By Ambika Polavarapu, Suhani Kollisetty, Arushi Sood
Type-1 diabetes is a national epidemic, with almost 1.25 million Americans suffering from this disease, and almost 40,000 people diagnosed every year. This number increases to 25,000,000 patients worldwide. Diabetes can result in several health complications, which include: vision loss, kidney failure, impaired sensation in hands and feet, digestive problems, high blood pressure, etc. Additionally, according to the American Diabetes Association, diabetes is the seventh leading cause of death, and the total cost of diagnosed diabetes in the US was $327 billion (Timmons, 2018).
Patients with type 1 diabetes cannot produce any insulin because their islet cells do not function properly. Islet cells are found in the pancreas, where they are responsible for making the hormone insulin. Insulin is essential for the human body because it regulates the amount of glucose, a type of sugar that provides cells with energy, in the blood. The most common form of treatment for diabetics is insulin injections. However, this treatment is very expensive and tedious.
Another form of treatment is islet cell transplants. Through this treatment, healthy islet cells from a donor are transplanted into a patient’s portal vein. These transplanted islet cells perform in place of the destroyed islet cells in a patient’s pancreas by producing the insulin that the patient cannot. However, there are some limitations to this form of treatment.
According to a study by USCF, islet cell transplants are very expensive with a cost of approximately $20,000. There are also some important health risks, such as bleeding of the liver, clotting in the liver vein, and liver infections. In addition, patients are at a higher risk of contracting other infections because of immunosuppressants used to block the immune system from attacking the new islet cells. Another major limitation of these transplants is the shortage of donor islet cells. Transplants need 10,000 islet cells per kilogram of bodyweight, which can be very hard to obtain.
These limitations can be harmful to the patients, and if any error occurs, then there can be dire consequences. Due to these risks, it is important to remove these limitations in order to make sure the patient is safe and is at a lower risk level. Although it is difficult to tackle all these limitations at once, it is possible to solve them separately. Our solution proposes to help fix the shortage of donor islet cells by releasing enough insulin to bridge the gap between how much insulin the islet cells make and how much the body needs.
Our solution is to insert a device alongside the portal vein in order to release additional insulin if there is a shortage of insulin from a lack of substantial islet cells. The device will release a certain amount of insulin when a secondary external device controlled by the patient detects an unhealthy amount of sugar in the blood. Blood glucose monitors are commonly used by diabetic patients. They detect blood glucose levels by examining small amounts of blood taken from the finger, which is very similar to our secondary device.
However, our secondary device will be connected to the internal device which releases the insulin. High frequency sound waves and detection will be used to communicate with the internal device. When the internal device is activated, it will begin releasing insulin proportionate to the patient’s body weight. The total daily dose of insulin is 0.3 units per kilogram of the patient’s body weight. Each device is filled with a specific amount of insulin for the patient based on their weight. The internal device will be made from polyethylene due to the fact that it does not degrade in the body.
One limitation is that this solution can be risky because in order to insert our device, the patient will have to undergo surgery. This makes it more invasive compared to islet cell transplants with a catheter. However, our device is extremely small compared to others. Therefore, the area of surgery will be of a smaller size than usual incision sites. Not only does this make this treatment less complicated, but it also ensures that the surgery will be quicker and at a lower cost.
Another limitation of this solution is that it will require extra work to be put into the process along with the need for advanced technology. While having advanced technology is beneficial to doctors and nurses, this treatment fully depends on the technology itself. Although the technology is advanced, the treatment itself is not as complicated. The internal device uses simple diffusion to release insulin. Additionally, the two devices working together is not complicated because there is a simple, non harmful connection through high frequency sound waves.
One of our group members asked Ms. Michelle, a teacher and former microbiologist, from the Hudson Montessori School about her opinion on the insulin pump. She said that the solution showed great promise and that she had been researching to see if there are any similar products to help us learn from their experiences. She recommended articles to help with our solution, one of which mentioned an implantable insulin pump similar to ours.
