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IBCR:Internal Beta Cell RegulatorIshan Vaish, Sneha Kadiyala, Shirin Kuppusamy, and Suma YarabarlaNorthview High SchoolAbstract:Diabetes is a problem raging across America. Studies show that over 14 million people have some form of diabetes. Out of this 14 million, 3 million have Type 1 diabetes, and the IBCR will help to solve and cure this problem. The IBCR will be placed on the pancreas through Laparoscopy, a safe and secure method of surgery. The IBCR relies on genetically modified DNA and a Bluetooth encrypted with a filter that senses the production and growth of B-Cells. The DNA solely affects B-cells changing their genetic structure allowing them to go undetected; the Bluetooth will stay implanted in the pancreas and will regularly update both the doctor and the patient, through an app, on the efficiency and normalcy of the protected B-Cells.Present TechnologyDiabetic patients can currently use many different monitoring techniques, including insulin injections and glucose sensors. The glucose monitor reads glucose levels in the patient’s blood through manual pricking of one’s finger. Using these readings, daily injections or continuous infusion of insulin with a pump through needles under the skin (“JDRF”, 2014). Most of the other offered present technologies are variations of these methods. Auto injectors, for example, are types of insulin injectors. They automatically deliver the correct amount of insulin instead of requiring manual injections (“Epipen”, 2014). Another way to control blood sugar that isn’t as dependable is through food. These boost foods often do not reach the patient fast enough in emergencies (“The Facts”, 2014).Another current technology relevant to the IBCR is the pacemaker (“The Facts”, 2014). Pacemakers are small in size, and they function using an intricate system of wires and a generator controlled by an external computer (Sunil, 2013). They have the ability to monitor factors such as blood temperature as well as the patient’s heart rate offering a valuable input to the doctor ("What Is a Pacemaker?", 2012).Apps, a simple way for people to access information, will influence the IBCR. For diabetics, apps can reduce the strain of constant doctor visits as well as other unavoidable nuisances (Sunil, 2013). Mint, a financial app, syncs with the client’s finances providing easy access to bank statements and programs simplifying budgeting ("BE GOOD WITH YOUR MONEY", 2014). Fitbit, an app linked to an actual device, is used to monitor the client’s sleep, diet, and exercise guiding the client to a healthier lifestyle. Apps are a useful modern technology that would be a beneficial addition to the medical community closing the gap between the patient and the doctor ("There's a Fitbit product for everyone", 2014).Surgical development can significantly decrease the duration of surgery and recovery. Pancreatic laparoscopic surgery is a recent surgical development that has many benefits including higher success rates. Because the procedure for the IBCR does not require the replacement of the entire pancreas, success rates will be even higher than the current 85% (“Pancreas Transplant”, 2014). Shorter surgeries also lead to faster recovery to optimal health (“What is Laparoscopic Surgery”, 2002). Laparoscopic or minimally invasive surgery is a specialized technique because it uses several 0.5-1cm incisions. The entire body is not cut open, and often, the surgeons only use tools to complete the surgeries. Therefore, this method will be optimal for inserting a small device to attach onto the pancreas as it inflicts less harm than traditional surgical methods (“Laparoscopic Surgery”, 2012)The principles behind the MDLAP system, which is “a full closed-loop system (i.e., insulin is administered according to the glucose readings in a fully automated manner)”, may also be used in our proposed technology. Since the MDLAP system is centered around the “individual patient's treatment management, which includes the patient's physical characteristics, insulin delivery regimen (insulin basal plan and insulin correction factor), and insulin pharmacodynamics parameters”, this method is highly effective and efficient (“MD-Logic”, 2014). This is possible because the MDLAP system uses a traditional linear control theory depending on mathematical models of glucose-insulin dynamics to function. (Hann et al., 2004). The model integrates two time-varying patient specific parameters for glucose effectiveness and insulin sensitivity; this is mathematically reformulated in terms of integrals enabling a novel method for the identification of the patient’s specific parameters. Therefore, the theories and principles used to develop the MDLAP system can also be used in future technologies (Atlas et al., 