Patent Publication Number: US-2012035446-A1

Title: Method and apparatus for monitoring diabetic patients

Description:
RELATED APPLICATIONS  
     This application claims priority to U.S. Provisional application Ser. No. 61/370,862 filed Aug. 5, 2010 and incorporated herein by reference in its entirety. The subject matter of this application is also related to application Ser. No. 13/004,267 filed Jan. 12, 2011, claiming priority to provisional application Ser. No. 61/294,154 filed Jan. 11, 2010, incorporated herein by reference. 
    
    
     BACKGROUND OF THE INVENTION 
     A. Field of Invention 
     This invention pertains to a method and apparatus for monitoring diabetic patients who are treated with insulin and/or other drugs. In the present invention, the results of the tests are automatically recorded, uploaded to a data base and shared with health care providers. 
     B. Description of the Prior Art 
     Diabetes is a major disease that affects many patients throughout the world. The disease pertains to the lack of a patient&#39;s body to either manufacture adequate supply and/or fails to utilize insulin in it metabolism. At present there is no cure for the disease but it can be manage thus allowing a patient a better quality of life. This management includes testing the blood sugar of the patient one or more times a day and taking insulin and/or other drugs. (The term “taking” is Used herein generically to any act of administering a drug to a patient, including administration of the drug by taking the drug orally, by injection, etc., and administering the drug by the patient or another person). Often both the testing and the administering are done by the patient himself. 
     The patient then visits his physician at somewhat regular intervals and gives the physician a list of the days on which his blood sugar was measured, the data obtained and the amount of medicine that the patient took. The physician then analyzes this data and modifies the amount of insulin/drugs that the patient has to take in the future based on this analysis. 
     While somewhat successful, this process is not very desirable since it is relies too much on the patient. The patient first must remember to measure the blood sugar level, which is already a daunting process since it involves taking a sharp object pricking the patient&#39;s finger or other member and then applying a drop of blood on a strip. Next, the strip is inserted into a glucose meter. Next, the glucose meter is read and the data is recorded together with the date (and, optionally, the time of day) for each reading. These are already difficult tasks to be performed routinely, especially in elder patients—a large number of the diabetic population. 
     Moreover, recently some reports have estimated that the data obtained this way is wrong 70% of the time and, in order to correct this problem a secondary test has been suggested as well. This second test involves having a patient go every three months to a lab or other similar facility and have a separate blood test done to determine their HbA1c level. The results of the test are transmitted to the physician who then compares them to the data obtained from the glucose meter by the patient to determine how to modify the administration of insulin/drugs for the patient. In other words, the insulin management process is becoming more and more complicated. 
     SUMMARY OF THE INVENTION 
     In the present invention, a system is provided wherein data from a glucose meter at the patient site is obtained and automatically uploaded to a data base. A master monitor reviews the data and collates it for the physician as needed. For example, the physician may obtain the data on a daily, weekly, monthly basis and/or during a visit by the patient. Optionally the HbA1c level in the blood is also measured at regular intervals (preferably monthly) at the patient site and data is also uploaded, stored in the data base, and reviewed by the physician to confirm the data from the glucose meter. The central monitor can also be configured to monitor the data from each patient on a regular basis and to alert the physician and/or others if abnormal glucose levels are detected. 
     The system and method has several advantages, as discussed below. 
     All patients will have mandatory monthly HbA1c testing at home. This provides a much more accurate picture of what is happening with the patient without requiring the patient to go to a separate lab. 
     In one embodiment, the communication channel used to collect the data is also used to (a) remind each patient to test his blood; and (b) take his medicine if no indicated. Each patient will be contacted as a reminder to complete this portion of the testing. The patient may also be asked to provide not only the test data but to confirm that he has taken his medicine (and/or has given himself on injection). This process has the added benefit of providing information to the master monitor and/or another service indicative of how much drugs the patient has, and, if necessary, to alert the physician, drug store, etc., that the patient is about to run out of a certain drug. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  shows a block diagram of a system configured in accordance with this invention; 
         FIG. 1A  shows a diagrammatic view of a device used to test a blood sample for two different criteria; 
         FIG. 2  shows a flow chart illustrating the operation of the system; and 
         FIG. 3  shows a more proactive method for operating the system. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     The invention is now described in conjunction with the drawings. Starting with  FIG. 1 , a system  10  constructed in accordance with this invention includes several elements. Some of the elements are at a patient site while others are at one or more remote locations that are interconnected by the Internet, a private communication, network and could be cloud-based. 
