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Diabetes and Health News
For week of 12/26/98

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MiniMed Plans For February Meeting With The FDA

MiniMed says the Food and Drug Administration (FDA) will review its premarket approval application (PMA) for its continuous glucose monitoring system on February 26, 1999. Its minimally invasive continuous glucose monitoring system measures interstitial glucose levels and is designed to be inserted into the subcutaneous tissue, usually in the abdominal area, utilizing a soft cannula type device. MiniMed's first product will be a monitor to be used by physicians as a diagnostic tool in treating patients with diabetes, much like current cardiac holter-style devices. If the FDA grants approval of the PMA, MiniMed plans later to market a testing device for use by consumers. You can also read CEO Al Mann's promotional comments given to The Wall Street Transcript.

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Encelle Receives Research Funding For Beta Cell Transplants

A small biotech company, Encelle, has raised $5 million to expand testing of beta cell transplants for diabetes, eliminating the need for insulin shots. Encelle Inc.'s bioartificial pancreas has functioned successfully in diabetic dogs and rabbits for up to four months. The company's Encellin XP uses cells from a pig's pancreas to produce insulin. Encelle has a 19- person scientific operation in Greenville, North Carolina, and reports receiving a total of $4.5 million in venture-capital financing.

Scientists have been trying to produce a bioartificial pancreas for years, without success. Encelle uses a proprietary process to mechanically separate the tissues of a swine pancreas. Then it injects an artificial connective substance, called a hydrogel matrix, that enables storage of the insulin-producing cells at low temperatures without degrading them. Others haven't been able to do this, according to Anton-Lewis Usala, a physician who is Encelle's founder and chief technical officer, because as water cools it expands and damages the pancreatic tissue. "We've kept pancreatic tissue alive for two years in a refrigerator," he says. "No one else can keep it alive for 14 days." 

In order to transplant these swine cells into a patient's pancreas, Encelle needed a way to prevent the human immune system from recognizing the cells and attacking them. Encelle believes it has accomplished this by coating the cells with a patented, microscopically thin, permeable polymer coating that prevents the immune system from binding with the swine cells. The ultimate goal for Encelle is to enable patients to avoid insulin injections altogether. But in the short term it is more likely that the company's first Encellin XPs would let diabetics get by with just one shot of low-dose insulin daily, rather than the multiple shots many diabetics face today. 

Usala himself has had diabetes since infancy, and that has been a powerful motivating force for him. Whether the Encellin XP will work in humans is not known. But Encelle now has the funds to do the testing needed in dozens more diabetic animals. If those tests go well, Encelle hopes to submit an application to test the product in humans to the FDA in the second half of 1999.

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Pennsylvania Passes New Diabetes Coverage

A  recent report by the Pennsylvania Health Care Cost Containment Council blames diabetes for $4 billion in direct hospital costs and 14.7 percent of all hospitalizations in Pennsylvania last year. Senate Democratic Whip Leonard J. Bodack (D-Allegheny) says these figures support the need for Pennsylvania's newly enacted diabetes control law (HB 656, Act 98) which will take effect in Pennsylvania early next year. Bodack says the diabetes control law is "long overdue." According to the health care council, diabetes is far more common in Pennsylvania than it is nationally. They report that 1.1 million Pennsylvanians, or 9 percent of the state's population, have diabetes compared to the national average of 5.9 percent. 

Effective February 13, 1999, Act 98 of 1998 will require all private and group health insurance plans in Pennsylvania to provide coverage for diabetic supplies like blood glucose monitors, test strips, syringes, insulin, etc., and to provide education to help diabetics manage their disease. According to the health care council's findings, 262,817 diabetes patients were admitted to Pennsylvania's hospitals for a total of nearly 2 million hospital days in 1997. Diabetes affects 1 in every 11 Pennsylvanians, while nationally it affects 1 in every 17 people, and is an underlying or contributing cause of death for 12,000 Pennsylvanians each year

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Abbott Offers New Diabetes Products

Abbott Laboratories announced it has two new diabetes products: the Ensure Glucerna nutritional bar and Ensure Glucerna OS beverage. Both products are formulated to help make blood glucose control easier. Abbott says the products' nutritional profiles meet the recommendations of the American Diabetes Association. The company also says clinical data shows the Ensure Glucerna bar and beverage are better at helping people with diabetes manage their blood glucose levels than an ordinary snack bar or standard nutritional beverages.

