Laser monitor approved for home use by diabetics
Skin patch monitor may not be far away
The pain of blood glucose monitoring could soon be a thing of the past, providing a boon to diabetics and a boost for compliance.
A laser perforator has been approved by the U.S. Food and Drug Administration (FDA), and a non-invasive transdermal patch, which is paired with a glucose monitor, is entering final clinical trials and could be available by the end of the year.
A nearly painless’ method
The Lasette, developed by Cell Robotics International Inc. of Albuquerque, NM, is advertised as a "nearly painless" method of drawing blood for glucose testing purposes. The Lasette, approved by the FDA in early December, according to Ronald Lohrding, PhD, president and CEO of Cell Robotics, directs a small beam of laser light on the long wave length through the skin at a very high speed.
"It leaves a small hole," says Lohrding. "You feel a tap, and you next to never feel pain. Many people with diabetes avoid conducting daily glucose tests because of the pain associated with the needle sticks necessary to draw adequate blood, resulting in a deterioration of health." The company hopes the Lasette will encourage more frequent monitoring and, consequently, improve the health of diabetic patients.
The device uses an Erbium:YAG laser, runs on a battery, and is similar in size and shape to a VCR tape. It is adjustable to skin type and produces one drop of blood.
The FDA says clinical trials show "adequately trained patients can perform the finger pricks with the laser device as easily and accurately as with lancets." In addition, the FDA says the laser device may be particularly helpful for diabetic children who have difficulty using lancets.
Lohrding says there has been an unexpectedly large demand for the device despite its price (about $2,000). He thinks the strong response from physicians is in answer to a demand for increased testing compliance.
Cell Robotics is working on a smaller model with a somewhat lower price tag, Lohrding says. He hopes it will be available by mid-1999. The current device is available through ChroniMed Inc. of Minneapolis.
Patch works in tandem with monitor
The skin patch monitor is now undergoing final clinical trials at three university medical centers for submission to the FDA later this year. The device is composed of a single-use skin patch, similar to those that deliver nicotine or pain medication, and is placed on the user’s forearm for five minutes.
The patch permits dermal glucose to be drawn and causes a chemical reaction and color change in the patch’s membrane, which is read by a monitor the size of a small flashlight. The "smart meter" runs on a 9-volt battery and contains a 32K processor that can store up to 120 days of readings by day, date, and time as many as six times a day. Data are downloadable to disks or over the telephone.
The device, called the TD Glucose Meter, paired with the TD Glucose Patch, was developed by Technical Chemicals and Products Inc. (TCPI) of Pompano Beach, FL. The system requires complex algorithms to calibrate it to each individual patient, according to Howard Goldman, TCPI’s vice president of investor relations. The devices will be calibrated by the individual’s physician.
"This means that patients will test themselves more often, and more times a day means better compliance," he says.
Goldman says the monitor will cost about $100, and the patches will cost about 80 cents each.
For further information, contact Ronald Lohrding, PhD, President and CEO, Cell Robotics International Inc., Albuquerque, NM. Telephone: (800) 866-1633. Howard Goldman, Vice President of Investor Relations, Technical Chemicals and Products Inc., Pompano Beach, FL. Telephone: (954) 979-0400.
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