This draft guidance is an important step forward in artificial pancreas development. We are most concerned about study recruitment and cost given the safety requirements outlined in the guidance — an AP must not increase the rates of severe hypoglycemia, hyperglycemia, or diabetic ketoacidosis. While this is certainly a reasonable safety bar, the low rates of these events mean that long and large studies will be needed. Alternatively, studies must enroll individuals with recurrent severe hypo- or hyperglycemia (a fairly small population). The Agency also prefers enrollment of experienced CGM/pump users (>3-6 months), or at minimum, pumpers who undergo a four- to six-week CGM training period. With all of this in mind, we anticipate that recruitment for these studies will be somewhat challenging, time-consuming, and relatively expensive. Nevertheless, at this point, we believe it's less a question of "how" and more a question of "when" such a system will come to market.
The current version of the guidance document is a "draft" because it is open for public comment from patients, researchers, and industry representatives. If you're interested in reading the fairly technical document, please click here. Public comments will be accepted until March 5, 2012, and can be submitted here. We hope that as the FDA finalizes the document and begins evaluating artificial pancreas trials, it keeps in mind the daily risks of living with type 1 diabetes and the potential for even first-generation AP systems to lower these risks. Despite the best technology today, insulin is still a hard medication to dose, and unfortunately mistakes are made all the time. We welcome anything that could reduce those errors and improve A1C.
For those unfamiliar with an artificial pancreas, please see Chapter 5 of our free book, Targeting a Cure for Type 1 Diabetes: How Long Will We Have to Wait?, available at www.diaTribe.us/cure. For the most recent updates on the artificial pancreas, see our coverage of the recent Diabetes Technology Meeting in Conference Pearls in diaTribe #38. Finally, for those interested in artificial pancreas studies, we suggest visiting JDRF's Artificial Pancreas Project Consortium and ClinicalTrials.gov. -AB
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NOTE: This information is not intended to be a replacement or substitute for consultation with a qualified medical professional or for professional advice related to diabetes or another medical condition. Please contact your physician or medical professional with any questions and concerns about your medical condition.
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