Diabetics pleaded with the government Monday to approve the first pain-free way to measure their blood sugar, but a panel of experts said there was no proof the machine works well enough to keep their disease at bay.
“I will apologize to every diabetes patient … in this room that I cannot be more enthusiastic,” said panel chairman Dr. Arthur Karmen of Albert Einstein College of Medicine. “But hopefully what you want to get is the right answer” from a test.
The Food and Drug Administration advisory committee decided Biocontrol Technology Inc. needed to study its Diasensor again - but quickly - to prove it could be used safely. So far, its only evidence showed that Diasensor could test perhaps one of every four insulin-dependent patients.
Biocontrol argued that those patients deserved to use the machine, the first non-invasive blood-sugar test, while scientists figure out how to improve it. Angry diabetics agreed.
“I can’t tell you how frustrating it is to know this device exists but is just out of reach of Bonnie,” said Glenn Sklar of Columbia, Md., who draws blood from his 3-year-old’s finger six times a day to control her disease.
The FDA is not bound by advisory panel decisions but usually follows them, and FDA device chief Dr. Susan Alpert immediately asked Biocontrol to meet with her this week.
But with the test being questioned, Biocontrol’s stock plunged almost 41 percent on Monday, even before the committee’s decision. Biocontrol fell $1.68-3/4 to close at $2.43-3/4 a share on the Nasdaq Stock Market.
The Diasensor uses military technology that detects heat-seeking missiles to read a diabetic’s glucose levels when the patient simply lays an arm on the machine. Infrared light is reflected through the patient’s arm and measured by a sensor that recognizes how far away from his or her ideal glucose level the blood currently is.
Diabetics have clamored for the Diasensor since it began clinical testing in 1992, and Sklar last year told Congress the FDA was delaying the device after Biocontrol applied for approval in 1994.
But Biocontrol conceded Diasensor cannot test everyone who wants it - and was able to prove it helped just eight patients.