The nutritionally-balanced Ensure Glucerna bar and beverage are vitamin-, mineral- and fiber-enriched "snacks" that help reduce the typical rise in blood glucose levels seen following high-carbohydrate snacks. They contain 24 key vitamins and minerals and provide 100 percent of the Reference Daily Intakes for the antioxidant vitamins E and C. They are also low in saturated fat and cholesterol and are enriched with fiber. The bar uses a key ingredient called guar gum to delay carbohydrate absorption into the bloodstream. The beverage, however, uses a reduced-carbohydrate, monounsaturated fat-enriched formulation to delay carbohydrate absorption. Both products contain higher levels of antioxidant nutrients and monounsaturated fats than most other snack products. 

In a single-blinded, randomized, three-way crossover study, significant reductions in postprandial blood glucose and insulin responses in 30 individuals with Type 2 diabetes were noted following consumption of the Ensure Glucerna nutritional bar compared to the responses observed after the consumption of an ordinary snack bar. Significant reductions in postprandial blood glucose response also were shown in a prospective, randomized, controlled trial of 118 Type 2 diabetic subjects following consumption of the Ensure Glucerna nutritional beverage compared to the response seen after the consumption of a standard nutritional beverage or a commercial weight loss beverage. 

Both the bar and beverage can be used as a snack, a meal supplement or occasional meal replacement. The nutritional bar comes in two flavors, chocolate graham and lemon crunch. The beverage is available in chocolate, vanilla and butter pecan flavors. They can be found in major drug stores, supermarkets and superstores.

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Mark Collie Foundation Raises Diabetes Research Dollars

The Mark Collie Foundation is raising funds for diabetes research by taking to the track and driving racecars at the Nashville Speedway in the "Race For A Cure." A portion of the proceeds received by On-Line Entertainment Network from the show will go toward the Mark Collie Foundation's efforts for research for a cure for diabetes, a debilitating disease that strikes many, including singer Mark Collie. 

On-Line Entertainment Network Inc., in Association With Fox Sports South announced the immediate availability, through its Web site OEN.com, of the "Audio-On-Demand" "Mark Collie Celebrity Race All Access Show" that was produced in association with Fox Sports South. The show is a behind-the-scenes look at the Mark Collie Celebrity Race that was recorded on Oct. 6 and 7 of this year, and features performances and concert interviews, as well as high-resolution digital stills by such celebrities as Mark Collie, Loretta Lynn, her daughters The Lynns, John Anderson, T. Graham Brown, The Nelsons and others. 

The show also includes behind-the-scenes race track pit interviews and digital stills with Mark Collie, Faith Hill, Pam Tillis, Tim McGraw, Brooks and Dunn, Tracey Lawrence and many others, all of whom did their part to help The 90-minute special on OEN splits its air-time between the event's Charity Concert which took place at Nashville's Wild Horse Saloon, and the actual race interviews, recorded in the pit areas at the Nashville Speedway. Fox Sports South covered the concert and the race for a television special that began airing in November and will air again on Dec. 24 at 7:30 p.m., Dec. 28 at 6 p.m. and Jan. 16 at 11:30 a.m. Central Time. To hear the concert on the Internet, go directly to OEN or link through Foxsports any time and then click on the Mark Collie Celebrity Race icon. 

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City Life Not All Bad

City dwellers may be more active than those living in small towns according to reseachers at the Centers for Disease Control and Prevention in Atlanta in a recent issue of the CDC's Morbidity and Mortality Weekly Report. In a 1996 survey, they found that 37 percent of rural dwellers, those who live in areas with populations below 2,500, are inactive. But the researchers found that in cities with populations of more than 1 million only about 27 percent say they get no exercise. Those living in the South were the most sedentary, whereas people in the West were the most active. These results held true even after age, income and education levels were taken into account (Those living in rural areas were generally older, poorer and less educated than city dwellers.). 

During 1996, scientists found that almost one third of adults living in the United States consider themselves couch potatoes. This number has jumped from 28.7 percent in 1992 to 29.4 percent in 1994 and stayed at that level in 1996. The study resulted from a survey of 119,000 Americans in the month before the survey was conducted. The next survey is scheduled for the year 2000.

Reacting to the study, Health and Human Services Secretary Donna E. Shalala said, "As the new year begins, almost one-third of Americans should be making a resolution to get the moderate physical activity they need...You don't need to be a star athlete to get exercise, but you need to set aside time for moderate physical activity in order to get the health benefits." 

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Information provided by The Diabetes Mall, (http://www.diabetesnet.com) 1-800-988-4772 or 011-1-619-497-0900

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