Wireless Glucose Monitoring System

1. Wireless Glucose Monitoring System Erin Loutzenhiser, Dan Lopez, Matt Crooks, Matt Schultheis, Mihai Petrescu

2. Why Do We Need This System? • Every day millions of people are inconvenienced by the need to keep their diabetes in check. For many, this requires daily multiple tests of blood sugar levels and often times insulin shots. • Most diabetic patients would admit that blood sugar tests are inconvenient and painful. • According to the CDC 9.6% of adults in the US over the age of 20 are affected by type 1 or type 2 diabetes. This number increases to 20% of adults over 60. • With a growing number of baby boomers approaching age 60 the number of diabetics can be expected to increase drastically in the next 10-20 years.

3. Why Do We Need This System? • This growing number of diabetics will translate into millions of dollars being spent on glucose monitoring equipment. • We hope to offer a low cost, reusable system (no strips or extra parts required) that will continuously monitor glucose levels and record daily trends for patient/doctor review. • While a cure for diabetes is the ideal solution, making daily monitoring and maintenance of diabetes easier and less painful will help to lower the stress involved in managing this affliction. • The system also has potential to help researchers gain valuable insights into diabetes by increasing their data on glucose trends exponentially.

4. What Do We Hope To Accomplish? • We want to create a system for diabetics that: • would be less painful, non-invasive, and more convenient for daily multiple use • would be continuous, autonomous and easy to use • would archive the patient’s data for later review • would be cost-effective to the customer • We want to create a system for the company that: • uses existing wireless technology so the system can “go where you go” • is accurate • is cost-effective to produce • achieves the maximum profit for the company and it’s shareholders

5. What Do We Hope To Accomplish? • Keeping development costs low • By utilizing existing glucose monitoring technology, wireless protocols, storage mediums, and internet database tools, R & D tasks can be held to a minimum. • System components can be subcontracted to leading technology developers who specialize in certain areas. • Marketing of the system • The system will be made available at retail stores and online. • The system will be marketed to both individuals and insurance companies. • Emphasis will be placed on the non-invasiveness and frequency of measurements and the long term storage of glucose data.

6. Top Level Requirements • The system will take patient blood glucose reading every fifteen seconds, and be saved every sixty seconds • Current glucose reading will be displayed to the patient in real time • The system is capable of providing readings to the patient any time the patient chooses to use the system

7. Top Level Requirements • The accuracy of the blood glucose readings will meet and exceed the accuracy regulations set forth by the FDA • Should the patients glucose reading be in a pre-determined critical range, proper medical attention will be summoned. • Usage of the system by the patient will be no more obtrusive than use of a standard wristwatch or pager, leaving the patient free to perform their normal activities

8. Top Level Requirements • System down time is estimated at less than one day per year, with no one even longer than 15 minutes • Collected data will follow standard IT practices for data transfer, storage, and validity. • Individual components of the system can be hot-swapped for easy replacement

9. Top Level Requirements • No user level repair is necessary short of complete failure and replacement • User maintenance will be limited to simple cleaning, and battery recharges that are alarm indicated • High levels of data encryption will be used when transferring patient data to ensure confidentiality

10. Top Level Requirements • Operating environment similar to most wearable consumer electronics, daily activities of most users will not exceed system allowances • Non-operating (shipping, downtime) environments similar to most wearable consumer electronics

11. Proposed Solution The Wireless Glucose Monitoring System • The Wireless Glucose Monitoring System will provide continuous glucose monitoring for diabetes patients using a non-invasive wristwatch glucose tester to monitor blood sugar levels. The results of that monitoring are then wirelessly transmitted to a secured database for later viewing by the patient and health care professionals who can analyze the data, allowing for more advanced and cost-effective treatment for diabetes patients.

12. Wireless Glucose Monitoring System “Cellular Network” WristwatchGlucose Monitor (WGM): Worn by the patient as a non-invasive glucose monitor. Continuously displays the patient’s blood sugar level. Base Station (BS): Receives data from the patient’s monitor and communicates that data to the hub via a cell phone network. Hub: Serves as a database for the patient’s medical information. Also uses a web application to allow the patient and their health care provider to view the patient’s data

13. WGMS Functional Allocation • The functional requirements of the system have been broken down into two major sub-categories • Operating the WGMS • This includes daily operation of the system and is mainly concerned with the actual process of taking, communicating, and storing the data • The WGM, the BS, and the Hub, combined with the inter-device communication comprise the operation • Maintaining the WGMS • This includes aspects not directly related to the day to day operation of the WGMS, but those aspects required to keep the WGMS in working order • Battery life and fault handling comprise the majority of the maintenance

14. WGMS Functional AllocationOperating the WGMS • The major functions pertaining to operating the system include • The WGM taking glucose measurements • The WGM communicating the glucose measurements to the BS • The BS will process and analyze the data, checking for data validity, creating a local copy of the data for user reviewing, and format the data to be sent to the Hub • The Hub will receive data sent from the BS • The Hub will then analyze the data for potentially dangerous conditions, evaluate the severity of the risk, and take appropriate actions • The Hub will also store data for later viewing by either the patient, or another authorized person

