Joslin Diabetes Center to Conduct FDA Trials on Noninvasive Meter


By: Sharon Mulry

Biocontrol, one of many hopeful developers of a noninvasive glucose monitoring device, will link with the Joslin Diabetes Center in Boston. Joslin researchers will conduct clinicals trials for approval of Biocontrol’s Diasensor 2000, a device that measures glucose levels with spectroscopy (technology using infrared light).

Pittsburgh-based Biocontrol has begun its Premarket Approval application, the process by which medical devices are approved, with the U.S. Food and Drug Administration (FDA). Joslin developed a trial protocol as part of that process. Participants will use the Diasensor at home, with links to Joslin through the Internet.

The 13 years Biocontrol has been working on the Diasensor have been marked by controversy over fund raising. Biocontrol and its subsidiary, Diasense, have been accused of illegal fund raising tactics, giving executives huge salaries and plentiful perks with investors’ money and no product to sell, misleading investors with exaggerated claims of the Diasensor’s functioning and doctoring clinical trials results for FDA approval.



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