     At the patient site, there is provided a glucose tester that is similar to testers available from various sources in that it is able to accept s a blood sample from the patient, either directly, or via a strip provided for this purpose. The glucose tester determines the current sugar concentration in the blood of the patient. Once this determination is made, the resulting number as well as the current date and time are stored in a data memory  14 . There is further provided a modem  16  that is connected to the data memory to transmit the data recorded therein to a remote location. The modem  16  includes a USB port, a jack for a land-line telephone, a port for a cell phone connection and/or any other similar port that can be used to establish data communication with the remote location. 
     In addition, there is also provided a A1C tester  18 . This tester  18  also receives a blood sample and determines the HbA1c level therein. Testers of this sort are presently available, for example, from Bayer, however, they merely provide a reading and do not transmit it anywhere. Instead the results are recorded manually. In the present invention, the recording from the A1c tester are also recorded in the same data memory  14  or a separate data memory and are then transmitted by modem  16  as well. 
     The arrangement shown and discussed so far on  FIG. 1  can be implemented in a number of different configuration. In one configuration, two separate independent testers are provided, each performing its own test, data storage and modem. In another embodiment, two physically separate testers are provided that share a data memory and/or modem. In yet another embodiment, the testers  12 ,  18 , the data memory  14  or memories and the modem  16  or modems are disposed in a single hand held unit. 
     In any event, the system further includes a master monitor  20  that is connected to a central data bank  22 . The central data bank receives information and stores from the modem  16  via a communication channel  24 , as well as similar information from other patients. The master monitor  20  sets up What information is to receive in order to establish an effective diabetes management process for each patient. As part of this process, the master monitor exchange information with several physicians, or other health care providers and/or pharmacies and hospitals, all commonly indicated in  FIG. 1  by numeral  26 . In addition, the master controller  20  can also provide a reminder service  28  to its patients, and if necessary, activate an emergency service  30 . 
       FIG. 1A  shows a somewhat diagrammatic representation of a device  40  used to collect data. The device includes two ports or other means  42 ,  44  for receiving respectively a sample of blood for testing sugar level and A1c, respectively. Once the samples are provided at the respective ports, a respective button  46 ,  48  is activated to indicate to the device  40  that samples are ready to be tested. The device  40  further includes several communication ports  50 ,  52 ,  54  that may be, respectively, a USB port, an Ethernet port, a phone jack/wireless access port, etc. 
     Once the device  40  completes its test, the result together with other information, such as the type of test, the date and the time, are shown on a screen  56 , typically an LCD screen. The result is also stored in the data memory  14 . The patient then activates a button  58  requesting that the information be sent to a remote location. Alternatively, the data can be sent automatically. 
     Device  40  is also provided with several indication lights  60 ,  62 ,  64 . Light  60  may be used to alert the patient that it is time for a test an/or the administration of a drug. Light  62  may be used to indicate to the patient that the data has been correctly received and stored, or that the data seems to be wrong and the test should be repeated. Light  64  may be used for other indication, such as a reminder or a request that he should visit his physician or other health care provider, or that his medicine is about to run out and should obtain a new supply. 
     One mode of operation is now described for the system in conjunction with the flow chart of  FIG. 2 . In step  100  a patient registers with the system and at least some of the following information is collected. This can be done in various forms, such as having the patient fill in a form manually or electronically:
         a. Name   b. Address   c. Telephone   d. E-Mail   e. Medications   f. Name of physician   g. Physician Telephone   h. Physician Address   i. Physician E-Mail   j. Escalation Notification 1   k. Escalation Notification 2   l. Escalation Notification 3   m. Any kind of authorization needed for HIPA   n. Any kind of authorization for billing insurance or Medicare/Medicaid Patients and any consent form to collect demographic information.   o. Any information for supplies and prescription from the physician in order to bill for these supplies.   p. Supply order form. Based on the amount of times the pt is testing would give the system the amount of supplies needed per month. An area on the pt form should have choices such as:
           ______ I test twice daily   ______ I test once daily   ______ I test once weekly   
               

     In step  110 , information not received from the patient is obtained from another source, such as the physician. This information may include the amount of drugs required for the the patient, etc. 
