Positive Results for Animas’s Insulin Delivery AlgorithmPositive Results for Animas’s Insulin Delivery Algorithm

There may be another leap toward an artificial pancreas thanks to new research released by Animas Corp. At the Advanced Technologies & Treatments for Diabetes Conference in February, the company, part of the Johnson & Johnson family of companies, announced positive results of a study conducted to examine an algorithm for running a closed-loop insulin delivery system.

The algorithm, designed to predict changes in blood glucose, was tested as part of Animas’s Hypoglycemia-Hyperglycemia Minimizer (HHM) System, which also includes a continuous subcutaneous insulin infusion pump, a continuous glucose monitor. The algorithm used in the HHM System is based on a control technique known as model predictive control (MPC), which uses recent measurements of physiological variables (e.g., glucose concentration and insulin delivery amounts) to make predictions of glucose trends in the near future via a proprietary mathematical model,” says Ramakrishna Venugopalan, director of R&D at Animas. “The benefit of MPC is that the algorithm, by design, doses insulin proactively so as to mitigate or even avoid future hypo- and hyperglycemia.”

As a “proactive”system the HHM can increase or decrease (including suspending and restarting) insulin delivery in order to drive blood glucose levels to a specific range. “The keys to this proactive insulin adjustment, in part, are proprietary mathematical models of physiological variables, and governing equations that utilize them; they are the results of rigorous academic and industrial research,” Venugopalan says.

Animas’s study, which was conducted in 20 adults with type 1 diabetes provided insights into the sensitivity of the system and also demonstrated that the system was able to trigger timely warnings and reduce insulin delivery in advance of hypoglycemia. The study also showed the system was able to reduce insulin delivery in advance of hypoglycemia and trigger timely warnings for imminent hypoglycemia. “Our studies have indeed indicated challenges for our System, due to an unavoidable degree of uncertainty in therapy regimens – pharmacodynamics/kinetics, measurement accuracy, and influences of unmeasured environmental factors,” Venugopalan says. “That said, we are encouraged by the positive data we have seen in our clinical studies to date, which indicate a robustness in our closed-loop insulin delivery system.”

While the company could not comment on the specifics of its development efforts moving forward, Animas is encouraged by the study results. Venugopalan says, “Confident in our technology platform, we are currently working to evolve our research and development plan as we continue toward our goal of a first-generation closed-loop insulin delivery system for patients.” Interested parties can visit clinicaltrials.gov more information on Animas’s clinical trials and about study start and end dates and site locations as they are planned.

-Chris Wiltz is the Associate Editor of MD+DI

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