Review by Richard Lehman – 03/31/2017 – 11:56am

Data Request Number: 2017-1466 Is the scientific purpose of the research proposal clearly described?: No If no, please explain:

This proposal is full of ambitious language but I am left unclear about the possible clinical relevance of their approach. These trials only measured a single surrogate endpoint (HbA1c) over relatively short periods of time against a small number of comparators. At best, this can only be an exploratory methodological study of a particular approach to “personalization”.

Will request create or materially enhance generalizable scientific and/or medical knowledge to inform science and public health?: Unsure, further clarification from requestor is needed Can the proposed research be reasonably addressed using the requested data?: Unsure, further clarification from requestor is needed Please use this space to provide any comments, feedback or concerns (optional):

I am skeptical about the value of this proposal and the feasibility of using the data set to achieve anything other than an exploratory foray. On the other hand, it could be argued that this a bona fide attempt which should not be dismissed.

Recommendation for this data request: Not Approve