Unfortunately, with less than 500 people with an insulin pump worldwide, it is not widely used and remains unsupported in nations like the US. Although our solution is similar to the insulin pump, we are positive that it will gain a better reputation around the world and will prove to be the most effective. Our feedback overall has been very positive. Mr. Kollisetty, who is a pharmacist assistant from New York, has stated that our idea is creative. He says that not only is our solution simple and sweet, it is also an advancement in medicine. He does have a concern about refilling the device with insulin and how often it would happen, but our solution to this is to refill the device with an IV every month. Our response to the concern is to refill the device with an IV every month. We know that having surgery done every month to get the device out and refill it is tedious so we would just connect an IV to the device and pump in 52 mg into the device every month. But overall, he approves the idea and believes that our new version of insulin production for those with diabetes might be successful and a great help in the future.
This addition has caused us to make an adjustment to our final solution. Instead of having the device placed deeper into the patient’s body, we would have to keep it near the surface of the patient’s body. This way, connecting the device to the IV would be easier.
Our experiment involves 50 human subjects in order to get a more precise and accurate result of the efficiency of the insulin device. The subjects would be type-1 diabetics from 30 to 40 years old. The subjects will be randomly assigned to two groups - 25 subjects with the device and 25 subjects taking the standard insulin injection. Those with the device will be in the experimental group and those who are using their normal medication will be in the control group. We will have the patients eat their normal diet, and monitor the blood glucose levels directly after they eat. The experimental group will use the secondary device to track the blood glucose levels. The control group will inject the insulin themselves, while the experimental group will have the internal device release the insulin based on the signal from the secondary device. After 2 hours, the patient’s blood glucose level will be measured once again. This experiment will last for four weeks to ensure replication and accurate results.
Our solution follows ethics because we are not intentionally harming anyone through the testing process. We are being completely honest with our idea and this proposal is only to help anyone with a lack of insulin and is undergoing islet cell transplantation. All testing would be done with consent from the patient during human testing.
The medical industry is filled with advanced technology and it is constantly improving. Although there are some great methods of treatment, there are also so many upgrades to be done. Many victims of diabetes use insulin injections to maintain a regular amount of glucose in their body. However, this common treatment is not efficient, thus our solution will tremendously help the medical industry, providing patients with an upgraded and refined way of tending to diabetes. Novo Nordisk A/S , Julphar, Eli Lilly and Company are key players in the insulin market. Lantus, Sitagliptin, Levemir, Humalog & Novolog are some brands that have had high sales in the market, making them our competitors. Although insulin injections are the most reliable at the moment, it is essential to continue generating innovative improvements to existing products. .Many children with diabetes have to keep track of their glucose levels, which is difficult for their age, and insulin injections can have several side effects. Severe side effects that may not go away include itching, redness, and swelling at the injection site. The quicker, less time-consuming, and efficient version of taking in insulin is our insulin device.
The Digestive Process: What Is the Role of Your Pancreas in Digestion? (n.d.). Retrieved December 10, 2020, from https://www.hopkinsmedicine.org/health/conditions-and-diseases/the-digestive-process-what-is-the-role-of-your-pancreas-in-digestion
Hyperarts, R. (n.d.). Islet Transplant for Type 1 Diabetes. Retrieved December 10, 2020, from https://transplantsurgery.ucsf.edu/conditions--procedures/islet-transplant-for-type-1-diabetes.aspx
Islet Cell Transplant. (2020, May 20). Retrieved December 10, 2020, from https://medlineplus.gov/isletcelltransplantation.html
Kelly, J. (2014, August 01). Continuous Insulin Infusion: When, Where, and How? Retrieved December 10, 2020, from https://spectrum.diabetesjournals.org/content/27/3/218
Pancreatic Islet Transplantation. (2018, October 01). Retrieved December 10, 2020, from https://www.niddk.nih.gov/health-information/diabetes/overview/insulin-medicines-treatments/pancreatic-islet-transplantation
University of Wisconsin Hospitals and Clinics Authority. (n.d.). Islet Cell Transplantation Benefits and Risks. Retrieved December 10, 2020, from https://www.uwhealth.org/transplant/islet-cell-transplantation-benefits-and-risks/12631