This morning’s newspaper about Rezulin, the medication that was taken out of the type 2 diabetes prevention study because it was implicated in the death of a subject. The article, dated July 28, 1998, with a Washington, D.C. byline, states that seven months after being banned in Great Britain because of its liver risks, consumer advocates here, citing at least 26 world-wide deaths, have asked for the same ban in the United States.
The Food and Drug Administration (FDA) responded that the drug offers an important benefit to type 2 diabetics who are not helped by other drugs. They indicated that physicians were not following repeated warnings to test patients on Rezulin to monitor any developing liver disease so that it can be stopped before permanent damage occurs.
Deaths, according to the FDA were caused by improper monitoring. Parke-Davis, the manufacturer, will send letters to 800,000 U.S. Doctors saying that the FDA has upgraded its warning for Rezulin. Doctors should test patients on Rezulin monthly for liver toxicity for the first eight months of therapy. If you are currently on this medication, talk to your physician if you have not had these monthly tests, or if you are concerned about side effects or liver disease.
Monitor Recall
A warning from the U.S. government and a recall of the Sure Step blood glucose monitor by LifeScan. The monitor may flash ERROR rather than register very high glucose levels. If you have one of these machines, contact the manufacturer or the place where you purchased it. LifeScan phone numbers are available later in this article after the announcement of a new monitor by this company.
Noninvasive Blood Glucose Monitoring Studies
July 22, 1998 Journal of the American Medical Association has a review article on the Development of Noninvasive methods to Monitor Blood Glucose Levels in People with Diabetes. The article reviews information from the Juvenile Diabetes Foundation sponsored meeting of the National Aeronautics and Space Administration, National Institute of Diabetes and Digestive and Kidney Diseases, and the National Center for Research Resources.
Infrared and axon spectroscopy, polarized light rotation, and minimally invasive devices that analyze the interstitial fluid secretions harvested from the skin are some of the methods being tested. Ultimately, the goal is to link these procedures to a device that will automatically deliver the correct amount of insulin, effectively creating an artificial pancreas.
The article goes on to say that although much progress has been made, truly noninvasive glucose monitoring is not a reality. There is, however, much research and manufacturing interest in the concept.
The glucose module reacts as it is exposed to various wavelengths of electromagnetic energy. Different methods using differing wavelengths have been developed to solve the problem on noninvasively measuring these reactions and so determining glucose concentration.
Each method has its proponents, each holds promise, each has it difficulties. They all face the same problem: how to magnify small perturbations of the glucose molecule as it responds to a beam of electromagnetic radiation sufficiently to obtain a totally useful reading. Recent electronic technical developments may enable measurement of the very tiny increments of energy involved.
Electromagnetic Radiation has four different types:
Near-infrared spectroscopy uses an external light source whose wavelength is just above the visible spectrum. The light passes through or is reflected by a part of the body, and glucose and other parts of the blood absorb a small amount of the light at each wavelength. The reflected light is analyzed to determine the blood glucose level.
Mid-infrared radiation spectroscopy measures natural thermal emissions. When radiation in the mid-infrared passes out of the body, glucose in the blood absorbs some of it. The absorption can be stectroscopically determined by comparing measured and predicted amounts of thermal energy at the skin surface and the difference can be converted into a measure of the blood glucose concentration.
Radio wave impedance works when waves pass through the blood with glucose present. The glucose interacts with the beam to attenuate the amplitude and shift its phase. Using a conversion factor, the glucose concentration can be calculated from measuring the impedance of the radio wave as it passes across a finger.
A fourth method is to measure the optical rotation of polarized light which rotates in proportion to the concentration of glucose in the blood. A beam can be passed through a body component such as the ocular aqueous humor, and the amount of rotation then used to calculate the glucose concentration.
Interstitial Fluid Measures:
These are minimally invasive methods of harvesting interstitial fluids from the skin. They all rely on recent research that dermal interstitial fluid glucose is directly proportional to blood glucose concentrations. Because it is easier to get this information, minimally invasive methods are closer to clinical application than are noninvasive devices.
Methods described at the meeting:
Using reverse iontophoresis, one method extracts fluid from the skin by the application of an electric current. This fluid contains salt, water, and glucose. The glucose concentration is then measured. The GocoWatch, made by Cygnus Inc. of Redwood City, CA. who demonstrated this watch which can read glucose levels up to three times an hour and can sound an alarm if glucose levels fall too low or rise too high. The manufacturer states that the device has been tested clinically and is as accurate as current glucose monitors.
Another device described as a transdermal patch is called the TD Glucose patch. It is made by Technical Chemicals and Products of Fort Lauderdale, FL. The patch is placed on the skin to 5 minutes. It draws the interstitial fluid using a combination of skin enhances and a medium for transporting the glucose in the fluid. When a small amount of fluid reaches the patch, the glucose undergoes a biochemical reaction resulting in a color formation that is directly measured by a meter directly correlated to the blood glucose levels.
Currently this device is undergoing comparison testing at three university-affiliated diabetes clinics in the U.S. The owner of the company expects these studies to be completed later this year at which point he expects to be able to file with the FDA for marketing approval of the device.
New Glucose Monitor: FastTake
LifeScan, a division of Johnson and Johnson, has come out with a new glucose monitor, the FastTake which they claim has an all-new contoured styling. It is slender and lightweight in design with large, easy-to-read display. The meter has a fast 15 second test time and yet is described as compact in a sporty carrying case.
It requires a very small amount of blood and a touch-anywhere test strip. The meter comes with a 150 test memory with date and time, automatic 14-day averaging, and it can interface with a computer for in-depth test results. This meter comes with a 5-year warranty and 24-hour toll-free customer assistance. LifeScan also has an excellent video tape for showing to groups. Information about products is available in both English and Spanish.
Laser Irradiation Improves Skin Circulation in Diabetics
Diabetes Care: Volume 21, No.4 has an article on Low-Intensity Laser Irradiation Improves Skin Circulation in Patients with Diabetic Mocroangiopathy by Schmidl, Andreas, M.D. et al. The researchers knowing that food problems due to angiopathy and neuropathy account for 50% of all nontraumatic amputations and that low-intensity laser irradiation has been shown to reduce wound healing in conditions of reduced microcirculation, investigated the influence of low-intensity laser radiation by means of infrared thermography on skin blood circulation in diabetic patients with Mocroangiopathy.
Thirty patients with diabetic ulcers or gangrene and elevated levels of glycosylated hemoglobin were treated randomly. The results indicated that after a single transcutaneous low-intensity laser irradiation a statistically significant rise in skin temperature was noted and demonstrated an increase in skin micocirculation due to athermic laser radiation in these diabetic patients.
Diabetes Research 