2010).Currently, a team lead by scientist, John Rogers, has developed a new technology that can completely biodegrade in water or in the body. Their technology is based off the use of silicon in conjunction with Magnesium ( HYPERLINK "" \l "auth-1" Bourzac, 2012). Since Silicon is “a common trace element in humans”, Silicon is ideal for internal use (Park, 2009). In addition, the silicon can dissolve in water at a faster rate than other metals because it is less than 100 nanometers thick and dissolves at a rate of 4.5 nanometers per day. The magnesium is used for the wiring connection because it is conductive but reactive, especially when wet. By combining Silicon Electronics principles and the principles behind Omenetto’s tough, biocompatible silk, Rogers and his team were able to create this technology ( HYPERLINK "" \l "auth-1" Bourzac, 2012). Since the silicon can be used in an “implantable [device] that function[s] for medically useful time frames but then completely disappear[s] via resorption by the body”, the IBCR’s capsule can potentially function using the same principle (Huang, 2012). Another important technology for the IBCR is modifying the genetic code. Since the IBCR cures the beta cell by altering its DNA to protect it from an immune system attack, this is crucial to the IBCR. (Bourzac, 2012) Currently, genetic engineering is “physically removing a gene from one organism and inserting it into another, giving it the ability to express the trait encoded by that gene.” () For example, if DNA coding for an ear is taken and implanted in a mouse, the ear can be grown on the mouse (Huang, 2012) Using this technique, DNA from a different bacteria could alter the beta cell just enough to disguise it without hindering the function of the cell. HistoryGlucose testing was established in the mid 1800’s when sugar levels were extracted from urine. While time consuming and impractical, this system initiated diabetes research. After a hundred years, Anton Clemens at the Ames Research Division in Elkhart, Indiana created the first blood glucose meter composed of chemical strips with reflectance photometry to measure blood glucose using dry chemistry (Nugent, 2015). By the late 1980’s and mid 1990’s the first, self-monitoring meters were created. They were more precise and stored results in their memory, and they all had built-in USB ports. Using the same base concept, today’s glucose monitors can be connected to smartphones and gadgets (Bigelow, 2012). Most recently, an external patch like device has been created that will constantly monitor and regulate sugar levels of a person. (Continuous Glucose Monitoring, 2013). Another important component of the IBCR is the Bluetooth inside the dissolvable capsule. Invented in 1994 by Ericsson Mobile Communications, the Bluetooth was originally designed, “to investigate the feasibility of a low-power, low-cost radio interface between mobile phones and their accessories” (History of Bluetooth, 2015). Intel, Nokia, Motorola, IBM and Toshiba invested in the Bluetooth Special Interest Group in 1998. In the 2000s, the project became more widespread. Originally enabled as a head set, Bluetooth Technology shrank in size connecting and synchronizing data. Sending and receiving information became simpler and faster. People now use wireless printing and music streaming from phones to speakers (Mary, 2012). In recent years, Bluetooth technology has gradually spread into the medical sector, enabling doctors to monitor the daily lifestyle of the patient for asthma, blood sugar, activity, and temperature. By reviewing live data and information streams, doctors have an in-depth and unique look at patients’ lives (Akpakpan, 2013). In addition, the Pacemaker was designed in 1932 by Albert Hyman to monitor heart waves. Albert Hyman noticed that injections and medications dealing with the heart were risky and at times fatal. However, the Pacemaker’s internal structure, constant monitoring, and action behavior made it safer and more reliable (Mohee, 2015). 20 years later, the first clinical application of the Pacemaker took place and led to further devolvement of the pacemaker. In 1950, a stronger pulse generator was added to the heart, and the size of a Pacemaker was reduced to the size of a cigarette box. In 1970, lithium batteries successfully led to a longer and more resistant pacemaker (Pacemaker, 2015). Current Pacemakers offer a wide variety of features and are significantly more effective, resulting in low mortality rates (Pacemaker, 1998). Another important feature, Laparoscopic surgery was first developed in the late 18th to early 19th century (Mishra, 2011). No one knows who first used Laparoscopy, but the first reported and successful operation was Dr. Kelling’s examination on a dog’s abdominal cavity. In 1910, Doctor Jakobeus