PROPOSAL Group 1: Jacob Delgado, Andre Deosaran, Brian Garcia
Diabetes is a condition in the body where the blood glucose level can become radically high. This disease affects millions of individuals in the United States and is one of the leading causes of death. Currently there is no cure for diabetes, however, there are different methods to treating and tracking this disease such as a glucometer. This proposal intends to introduce a new system that consistently records the blood glucose levels of a user referred to as the continuous glucose monitoring system. This application will revolutionize the way users can measure their blood glucose levels due to its efficiency and accessibility. Through standardized clinical trials and approved testing by the Food and Drug Administration, the continuous glucose monitoring system will soon be available for diabetic users. The initial cost of production of one continuous glucose monitoring system is estimated to be $750 with aims of working with manufacturers to bring this product to market and lower costs.
The objective of the continuous glucose monitoring system is to provide individuals with diabetes a more accessible method of tracking their glucose concentration. The continuous glucose monitoring system will offer a more efficient and alleviating practice of recording information than traditional glucometers. This system intends to reduce the amount of single use blood glucose tests diabetic users apply to themselves in exchange for a convenient and easy to navigate application from their mobile devices.
In 2018 34.2 million Americans had diabetes and every year there are about 1.5 million new diagnoses (American Diabetes Association (ADA)). In 2017 alone, there were 270,702 confirmed cases of people dying from diabetes excluding the 65% of people whose death certificate failed to indicate diabetes (ADA). Diabetes is an epidemic. We can all agree that anything that can be done to make a dent in these alarming death rates should be done immediately. Yet this is an issue that is largely ignored by society.
The most important part of a diabetics life is monitoring blood sugar levels. Ensuring that their numbers are stable and in a normal range is vital. Diabetics have to use their glucometer several times a day to check their glucose levels. Especially when eating or exercising. Eating and not properly covering for the carbohydrates you consumed with the correct amount of insulin, can lead to a spike (hyperglycemia) or drop (hypoglycemia) in blood sugar levels. When exercising if not careful, a diabetic can unknowingly experience a drop in blood sugar. Low and high blood sugar levels have harmful effects on the body. Hyperglycemia can cause several issues including cardiovascular disease, nerve damage, kidney damage, and even in some cases lead to the amputation of feet just to name a few (Mayoclinic). Hypoglycemia can lead to seizures and loss of consciousness (Mayoclinic). Both hypoglycemia and hyperglycemia are very deadly.
Knowing how deadly and damaging hypoglycemia and hyperglycemia are, we can understand the importance of diabetics keeping a close eye on their blood sugar. Another issue has been monitoring blood sugar throughout the night. How can a diabetic know if their number is too low or too high while they’re asleep. What if the person is a heavy sleeper? The solution can’t just be not to sleep. There have been several cases where diabetics actually die in their sleep because of experiencing hyper or hypo glycemia. A matter of fact studies show that almost half of all hypoglycemic episodes occur while sleeping (Johns Hopkins Medicine). The heartbreaking story of a man waking up next to his dead wife who passed in her sleep from hypoglycemia after they had just finished celebrating their anniversary, is just one of many (The Daily Mirror). Diabetics monitoring their blood glucose levels is as vital as drinking water. However, the current method of pricking your finger and using a glucometer is far too inefficient.
Using a glucometer and pricking your finger are inefficient ways to monitor blood sugar. There are too many variables that can impact the accuracy of the reading. For example test strips can be affected by heat or moisture, not enough blood being applied, and having contaminants on your hands such as oil, lotion, or food (AgaMatrix). Diabetics may also not have enough privacy to check their blood sugar like on a crowded train or other public spaces. Should diabetics have to stop enjoying a night out or time with friends and family just to find a place to check their blood sugar. This is a process that needs to be modernized and has been ignored for way too long.
The glucose monitoring systems will allow individuals to gain real time information on current glucose in their blood. This will provide attention to users when levels get too low or high supplying short wait times compared to glucose meters. The glucose monitoring system will not replace current glucose meters, it will offer an alternative method to tracking an individual’s glucose levels. Furthermore, the glucose monitoring system is not a solution to fluctuating glucose levels or other symptoms formed from diabetes.
