Managing Diabetes Complications: Focus on the Fundamentals of Care
The serious complications of diabetes are well known: cardiovascular disease, nephropathy, retinopathy, and neuropathy. These microvascular and macrovascular complications can have devastating consequences on the health of people with diabetes.
Health plans can improve the quality of care in this area by:
The first step in preventing or delaying the onset of diabetes complications is raising patients’ awareness of risk. Table 1 gives a brief overview of the risks of cardiovascular disease (CVD), nephropathy, retinopathy, and neuropathy in different populations. Other common complications of diabetes include periodontal disease, birth defects or spontaneous abortions of babies in mothers with uncontrolled diabetes, and biochemical imbalances that can cause life-threatening events, such as diabetic ketoacidosis and hyperosmolar (nonketotic) coma. There is also a greater risk of contracting and dying from other illnesses, such as pneumonia or influenza.
Controlling the ABCs of Diabetes
The top priorities for minimizing the risks of all microvascular and macrovascular diabetes complications are the “ABCs of Diabetes”—A1c control, lowering blood pressure, and lowering cholesterol.[1,8] The ADA and the ACC have developed an initiative called Make the Link! Diabetes, Heart Disease and Stroke to educate diabetes patients and health care professionals about the importance of managing these important risk factors. The initiative includes a Web site with information and an interactive program for patients. For professionals, the site contains a newsletter, a tool kit with patient handouts, clinical practice recommendations, and a links library.
The foundation of diabetes treatment is improved glycemic control, which reduces the risk of microvascular complications and is associated with lower risk of macrovascular disease and atherosclerosis. In patients with type 2 diabetes, the risk of diabetic complications is strongly associated with previous hyperglycemia.
Evidence is accumulating that controlling hypertension and cholesterol levels is also important for reducing diabetic vascular complications. Blood pressure control can reduce CVD by 33% to 50% and can reduce microvascular disease by about 33%. Improved lipid control can reduce CVD complications by 20% to 50%.
As discussed previously, the HEDIS rates for control of A1c and lipid levels in diabetic patients are improving. However, in the NHANES 1999-2000 survey (which assesses the general population), only 7.3% of people with diabetes met the ADA recommended guidelines for all three risk factors: blood glucose, cholesterol, and blood pressure levels. To improve quality of care, health plans need to promote screening and proactive treatment to reach the ABC goals.
Studies have shown that, in general, every reduction in A1c level of 1% (e.g., from 8% to 7%) reduces the risk of developing microvascular complications by 40%.2 The ADA recommends a treatment goal of A1c <7%. In the NHANES 1999-2000 survey, about 37% of patients with diabetes had an A1c level higher than 8%, the level at which the ADA recommends focused treatment action.  Achieving glycemic control requires an active partnership between the patient and his or her physician.
Self-Monitoring of Blood Glucose
Self-monitoring of blood glucose (SMBG) allows patients to evaluate their response to therapy and assess whether they are reaching their A1c target. Physicians can use SMBG results to adjust medications. Patients who take insulin need to monitor blood glucose at least daily to prevent asymptomatic hypoglycemia and hyperglycemia. Most patients with type 1 diabetes need to monitor three or more times per day. Patients with type 2 diabetes on oral drug therapy need to monitor often enough to reach their A1c goal.
Because accuracy of SMBG depends on the instrument used and the user’s technique, caregivers must ensure that patients learn how to use the instrument and monitor the patients’ technique at regular intervals. Patients also need to know how to use the data to adjust their food intake, physical activity, or drug therapy to achieve specific glycemic goals.
Lifestyle changes (diet and exercise) are typically the first-line treatment for type 2 diabetes and can be very effective in controlling blood glucose levels early in the disease. When this treatment fails to maintain adequate glucose control, oral antihyperglycemic agents are usually the next step.Over time, due to the progressive nature of type 2 diabetes, a combination of oral agents is frequently necessary to maintain glucose control.
In type 2 diabetes, insulin is generally initiated only after oral agents are no longer able to maintain adequate glucose control. Unfortunately, physicians may delay the appropriate use of insulin, at least in part because of resistance from the patient. Techniques to address patient and physician resistance to the initiation of insulin are discussed in the section titled “Addressing the Quality Gaps in Diabetes Prevention and Care”.
The goal of insulin therapy is strict glycemic control without significant hypoglycemia. Because older insulin products do not closely mimic normal insulin secretory patterns, they can be problematic. Insulin analogs, both rapid-acting (postprandial) and long-acting (basal), are now available. Three of these analogs—lispro, aspart, and glargine—have been widely studied, and others are being developed.
