From November 8-10, 2012, the biggest names in the field of diabetes technology met for an annual summit in Bethesda, MD. The Diabetes Technology Meeting (DTM) always represents a great update on the field of devices, though it’s also becoming a great opportunity for researchers, companies and the FDA to interact. This year saw a particularly strong presence from the Agency, as FDA speakers offered candid insights on the biggest challenges facing our current regulatory process. As expected, the conference’s biggest topic of discussion was the quest for the artificial pancreas (also called the “closed loop”). As a refresher, the artificial pancreas takes CGM readings, processes them through a control algorithm, and directs insulin dosing on a pump, in order to automatically control glucose. For an introduction to this area of research, please see learning curve in diaTribe #39 and conference pearls in diaTribe #40.
Next Steps for the Artificial Pancreas
One of the big questions facing the development of the artificial pancreas is how best to minimize the risk of overnight hypoglycemia. One possibility put forward by researchers from the University of California Santa Barbara was to modify the closed-loop control algorithm, which during nighttime hours would automatically widen the boundaries of acceptable blood glucose levels. In other words, while the acceptable daytime range for blood glucose might be set at a tight 80-140 mg/dl, this range would shift upwards at night and expand to 110-220 mg/dl. Setting the lower limit at 110 mg/dl should decrease the risk of hypoglycemia, but it could also run the risk of raising A1c levels. Whether that would be an acceptable tradeoff to the FDA, insurers, doctors, and particularly patients is going to be a big question for artificial pancreas researchers. Still, it’s worth noting that this relaxed overnight glucose control might not actually increase A1c, especially since the reduction of hypoglycemia should also reduce the incidence of overtreatment and subsequent hyperglycemia.
Is the Closed Loop the Best Goal?
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