successfully operated on person and officially dubbed this form of surgery as Laparoscopy. Ten years later, Yanosh Veresh created a safe and more efficient needle. Over the next 30 years, the form of surgery was further refined and became increasingly popular (Spaner, 1997). Currently, Laparoscopy is most commonly used for kidney operations and gynecology cases (Laparoscopy Surgery, 2015). The closed loop system is significantly different from the open looped system because the open loop system was problematic and inefficient ("Closed-loop System and Closed-loop Control Systems", 2013). The producers made a self-adjusting system and designed it to maintain the output condition by comparing it to the real condition. This made the system more versatile ("Open Loop vs. Closed Loop", 2014). The designers also enabled a stabilizing feature incase problems arose. The closed loop system receives feedback and transmits information both ways, instead of only one way (Closed-Loop Control System, 2006).Treating diabetes using crude drugs was created in 1955 (Dean, 2004). In addition, people began to develop transplants for the pancreas; the first successful pancreas transplant occurred in a University of Minnesota Hospital in 1966 (“Diabetes History”, 2014). In 1976, the first insulin pump was invented. In 1978, scientists created insulin identical to E. coli bacteria’s natural insulin as an alternative for diabetics. Though diabetes has been growing, people are currently trying to help decrease diabetes diagnoses (Dean, 2004). Many people in the modern society can avoid getting diabetes with the help of current technologies (“History of Diabetes”, 2014). The IBCR requires a biodegradable capsule to function. At first, scientists were only aware of naturally biodegrading, such as fruits skins. Later, scientists discovered that even plastic bags and metal can biodegrade in two to three years ("Measuring biodegradability", 2008). This then spurred the idea of making medicinal technology from various biodegradable metals to use in the body. Though they were unable to find one material with all of the required properties, many metals fit some of the requirements. For example, Tin has low toxicity levels and is highly malleable and ductile. However, it is too soft for surgery. By combining Tin with Aluminum or other harder metals, they figured a stable metal could be created ("The Element Tin", 2014). Unfortunately, metals, such as Tin and Aluminum, take 50-100 years to biodegrade ("Measuring biodegradability", 2008). This would defeat the purpose of a biodegradable capsule. Luckily, Rogers’ discovered that Silicon can be used instead. Rogers’ team combined a Silicon structure with Copper or Silver electronics to build a biodegradable device. However, the Copper and Silver left chunks of metal in the body. Therefore, they continued to research until they found the present day solution ( HYPERLINK "" \l "auth-1" Bourzac, 2012). Future Technology:The IBCR is a microscopic, circular device (approximately 150 nm in diameter) that is attached to the diabetic’s pancreas, similar to a glucose monitor (Molecules to the Max, 2012). However, the IBCR will do more than monitor blood sugar levels. The IBCR has two parts: a biodegradable capsule containing a blood glucose and insulin monitor, and nanotechnology that will disguise B-cells from any future attacks. Beta cells create insulin. When they fail to work, a person is diagnosed with type 1 diabetes, and the B-cells are attacked by the person’s own immune system. If the B- cells are genetically altered, the immune system will not recognize them as a threat, thus curing the person of diabetes. The nanotechnology we designed uses the atomic layer deposition technique to create a thin layer of an altered strain of B-cells to protect the B-cells from attack. The atomic layer deposition uses a controlled chemical reaction that creates an accurate, microscopic layer. The layer will also contain the altered strain’s DNA to regenerate the B- cells before protecting them. This technique is already implemented by HIV.In HIV/AIDS cells, the virus stores pockets of genetically altered HIV to protect it from complete eradication if the person is taking HIV medication. The F1 generation of B-cells after treatment will still be coated with the layer, in the F2 generation, the cell’s DNA will combine/mutate preventing any further requirements. It will be a one-time operation with a life-time cure. However, in case of volatile reaction, a backup mechanism is provided. After the nanotechnology cures the patient, the monitor ensures a permanent solution. After B- cell regeneration recovery, insulin levels will fluctuate leaving old doses irrelevant. The monitor in the IBCR will determine the amount of insulin needed. This routine is a stress