LAB 2 WRITE-UP
Device Image and Description
Our device is a variation of an insulin patch. This patch would use artificial vesicles to carry out the same function as beta cells which would sense an increase in blood sugar levels and release insulin into the bloodstream. The patch would be made out of silicon which would contain 100+ micro-needles in order to pierce the skin in a painless and less invasive way than current diabetes treatment methods offer. The patch would also contain a sensor that would detect the glucose levels in the blood. This sensor can be reused so that there is only a one time purchase.
Technical and Clinical Feasibility
What technologies are needed?
(a) Store the appropriate amount of insulin required
(b) Distribute insulin through the skin
2. Electronic Skin Sensors
(a) Detect blood glucose levels by measuring pH, temperature, sweat, etc.
3. Bluetooth or Wifi Transmission Technology
(a) Record and store history of blood glucose information
(b) Allow patient or doctor to access and view monitoring information on an electronic device
4. Silicone (to make device)
What are the challenges?
1. Integrating sensor with patch
(a) Combine detection with delivery
(b) The sensor detects blood glucose levels and causes microneedles to deliver insulin through the skin
2. Determining the amount of insulin required for each different patient
(a) Clinical trials
(b) Calculations based on required amounts that current diabetes patients use with insulin pumps/injections
3. Figuring out the best way to deliver insulin through the skin
(a) How the insulin will be released over time
(b) How effective the insulin will be at reaching the blood vessels through the skin
4. Determining how long each patch will last
(a) Clinical trials, testing
(b) Calculating how much insulin can be stored within the microneedles and how much each patient requires per dose
5. Creating an efficient and user-friendly platform that people want to use in combination with the patch to read their blood glucose reports
What could go wrong?
1. Failure to achieve effective drug delivery through the skin
2. Incorrect insulin dose could lead to hypoglycemia
(a) Trials would be required to determine an average value for insulin that each different patient would need based on age, weight, height, gender, metabolism, etc.
3. Patients might forget when they need to change out their patches
4. Integration with sensors could be difficult
Will it work in the clinic?
1. Yes, the product will work efficiently in the clinic. There have been studies on animals that have shown blood glucose levels to decrease gradually over time with use of a similar microneedle patch.
What are the clinical risks?
1. A patient's blood levels can potentially drop dangerously low with the administration of too much insulin. Since insulin is required to bring down high blood glucose levels, too much insulin can lead to low blood glucose levels. The treatment used too counteract this phenomenon is glucagon, which might not be readily available for patients in their homes.
Have similar products been in clinical trial? (Cite competitors)
1. CeQur: PAQ - an insulin infusion patch that does not include microneedles. The trial has existed for about 5 years, and it has not yet been approved by the FDA.
2. Yale: InsuPatch - the clinical trial studied how well adolescents' and young adults' blood sugars can be controlled by a "closed loop artificial pancreas" using a continuous glucose sensor, an insulin pump, and a computer program that automatically detects how much insulin to administer based on glucose levels.
3. North Carolina State University: Smart Insulin Patch - a synthetic patch filled with natural beta cells that can secrete doses of insulin to control blood sugar levels on demand with no risk of inducing hypoglycemia. Animal testing with models of type-1 diabetes show that the patch can quickly respond to "skyrocketing" blood sugar levels and significantly lower them for 10 hours at a time. Results published in Advanced Materials.
"Effect of the InsuPatch on Automated Closed-loop Glucose Control in Type 1 Diabetes (IPCL)." ClinicalTrials.gov. N.p., n.d. Web. 08 Feb. 2017. <https://clinicaltrials.gov/ct2/show/NCT01787318?term=insulin%2Bpatch%2Bdiabetes&rank=12>.
"Electronic Sensors Stuck To The Skin Could One Day Control Your Mobile Devices." Tech Times. N.p., 10 Aug. 2015. Web. 08 Feb. 2017. <http://www.techtimes.com/articles/75579/20150810/electronic-sensors-stuck-skin-one-day-control-mobile-devices.htm>.
Nowogrodzki, Anna. "35 Innovators Under 35 - Zhen Gu." MIT Technology Review. MIT Technology Review, 01 Feb. 2016. Web. 08 Feb. 2017. <https://www.technologyreview.com/lists/innovators-under-35/2015/pioneer/zhen-gu/>.
"Painless Patch, Insulin-producing Beta Cells Control Diabetes." Today's Medical Developments. N.p., n.d. Web. 08 Feb. 2017. <http://www.todaysmedicaldevelopments.com/article/smart-insulin-medical-patch-research-41216/>.
"Pathway to Stop Diabetes Scientist Generates Smart Insulin Patch." American Diabetes Association. N.p., n.d. Web. 08 Feb. 2017. <http://www.diabetes.org/research-and-practice/we-are-research-leaders/recent-advances/scientist-generates-smart-insulin-patch.html?referrer=https%3A%2F%2Fwww.google.com%2F>.
"Study of PaQ™ (a Simple Patch on Insulin Delivery Device) in Patients With Type 2 Diabetes Mellitus." ClinicalTrials.gov. N.p., n.d. Web. 08 Feb. 2017. <https://clinicaltrials.gov/ct2/show/NCT01535612?term=insulin%2Bpatch&rank=8>.
Talbot, David. "Controlling Diabetes with a Skin Patch." MIT Technology Review. MIT Technology Review, 22 Mar. 2016. Web. 08 Feb. 2017. <https://www.technologyreview.com/s/601064/controlling-diabetes-with-a-skin-patch/>.
Our product is more valuable compared to other products because it is painless, efficient, inexpensive and noninvasive. Our device lasts about 5-7 days which is much longer than other forms of measuring glucose and distributing insulin. This device allows flexibility and a patient will hardly tell that its there. A patch such as this is still in the process of being created however, those that are being tested now do not include a sensor that detects glucose levels as well as distributes insulin; it is normally just one or the other. Our patches come in different sizes depending on the average intake of insulin of the patient.
- Silicon: $1.11
- Insulin per unit: $1.45
- 100 microneedles: $1.48
- Sensor (one time purchase): $23.23
- Total Manufacturing cost: $27.27 or ~ $30
- First time purchase: $50
- After first time: $6.00-$10.00
- Total number of people with diabetes in the US: 29.1 million
- Percent of people with diabetes who use insulin for treatment: 18%
- Our market size: ~5,238,000 people * $60 (per patch and insulin) = ~$314,280,000
"Age-Adjusted Percentage of Adults with Diabetes Using Diabetes Medication, by Type of Medication, United States, 1997–2011." Centers for Disease Control and Prevention. Centers for Disease Control and Prevention, 20 Nov. 2012. Web. 08 Feb. 2017.<https://www.cdc.gov/diabetes/statistics/meduse/fig2.htm>
"2014 National Diabetes Statistics Report." Centers for Disease Control and Prevention. Centers for Disease Control and Prevention, 15 May 2015. Web. 08 Feb. 2017.<https://www.cdc.gov/diabetes/data/statistics/2014statisticsreport.html>
Competitors = 2
Customer Validation = 2
IP Position = 2
Market Size = 1
Clinical feasibility = 2
Clinical feasibility was given a score of 2 because of the amount of trials done on monitoring glucose and distributing insulin. Our group was unable to give a 3 because there are not many trials specifically with a patch that is distributing the insulin.
Technical feasibility = 2
Technological feasibility was given a 2 because all of the technologies are created and available but someone just needs to connect the ideas together.
Our device should be funded because we have a decent market size with an innovative product that will change how insulin is delivered. Despite the scores not seeming well it is because the idea is dealing with new technologies.