Artificial pancreas trial for type 1 diabetes a success

Jun 10 2012 - 3:22pm
Artificial pancreas trial success announced.
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Results of the first human clinical trial for a first generation artificial pancreas system for treating type 1 diabetes shows success for helping people living with the disease keep their blood sugars normal, without any adverse effects.

The results, presented at the 72nd Annual American Diabetes Association Meeting in Philadelphia, June 10, 2012, could be a major breakthrough for treatment of type 1 diabetes.

Artificial pancreas detects high and low blood sugars

The artificial pancreas system, called the Hypoglycemia-Hyperglycemia Minimizer (HHM), was tested in the United States among 13 study participants.

The primary goal was to see if the system could detect high and low blood sugar levels and command the pump to suspend or deliver more or less insulin.

The go-ahead for the clinical trial was approved by the FDA in June, 2011, which is a collaboration between the Animas Corporation in collaboration with the Juvenile Diabetes Research Foundation (JDRF), after an FDA panel concluded the device was safe.

The closed loop system includes an implanted subcutaneous (just below the skin surface) insulin pump, a continuous glucose monitor and software designed to detect changes in blood sugar levels. Development of the artificial pancreas began in 2010.

Each participant was studied for 24 hours using the closed loop and an open loop system. An algorithm was developed to predict when blood sugar levels would rise and fall above or below pre-set thresholds to either deliver or suspend insulin delivery. A safety module was also run from a laptop.

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A secondary goal of the study was to see if the HHM artificial pancreas system could keep blood sugar levels in normal range.

Aaron Kowalski, Ph.D., Assistant Vice President of Research at JDRF said in a media release, "An artificial pancreas system that can not only detect, but can predict high and low blood sugar levels and make automatic adjustments to insulin delivery would be a major advance for people with Type 1 diabetes. Such a system could alleviate a huge burden of managing this disease."

Development and study of the system is part of the JDRF's Artificial Pancreas Project, the goal of which is to speed development of devices that can help people manage the autoimmune disorder that affects 3 million children, adolescents and adults in the United States.

In a 2010 JDRF press release, Kowalski, who was diagnosed with type 1 diabetes himself at age 13, wrote, "Without a doubt, the biggest worry for parents of kids with type 1 diabetes is that their child will have a low blood sugar emergency during the night, when they're hard to identify.”

The original investigation showing feasibility for the current trial involved 3 separate studies that involved 17 children with juvenile, or type 1 diabetes. Glucose measurements were fed into a computer every 15 minutes to measure insulin requirements.

The Artificial Pancreas Project was designed to bridge the gap until a cure is found for the disease. The system could more manageable and improve quality of life for millions who are living with the burden of type 1 diabetes. The first successful human clinical trial for an artificial pancreas system is a major advance for type 1 diabetes treatment. The next step is more clinical trials.

Source:
72nd Annual American Diabetes Association Meeting
June 10,2012

Image credit: Wikimedia commons

Updated 11/21/2015

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Comments

I'm not a diabetic, so this is a question to educate me. How does this differ from a typical insulin pump?
The pump is an open loop system and insulin is manually delivered after blood sugars are checked by the patient. The artificial pancreas is a closed loop system that has a continuous monitor and the computer software delivers the insulin. Eventually, if this pans out, they would become more sophisticated. I hope that helps! See this video at JDRF: http://www.artificialpancreasproject.com/videos/default.html
As a mother of a type 1, who was diagnosed at age 2, this sounds like a MIRACLE. Lexi is already on a pump, which made her life easier than shots, but sometimes (ok every day) I worry about her getting too much basal and dropping too low. Sometimes she does not recognizes lows in the 40's! Scary! This would make me sleep easier and would minimize the complications diabetes (even closely managed diabetes) would have on Type 1 diabetics! Do you know if they need more research volunteers
Jessie - I would just go to the JDRF site regularly for updates about the Project. I think you can stay in touch with them regularly that way too; perhaps via e-mail alerts.
My daughter has an insulin pump. We have to check her blood sugar and enter it into the pump and add her carbs and the pump delivers the insulin. The artificial pancreas would check her sugar and deliver the insulin automatically.
Exactly - and eventually they hope to implant tissue that delivers insulin and acts like a pancreas.
An insulin pump only delivers insulin according to inputs initiated by the user. These can be either a basal amount, which is a small amount preprogrammed to be delivered automatically during the day, or a bolus, a larger amount based on a carbohydrate count from meals or based on a high blood sugar. Certainly the basal amounts help keep a diabetic's blood sugar more normal, and the boluses are delivered much easier and there's much more flexibility with a pump, but blood sugars still require frequent monitoring with finger sticks and a meter and insulin delivery has to be input by the user. The artificial pancreas will behave, as I understand this, much more like the real pancreas to better tune blood sugar. I can't wait for it to be available for my teenage son!!!
Thank you SO much for all of the information, I had no idea...I thought the insulin pump just "did' it. Now I realize how hard it really is. Thanks again...this device seems to be very promising!!!