Animas Corporation today shared encouraging results from its predictive hypoglycemia-minimizing algorithm in development. Data from a clinical feasibility study demonstrated that the algorithm was capable of helping maintain glucose above hypoglycemic levels an average of 99.1 percent of the time for the 12 participants investigated, all of whom were adults with type 1 diabetes. The study was conducted by Animas in collaboration with industry, academia and JDRF as part of an effort to advance the development of a predictive blood glucose-regulating system for patients with type 1 diabetes.
The investigational device, comprised of an Animas insulin pump, Dexcom's G4™ PLATINUM continuous glucose monitor (CGM) system and predictive algorithm, dosed basal insulin automatically based on participants' CGM values to minimize exposure to hypoglycemic levels (glucose <70 mg/dL). Eight participants' CGM tracings were maintained entirely above 70 mg/dL, while the other four experienced short glucose excursions below this threshold. The results are encouraging, indicating the system's potential to help reduce hypoglycemia via a technological approach.
As a part of the study, a parameter known as the "aggressiveness factor," which affects the insulin dosing characteristics of the predictive algorithm, was varied to test its effect on the algorithm's ability to reduce hypoglycemia. Significant differences in the system's insulin dosing response were observed as the aggressiveness factor was varied from conservative to medium to aggressive settings, particularly in the critical times when glucose was between 90-120 mg/dL and decreasing. These insights will inform future development decisions, and they underscore the need for diligence in investigating configurations that will provide the greatest benefit across the patient population.
The results from this third clinical trial were presented at the 74th Scientific Sessions of the American Diabetes Association (ADA) in San Francisco, California.
- Animas began collaborating with industry, academia and advocacy organizations, including the JDRF (formerly the Juvenile Diabetes Research Foundation), in 2010. Together with these key partners, Animas continues to work toward developing an automated system to help people living with type 1 diabetes better control their disease.
- Hypoglycemia is one of the main barriers to attaining glycemic control, causing significant morbidity among patients with diabetes.
- Animas' predictive hypoglycemia-minimizing algorithm was capable of maintaining glucose levels above hypoglycemic levels (glucose <70 mg/dL) for an average of 99.1 percent of the time across the 12 study participants.
- The algorithm parameter investigated in the study, known as the "aggressiveness factor," affects how readily the algorithm adjusts insulin delivery to prevent or mitigate predicted hypoglycemia.
- Significant differences in the system's insulin dosing response were observed as the aggressiveness factor was varied, which underscores the need for diligence in investigating configurations that will provide the greatest benefit across the patient population.
- The FDA has designated closed-loop insulin delivery as one of its "critical path" initiatives.
Krishna Venugopalan, Director and Head of Research Development, Animas Corporation, said: "The positive results from this study provide us with additional confidence in our predictive algorithm technology and our ability to potentially reduce hypoglycemic events in patients, which is critical to better management of diabetes. By honing in on this essential aspect of our hypoglycemia-minimizing system, I'm optimistic we can bring a much-needed product to market that will truly make a difference for people with diabetes."
Aaron Kowalski, Vice President, JDRF, said: "Delivering progressively more advanced artificial pancreas systems is the core of JDRF's artificial pancreas research strategy. Such an approach allows us to transform technology into patient-centric products as the technology advances and to progressively improve type 1 diabetes management. A predictive algorithm technology that can reduce or potentially avoid hypoglycemic events will results in significant benefit to our patients, while we pursue our broader vision of fully automated artificial pancreas systems. We look forward to the continued work on this project and to bettering the lives of those with type 1 diabetes through our joint efforts."
Juan Toro, Vice President, Animas Corporation, said: "At Animas, our promise is to offer people living with diabetes the resources they need to perform at their best. With that in mind, we want to provide patients with the safest and most advanced management solutions possible. Therefore, we are excited by the results of our research because they bring us one step closer to getting this life-changing technology into the hands of patients."