Researchers have been attempting to find alternative methods of delivering insulin for the past 75 years, but success has been limited. Recent clinical studies suggest that inhaled insulin, either a dry powder formulation or a liquid aerosol formulation, may become the first nonsubcutaneous route of insulin administration for widespread clinical use.
Blood Pressure Control
Hypertension is also a well-known cardiovascular risk factor that is highly prevalent in type 2 diabetes and in persons with overweight/obesity. It is also a component of metabolic syndrome.[19,20] A recent study of young white men found that elevations in blood pressure preceded the development of type 2 diabetes in middle age by 20 to 25 years. The ADA recommends a blood pressure (BP) treatment goal of <130 mm Hg systolic and <80 mm Hg diastolic.
According to the United Kingdom Prospective Diabetes Study (UKPDS), each decrease of 10 mm Hg in mean systolic BP was associated with the following reductions in risk:
Patients should have BP measured at every scheduled diabetes visit, both in the supine and standing positions. Those whose BP is elevated on two occasions separated by at least one week can be diagnosed with hypertension.
Treatment With Multiple Medications
Research has shown that angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers, low-dose thiazide diuretics, and ß-blockers are all effective antihypertensives. Some patients require three or more drugs to achieve target levels of BP control. In the UKPDS, 29% of patients in the tight BP control group required three or more antihypertensive drugs after nine years of follow-up.
The ADA recommends the following treatment goals for lipid control:
Adults with diabetes need to be screened for high cholesterol levels at least once a year. Children over two years of age should be tested at diagnosis, after glucose control has been achieved, and every five years thereafter.Medication Treatment
If the patient is at high risk for CVD, the ADA and the ACC recommend that physicians consider beginning drug therapy at the same time as behavioral therapy for cholesterol, even in patients with borderline values. For patients otherwise not at high risk for CVD, lifestyle behavioral changes may be tried first and evaluated at six-week intervals. If these changes do not result in achieving treatment goals within three to six months, drug therapy should be initiated.
Statins are the first-line medication for lowering LDL levels. Fibrates reduce CVD risk for patients with low HDL and slow carotid intimal medial thickness progression. When prescribing both a statin and a fibrate or niacin in combination, physicians need to be cautious of adverse effects.
Screening for and Treating Diabetes Complications
Early detection of complications has the potential to alter the course of the complication and reduce mortality through recommendations for modifying lifestyle and pharmacological and other therapy. Adding screening and treatment for complications to control the ABCs can have a large impact on the quality of life for patients with diabetes.Cardiovascular Disease
More than 65% of people with diabetes die from heart disease or stroke. Unfortunately, according to a 2001 survey by the ADA and the ACC, 68% of diabetic patients did not think CVD was a serious complication of diabetes, and only 18% believed that they were at increased risk for CVD.[25-27] The proportion of Hispanics and older adults who lacked knowledge of CVD risk was even higher at 75%. The ADA recommends that physicians assess cardiovascular risk factors in their patients with diabetes at least once a year and consider use of aspirin therapy, which is effective and inexpensive.[12,28]
For more information on CVD, please refer to Quality Profiles™: The Leadership Series—Focus on Cardiovascular Disease.Nephropathy
Nephropathy occurs in 10% to 21% of all people with diabetes and is the leading cause of end-stage renal disease (ESRD). ESRD occurs in 50% of patients with type 1 diabetes with overt nephropathy within 10 years and in more than 75% by 20 years. The risk of nephropathy in type 1 diabetes is 12 times as high as in type 2 diabetes. Risk factors for nephropathy include race, genetic susceptibility, hypertension, hyperglycemia, hyperfiltration, smoking, and possibly advanced age, male sex, and dyslipidemia.
Control of blood glucose and blood pressure are important strategies for slowing the progression of nephropathy. Large prospective randomized studies have shown that intensive diabetes management with the goal of achieving near normoglycemia delays the onset of microalbuminuria and delays the progression of microalbuminuria to macroalbuminuria in patients with both type 1 and type 2 diabetes.
Controlling blood pressure can also reduce the risk of developing nephropathy. One study demonstrated that the use of ACE inhibitors to treat hypertension was more effective than other classes of antihypertensives in delaying the progression from microalbuminuria to macroalbuminuria.
