Non-Invasive Monitoring and Real-Time Data Logging, Archiving, and Research Networking for Type I Diabetics
DESIGNERS: Boris A. Vassilev (301) 760 - 6224

Michael T. Willems (240) 475 - 6908

PROPOSAL Social networking moguls such as Brad Greenspan and Mark Zuckerberg have long realized the profitability of personalized Internet data storage, but the Internet's potential for research data management has remained largely untapped. The field of bioinformatics has begun to exploit the powers of the Internet for global data transfer and statistical collaboration on molecular biology, and there have been efforts to arrange information sharing between hospitals and research centers, but never has this functionality been extended to patients on the individual level. Furthermore, previous networking efforts have never been applied directly to research, only to comparison of results. The proposed system, glycoLINK integrate diabetes data collection, on a personal basis, with existing networking technology to provide a massive new resource for diabetes research and support. Additionally, by providing patients with instantaneous feedback about their condition and access to a readily available source of help and information, the risks and difficulties of mild and serious glycemic imbalances will be greatly offset. Finally, the long term impact of the resulting dataset, cross-referenceable with unprecedented specificity to environmental and behavioral conditions, will provide invaluable insight into the causes and trends of diabetic symptoms, pushing us forward towards a cure. FORM The described capabilities require a markedly improved method and device for gathering and storing biological information. glycoLINK houses all the necessary physical components in a convenient, comfortable and stylish armband which replaces the entire glucose monitoring system except for the mechanical aspects of the pump, the shape restriction and size of which is significantly reduced by housing its user-interface components in the armband. The armband will communicate wirelessly with the pump and with any mobile phone, and vital data will be instantly reported via a customizable mobile software interface. All biological measures are performed by the arm band, and communication with the patient is handled entirely through their cell phone or PDA, which already contains a convenient source of computing power. The mobile device then transmits all collected data via the Internet, or the device's mobile carrier data link, to the user's personal health record on a private remote server, where the patient's data is securely archived and associated with the local environmental conditions at the time and place where the reading was reported. The patient can then access this information with a password from any Internet connection, and see the correlations between all reported behavioral, biological, and environmental readings. With the patient's permission, this data will be anonymously included along with demographical information in the largest pool of research-grade data on diabetes ever assembled. TECHNOLOGY Incredibly, all of the technologies necessary to assemble this system already exist, although they must be tailored for this application. Some of the most recent and novel technologies that will be applied are Mid-Infrared Spectroscopy monitoring of blood glucose levels (BGL's), stretchable single-crystalline silicon logical chips, Bluetooth and WAP wireless protocols, and web-based access to localized weather and dynamic environmental factor readings. Combined, these technologies will not only yield powerful statistical information, but will ease the discomfort, hassle, and uncertainty associated with the treatment of type I diabetes. This technology will be explained in greater detail along with the specific description of its use in the following sections. MONITORING Clearly, the most important function of glycoLINK is to monitor glucose levels. The armband will do this continuously, as many transdermal devices currently do. However, this system will not involve any transdermal components, and readings other than BGL's will also be collected by the armband unit, including body temperature, blood pressure, and heart-rate. All of these readings are taken automatically and non-invasively by the armband unit. The armband uses Bluetooth technology to wirelessly report glucose levels to the patient's mobile device, which can display the data and, using a simple application or slightly modified firmware, create custom profiles for alerting the patient of any abnormalities in blood sugar levels. This will allow patients to customize their alerts to their surroundings just as ringer profiles can be modified. This means that alarms and alerts can become silent in libraries, or set to be extra loud at a sporting event. Furthermore, a patient's condition is kept relatively private, because only a phone has to be checked. Basal rates and physical activities (such as eating) can be logged in an integrated planner, as well as the amounts and effects of previous boluses. Perhaps most importantly, in particularly serious cases where BGL's can very quickly go awry, the phone can automatically request emergency medical attention if it does not receive a response from the patient following an alert.

