New paradigm: Treat diabetes by stage
New paradigm: Treat diabetes by stage
Programs target caregivers as much as patients
Clinicians are beginning to think of Type 2 diabetes as a progressive or even degenerative disease. And they are discovering that by aggressively managing diabetes and acting quickly to adjust medications when necessary, they can slow the progression of the disease and delay the onset of complications.
The newest thinking is far from fatalistic, although all recent studies point to a grim prognosis for patients who fail to maintain tight glycemic control.
"In many patients, all strategies will fail over time," says Mitchell Hamburg, MD, FACE, associate clinical professor of medicine at the University of Missouri-Kansas City Medical School and consulting physician at St. Luke’s Hospital in Kansas City, MO.
Hamburg is an advocate of a metformin and sulfonylurea combination therapy, which "may be the best at all stages of the disease."
"I wouldn’t call diabetes a degenerative disease," he says. "It’s a disease with two facets — diminished beta cell function and insulin resistance. Over time, the beta cells will fail and insulin will become necessary."
"Whatever it takes to control diabetes, you’ve got to do," says Phil Levy, MD, a member of the board of directors of the American Association of Clinical Endocrinologists and a practicing endocrinologist in Phoenix.
Finding some answers
Developing easy-to-follow treatment plans and signals for deteriorating conditions is key to helping busy primary care physicians manage their diabetic patients, Levy says.
For 11 years, the International Diabetes Center (IDC) in Minneapolis, has done just that, adjusting and re-adjusting algorithms for treatment plans as new research, new therapies, and new treatments become available.
The IDC’s most recent version of its Master DecisionPath for Type 2 diabetics was recently readjusted after troglitazone came on the market and conforms with the results of the United Kingdom Prospective Diabetes Study released last fall. It is one of several diabetes DecisionPaths aimed at primary care physicians and their care teams to make their jobs easier. (See DecisionPath, inserted in this issue. )
"It’s important for us to remember that the patient doesn’t fail; the therapy fails," says Renea Bradley, RN, MSN, ARNP, CDE, manager of the IDC’s Staged Diabetes Management Training. Bradley helped develop most of the guidelines currently in place.
So, Bradley says, therapy needs to be ever-evolving. "Every time there is a new drug approved by the FDA, we change our DecisionPaths," she says. "Our mission is to translate research into practice."
Bradley says it is now well-recognized that beta cells become exhausted as diabetes progresses, making glycemic control more difficult to achieve and requiring even more potent drug therapies to keep HbA1c results at acceptable levels and prevent or delay the onset of complications.
Six stages
She defines these stages of Type 2 diabetes and their drug treatments:
Stage 1: There are slight elevations in blood glucose — diet and exercise program recommended.
Stage 2: The patient requires treatment with a single oral agent — usually sulfonylureas or metformin.
Stage 3: The patient receives a combination therapy of oral agents — troglitazone and/or sulfonylureas and/or insulin.
Stage 4: Insulin therapy is initiated.
Stage 5: Additional insulin injections are added if patient experiences persistent midafternoon hyperglycemia.
Stage 6: Additional insulin injections are added if patient continues to experience midafternoon hyperglycemia and begins nocturnal hypoglycemia.
Of course, Bradley says, some patients enter the chart at higher stages depending on their plasma glucose levels at diagnosis. She also notes some patients can move to lower stages as they achieve control, particularly if they had an extremely high blood glucose at diagnosis (greater than 300 mg/dL).
Bradley says patients don’t get "stuck" at a particular level for long periods of time.
In the staged diabetes management (SDM) program, if they don’t reach their target goals in a very short period of time — two to four weeks in the oral agent monotherapy stage — they are moved to the combination therapy stage. If they reach their target goals, their caregivers try to keep them there. They’re moved to progressively aggressive insulin therapy in equally short order if they don’t respond to combination therapy.
Physician- and patient-friendly
"Our job is to take a complex disease and organize it in a way that is understandable and user-friendly for physicians and patients alike," says Bradley.
The IDC’s staged diabetes management training, based on American Diabetes Association guidelines, is offered all over the world. It has shown dramatic results in terms of lowering HbA1c and cholesterol levels, while lowering per-patient costs to the wide range of clinics, hospitals, managed care plans that use IDC’s comprehensive education programs.
Each course includes all members of the care team and lasts between four and eight hours.
But the training is more involved than attending the sessions. Assessments precede and follow the training. Educational materials are provided, and there is considerable support for the team as it decides what strategy to follow, which "gets everybody on the same page in terms of treatment," Bradley.
"We now know these therapies and tight control make a difference," she says.
Data support SDM
A wide variety of studies show the benefits of SDM. Many of these studies were conducted by Bradley’s pioneering team. Over and over they show dramatically improved outcomes in a broad spectrum of settings:
In a rural primary care clinic, 660 patients with an average age of 62 dropped their average HbA1c from 8.7% to 7.5% over a one-year program. In an Indian Health Service clinic, the number of lower-extremity amputations was reduced by 48% over an 11-year period with increasingly tight control, neuropathy screenings, and aggressive treatment of foot ulcers. Twenty-two people were able to avoid amputations. In an SDM management program designed to change the practice behavior of health care providers in managed care, HbA1c levels of 130 patients dropped from 8.6% at baseline to 7.2% in three months and dropped another .4% in the following three months. In a program at Tufts University, eight hours of SDM training for doctors in an internal medicine residency resulted in an increase in referrals to a diabetic educator from 17% to 83%. Referrals to a nutritionist increased from 26% to 74%; annual influenza vaccine rates increased from 52% to 74%; annual lab screenings for cholesterol and microalbumin increased from 30% to 70% and 52% to 82% respectively. In another study, the training of nurse-dietitian teams was productive in lowering HbA1c levels from 9.6% to 7.6% in six months. Patients were able to lower their cholesterol levels from a baseline average of 218.5 mg/dL to 203.7 mg/dL in the same period. HDL levels increased from 38.2 mg/dL to 42 mg/dL. Significant cost savings were demonstrated with SDM programs as opposed to typical primary care. A group of 183 patients with Type 2 diabetes showed a cost savings of $171,000 to one health plan over one year, which translated to a savings to the health system of $2.57 for every dollar spent on staged diabetes management.Bradley says she isn’t daunted by the Herculean task of tackling diabetes and slowing its progression because treating the disease in stages means approaching it one step at a time.
[Contact Renea Bradley at (612) 993-2721.]
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