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ByLauranNeergaard TheAssociatedPress WASHINGTON Transplants of insulin-producing pan- creas cells are a long hoped- for treatment for diabetes — and a new study shows they can protect the most seri- ously ill patients from a life- threatening complication of the disease, an important step toward U.S. approval. These transplants are usedinsomecountriesbutin theU.S.they'reavailableonly through research studies. Armed with Monday's find- ings, researchers hope to li- cense them for use in a small number of people with Type 1 diabetes who are most at risk for drops in blood sugar soseveretheycanleadtosei- zures, even death. "Cell-based diabetes ther- apy is real and works and offers tremendous potential for the right patient," said study lead author Dr. Bern- hard Hering of the Univer- sity of Minnesota, whose team plans to seek a Food and Drug Administration li- cense for the therapy. In Type 1 diabetes, the immune system destroys the pancreatic cells respon- sible for making insulin, a hormone crucial to convert- ing blood sugar into energy. About 1 million Americans have Type 1 diabetes and depend on regular insulin shots to survive but still can experience complica- tions due to swings in their blood sugar. Diabetics who get kid- ney transplants sometimes also receive pancreas trans- plants at the same time, es- sentially curing their diabe- tes. But it's an uncommon and grueling operation, so scientists for years have worked on a minimally in- vasive alternative: Infusing patients with just islet cells, the insulin factories inside the pancreas. The questions: How best to obtain those islet cells from deceased donors, and who benefits most from transplants? When glucose levels drop too low, most people with Type 1 diabetes expe- rience early warning signs — slurred speech, trem- ors, sweating, heart palpi- tations — so they know to eat or drink something for a quick sugar boost. But even with optimal care, about 30 percent eventually quit ex- periencing those symptoms, a condition called hypogly- cemia unawareness. They can be in grave danger if their blood sugar plummets when no one else is around to help. Continuous glu- cose monitors can counter- act that problem, but even those don't help everyone. The National Institutes of Health targeted that frac- tion of highest-risk patients, funding a study that gave 48 people at eight medical centers at least one islet cell transplant. A year later, 88 percent were free of severe hypo- glycemia events, had their awareness of blood sugar dips restored, and harbored glucose levels in near-nor- mal ranges. Two years later, 71 percent of participants still were faring that well, concluded the study pub- lished by the journal Dia- betes Care. The goal wasn't insulin independence, which re- quires more functioning islet cells than merely re- storing blood sugar aware- ness. But some patients — 52 percent after one year — no longer needed insulin shots and others used lower doses. "It's just an amazing gift," said Lisa Bishop of Ea- gle River, Wisconsin, who received new islet cells in 2010 and no longer needs insulin shots. Bishop re- calls the terror of learning she'd become hypoglyce- mic unaware, and the diffi- culty of even holding a job. She hasn't had hypoglyce- mia since the transplant and says if her blood sugar occasionally dips a bit af- ter exercise, "now my body senses it." Another key: The trans- plants have long been used experimentally but differ- ent hospitals use different methods to cull the islet cells from a donated pan- creas and purify them — and it wasn't clear which worked best, explained Dr. Nancy Bridges, chief of the transplant branch at NIH's National Institute for Allergy and Infectious Diseases. The FDA made clear that there had to be a standard method for is- let cell transplants if they were ever to be approved — which is necessary for in- surance coverage — so the researchers developed that recipe, Bridges said. Side effects include bleeding and infection, and recipients need lifelong im- mune-suppressing drugs to avoid rejecting their new cells. Even if given the OK for more routine use, do- nated pancreas cells are in limited supply. Still, "it's a very beau- tiful study," said Dr. Julia Greenstein of the diabe- tes advocacy organization JDRF, who wasn't involved in the latest research. "For most people in the U.S., this was not an available choice, and this is the first step in making that an available choice." STUDY Pancreas cell transplants backed for severe diabetes ASSOCIATEDPRESSFILEPHOTO A woman diagnosed with diabetes gives herself an injection of insulin at her home in the Los Angeles suburb of Commerce. Transplants of insulin-producing pancreas cells are a long hoped-for treatment for diabetes, and a new study shows they can protect the most seriously ill patients from a life-threatening complication, an important step toward U.S. approval. By Ricardo Alonso- Zaldivar The Associated Press WASHINGTON They work for the government and