The continuous glucose monitor would be a small device that is attached to the skin of the patient. Depending on the preference of both the patient and healthcare provider, it will be decided whether the abdomen or upper arm is the best area to attach the continuous glucose monitor. This application is geared towards the comfort of the user by reducing the amount of discomfort compared to traditional single use glucometers such as the finger stick glucose test (Heinemann, 2008).
The continuous glucose monitor device is composed of three parts, the sensor, transmitter, and the mobile or online application. The sensor allows for the detection of glucose using the glucose oxidase enzyme which catalyzes in the presence of glucose to produce hydrogen peroxide and an electrical current. This sensor would be implanted into the subcutaneous tissue of the patient, composed of many fat cells, and would measure levels of glucose in the interstitial fluid (Freckmann, 2018). With the proposed outline, the sensor would need to be replaced quarterly and with further implementation upwards to semi-annually.
The second component of the continuous glucose monitoring system is the transmitter. The transmitter is attached to the sensor and records the data provided by the sensor concerning the concentration of glucose. The transmitter is visible because it would be secured to the outer surface of the skin. Ideally, the transmitter would be able to instantaneously convey data for real time updates. Currently the transmitter would have a short delay in order to steadily record and track information without any interruptions or feedback.
The final component of the continuous glucose monitoring system is the online application that will be downloaded to the user’s mobile device or other technological device. Through the use of Bluetooth, the transmitter would communicate data for the application to store as a record. This application will be formatted to provide easy-access to all users of the continuous glucose monitor system. This enables the user to be able to track their glucose concentration levels through the use of their mobile device. Users will be able to store, access, and record data to be able to readily share with their medical providers if needed. The application will also have the feature of automated alerts and reminders when the glucose level has surpassed or dropped below a certain level to indicate the user of a potential safety issue. Additionally, a setting can be activated where if the user does not respond to a dangerously high or low glucose level indicator on the application in a set amount of time, a notification will be sent out to both the primary guardian or person of interest in the user’s contact list and a medical official in the area. This feature may provide assistance to a user in need who is unable to respond or call for help due to hypoglycemic or hyperglycemic symptoms.
Figure 1: Diagram of the Continuous Glucose Monitoring System.
Making a new device to compete against glucometers may be difficult due to the vast audience and buyers it has built up over the years; however, with enough evidence and tests, the glucose monitoring system can become a leading choice for individuals. Through thorough testing between the transmitter’s connectivity and the sensor’s detection of accuracy on varying glucose samples, the next phase of testing would be clinical trials on individuals. The test results will provide information on the percentage of continuous monitors on glucose levels in more or less real time. With a transmitter that will demonstrate the real time results, it will be able to keep people updated on their phones or separate devices on their glucose levels. After successful clinical trials, the continuous glucose monitoring system will be able to enter the market. Having a sponsor or grant to support this project will assist and expedite the progression to present and implement this product to hospitals and companies. Additionally, the cost per device will play a factor into whether this will go through as it will mostly be used by diabetic people seeing a reasonable production to sell value. Another potential drawback includes the fear of invasiveness from some users due to the technology and data management. This drawback can be diminished with high performing data security incentives to ensure users their information is always secure.
Benefits and Consequences:
Implementing our idea will have several benefits. First, we will make monitoring blood sugar much more convenient for diabetics. At any moment throughout the day a diabetic can just pull out their phone and easily see their blood sugar levels through the app. Our idea makes the most crucial aspect of a diabetics life simpler and easier to manage. Second, this will certainly contribute to decreasing death rates amongst diabetics. Our automated alerts will warn diabetics before they experience hypo or hyper glycemic episodes which can be very deadly as previously noted, thus giving them the opportunity to prevent these episodes well in advance. Even if someone is sleeping, they will be awoken by the sound of an alarm notifying them that their blood sugar is approaching dangerous levels. This will obviously positively impact the number of people dying from hypoglycemia and hyperglycemia. This removes a heavy burden that diabetics all across the world carry. They can rest easy knowing they don’t have to go to sleep in fear of whether or not they will wake up in the morning. They can finally enjoy their physical activities and dinners with family without having to step away to annoyingly prick their finger. We are giving diabetics more control over their blood sugar.
