Bionic Pancreas

The Bionic Pancreas is a medical device that combines insulin delivery with glucose monitoring. The device is the first and only one of its kind to also integrate glucagon delivery.

A normal, healthy pancreas regulates blood glucose levels by arranging the secretion of insulin and glucagon, which raises blood glucose. These hormones work in tandem raising and lowering blood glucose when appropriate.

The Bionic Pancreas is used by people with Type 1 diabetes to control blood glucose and to deliver insulin. It was developed by Edward Damiano and Firas El-Khatib of Boston University/Massachusetts General Hospital[1] and is awaiting Food and Drug Administration (FDA) approval. Damiano and El-Khatib first began testing the Bionic Pancreas on pigs in 2005. Since then, they have completed several clinical trials on adult and pediatric participants.[2] The goal of the project is to get the device approved for market distribution by 2017. According to Art Jahnke, Damiano was motivated to build the Bionic Pancreas before his son left home for college because he feared that his son’s blood sugar would dive dramatically while he was asleep, a phenomenon known as “Dead-In-Bed-Syndrome".[2]

The Bionic Pancreas combines the Dexcom G4 Platinum Glucose monitor with the Tandem T: Slim pump (Bionic Pancreas, 2015). An iPhone app allows the two devices to communicate with each other. Every five minutes, the Dexcom takes a blood glucose reading and checks in with the T: Slim pump, which then calculates how much insulin or glucagon should be administered.[2] The device has undergone several FDA clinical trials and is likely to be approved in 2017. The creators of the Bionic Pancreas intend to lower its cost before it becomes commercially available since glucagon alone can cost up to $160 a day.[1]

Type 1 Diabetes

About five percent of Americans have Type 1 Diabetes.[1] Type 1 diabetes is an autoimmune disease. It destroys healthy cells that help the pancreas make insulin. If a person has Type 1 diabetes, their immune system attacks insulin-producing cells in their body, resulting in high blood glucose.[3] High glucose levels will damage blood vessels and can lead to blindness, heart disease, stroke, and kidney failure.[2] Very high blood sugar levels can result in nerve cell death and subsequent limb amputation. However, if too much insulin is injected, it can cause coma or death. The purpose of the Bionic Pancreas is to prevent dangerous highs and lows.[4]

Functions of the Bionic Pancreas

According to the Bionic Pancreas website, “the bionic pancreas makes 288 dosing decisions per day, 7 days per week and 365 days per year." The Dexcom G4 Platinum Continuous Glucose Monitor (CGM) measures glucose every five minutes to estimate overall glucose level. A glucose sensor is placed into the body with an automated injector. A transmitter is attached so data can wirelessly connect to the Dexcom receiver to Bionic Pancreas. A custom app is specifically run by the Dexcom G4 receiver. The apps send instructions via Bluetooth to the Tandem t: a slim, dual-chambered pump. One of the chambers is filled with insulin and other is filled with glucagon.[5]

Clinical Trials

Damiano, El- Khatib and Russell began a series of clinical trials in 2009.[2] The first clinical trial testing the Bionic Pancreas was a 24-hour experiment on adult subjects with type 1 diabetes that took place at Massachusetts General Hospital. The first clinical trial was so successful, Damiano received Investigational Device Exemption (IDE) approval from the FDA. After the FDA approval, Damiano began his second trial. In July 2010, the second generation of the Bionic Pancreas was born. It was a fully automated device that was tested in a 48-hour experiment in the second phase of the clinical trial. The trial was conducted on children and adults with Type 1 diabetes from Massachusetts General Hospital. The Beacon Hill Study and Summer Camp study showed that the Bionic Pancreas dramatically improved average glucose levels and almost eliminated hypoglycemia, compared to people who were not wearing the Bionic Pancreas.[4] In 2014, adults spent two days in the hospital and had their glucose controlled for 51 continuous hours using the Bionic Pancreas. They only had six meals and did light exercise that would send their glucose downward, in an effort to replicate the conditions of real life. The study showed marked improvement in glucagon control.[2]

Developer

Edward Damiano, creator of the Bionic Pancreas, is an associate professor of Biomedical Engineering at Boston University. He holds a Ph.D. in Applied Mechanics, from Rensselaer Polytechnic Institute, an M.S. in Mechanical Engineering from Washington University and B.S. in Biomedical Engineering from Rensselaer Polytechnic Institute. His research includes mathematical modeling, computational analysis and experimental investigations.[6]

Damiano has a teenage son with Type 1 diabetes. His goal is to secure FDA approval and get the Bionic Pancreas to market in enough time for his son to go to college in 2017.[7]

Articles

References

  1. 1 2 3 Fox, Maggie (13 June 2014). "NBCNEWS". 'Bionic Pancreas' Astonishes Diabetes Researchers. Retrieved 19 March 2015.
  2. 1 2 3 4 5 6 Jahnke, Art (19 June 2014). "BU Today". ENG Prof’s Bionic Pancreas Takes a Big Step Forward. Retrieved 19 March 2015.
  3. ↑ Dansinger, Michael (11 June 2014). "WebMD". Type 1 Diabetes. Retrieved 19 March 2015.
  4. 1 2 Pearls, Conference (31 March 2014). "diaTribe". Dr. Ed Damiano Presents Next Set of Bionic Pancreas Study Results at ATTD. Retrieved 19 March 2015.
  5. ↑ "Bionic Pancreas". About Us. The Bionic Pancreas Team. Retrieved 19 March 2015.
  6. ↑ Damiano, Edward. "BU Biomedical Engineering". Edward Damiano, Ph.D. Retrieved 19 March 2015.
  7. ↑ Edward, Damiano. "Bu Center for Information & Systems Engineering". Edward Damiano. Retrieved 19 March 2015.
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