A small Bluetooth unit, or a more-compact, application-specific interface will be integrated into the pump unit. Without having to contain any user interface, now located on the armband unit, the pump can be smaller and lighter, and unlike pumps with self-contained interfaces, it could be stored in a places that are not readily accessible, or even at the injection site. This would decrease the need for extra tubing and practically eliminate the problem of kinks and tangles. Finally, the shape and structure of the pump itself will not be constricted by the necessity for a screen or buttons, allowing for flexibility in its design. CONSTRUCTION According to the MIT Technology Review, researchers at the University of Illinois at Urbana-Champaign have been able to create thin, flexible, and stretchable silicon-based circuits with performance matching that of rigid semiconductors1. While flexible circuits in the form of organic semiconductors have been around for several years, their speed made them impractical for serious computing. By contrast, this new technology can be used to yield powerful computing even in atypical geometries. The armband will be constructed of breathable and hypoallergenic lycra material impregnated with bands of these flexible circuits. The small batteries will be stored in a pouch on the outside of the armband, and can be replaced with easy access. The band will be worn around the upper arm, where a high density of blood vessels exists very close to the surface of the skin. Because of this positioning and because of the armband's elastic nature, another integrated band, located close to the elbow, will be able to take pulse and blood pressure readings in much the way a standard cuff would. Notably, the electronics could be removed from the armband to make it washable. Glucose and temperature readings will be performed with active IR sensors, placed at intervals on the inside of the armband for increased accuracy of multiple readings. Glucose levels will be taken using attenuated total reflection infrared spectroscopy (ATR), which uses active sensing to infer BGL directly from the skin's surface, and works well on areas with relatively thin skin, such as the inside of the upper arm2. This method uses signal-to-noise ratio to detect the IR signatures of glucose in the skin. The same infrared sensors can also be used to detect absolute heat, not just relative signals. Thus, temperature readings can also be taken with the same elements. These elements are relatively small, and could easily be connected to the circuit without any noticeable obtrusion. DATA COLLECTION Environmental factors are known to affect many aspects of health and disease, and diabetes is no exception. Especially in immune-mediated type I diabetes, where autoimmune response is a key player in the appearance of symptoms, environmental conditions such as temperature, air quality, pollen count, and humidity can all affect one's health and BGL3, 4. Fortunately, the National Weather Service collects hourly data of all these counts. By logging the location of the cellular broadcast tower that transmits the phone signal, or through built-in GPS modules as are present in many modern cellular devices, and storing the NWS's reported current conditions for that area, any reported biological readings can be cross-referenced and stored with the conditions where the reading was taken, as well as any personal factors that could contribute to diabetic symptoms, such as weight, age, height, ethnicity, etc. Any WAP-equipped phone (nearly all mobile phones are) can access the primary remote server once registered to the patient. For all the data that is submitted to the anonymized research pool, the public statistics and datasets could be accessed by research institutions across the globe, and used to formulate and support hypothesis and proposed treatment variations. There are several important advantages to this style of data collection over methods of conventional research. The first is that it is no hassle for researchers or patients. Once a patient agrees to be included in the public data pool, all readings will be reported automatically, and without effort. Another advantage is that the cost of controlled research is high, and cannot always simulate real conditions well. This data will provide accurate information on patients in real-life situations, and will require no expensive experimental or observational constructs. Most importantly, the number of data elements will be much greater than that of any private study because of the number of participants and because of the sheer frequency of the data collected. Readings can be reported daily or hourly over years, very quickly building a huge statistical base. One downside of constant data reporting is that it requires a mobile plan that includes internet access, which usually costs extra to the consumer. It is very cheap however, for mobile service providers to simply not disable WAL functionality and supporting type I diabetics with free or subsidized internet components of their wireless plans would be a great PR booster for service providers. Additionally, some of the research funding for diabetes could be redirected into this subsidization, which would replace other research expenditures, thereby eliminating any extra cost for the patient.

ARCHIVING Collected data will be stored on a central server, or many, which could also be provided by any corporation looking to improve their image. The staggering amount of data collected will pile up very quickly, so the data could be archived in a time-collapsing fashion. As such, data would get compiled into averages as time goes on. For example, hourly data points from the last week will be stored intact, while only daily averages for the past month are stored, monthly for the past year, and so on. Since the data will already be compiled into global statistical data, stored separately, no further retention is necessary. Alternatively, the data points could be kept intact at the cost of server space, but with the benefit of ability to incorporate new or outside measures into the comparison after inception. Another way to minimize memory usage is to combine all conditions as aspects of a single data element, referenced by time. NETWORKING An important aspect of this reporting would be the ability to network with other diabetics. While support groups exist, even online, the global reach and access of the data set will link patients to a myriad of experts and researchers that may be able to help their particular situation. This would also allow for integration with online support groups and encourage knowledge sharing by its principle. This networking will also provide diabetics and researchers with a feeling of unity and mutual contribution. Indeed, it will allow every diabetic the opportunity to impact, in a very real way, the battle against their disease. IMPACT The amount of data that will be collected via the outlined means, using our proposed device, will quickly become the world's single largest database of diabetic patient logs. By analyzing correlations between environmental and bodily conditions, this network should provide a huge collection of clues about how diabetics can further improve their health through their lifestyles. It's public nature will allow researchers to independently analyze the data for correlations that could lead to insight about the specific causes of diabetes. Additionally, if patients will use their phones to log activities and medications, the medical industry will have great motivation for supporting this effort financially, as it will provide unbiased, reliable, and free data on the effectiveness of their products. Likewise, people with diabetes, and their doctors, will be privy to unbiased statistics on the effectiveness of drugs while investigating treatment options. Even simple implementation of the glycoLINK meter device will greatly reduce the pain and hassle of living with diabetes, while contributing to a stylized and consumerdriven range of products. The most novel and significant part of this proposal is that its realization will open communication between researchers, device suppliers, and patients; its very concept revolves around that communication. SOURCES 1) 2) United States Patent #6424849 : Self-contained method for determining blood glucose levels from an IR beam reflected from the surface of the skin 3) 4)

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