Controlling blood glucose levels is one of the key aspects in slowing down complications in Type I Diabetes patients. The old model was to check glucose levels (via lancet pricks) with meals and before going to sleep, then injecting a varying amount of insulin based on a pre-determined scale. As you can imagine, this level of complexity doesn’t always lead to optimal results. A promising development was the continuous subcutaneous insulin pump, which is a pager-like device that can deliver a basal rate of insulin and is manually programmed to give bolus doses around meals. Then came continuous glucose monitoring, which gives readings much more often than the traditional 4-times-a-day spot-check method. So, at this point, we had high-frequency measurements of the input variable, but the output (insulin dose) still had to be programmed manually.
The effort to make this a closed-loop system has evolved into the Artificial Pancreas Project, fronted by the Juvenile Diabetes Research Foundation. The effort to fast-track this project through the FDA has been a revealing interaction between government regulators, industry, and the JDRF.
Fortunately, this project is making progress, and the first human trial has shown positive results. The Hypoglycemia-Hyperglycemia Minimizer (HHM) System from Animas Corporation is a closed-loop artificial pancreas system that incorporates a continuous, subcutaneous insulin infusion pump, continuous glucose monitor, and control software. The system adjusts the insulin dosage automatically based on changes in blood glucose. The study enrolled 13 patients, and each patient was monitored for 20 hours with the system. The device adjusted the level of insulin infusion appropriately and, most significantly, there were were no episodes of DKA (diabetic ketoacidosis) or severe hypoglycemia reported. The press release describes an algorithm that actually predicts glucose trends using a proprietary algorithm, but this was not fully tested in this trial.
“The successful completion of this study using the HHM System in a human clinical trial setting is a significant step forward in the development of an advanced first-generation artificial pancreas system,” said Dr. Henry Anhalt, Animas Chief Medical Officer and Medical Director of the Artificial Pancreas Program. “It lays the foundation for subsequent clinical trials, bringing us one step closer to making the dream of an artificial pancreas a reality for millions of people living with Type 1 diabetes.”
This is only a feasibility study, and there is much work left to be done, but this is an exciting proof of concept that we will be sure to follow here at Medgadget.
Presentation abstract from last week’s scientific sessions of the American Diabetes Association: Performance Metrics of the Hypoglycemia-Hyperglycemia Minimizer (HHM) System in a Closed-Loop Feasibility Study