even their closest relatives have no idea what they do. It's not because they're spies or nuclear scientists, but because their jobs are so arcane: trying to rein- vent Medicare to improve it, and maybe save taxpay- ers money. In a sprawling, nonde- script office park near Bal- timore, some 360 people at the Center for Medicare & Medicaid Innovation are trying to change the health care system, using the gov- ernment's premier insur- ance program as leverage. If they prevail, the U.S. may no longer have the worst of both worlds: unsustainable spending and unenviable results. "I want Medicare to ex- ist not just for my mother, but for me and my kids," said the director, Patrick Conway, 41, a pediatrician who also serves as Medi- care's chief medical offi- cer. At the center are doc- tors, lawyers, health policy experts, and career Medi- care employees. Many came from outside government. They're somewhat younger than Medicare's core staff. Some have seen how par- ents and grandparents can be harmed in the nation's disjointed health care sys- tem. The center's physical layout is meant to en- courage discussion and debate. Meeting rooms have walls you can write on to diagram ideas. Lap- tops are at every meet- ing, but for thinkers who like to have a toy in their hands to play with, there's a cigar box with colorful dinosaurs in one confer- ence room. The innovation center can't yet claim it's saving Medicare from extinction. Its experiments have pro- duced modest results that on balance are encourag- ing. The center is in its sixth year, and its influence is starting to be felt through- out Medicare in areas from joint replacement surgery to cancer treatment and front-line primary care, which remains a principal focus. Medicare started out as an efficient bill-paying ser- vice that asked doctors and hospitals few questions. Lawmakers eventually re- alized that was a path to financial ruin, and they turned to blunt cuts that caused new problems. The idea now is to use Medicare payments to cre- ate financial incentives for doctors and hospitals to work together, helping patients avoid costly hos- pitalization whenever pos- sible. That might mean paying a primary-care practice to hire a clinical coordinator who keeps tabs on patients with chronic illnesses. It could mean holding hos- pitals accountable for the overall cost and quality of joint replacement surgery, to encourage attention to rehabilitation. Success- ful experiments can be ad- opted as permanent policy without seeking approval from Congress. Because the center was created by President Barack Obama's health care law, its future under a Republican president is questionable. But Republicans would be wise to keep the center run- ning, said Mark McClellan, the Medicare chief under former President George W. Bush. "The authority to try out and then expand successful models of Medicare reform is a very useful capability," he said. A Republican adminis- tration might do more to engage Medicare beneficia- ries to bring about change, McClellan said. That could involve of- fering financial rewards for healthy behavior. Right now very few of Medicare's 55 million beneficiaries have any idea that changes they're starting to see are part of a deliberate effort to remake the traditional side of the program. Back at the center, adult medicine specialist Hoang- mai "Mai" Pham serves as a kind of problem-solver-in- chief, working with differ- ent project teams to iden- tify and resolve common issues. Her work is also guided by personal expe- rience. Pham has been closely involved with "account- able care organizations," or ACOs. That's a major effort to set up networks of hospi- tals and doctors that work together, striving to keep patients healthier and meet quality and cost goals. At first, Pham found it stressful working with med- ical practices around the country making the transi- tion to a model of account- ability, with payment hing- ing on results. "You need to build up a lot of trust," she said. A key was provid- ing access to Medicare data that gave the practices a comprehensive view of their patients. Now Pham says she's had doctors tell her, "this is what we always wanted to do." About 9 million ben- eficiaries, or close to 1 in 4 of those with traditional Medicare, are currently in ACOs. Among the center's more than 60 experiments: • A "Comprehensive Pri- mary Care Plus" initiative that will involve 5,000 med- ical practices. They will get upfront payments to coor- dinate care. • A change in the way Medicare pays for drugs ad- ministered in a doctor's of- fice, including chemother- apy. Medicare says it wants to reduce incentives for doc- tors to prescribe the most expensive drugs. Cancer doctors are opposing the proposal, which is still open for public comment. • A program started this month that holds hospi- tals in 67 major metro ar- eas accountable for costs and quality for hip and knee replacements, the most common inpatient procedure for Medicare patients. 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