Diabetes News for January 23, 2000

Endos Best For Diabetes Care

Endocrinologists provide the best health care to patients with diabetes according to a press release from the American Association of Clinical Endocrinologists (AACE). They state that clinical data shows that endocrinologist-led health care teams for people with diabetes are better and more cost-effective than care provided by other medical personnel. They say that endocrinologists reduce HbA1c values, incidence of hypoglycemia, emergency room visits and hospital admissions for diabetic emergencies. They also treat diabetic ketoacidosis better and shorten hospital stays.

Why is AACE promoting themselves? Because they are taking exception to the interpretation of a study published in the January 5, 2000, issue of the ``Journal of the American Medical Association'' (JAMA) that states that the care provided for people with Type 2 diabetes is equally good whether Nurse Practitioners (NP) or Primary Care Physicians (PCP) provide it. This conclusion is based on data from a study of 46 PCP-managed (non-endocrinologists) and 58 NP-managed participants with diabetes which showed that the participants achieved similar mean HbA1c values whether they were treated by NPs or PCPs (9.4% vs. 9.5%). 

The AACE says the results of the NP versus PCP study should be interpreted to say that both NPs and PCPs deliver equally inadequate care to diabetic patients. The AACE is concerned that the study may mislead consumers into an inadequate level of care. They assert that the standards of care should be those outlined in the AACE Medical Guidelines for the Management of Diabetes Mellitus: the AACE System of Intensive Diabetes Self-Management-2000 Update.

AACE recommends a HbA1c (GlucoseAverage(TM)) for a Type 2 patient of 7 percent or less. (A person without diabetes is in the the normal range of 4 to 6 percent.) In both the Diabetes Control and Complications Trial (DCCT) and the United Kingdom Prospective Diabetes Study (UKPDS), a HbA1c (GlucoseAverage(TM)) over 9 percent was associated with higher levels of diabetic eye, kidney and nerve complications. Good blood glucose control can reduce these risks.

The AACE also points out that the study reported in JAMA was not consistent with practice in the actual world. Instead, the population was homogeneous, and set within an academic health center. Furthermore, the study was conducted for only six months, so that the health problems that occur over a longer period of time with diabetes were not encountered.

AACE leaders urge people with diabetes to review the AACE Diabetes Guidelines which will prompt them to choose the care provided by the endocrinologist.

FDA Approves New Diabetes Pain-Free Monitor

The Food and Drug Administration has cleared a virtually pain-free blood glucose monitor for people with diabetes called FreeStyle, developed by TheraSense, a company in Alameda, California.

The company says that because it uses only a fraction of the blood sample currently required by other meters, it gives people the freedom to test sites other than their fingertips, like the forearm or thigh. These sites are less painful than the fingertips which are more sensitive because they have more nerve endings. The product is expected to be available in pharmacies and on the Internet in the second quarter of 2000.

TheraSense also is developing a wireless continuous monitoring system, called In Vivo, which resembles SpectRx's meter. The company plans to launch this product in 2001, once FDA approval is obtained. It is minimally invasive with a miniaturized sensor placed under the skin on the abdomen and a wireless, remote device to read the glucose level in the interstitial fluid.

New Diabetic Retinopathy Drug Studied

The growth of new blood vessels sounds like it would be a good thing, and it is in some cases. But the growth of new blood vessels in the eye, called proliferative retinal angiogenesis, is abnormal and destructive. It is the leading cause of blindness in the United States.

The best treatment for retinal angiogenesis is to inhibit the growth with an anti-angiogenic agent. Magainin Pharmaceuticals Inc. has a new product called squalamine that researchers at Georgetown University Medical Center will study as an anti-angiogenic molecule that blocks endothelial cell activation, migration and proliferation by multiple growth factors. Squalamine's multi-faceted mechanism contrasts with many other angiogenesis inhibition programs, and may allow broad application across proliferative eye diseases, as well as various cancer types.

The research, funded by the Juvenile Diabetes Foundation, will attempt to use squalamine and captopril to prevent and intervene early in the progression of diabetic retinopathy without negatively affecting normal growth and health. The research may also be applicable to macular degeneration and certain forms of glaucoma.

Currently, there is no effective drug therapy for diabetic retinopathy, other than possibly ACE inhibitors and high dose vitamin E. Current therapy is focused on the use of laser therapy that often slows vision loss, but is expensive and may itself cause some visual loss.

New 4 Minute HbA1c Test Device

Provalis'  Glycosal test is the first four minute, low cost, diagnostic test to measure the level of glycated hemoglobin (HbAlc) in blood in the clinic or general practitioner' office. The test device will be launched in the first quarter of 2000.

ProMetic BioSciences and Provalis have been collaborating since 1998 to develop a ligand that meets the stringent specifications necessary for the Glycosal test. They have now signed a ten-year contract to provide a secure and reliable source of the critical ligand.

Diabetes Drug May Harm Liver

Avandia, a new drug for Type 2 diabetes that helps the body's natural insulin work better, has been associated with serious liver reactions in two people on the drug, researchers are stating in the Annals of Internal Medicine. This revives fears that the class of drugs like Avandia might be injurious to the liver.

The good news is that both patients recovered after they stopped taking Avandia. Furthermore, clinicians are not sure the problem was caused by the drug at all, but by other medical problems that cause liver reactions such as alcoholism, which one of the patients has had, and arterial disease, which the other patient suffers from.

More good news is that SmithKline's Avandia has not exhibited the problems that Warner-Lambert's Rezulin, another drug in the same class, has shown. Rezulin has been linked to 28 deaths and 12 other cases of liver failure, which has caused the FDA to tell doctors to limit their prescriptions of Rezulin. Over a million prescriptions have been written for Avandia, so if there is a problem it does not appear to be common. Doctors, of course, are advised to monitor the liver of any patient who is taking any drug in this class.

The FDA has said both Avandia and a related drug, Eli Lilly's Actos, appear to have a safer profile than Rezulin.

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