The necessary reduction in calories to accomplish this goal is more likely to take place if the patient is provided food choices that are more acceptable to them. It is also more likely if the dietary recommendations include recommended quantities of the foods for consumption, and the timing of their consumption.
In another aspect, the invention relates to uniquely tailored advice and recommendations, particular on diet, based on patient preferences. The advice and recommendations are continually updated and further refined as new information on preferences is added by the user. The individual tailoring of recommendations and advice is performed in view of the user's preferences, limitations and individualized risk assessment as continually updated. Normally, due to the higher volume of data and programming capacity needed to analyze the patient preferences with the updated information constantly incoming, this analysis is performed by a linked server, which receives information from the patient's device and sends information for display on the patient's device. But the analysis could be performed by the onboard functions where they were programmed with preferences and had the computing capacity.
A selection algorithm (see
Exercise Choices:
Can individual run? (excess obesity, leg and foot condition are considerations—patient preferences)
Can individual walk? (same considerations as for running—patient preferences)
Can individual bike? (access to a bicycle, age and knowledge of how to ride—patient preferences)
Can individual swim? (access to a pool, knows how to swim—patient preferences)
Patient preferences on exercises are entered and considered and compatible exercises are recommended. For example, if a patient likes running because they prefer vigorous exercise, other vigorous exercise like swimming, mountain hiking/climbing, triathlon training, may be recommended.
Food Choices:
Avoid high calorie foods for anyone obese; avoid simple sugars for everyone.
In preferences, if a patient indicates they like corn because its soft and sweet algorithm recommends other foods with similar attributes—e.g., yams.
In preferences, patient indicates times of the day for food preferences; e.g., eggs in the morning.
Education Choices:
Patient requests information on particular topics, e.g., best time to exercise; best foods for weight loss; foods to avoid for enhancing weight loss.
The algorithm then sorts through the information and provides uniquely tailored advice, recommendations and education for the patient. The number of selections by the algorithm quickly increases as the patient continues to provide feedback, leaving a set of instructions which is so detailed as to essentially be a unique code for the patient.
Tables 1-6 below show some exemplary patient status values, and some exemplary messages and instructions displayed on the patient's device in response.
.com to order supplies.”
Table 5 below shows an exemplary educational message which can be displayed in response to values received from the patient:
Table 6 below displays some exemplary educational messages provided to the patient from the server.
After educational materials are received by the patient, for example, one or more of the messages in Table 6, the patient can acknowledge receipt and understanding of the message on the portable device, or request information on the same or a different topic.
Referring to
The specific methods and compositions described herein are representative of preferred embodiments and are exemplary and not intended as limitations on the scope of the invention. Other objects, aspects, and embodiments will occur to those skilled in the art upon consideration of this specification, and are encompassed within the spirit of the invention as defined by the scope of the claims. It will be readily apparent to one skilled in the art that varying substitutions and modifications may be made to the invention disclosed herein without departing from the scope and spirit of the invention. The invention illustratively described herein suitably may be practiced in the absence of any element or elements, or limitation or limitations, which is not specifically disclosed herein as essential. Thus, for example, in each instance herein, in embodiments or examples of the present invention, any of the terms “comprising”, “including”, containing”, etc. are to be read expansively and without limitation. The methods and processes illustratively described herein suitably may be practiced in differing orders of steps, and that they are not necessarily restricted to the orders of steps indicated herein or in the claims. It is also noted that as used herein and in the appended claims, the singular forms “a,” “an,” and “the” include plural reference, and the plural include singular forms, unless the context clearly dictates otherwise. Under no circumstances may the patent be interpreted to be limited to the specific examples or embodiments or methods specifically disclosed herein. Under no circumstances may the patent be interpreted to be limited by any statement made by any Examiner or any other official or employee of the Patent and Trademark Office unless such statement is specifically and without qualification or reservation expressly adopted in a responsive writing, by Applicants. The invention has been described broadly and generically herein. Each of the narrower species and subgeneric groupings falling within the generic, disclosure also form part of the invention.
The terms and expressions that have been employed are used as terms of description and not of limitation, and there is no intent in the use of such terms and expressions to exclude any equivalent of the features shown and described or portions thereof, but it is recognized that various modifications are possible within the scope of the invention as claimed. Thus, it will be understood that although the present invention has been specifically disclosed by preferred embodiments and optional features, modification and variation of the concepts herein disclosed may be resorted to by those skilled in the art, and that such modifications and variations are considered to be within the scope of this invention as defined by the appended claims.
This application claims priority to U.S. application Ser. No. 13/485,849, filed May 31, 2012, which claims priority to U.S. application Ser. No. 12/693,849, filed. Jan. 26, 2010, which in turn claims priority to U.S. Provisional No. 61/147,157, filed Jan. 26, 2009.
| Number | Date | Country | |
|---|---|---|---|
| Parent | 13485849 | May 2012 | US |
| Child | 13656692 | US | |
| Parent | 12693849 | Jan 2010 | US |
| Child | 13485849 | US |