The ADA recommends yearly screening for microalbuminuria in patients who have had type 1 diabetes for five years or more and in all patients with type 2 diabetes. Protein restriction may benefit patients whose nephropathy is progressing despite optimal glucose and blood pressure control.
The prevalence of retinopathy is strongly related to the duration of diabetes. Nearly all patients with type 1 diabetes develop retinopathy, and most type patients with type 2 diabetes eventually develop some degree of it.
As in nephropathy, control of blood glucose and blood pressure are important strategies for reducing the risk and slowing the progression of retinopathy; in fact, nephropathy and retinopathy are frequently seen together in patients with diabetes.
Intensive diabetes management with the goal of achieving near normoglycemia prevents or delays the onset of retinopathy, and lowering blood pressure reduces its progression. The ADA recommends an initial eye exam for those who have type 1 diabetes within five years of diagnosis and shortly after diagnosis for those who have type 2 diabetes. Thereafter, nearly all patients with diabetes should have annual exams, and more often if retinopathy is progressing. One of the main reasons for screening is to allow for early detection of the condition when interventions such as laser photocoagulation surgery can prevent vision loss.Neuropathy
Approximately 45% of patients with diabetes have neuropathy during the course of the disease. Neuropathy is associated with pain in about 4% to 5% of all patients with diabetes.
Foot ulceration and amputation are the most common consequences of diabetic neuropathy and are major causes of morbidity and disability in people with diabetes.
The risk of ulcers or amputations is higher in people who:
Approximately 60% of nontraumatic lower-limb amputations in the United States occur among people with diabetes, and 85% of those are preceded by a foot ulcer. Comprehensive foot care programs can reduce amputation rates by 44% to 85%.
Preventive strategies should focus on:
The ADA recommends that all patients with diabetes receive a comprehensive foot exam annually and those with neuropathy at every health care visit. High-risk patients should be referred to a foot care specialist.
Because peripheral arterial disease (PAD) is a major risk factor for lower-extremity amputation and because many patients are asymptomatic, screening for PAD is another important way to prevent amputations.
Disease Management: A Tool for Improving Care
Disease management programs help health care organizations address many of the issues patients and physicians face when dealing with a chronic disease like diabetes. Those health care organizations that use disease management programs appear to have lower medical costs over the long term while improving results (A1c testing, A1c levels, eye exams, LDL levels, nephropathy screening, and hypertension).[40,41] Patients with diabetes in disease management programs also appear to have lower hospitalization rates, make fewer emergency room visits, and comply more often with recommended office visits.[41,42]
While there are no definite randomized controlled trials that “prove” the value of disease management, there is a fairly large body of evidence accumulated that suggests the efficacy of disease management in improving quality of care in diabetes.Targeted Disease Management Outreach Improves Patient Health and Utilization
One diabetes disease management program administered by a vendor service included general education, nurse-initiated enrollment calls, clinical assessments, and ongoing telephone monitoring by a nurse. Physicians received a patient evaluation and a written action plan.
The results found:
In another organization, a rural not-for-profit HMO, a chart review to determine the impact of a diabetes disease management program with 3,118 enrolled patients showed good results. The program involved one to four annual visits with a nurse in the primary care setting and patient education by nurse educators about self-management techniques and preventive care. The program’s treatment guidelines were based on the HEDIS diabetes care measures.
The results of the chart review found:
Florida: A Healthy State is a patient-centered disease management program for Medicaid beneficiaries with any of four chronic diseases, including diabetes. It comprises a clinical support network that uses community-based care teams operating out of hospitals and an off-site call center. The care teams use one-on-one contact and technology tools provided by the program to educate patients about their disease, improve their ability to change behaviors, and reinforce changes with home health devices and individualized care plans.
Educational materials are culturally sensitive and written at appropriate literacy levels in both English and Spanish. Results for the targeted patients with diabetes, based on disease-specific measures and utilization analysis, included:
2. American Diabetes Association. National diabetes fact sheet. Available at: http://www.diabetes.org/utils/printthispage.jsp?PageID=STATISTICS_233193. Accessed March 14, 2005.
3. American Diabetes Association, American College of Cardiology. Diabetes & Cardiovascular Disease Review. Coronary Heart Disease in Women with Diabetes. Issue 5. Available at: http://www.diabetes.org/uedocuments/Issue5.women.diabetes.cvd.pdf. Accessed March 14, 2005.
5. American Diabetes Association. Diabetes and nephropathy (kidney complications). Available at: http://www.diabetes.org/utils/printthispage.jsp?PageID=STATISTICS_233191. Accessed March 14, 2005.
