Artificial pancreas trial for type 1 diabetes a success
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.
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.