The 2013 Guidelines for Diabetes Care
Diabetes really ought to come with an owner's manual—a friendly guide that explains how to manage this chronic disease from cradle to grave.
Such a guide does exist, although it's written specifically for health care providers (and it is not a breezy read). That document is the Standards of Medical Care in Diabetes (SOMC), published each January by the American Diabetes Association (ADA).
Few folks living with diabetes know the document exists; fewer still have read it. Yet, the wisdom filters down, through your doctor's office visits, diabetes education programs, and in books and magazines.
|Making Strips Count|
|Previously, the ADA guidelines were misinterpreted as limiting test strips to three per day for people using insulin. Now they list specific situations when people on multiple daily injections or pump therapy should monitor blood glucose: at least prior to meals and snacks, sometimes after meals, at bedtime, prior to exercise, when they suspect low blood glucose, after treating a low until levels return to a safe range, and prior to critical tasks such as driving. Will these specifics ease limits on test strips or the high-use paperwork demanded by insurance plans? It's too soon to tell.|
"The standards are meant to provide recommendations for diabetes care from A to Z," says Sue Kirkman, MD. In her former role as ADA senior vice president of medical affairs and community information, Kirkman shepherded the annual review and publication of the SOMC from 2008 to 2013. The new document is 56 pages long—16 of those are references—and it's speckled with footnotes, asterisks, and tables.
That's in stark contrast to the original version, published in 1989. The guidelines for top-notch care fit into a scant four pages and were supported by just 10 references.
Even so, the position statement broke new ground. "Few organizations produced guidelines or standards," says Richard Kahn, PhD, former ADA chief scientific and medical officer, who championed putting recommendations in writing. "There was no such thing as evidence-based medicine" at the time, he says. Treatment was based on professional opinion rather than evidence.
By the mid-1980s, Kahn recalls, endocrinologists were concerned about stemming the tide of complications evident in people with diabetes who received care from general practitioners. The question about diabetes care became: "If the primary care doctor doesn't know how to do it, why doesn't the ADA say how to do it?"
Kahn typed a draft. He asked about 100 diabetes practitioners—the precursor of the ADA's multidisciplinary Professional Practice Committee (PPC)—to review it.
That first document, before some important diabetes trials in the early '90s, was based mostly on professional opinion, lacking a comprehensive review of content published in medical journals and graded medical evidence. After three or so rounds of revision, the standards were approved by the ADA board of directors and published in May 1989.
The ADA took some flak from the medical community. Kahn recalls receiving hate mail, along the lines of "Who is the ADA to be telling physicians how to practice medicine?" The idea of guidelines was too black and white for some practitioners. "There was enormous resistance by organized medicine," Kahn says. Some doctors disliked what they saw as a one-size-fits-all solution (more on that later).
|Control of this key health indicator has been raised slightly, from a systolic (top number) blood pressure (BP) goal of under 130 mmHg. Controlling blood pressure is key for safeguarding organs and blood vessels. Yet tight control may be difficult to achieve and in some cases dangerous, especially for the elderly or frail. The new guidelines for blood pressure: In general, people with diabetes and hypertension should be treated to a systolic goal of less than 140 mmHg. But a target of under 130 mmHg may be appropriate for younger patients.|
The recommendations have kept pace with medical advances. "We have the ability to frequently update when there is a major change in the evidence," Kirkman says.
The review is a methodical process carried out by the Professional Practice Committee, leading experts who volunteer their time. What's crucial is having a transparent process firmly grounded in science, Kahn says. "Is it undergoing a fair and comprehensive review by a body that doesn't have a vested interest? Can we defend it?"
Evidence is graded (for example, evidence from a multicenter randomized controlled trial is graded more highly than evidence from observational studies). Clinical experience is still valuable, however. "Some places we just have to make a recommendation based on expert opinion and clinical experience," Kirkman says. "We're never going to have a randomized controlled trial on everything."
In addition to providers, other players in the health care system pay close attention to the SOMC. Insurance companies, for example, consider the recommendations when deciding what services and medications they'll pay for. "We anticipated this would be the mechanism to get primary care providers to move toward better care," Kahn says. "We didn't figure reimbursement would be tied to this." But it is, which means each word is considered (see "Making Strips Count," opposite).
Kirkman notes that the standards are used by insurance companies to alert physicians to "missed" tests, for example. "The guidelines are often translated into performance measures, for better or worse," she says. After all, what's generally good for a population may differ from what's good for an individual.
Evidence can't help but focus on the middle ground. "We're still just talking about the average in each recommendation," Kirkman says. "Evidence is about averages. You and your health care provider need to do the experiment with you."
The balance between general guidelines for populations and customized treatment plans for individuals continues. "We're thinking a lot more of the whole spectrum of people with diabetes," Kirkman says, from babies to pregnant women, to people with 70 years of insulin use. The change in language about the A1C goal (a measure of average blood glucose over the past two to three months) is one example. Until 2009, the recommendation was less than 7 percent. After several trials found that tight control in older people with cardiovascular disease could increase the risk of death, the recommendation was clarified as being for "most people," with tighter or looser goals appropriate for certain individuals.
Kahn's biggest regret during the last years of his 25-year tenure at the ADA was that the guidelines, while focused on health benefits and risks and based on scientific evidence, failed to include analysis of whether the recommendations were cost-effective. "If it costs a ton of money to get a real but very small benefit, that information should be important to providers and patients," he says. Kirkman says, however, that the PPC often cites cost-effectiveness studies.
Both Kahn and Kirkman also note that something else is missing: the voice of the patient. The Institute of Medicine recommends that patients be included when developing guidelines. The ADA hasn't yet figured out the best way to find patients who are familiar enough with the science to contribute in meaningful ways—although some of the committee professionals do live with diabetes. The document has been available online for public comment since 2011, but few comments have been received, mostly from health care providers.
The 2013 SOMC is free at Diabetes Care. Skim the executive summary for a digest of significant changes. Online comments about 2013 document are accepted at professional.diabetes.org/cpr. That's a chance to get on the same page with health care providers to ensure the very best care for you.