The artificial pancreas will soon be a dream come true

The artificial pancreas will soon be a dream come true

Technological advances move forward successfully in the creation of a computer program or software that can interpret the results of a continuous blood glucose levels monitoring system and transmit them to an insulin pump located in a small device, called Artificial Pancreas, which can maintain blood glucose levels within the normal range.

By Joe Cardozo

Several studies funded by JDRF (Juvenile Research Foundation Diabetes), are being made to get these prototypes, which have been shown to work very well, to be approved as soon as possible by the US FDA.

Currently, people with Type 1 Diabetes have to get insulin injections several times a day and frequently monitor their blood glucose levels to be able to adjust their insulin doses, carbohydrate intake and physical activity, so they can keep their blood glucose levels as close to normal as possible, as well as Hemoglobin A1c below 7%, and prevent or delay the onset of the dreaded chronic complications associated with poorly controlled of Diabetes. In that sense, people with Diabetes need to take all necessary measures to prevent hypoglycemia or low blood sugar episodes and be cautious if this occurs, in which case they’ll need to counter it by eating rapid absorption carbohydrates (simple carbohydrates) or requiring a Glucagon injection. Glucagon is a medicine that is injected to raise blood glucose levels, when the patient has lost consciousness due to hypoglycemia.

The Artificial Pancreas represents an extraordinary control tool that will revolutionize the treatment of Diabetes, as it will allow people with Type 1 Diabetes maintain their blood glucose levels within the normal range (70 m /dl to 110 mg/dl) without insulin or having to monitor their blood glucose levels.

Developing such a device isn’t easy

First, the device needs to be able to continuously detect blood sugar levels in patients, and whether the trend is for levels to rise or fall too much, and thus be able to keep within the normal range (70mg/dl 110 mg/dl) at all times.

This requires the Artificial Pancreas to automatically provide the precise dose of insulin the body needs when blood sugar levels are rising above normal (hyperglycemia) and on the other hand, to deliver the exact dose of Glucagon when blood glucose levels are falling below normal (hypoglycemia).

The Artificial Pancreas is a device that consists of a closed circuit that doesn’t requires user intervention in the decision-making process and which is responsible for maintaining glycemia levels well under control, using sophisticated computer algorithms, which deliver the required insulin through a pump and prevents hypoglycemia through a Glucagon reservoir, based on the results transmitted by the integrated blood glucose monitoring system.

The story of one of the participants of this study

Elle Shaheen is a young teenager with Type 1 Diabetes, who participated in a study conducted at Massachusetts General Hospital in Boston, where she got an Artificial Pancreas connected to a laptop. In the future this device will be the size of a cell phone.

Dr. Steven Russell, an instructor of the Harvard University School of Medicine and leader of this research team said: “For three days the device did what Elle’s pancreas could never do” and added “her blood sugar levels control was very good and we were very, very pleased with what we observed with her”

Edward Diamano, associate professor of Biomedical Engineering at Boston University and one of the researchers, said that the device learned Elle’s blood glucose patterns and made the necessary adjustments, “the device made adjustments every 5 minutes” he concluded.

During that weekend, Elle didn’t have to use her insulin pump or monitor her blood sugar levels and was also able to eat meals in large quantities, which she hand’t been able to eat for more than 4 years. “She ate baked spaghetti with cheese and fries” said Stefany Shaheen, Elle’s mother and added “she ate between 67 to 100 grams of carbohydrates in every meal, when she can only eat 40 to 50 grams of carbohydrate.”

Upon completion of this trial, Elle had to leave the Artificial Pancreas and return to her usual insulin pump treatment, counting carbohydrates and monitoring her glucose levels every 2 hours.

“We are too eager to gain access to this wonderful device,” said Elle’s mom and concluded by saying “this will definitely revolutionize the way she lives.”

The Artificial Pancreas prototype is already in the FDA’s hands

Drs. Russell and Damiano have already presented a prototype of the Artificial Pancreas to the FDA regulators, which is so small that it can be carried in a pocket or attached to a belt. This apparatus has two tiny pieces that are inserted into the skin, one to continuously monitor blood glucose levels and the other to deliver insulin or glucagon based on the registered blood glucose levels.

The FDA has required that, until the Artificial Pancreas is approved, physicians need to keep their patients in the hospital while using this device.

Last year, Dr. Charles Zimliki, who leads the Artificial Pancreas initiative for the FDA, testified before a committee of the United States Senate where he said: “The potential benefits of the Artificial Pancreas are huge, but if it isn’t properly designed, using this device in outpatients could pose a significant risk for these patients.”

Dr. Russell stated that he expects the FDA to approve use in adults with Type 1 Diabetes by December 2015, so they can leave the hospital and walk around accompanied by a nurse. Russell also hopes that the children and adolescents who will participate in a holiday camp for children and adolescents with Diabetes, which will take place on the following summer, to be able to use it.

What do the representatives of the Artificial Pancreas Project think of the JDRF?

“I feel very optimistic but remain cautious,” said Dr. Aaron Kowalski, vice president of the JDRF treatment therapies area, and continued, “The FDA has really changed and moves much faster. My hope is that in one or two years, these devices will be proven to be able to adequately control blood sugar levels, and that’s just the tip of the iceberg”.

Kowalski concluded by saying that he believes the Artificial Pancreas will probably be approved in stages. “I don’t believe it’ll be a single product, but rather an evolution.”

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