     In step  120 , the physician or other competent authority sets up a monitoring schedule and several levels of alarm levels for various events as defined above for j, k and l. 
     At the end of step  130 , the central monitor  20  has only the information required for effective diabetic management process of the patient, including when the patient should receive insulin/drugs, how much he needs in a month, 3 months, etc., how often he should perform each test, including sugar tests and A1C tests (as discussed above, the sugar level typically are tested from 1 to 3 times a day, the A1c test is typically performed once a month). The management process also defines (as set by or suggested by the physician) what are the normal sugar levels, under what conditions should physicians and/or others, such as an alternate care giver, a relative or other responsible person, or, in extreme cases, an emergency service should be notified. All this information is stored in the data bank  22  and the system is now ready for operation. 
     In a basic mode of operation, shown in  FIG. 2 , staffing in step  130 , data is collected from each patient device, stored in the data bank  22  and analyzed. In step  140  a determination is made if the data is within certain ranges as previously defined for each patient. If the data is within range, data collection continues in step  130 . If the data exceeds a certain range or meets some other criteria, as initially defined, an alarm condition is established and data collection is continued for the other patients. Depending on preset thresholds, when an abnormal sugar level is indicated, notifications are sent automatically to the patient&#39;s physician an alternate giver, family member, emergency services, etc. 
     Moreover, while not shown in the flow chart, authorized personnel, including a patient&#39;s primary physician, is issued a password to allow the physician to access the patient&#39;s records at any time. For example, the physician can access the records just before, or during a standard (e.g., monthly visit), or When receiving an emergency message. 
     The data collection of step  130  can be implemented in various ways. For example, data can be collected asynchronously, whenever the analysis of a blood sample has been completed. Preferably, after the data is transmitted, the data bank and/or monitor analyzes the data to check if it is correct and then sends an acknowledgement that either turns on one of the indicator lights or activates a message on the screen  56  indicating that the test has been successful. 
     In another embodiment, the test data is stored in the memory, and the data bank poles all the data memory of the serviced patients and collects the data sequentially. 
     Of course, the system can be operated in another mode as well. For example, as shown in one embodiment depicted in  FIG. 3 , the process may start in step  200  by sending a reminder to the patient to take his medicine. This step may be implemented by either activating a light on the device (as discussed above in relation to  FIG. 1C ) or by other means. For example, the patient may receive an oral or text message on a land-line telephone, cell phone, e-mail, text message, etc. (A detailed description of this process is found in commonly owned co-pending application Ser. No. 13/004,267 fully identified above). In step  210 , the monitor looks for an acknowledgement from the patient that he has taken the medicine or at least has received the reminder. If no acknowledgement is received, an appropriate alert is sent to the physicians, relatives or others in step  220 . 
     If acknowledgement is received then in step  230  the monitor checks when was the last time the patient received a supply of drugs and whether that supply is getting low, the patient, or the drug store are alerted (steps  240 ,  250 ). Next in step  260  the patient is sent a reminder that he needs to test his blood sugar level. If this reminder is acknowledged (step  270 , for example by pressing an appropriate button on device  40 ), then in step  290  the results are stored and then analyzed as previously discussed. If the reminder for a blood test is not acknowledged, an alert is sent to the physicians and/or others (step  280 ). 
     The sequence of steps in  FIG. 3  are only exemplary and other sequences may be implemented as well. For example, determining how much drugs the patient should have can be made independently of the reminders. Moreover, the reminder to check for blood sugar may be before sending the reminder to administer drugs. 
     Many other modifications may be made to the invention without departing from its scope as defined in the appended claims.