Diabetes News for June 23, 2002
Diabetes Monitors Approved
Recently, the FDA approved two Palm-type devices that combine a blood sugar test meter with a PDA.
The devices that were approved are the FreeStyle Tracker Diabetes Management System, made by TheraSense Inc., and the Accu-Chek Advantage Module, made by Roche Diagnostics Corp. Both devices are designed to be modules which can be inserted into a Handspring Visor. TheraSense is selling their unit as either a complete unit (Handspring plus meter module) or as a separate module for those who have a Handspring device. Information about Roche's device is not yet available, but is believed to be similarly configured.
The modules contain a miniturized blood glucose meter which will use each company's respective strip. The data is then fed to the Palm unit where data analysis is done. The Therasense unit was planned to have a food database for easy carb counting, similar to the EZManager from Animas which has an 8,000 food database. However, it it not clear from the Therasense site whether this useful feature made it into the production model. BG testing is done similarly to a standard meter. The palm device assesses the glucose level, displays the results, and stores them in a database from which more detailed analysis can be done. Results can be uploaded to a personal computer.
  
Does Precose Prevent Diabetes?
For people who are at high risk for developing Type 2 diabetes, a recent study in the June 15th issue of Lancet offers hope that the diabetes drug acarbose may help prevent the disease.
The study, led by doctors from the University of Montreal, Canada, was funded by Bayer AG, the maker of acarbose which is sold under the name Precose. Acarbose works by slowing the digestion and absorption of sugars from food, and this helps reduce blood sugar levels as well as the need for insulin after eating. Participants in the study were either given three daily doses of 100 mg acarbose or a placebo for three years. All of the participants were between the ages of 40 and 70, and were overweight or obese.
At the end of the study, researchers found that 42% of the people taking the placebo had developed diabetes, while only 32% of the people taking acarbose had developed the disease. Those taking the drug were 25% less likely to develop Type 2, and were more likely to have their glucose levels return to normal. This risk reduction is similar to that found in a study of people who made lifestyle changes like eating healthier diets and exercising more, although lifestyle modification demonstrated a greater risk reduction at 58%. Further study at other sites must be conducted to determine if acarbose is an effective means of preventing Type 2.
Diabetes Drugs May Treat MS
Occasionally, doctors find that drugs used to treat one health condition are also effective in treating other conditions. Such may be the case with thiazolidinediones (TZDs), which are currently used to treat Type 2 diabetes and may soon be used to treat multiple sclerosis (MS).
TZDs work by helping the body's cells to use insulin. They bind to receptors that are primarily found in fat cells. However, researchers have recently found that the drugs also prevent lymphocytes (immune cells) from growing, and they reduce the production of compounds that lead to inflammation.
MS is an autoimmune disorder, which is caused by an excess production of inflammatory proteins. These proteins destroy protective insulation around nerve fibers, causing numbness, muscle weakness, stiffness, vision problems, and difficulty with coordination.
Recently, researchers from the University of Illinois in Chicago conducted a study to determine if TZDs could effectively treat MS, since they prevent inflammation. They gave the drugs to healthy mice and mice that already exhibited symptoms of experimental autoimmune encephalomyelitis, which is similar to MS. The drugs appeared to effectively treat a chronic form of the disease as well as a relapsing form, which is similar to the form found in humans.
The researchers have published their findings in the Annals of Neurology (volume 51, pages 694-702, June 2002). They say it is far too early to prescribe TZDs to people with MS, but further research is indicated to determine whether the drugs can effectively treat both disorders. There are also many other drugs which reduce inflammation and might be tested in a head-to-head trial with the TZDs.
Potential Blockbuster Drug For Treating Complications
The pharmaceutical company Eli Lilly and Co. may have a tiger in its tank. Called LY333531 and pronuounced LY triple three 531, this compound inhibits an inflammatory particle by the name of protein kinase C beta or PKC-beta. Previous research has identified PKC-beta as an important intermediate that is involved in all of the major mechanisms by which high blood sugars lead to both microvascular (ie, retinopathy, neuropathy and nephropathy) and macrovascular damage (ie, cardiovascular disease and atherosclerosis). These mechanisms include increased levels of advanced glycosylation endproducts, increased oxidative stress (especially increased levels of superoxide in endothelial cells and mitochondria), increased aldose reductase pathway activity (or increased polyol flux), and increased hexosamine flux.
