Joslin Diabetes Center to integrate clinical trial of new Diasensor 2000 into telemedicine programme

Pittsburgh 14 September 1999Clinical investigators at the Joslin Diabetes Center in Boston, Massachusetts, plan to co-ordinate and conduct a clinical trial to satisfy the requirements for the premarket approval (PMA) submission to the United States Food and Drug Administration (FDA) for the Biocontrol Technology Company's Diasensor 2000 Noninvasive Glucose Monitor. The trial will be conducted in accordance with a contract encompassing a protocol written by the Joslin Diabetes Center.

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The trial will evaluate the Diasensor 2000 and its use in a new telemedicine programme that wraps the monitor into an overall diabetes care treatment plan in which the patient, using the Diasensor in the home, will be linked via the Internet to a speciality diabetes clinic. Further details of the study, which is expected to begin within a few months, will be released when approved by all parties.

Joslin Diabetes Center constitutes an international leader in the treatment, research and education of diabetes. Established in 1898 and affiliated with Harvard Medical School, Joslin leads the field in the basic as well as clinical research and is devoted to educating both patients and professionals. Joslin is headquartered in Boston and has facilities throughout Massachusetts, and also affiliated diabetes treatment centres throughout the United States from New York City to Florida.

Biocontrol Technology began the modular PMA process with submission of its first module to the FDA in May of this year. Biocontrol President David L. Purdy states that the company is pleased to work with the Joslin Diabetes Center, whose integrity and reputation will certainly ensure a sound clinical trial of the Diasensor 2000 and the new telemedicine in-home health-care programme for people with diabetes.

Biocontrol Technology has its corporate offices in Pittsburgh, Pennsylvania, and is involved in the development and manufacturing of biomedical devices and environmental products. Subsidiary Diasensor.com, equally located in Pittsburgh, owns the patents, as well as marketing and distribution rights to the sensor, while Biocontrol has the exclusive rights to the research and development and manufacturing of the sensor.


Leslie Versweyveld

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