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I read the JAMA paper published last week. Although I'm not directly involved in the treatment of patients with diabetes, from a medical standpoint, the idea behind this technique is sound. It should always be borne in mind that when measuring or assessing biological events no method is perfect; "fuzzy logic" and/or "uncertaintities" play a significant role in the practice of medicine. Add to this, other uncertainties in the system, e.g., reimbursement. From what I gather, however, this paper nicely outlines the strengths and weaknesses of the technique. All of the findings are spelled out clearly in this paper and I think this is a novel technique, and likely do the trick. I have NO idea what FDA would do on December 6th in these types of cases. But, I do not see why this technique should not get a green signal, based purely on what was published in the journal. |