One of the most painful complications of diabetes is diabetic peripheral neuropathy, which involves severe nerve damage that can necessitate amputations. Late-stage trials of LY333531 are beginning for treatment of neuropathy, but, so far, only data regarding symptoms is available. Both 32 mg and 64 mg doses of the drug demonstrated a mild reduction in perceived symptoms after 1 to 12 months of treatment (abstracts 321-OR and 800-P in Diabetes, June 2002, vol 51, suppl 2). In another early study of retinopathy, LY333531 was found to improve blood flow to the eyes within one month of treatment. The PKC-DRS study will determine whether LY333531 can stop the progression of various stages of diabetic retinpathy in 251 patients in the U.S.
Although these studies are very early, if PKC-beta turns out to be a major player in the development of complications as is suspected by many researchers, LY333531 or similar compounds may start to provide a very interesting intervention strategy. Lilly plans to submit an application to market the drug in Europe in 2003, but have not yet set a date for their US application.
Inflammation May Lead To Type 2
Chronic inflammation has been shown to be linked to heart disease, which has many risk factors in common with Type 2 diabetes. New research shows that inflammation may also be connected to the development of Type 2 diabetes.
Dr. Bruce Duncan and other researchers at the Federal University of Rio Grande do Sul in Brazil, presented their findings at the American Diabetes Association's annual meeting this month in San Francisco (Diabetes, June 2002, vol 51, suppl 2, abstract 117-OR). They examined 651 people with Type 2 and 643 without, all of whom were participating in a larger study of 10,000 people who were followed for nine years. The researchers looked at four markers of inflammation, including C-reactive protein (CRP), orosomucoid, sialic acid, and interleukin-6 (IL-6). They also took into account other factors that may have led to the participants' development of diabetes, including age, gender, and ethnicity.
At the conclusion of the study, the doctors found that the participants with the highest levels of sialic acid had a 70% higher risk of developing diabetes than the people with the lowest levels. In addition, all four indicators of inflammation were linked to a two to three-times greater risk of developing diabetes. This risk was reduced when researchers adjusted for body mass index (weight) and glucose levels.
The researchers are not sure why the link between inflammation and Type 2 exists. They theorize that food intake can lead to a perpetual inflammatory response in people who are obese. The body's response to this inflammation may interfere with the normal function of insulin, thereby causing diabetes. Lots of additional research is already underway in this promising area.
Health Problems Loom Large In Kids With Type 2
The rapidly increasing rate of children with Type 2 diabetes is a relatively new phenomenon, and little research has been done on these children's health prognosis as adults. One recently completed study indicates that the prognosis is not encouraging.
The study was directed by Dr. Heather Dean, professor of pediatrics at the University of Manitoba in Winnipeg, Canada, and presented at the annual ADA meeting in San Francisco (Diabetes, June 2002, vol 51, suppl 2, abstract 99-OR). The study participants were 51 Native Americans between the ages of 18 and 33, all of whom had been diagnosed with Type 2 prior to their 17th birthday.
The researchers reported that three of the participants are on dialysis due to kidney failure, and two had died of heart attacks during dialysis. Five others died of causes unrelated to diabetes. One became blind at the age of 26. One had had to have a toe amputated. Only 35 of 56 pregnancies have resulted in live births. Although the study was small and involved a genetically distinct group, the results emphasize the need for aggressive prevention and treatment of Type 2 diabetes in children.
High Risk For Diabetes In Middle-Schoolers
A very disturbing trend was revealed when North Carolina researchers studied middle-school students. Researchers from the University of North Carolina evaluated 668 students in the sixth to eight grades in five Southern middle schools. After an overnight fast, 10.8% of the students were found to have elevated blood sugars in the pre-diabetes range (110 to 125 mg/dl), while another 1.5% were in the diabetes range of over 125 mg/dl. Although two abnormal tests are required for a diagnosis of diabetes or pre-diabetes, the percentage of young students showing elevated glucose levels in this study is higher than the prevalence of diabetes in adults over the age of 60!
The study, presented at the annual ADA meeting in San Francisco (Diabetes, June 2002, vol 51, suppl 2, abstract 106-OR), showed that more than one out of every eight middle-schoolers in this study are at high risk of Type 2 diabetes. After these results were analyzed, boys and girls were found to be equally at risk, and no statistical difference was found between different racial groups. The researchers stressed that a significant number of youth in the South may be at risk of developing Type 2 diabetes, and that interventions aimed at increasing activity and reducing obesity in children are needed.
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