free method which decreases chances of incorrect insulin dosage. The monitor will use a closed-loop system instead of the open-loop system of many current technologies. Open-loop systems have to be monitored continuously and closely to glean information from them. The closed-loop system automatically monitors glucose levels allowing its inputs and outputs of insulin to be continuous increasing the IBCR’s potential. It will require less human maintenance thus being more convenient for the diabetic. It also reduces error risks associated with manual operation making the entire process of maintaining insulin levels more efficient (Klonoff, 2007)Finally, a Bluetooth connected to the IBCR will transmit data to an app on most smart devices and computers. It will regulate and monitor the patient’s diet and sugar intake as well as prevent confusion on timings. Every time an influx or decrease in sugar levels is detected, the data will be sent directly to the patient and doctor. The doctor will receive the data through a system that will link to each patients' app. All records will be confidential from unauthorized personnel. Doctors will now have the ability to monitor the patient’s diet and sugar intake revolutionizing the doctor-patient relationship.Breakthroughs:A completely biodegradable capsule that can release the DNA layer without causing any adverse reactions is necessary (Autran et al., 1997). The material will have to be sturdy enough to last surgery but thin enough to fully deteriorate without affecting body parts and their functions (Staff, 2014). In addition, the material will have to quickly biodegrade to prove effective. By following the principles behind Rogers’ biodegradable technology, this can potentially exist. However, the struggle is to determine how thick the Silicon needs to be in order to properly release the DNA and biodegrade without breaking during surgery. Rogers says, “The team can control the degradation of the devices by tuning the properties of the silk, and by changing the thickness of the silicon and other materials.” Therefore, if the appropriate thickness is found, this breakthrough can be achieved. This new design will then prevent the patient from feeling discomfort or having to take injections and will result in biodegradability ( HYPERLINK "" \l "auth-1" Bourzac, 2012). The technology to get the DNA from outside the cell into the nucleus in a dead beta cell doesn't exist, yet. However, a base theory has been established. The artificial transformation process involves "lowering the membrane potential, which facilitated DNA to cross [the] inner membrane." The DNA will have to combine with another chemical to cross, but the cell membrane cannot break too much. After the B-cell regenerates, it still requires its cell membrane for the electron transport chain to make ATP and energy. To lower the membrane potential, a harmless ion concentration will have to increase outside the cell to allow passive transport to occur. However, the balance of the ions outside and inside the cell and the element used for the ions has not been determined yet. This task becomes even more daunting when the molecule attempting to diffuse is DNA since DNA uses RNA just to go in and out of the nucleus. The technology of moving DNA without the use of these helper cells is a major problem. Another theory of moving DNA from outside to inside the cell involves these helper cells ("Some Organisms Transmit Genetic Material to Offspring without Cell Division", 2014). The DNA will be packaged in the IBCR with another protein that could combine with the phospholipid cell membrane. This will lead to facilitated diffusion making it easier for the DNA to slip into the cell. The issue with this technique is the B-cell’s state of health (Purves, 2014). The B-cell will be “dead” when first coated with the DNA. The phospholipid membrane will not be strong enough to hold the protein without help from other molecules complicating this further. Finally, the most pressing issue regarding IBCR’s function is that the layer of DNA will have to coat the B-cells evenly and thoroughly without help. To do this, the layer will be made in the using Atomic Layer Deposition. ALD can be described as “sequential, self-limiting surface reactions [that] make alternating layers” (Gordon , 2015). It will use Layer-by-layer growth to grow a layer of conformal coating ("Atomic Layer Deposition (ALD)", 2015). The IBCR contains the modified DNA of B-cells. However, unlike in ALD, the IBCR will have to coat the cells off-site. The layer will travel inside the body within the IBCR’s capsule through Laparoscopic Surgery. After reaching the pancreas, the same principle used for the Enzyme’s lock and key model will be used here. The Lock and Key model is used to describe the relation of how