a) The artificial pancreas has raised hopes of some to bring Type I Diabetes patients to a higher quality of life.
This will include and may not be limited to:
- A subcutaneous glucose sensor
- A continuous subcutaneous insulin pump
- An algorithm system which will make the mathematical model.
b) Current treatment available to patients with Type I diabetes are:
- Need to check their blood glucose many times a day
- Administration of subcutaneous injections between two and five times a day
- Use of an insulin pump. At times this pump may cause image and social issues for the patient. The pump is not always easy to conceal and still has to be manipulated constantly by the patient.
- Use of constant glucose monitoring devices but the same as the pump this still requires a lot of self-effort on the part of the patient.
- These devices are part of what is considered an open loop treatment. (2, 3)This meaning that the patient has to manually close the loop in order for the treatment to be effective.
The image below shows the parts of an artificial pancreas device system. As you can see in the image and social issues as with the pump are present. But the difference with this system is the nearness to a closed loop system where the patient involvement is decreased. Below the image you will see the definitions of each section of the system
Picture : “Bionic” Artificial Pancreas Device system
Image source : http://www.fda.gov/
- Continuous Glucose Monitor (CGM) – This monitor is constantly checking the blood glucose level and sending it to a display the patient can see.
- Blood Glucose Device (BGD) – This is the device that all diabetic patients are accustomed to. The hope is that with the artificial pancreas system this will no longer be needed.
- Control algorithm – This is a software system that calculates the amount of insulin needed.
- Infusion pump – After the control algorithm decides how much insulin is needed the pump administers the subcutaneous dose.
- The patient – The hope is that the patient will have very little involvement in the decision making and dosage of each injection. The idea is to give the patient more freedom in their daily routines. (8)
What is the pancreas and what does it have to do with diabetes?
a) A hormone secreting organ
- Insulin – helps the body receive glucose
- Glucagon – causes release of stored glucose
- Digestive enzymes
b) Type I diabetes is due to the pancreas not producing the amount of insulin necessary for proper blood glucose regulation. Type II diabetes happens when the body is not a receptive to the insulin created in the body. [3,8]
c) Untreated diabetes can lead to many other chronic and serious illnesses which include and are not limited to:
- Cardiovascular disease
Uses of Artificial Pancreas –
- The whole idea of the artificial pancreas is to give those with Type I diabetics and some Type II diabetics with more freedom during their treatment.
- A usual goal for any patient is to maintain glucose with the range of 80-140 and keep it as constant as possible.
- Prevention of hypoglycemic episodes
- Patient safety and health
- Appropriate and proper insulin dosages (8)
- A decrease in exercise-induced and night time hypoglycemia. These are times when the patient is less likely to notice symptoms of hypoglycemia. (1)
Documented Clinical Trials and current research
a) Development and projects
- Patient safety is a very important issue when dealing with new devices which will remove the patient control. One study used the analogy of aircraft safety. They discussed how the takeoff and landing are the most dangerous times during operation. They state it is the same with this type of closed-looped system.
- Near misses are an important discussion point in health care recently. Near misses are documented when an error is noted before it reaches or harms the patient. New studies want to assure that near misses with any artificial pancreas system will be reported accurately before the patient enters into hypoglycemia. (4)
- A study was done to investigate patients acceptance of the artificial pancreas. Most of the patients reported an acceptance of the artificial pancreas mentioning that they did not trust it 100% but felt that with longer use they would come to trust its accuracy. They also felt that it would help to give them an overall better glucose control. (2)
Although Type I diabetes is considered an incurable disease JDRF has taken upon themselves to seek the cure. Through this goal, they also investigate treatments in order to give a better quality of life to those who have been diagnosed with Type I diabetes. Part of their work includes educating about what Type I diabetes is and why it needs to be cured.
They go as far as to boast that they want the world without Type I diabetes. They do donation based work and state that every dollar donated goes into research. Their initials stand for Juvenile Diabetes Research Foundation because they began by investigating juvenile diabetes. But now they include all Type I diabetes in their active research. (11)
Artificial Pancreas Brands
Medtronic is a company which normally works with pacemakers. They are the first company in the US to receive an approval to produce the automatic pancreas. Due to their success with pacemakers, the expectations are high. (12)
Development and Projects continue….
- Safety and control continue to be an issue (3)
- The goal is a closed-loop system which can shut off automatically. (4)
- Challenges may include correct usage of devices, reimbursement, and acceptance. (5)
- The image below shows the scenario results of what the closed-Closed loop delivery system should look like.
source : www.bmj.com
the FDA is in high approval of the continuation of studies and creation of the artificial pancreas. They hope to place research, clear guidelines, standards and sponsoring of the artificial pancreas as priorities. They have released a guide in order to assist those who are in the process of creating this type of treatment.
Through this guide and other methods, they are encouraging clear and efficient communication. (6) The FDA expresses their concern for safety and the health of US citizens when they express that other countries have initiated the use of similar types of systems but that they have high expectation of the outcome of studies done. (8)