FDA Approves Combo Device for Managing Diabetes

The race to develop an artificial pancreas just got tighter, as Animas Corp. has won FDA approval for its Animas Vibe insulin pump and continuous glucose monitoring (CGM) system.

A subsidiary of Johnson & Johnson (JNJ), Animas (Chesterbrook, PA) pairs its insulin pump with the previously FDA-approved Dexcom 4 Platinum sensing system to help those with type 1 diabetes better manage their insulin and glucose levels.

Too much blood glucose can lead to blindness and kidney failure. When blood glucose levels fall too low (hypoglycemia), patients may suffer confusion, disorientation, loss of consciousness, coma, or seizure. Keeping hypoglycemia at bay overnight is a high priority, especially for parents of children who have the disease.

The Dexcom CGM shows patients glucose data so they can administer insulin directly from the pump. The Animas Vibe system also provides patients with their latest glucose readings on the pump screen and a color-coded view of glucose highs, lows, and rates of change over time. This information complements finger-stick testing results and can be used to help patients make immediate and long-term insulin delivery adjustments, according to a statement by the company. Patients will also be able to customize alarms to indicate high and low glucose levels.

Animas is already taking orders in the U.S. for the Vibe system, which should be available in January 2015, the company said. It is available in Europe, Australia, New Zealand, and Canada.

Medtronic (Fridley, MN) has also been working steadily on creating an artificial pancreas. While acknowledging that it has not achieved the hoped-for closed-loop system, which would automatically send information from the CGM system to the pump, themedtech giant is taking the process step-by-step.

The FDA approved Medtronic's (MDT) MiniMed 530G with the Enlite CGM in September 2013. It automatically ceases basal insulin delivery for up to two hours if a patient does not respond to an alarm triggered when sensor glucose values drop below a preset level.

"The carb counting is THE hardest part of T1D!!," wrote Lori Mercil, the Minneapolis mother of two teenagers who have type 1 diabetes, in a Facebook post. "Anything that would take that piece out of the picture is what T1D families get SUPER excited about!! That would include any of the following: an automatic, closed loop pump system; smart insulin that is given less often and responds to blood glucose levels; and beta cell implants with encapsulation technology that protects these insulin-producing cells from the immune system's attack."

Canadian researchers apparently agree. In a study comparing the dual-hormone artificial pancreas, the single-hormone artificial pancreas, and conventional insulin pump therapy in 30 adult and adolescent patients with type 1 diabetes, they recently concluded that the external artificial pancreas improves glucose control and reduces the risk of hypoglycemia compared to conventional diabetes treatment. The results were published in The Lancet Diabetes & Endocrinology. The University of Montreal researchers plan to conduct a larger study.

Nancy Crotti is a contributor to Qmed and MPMN.

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