6. American Diabetes Association. Diabetes and retinopathy (eye complications). Available at: http://www.diabetes.org/diabetes-statistics/eye-complications.jsp. Accessed March 14, 2005.
8. American Diabetes Association, American College of Cardiology. Diabetes & Cardiovascular Disease Review. Hypertension in diabetes. Issue 2. Available at: http://www.diabetes.org/uedocuments/ADACardioReview_2.pdf. Accessed December 18, 2004.
9. American Diabetes Association. Make the Link! Diabetes, Heart Disease and Stroke. Available at: http://www.diabetes.org/utils/printthispage.jsp?PageID=TYPE1DIABETES3_232972. Accessed March 11, 2005.
10. Stratton IM, Adler AI, Neil HAW, et al, on behalf of the UK Prospective Diabetes Study Group. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ. 2000;321:405-412.
11. American Diabetes Association. Fight against diabetes and heart disease link intensifies: more efforts needed to help people with diabetes manage the “abcs of diabetes” [press release]. Available at: http://www.diabetes.org/utils/printthispage.jsp?PageID=MISCELLANEOUS3_273474. Accessed March 16, 2005.
15. Haran C. A passage to insulin: natural progression or failure? Available at: http://www.healthology.com/focus_article.asp?f=diabetes&b=healthology&c=diabetes_insulin. Accessed March 18, 2005.
17. Heinemann L, Pf¨utzner A, Heise T. Alternative routes of administration as an approach to improve insulin therapy: update on dermal, oral, nasal and pulmonary insulin delivery. Curr Pharm Des. 2001;7:1327-1351.20. Golden SH, Wang N-Y, Klag MJ, Meoni LA, Brancati FL. Blood pressure in young adulthood and the risk of type 2 diabetes in middle age. Diabetes Care. 2003;26:1110-1115.
22. American Diabetes Association, American College of Cardiology. Diabetes & Cardiovascular Disease Review. Diabetic dyslipidemia. Issue 3. Available at: http://www.diabetes.org/uedocuments/ADIACardioReview3.pdf. Accessed March 9, 2005.
23. Eyre H, Kahn R, Robertson RM, on behalf of the ACS/ADA/AHA Collaborative Writing Committee. Preventing cancer, cardiovascular disease, and diabetes: a common agenda for the American Cancer Society, the American Diabetes Association, and the American Heart Association. Diabetes Care. 2004;27:1812-1824.
24. American Diabetes Association. Diabetes and cardiovascular (heart) disease. Available at: http://www.diabetes.org/utils/printthispage.jsp?PageID=STATISTICS_233190. Accessed March 15, 2005.
25. Inzucchi SE. Poll shows people with diabetes unaware of risk for heart disease [press release: March 15, 2002]. Available at: http://www.ynhh.org/healthlink/cardiac/cardiac_3_02.html. Accessed February 10, 2005.
26. American Diabetes Association, American College of Cardiology. The diabetes-heart disease link: surveying attitudes, knowledge and risk. Survey results at a glance. Available at: http://www.diabetes.org/uedocuments/ataglance_1.pdf. Accessed January 27, 2005.
27. American Diabetes Association, American College of Cardiology. Diabetes & Cardiovascular Disease Review. Redefining diabetes control. Issue 1.Available at: http://www.diabetes.org/uedocuments/DCVDissue1.pdf. Accessed October 20, 2004.
30. National Institute of Mental Health. Depression and diabetes. Available at: http://www.nimh.nih.gov/publicat/NIMHdepdiabetes.pdf. Accessed March 17, 2005.
31. McMan’s Depression and Bipolar Web site. Depression and diabetes. Available at: http://www.mcmanweb.com/article-42.htm. Accessed March 18, 2005.
32. Watkins CE. Diabetes, depression, and stress. Available at: http://www.baltimorepsych.com/dmdepression.htm. Accessed March 18, 2005.
33. Hospital Practice. Managing painful diabetic neuropathy. Available at: http://www.hosppract.com/issues/1999/10/ceback.htm. Accessed April 18, 2005.
34. Centers for Disease Control and Prevention. History of foot ulcer among persons with diabetes—United States, 2000-2002. MMWR Weekly. 2003;52:1098-1102. Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5245a3.htm. Accessed March 15, 2005.
43. Florida: A Healthy State. A Florida First Health Care Initiative. November 2004 update. Available at: http://www.pfizerhealthsolutions.com/pdf/ProgramOverview2.pdf. Accessed February 23, 2005.
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