15. Functional AllocationMaintaining the WGMS • The major functions pertaining to maintaining the WGMS system include • Monitoring the battery level in both the WGM and the BS • The user will be able to determine when a charging of batteries is necessary • Both the WGM and the BS will be charged from AC/DC converters • If the WGM/BS enters a failure state, the user will be prompted to reboot the WGM/BS to clear the error • If failure state is not resolved, the vendor will be contacted for further assistance • Possible failure states that the user may encounter and could be cleared by rebooting include • Component Failure • Communications Failure • Database Failure

16. FFBD for Operating the System

17. FFBD for Maintaining the System

18. FFBD for Maintaining the System Detail View of Communication Failure

19. WGM Overview • One wristwatch monitor per patient, number of units in field dependent on quantity of sales • Can be store bought or purchased online and delivered via mail or package service. • Requires minimal setup by patient, setup could be instruction or video guided. • Operational anywhere environmental conditions permit, typically location would be limited to the patient’s environmental compatibility, not the monitor unit. • Monitor could be worn continuously by patient during sleep, bathing etc. patient would only take unit off at their discretion and for charging.

20. WGM Major Requirements • The WGM shall non-invasively take a patient’s blood glucose reading every fifteen seconds and display the results on the screen • The WGM shall transmit the stored blood glucose readings to the BS every sixty seconds • The WGM shall provide readings that meet and exceed the regulations outlined by the FDA • The WGM shall alert the user when a measurement taken falls outside of the acceptable range • The WGM shall have an availability of greater than 99.73%, a MTBF of greater than 43,800 hours, and a MTBM of greater than 13,140 hours • The WGM shall meet all WGMS environmental requirements • The WGM shall be sized to fit the 5-95 percentile male and female

21. Base Station Overview • One base station per patient, number of units in field equal to number of wristwatch monitors. • Can be store bought or purchased online and delivered via mail or package service, typically packaged with wristwatch monitor device. • Minimal patient setup. • Operational anywhere environmental conditions permit, typically location would be limited to the patient’s environmental compatibility, not the monitor unit. • While out of ones home, base station could be worn on clothing similar to pager or cellular phone, or in a purse, handbag, or waist pack. • While in home or in constant occupancy location, base station could be placed anywhere up to 10 [m] or 30 [ft] from patient. • Base station will be operational anywhere standard cellular phone networks operate (very good current national coverage and rapidly growing)

22. BS Major Requirements • The BS shall receive the most current measurement from the WGM and store it in internal memory • The BS shall send formatted data to the hub every 15 minutes • The BS shall be no more than ½”x1½”x2½” in size and no more than four ounces in weight • The WGM shall have an availability of greater than 99.80% and a MTBF of greater than 2,000 hours, and a MTBM of greater than 500 hours • The BS shall meet all WGMS environmental requirements • The BS shall be able to receive firmware upgrades

23. Hub Subsystem • The Hub subsystem is responsible for permanently archiving each user’s glucose data and providing a means for remote data viewing via the Internet. • The Hub consists of a web server, a secured database, and a secured dynamically created webpage. • The Hub will be located in a centralized location and can be scaled based on need.

24. Web Server • Server will have ample storage capacity for initial system deployment. • Server will be secured physically and use state of the art network security protocols. • Server will run a Linux OS with an Oracle 10g database. • Server will run the WGMS webpage.

25. Database • Oracle 10g Enterprise Edition offers Enterprise-class performance, scalability and reliability. • Oracle offers security and easily interfaces with web applications. • Oracle offers secured database backup options which easily integrate into the system.

26. Personalized Website • User customizable web interface. • Login secured by Account Number and Password. • Glucose data viewable in graphic or tabular form. • Account preferences give options to allow data sharing, alternate users and more.

27. System Maintenance • User level maintenance limited to proper care, cleaning, and recharging. • Automatic system maintenance includes rebooting of system components, predetermined calibration routines, low battery alarm, or gross system failure alarm. • General system maintenance includes upkeep of hub resources including staff, facilities, and servers

28. Initial Deployment Scheme • Initial deployment of the WGMS system will be limited to approximately five-hundred patients located within a populous city • Each patient will be equipped with one wristwatch monitor and one base station • A hub local to this city will provide service to the initial deployment group • This initial deployment will allow the design team to closely monitor any potential problems. • After a pre-determined evaluation period, any pertinent design or system changes will be made, and the new system will be scaled up to meet the need of the market

29. Conclusion • In conclusion, we wish to bring online a Wireless Glucose Monitoring System that would require minimum patient input and maintainability, and would free patients from painful self testing. Unlike self testing, if patients reached a critical state, they would be made aware of the results instantly, and should their blood glucose level not improve, medical assistance could be summoned.

30. Conclusion • Market research shows there is a large open section of the market that would take advantage of this service were it easy and cost effective.

31. Questions?