The consequences of not implementing this idea are simple yet drastic. Diabetics will continue to inefficiently monitor their blood sugar using a finger prick and glucometer. Hundreds of thousands of people will continue to die because of abnormal blood glucose levels. Loved ones will be lost and the rest of society will continue to ignore these prevalent issues. While allowing innocent lives to be lost knowing that something could have easily been done. Our idea can fix these issues plaguing diabetics around the world.
Figure 2: Comparison of Individual Components of the Continuous Glucose Monitoring System to Current Glucometers
Cost and General Breakdown:
Creating an app to replace the receiver can cost up to 100,000 to 150,000(Utility) dollars to create a database which will store information and receive results for yourself or the free option would be making it yourself if you are knowledgeable about coding. The app will be free to the public to not create issues of cost for patients. Putting a patent on the invention to make it ours, could cost up to 1500 to 10,000(Thervo) dollars depending on the complexity. As seen in the graph in red, sensors for the glucose would be 35 to 100(Healthline) dollars depending on quality, transmitter will be 400(Healthline) dollars as it is the device that will send the results to a receiver which is 200 dollars or with the use of an app that will be free. Lastly is the battery for the transmitter which can cost 500 dollars(Diabetes self management) lasting up to a year. Now compared to old traditional items colored in blue, glucose meters can range from 40 to 60 dollars and test strips can cost 50 strips for 60 dollars or an average cost for strips can be 100 dollars per month. Now adding all the factors for the continuous glucose monitor system it can cost up to 110,000 dollars including the app and 5000 dollars for patent, for the production of one cgm(continuous glucose monitor system). Ignoring the cost of the app and patent it will be around 750 dollars for one and for one thousands will be 750,000 dollars for mass production.
How long can we passively watch this epidemic destroy so many lives and not do anything about it? This project is our way of saying we will not stand by any longer. Our project is not only affordable and profitable but most importantly effective in helping diabetics all around the world. Its convenience is incomparable and its efficiency capable of surpassing the top glucometers currently available in the market. So will you join us in revolutionizing the medical field with this innovation?
AgaMatrix. (2020, June 25). Blood Glucose Meter Accuracy: What Affects Your Results? AgaMatrix. https://agamatrix.com/blog/blood-glucose-meter-accuracy/.
Collinson, D. (2015, April 23). ‘My wife died from diabetes in her sleep aged just 41’. mirror. https://www.mirror.co.uk/news/real-life-stories/wife-died-diabetes-sleep-aged-5565961.
Continuous Glucose Monitors (CGMs). diaTribe. (2020, October 1).
David Spero, B. S. N. (2015, March 18). Is Continuous Glucose Monitoring Worth It? – Diabetes
Self. Management. https://www.diabetesselfmanagement.com/blog/is-continuous-glucose-monitoring-worth-it/.
Freckmann, Guido & Ulbrich, S. Continuous Glucose Monitoring (CGM) in Diabetes Therapy (2019, November 7) https://www.researchgate.net/publication/329018354_Continuous_glucose_monitoring_CGM_in_diabetes_therap
Hoskins, M. (2020, February 19). Can You Buy CGM Supplies at the Pharmacy? Healthline.
How Much Does it Cost to Develop and Build an App. UTILITY. (n.d.).
Mayo Foundation for Medical Education and Research. (2020, June 27). Hyperglycemia in diabetes. Mayo Clinic. https://www.mayoclinic.org/diseases-conditions/hyperglycemia/symptoms-causes/syc-20373631.
Mayo Foundation for Medical Education and Research. (2020, March 13). Hypoglycemia. Mayo Clinic. https://www.mayoclinic.org/diseases-conditions/hypoglycemia/symptoms-causes/syc-20373685.
National Institute of Diabetes and Digestive and Kidney Diseases. Continuous Glucose .Monitoring https://www.niddk.nih.gov/health-information/diabetes/overview/managing-diabetes/continuous-glucose-monitoring#:~:text=A%20CGM%20works%20through%20a,the%20information%20to%20a%20monitor
Statistics About Diabetes. Statistics About Diabetes | ADA. (n.d.).
2021 How Much Does A Patent Cost?: Cost To File & Patent An Idea. Thervo. (n.d.).