Johnson & Johnson's ($JNJ) Animas division revealed positive results Friday from the second phase of clinical trials for its artificial pancreas candidate, demonstrating that the device maintained safe glucose levels overnight.
The Hypoglycemia-Hyperglycemia Minimizer System (HHM) is a closed-loop glucose-control device that combines a standard insulin pump with continuous glucose monitoring designed to mimic the function of a healthy pancreas. Animas presented the new data at the annual meeting of the American Diabetes Association in Chicago.
In a study of 20 adults with Type 1 diabetes, Animas sought to investigate the system's automatic control algorithm, which predicts the rise and fall of glucose levels. The study emphasized overnight efficacy between the times of 9 p.m. and 7 a.m., according to a release. Patients in the study spent over 90% of the overnight period within a healthy blood glucose range, and fewer than half of the patients dropped below that level during that time.
The device's first feasibility study, in 2011, was the first clinical trial of an artificial pancreas and showed that the device safely minimized the number, duration and severity of hypoglycemic events, according to J&J. But Animas is no longer the only kid on the block, as Medtronic ($MDT), Becton Dickinson ($BDX) and Tandem all have similar technologies making their way through development.
Ramakrishna Venugopalan, the R&D director at Animas, told FierceMedicalDevices that the next step is to begin a third feasibility study before pushing into the pivotal stage.
"These feasibility studies set the path for the pivotal studies later on, and we're making very steady progress into pivotal trials," Venugopalan said over the phone. "We're quite happy with the performance of the controls in the overnight period, and these studies have given us a high level of confidence in the product's functionalities."
- here's the release
Special Report: Top 5 Insulin-Delivery Techs To Watch