specific substrates can only bind to certain active sites. For the IBCR, the layer will be created in the lab so that it can only surround Pancreatic B-cells. Therefore, once the layer reaches the Pancreas and is dispatched from the capsule, it can only surround the B-cells, ensuring full coverage (Nowicki, 2008).Design Process:Originally, replacing the whole pancreas was more attractive. However, this idea was rejected because that would result in more expense and hassle, and it would be ineffective. Making a complete pancreas would increase the per unit price as there is more mass to create. With a smaller device, the IBCR will need less resources and surgical procedures, so the cost is also less. In addition, replacing the whole pancreas is dangerous. The pancreas is surrounded by vital organs and nerves. To replace the entire pancreas, one would have to extract and replace the organ without damaging any surroundings. The smaller device will enable one to use safer surgical methods such as laparoscopy. Finally, completely replacing the pancreas is ineffective. To replace the entire pancreas, one would have to recreate B-Cells all together. Using IBCR, one simply needs to re-activate the B Cells, which can then be monitored through Bluetooth devices unlike an artificial pancreas.Another idea initially proposed was the traditional method of using pig parts to replenish the insulin supply. For the IBCR to properly function, it needs continuous insulin supply. This method would be force doctors to operate on the patient every few weeks for insulin. Partly because of its unsustainability, this idea was dropped. They would also have to constantly monitor glucose levels eliminating the benefits of a closed-loop system. The DNA will regenerate insulin supply forever by activating the B-Cells. That way, the patient will not have to undergo multiple surgeries or injections. This will lead to a stable and an easy lifestyle for the patient in comparison to using pig parts.Finally, E. coli could have been an insulin source. However, this idea was mainly rejected because it is impractical to sustain bacteria while keeping them contained. If the E. coli were not contained, then it would pose the risk of infection. However, the E.coli must be alive for the IBCR’s function. This would require feeding the E. coli, regulating temperature and pH levels, and controlling the population growth of the E. coli. Although, there is a solution to the temperature and population control, it would be extremely difficult to feed the E. coli, therefore, making this idea ineffective.ConsequencesThe device is held sturdily inside the patient requiring little patient management. This is useful for both young and elderly patients; cases of forgetting to take an insulin injection or monitor glucose levels will decrease as well. The IBCR will make sure that children can play sports without having to pause for insulin or to worry about their blood sugar level dropping.Another benefit is its effectiveness. It provides more information directly to the health care providers reducing the risk of human error. For example, currently, if the patient forgot to report a dip in blood sugar or a missed insulin treatment, the doctor would not know without a fatal occurrence taking place. With the IBCR, the doctor, patient, or guardian will be alerted instantly if any problems occur. In addition, there will be no need to measure the insulin dosages as the DNA solves the problem of insulin altogether.In addition to these benefits, the IBCR is also more affordable than other options. Only one surgery will be required. While it may be costly, it is cheaper than weekly or even daily treatments. It will also minimize costs of doctor visits as the doctor will now constantly monitor the patient’s recovery electronically. In addition, this surgery will be cost effective because it only involves small parts. Therefore, to create these parts, less material will be needed making it cheaper. In addition, mass production can increase the supply making the price affordable for all eligible patients.Finally, the biggest benefit of IBCR is that it will cure Type 1 Diabetes altogether. By regenerating B-Cells through the DNA, the insulin supply will be restored. Also, coating the B-Cells with the DNA will protect them from autoimmune responses. Therefore, the cause of Type 1 Diabetes, which is the inability to produce insulin, will be solved.However, one disadvantage is that it may be unsafe in third-world countries. In countries where there is improper sanitation, the surgery procedure may cause the patient to acquire new, fatal diseases. In addition, since IBCR uses Laparoscopic surgery, involving many small cuts, the chance of acquiring infectious diseases increases. 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