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

Wireless Glucose Monitoring System

Erin Loutzenhiser, Dan Lopez, Matt Crooks, Matt Schultheis, Mihai Petrescu

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.

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.

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

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.

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

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

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

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

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

Proposed Solution

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.

The Wireless Glucose Monitoring SystemThe Wireless Glucose Monitoring System

Wireless Glucose Monitoring System

Wristwatch Glucose 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

“Cellular Network”

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

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

Functional Allocation Maintaining 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

4.1 WatchOperations

4.2CommunicateData to Base

4.3 BaseOperations

4.4Commuicate

to Hub

4.5 HubOperations

4.1.1 Takeglucose

measurement

4.1.2 Displaythe testresults

4.2.1 Establishcommunication

4.2.2 Transmitdata

4.3.1 Receivedata

4.3.2 Performcalculations

4.4.1 Establishcommunication

4.4.2 Transmitdata

4.3.3 Savedata

4.5.1 Receivedata

4.5.2 Performcalculations

4.5.3 Savedata

4.5.4 Displaydata

FFBD for Operating

the System

5.0Maintain &

Support System

5.1Battery Low /

Failure

5.2Component

Failure

5.3Communications

Failure

5.4Database Failure

OR

Ref.

FFBD for Maintaining the System

5.3Communications

Failure

5.3.1Wrist Watch to

Base Unit

5.3.2Base Unit to Hub

OR

5.3.2.1User will toggle transmitter ON/

OFF switch

5.3.2.3User will contact support staff at

Hub for assistance

5.3.2.2User will reboot

base unit

Ref.

5.3.1.1User will reboot

the watch

5.3.1.2User will reboot

the base unit

If necessary5.3.1.3

User will contact vendor for assistance

If necessary

If necessary If necessary

FFBD for Maintaining the System

Detail View of Communication Failure

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.

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

WGM Major Requirements

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)

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

BS Major Requirements

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.

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.

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.

Personalized Website

Glucose Levels (24 Hour)

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.

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

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

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.

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.

Questions?