Artificial Pancreas Phase II Trials Deliver Insulin, Maintain Blood Sugars
On Wednesday, January 13, 2010, JDRF announced a partnership with Animas Corporation to develop an automated insulin delivery system. The Artificial Pancreas Project is currently in phase 2 human trials.
The collaboration between JDRF and Animas will provide the funding and technology advancement in developing an automated diabetes management system and to pursue phase three trials, which would test the safety and efficacy of the Artificial Pancreas. Then, JDRF and Animas will submit the Artificial Pancreas to the FDA for approval. The hope is that the Artificial Pancreas will hit the market in 4 or more years!
"If successful, the development of this first generation system would begin the process of automating how people with diabetes manage their blood sugar," said Alan Lewis, PhD, President and Chief Executive Officer of JDRF. "Ultimately, an artificial pancreas will deliver insulin as needed, minute-by-minute, throughout the day to maintain blood sugars within a target range. But even this early system could bring dramatic changes in the quality of life for the 3 million people in the US with type 1 diabetes, beginning to free kids and adults from testing, calculating and treating themselves throughout the day."
What does this mean for us? This first generation will use a cgm and pump. The drawback to this early generation is that the wearer will still have to manually instruct the pump to deliver insulin for meals, activity or illness, so it is only semi-automated. The advantage of this pump is that it will automatically "treat the range," meaning it will attempt to keep blood sugars within the target of, say, 80-180 automatically.
Currently, the VEO from Medtronic will shut off when the cgm reads 70, but it does not increase insulin delivery when the wearer goes too high. The Artificial Pancreas will be able to shut off when too low and increase the amount of insulin when a high is detected automatically. Animas will produce the pump and dexcom will provide the cgm component.
One reason there is a 4-year wait is development of the sensors for the Artificial Pancreas. Currently, the sensors on the market only have one signal and in order to make the device fully automated the sensors have to be redundant and have more than one signal.
For 98% of the insulin dependant diabetes community, the pump has been the most successful tool for tight control. Tighter control will help stave off complications and that needs to be a primary focus for those of us living with diabetes.
While this is not a cure, it represents a bridge to building a cure. My hope has been to find a way to stay healthy and complication free while science works on developing a cure. I think between the Artificial Pancreas and development of Smartinsulin, the next 5 years we will see my hope become reality.