Continuous Quality Improvement Network Project #2
 Appropriate Treatment for ESTABLISHED Patients with Diabetes Mellitus

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Contents:

Explanation of importance of condition (why chosen)
 Rationale for criteria/quality indicators and supporting scientific evidence
 Definition of the condition
 Instructions for completion of the condition template
 Scope of the template
 References
 Bibliography


Explanation of importance of condition (why chosen)

  • Persistent hyperglycemia is the hallmark of all forms of diabetes. Treatment aimed at lowering blood glucose levels to normal or near normal in all patients is mandated by the following proven benefits:

    • The danger of acute decompensation due to diabetic ketoacidosis or hyperosmolar hyperglycemic nonketotic syndrome, with their accompanying morbidity and mortality, is markedly reduced.
    • The symptoms of blurred vision are alleviated, and the potential danger of comorbidity may be decreased.
    • The development or progression of diabetic retinopathy, nephropathy, and neuropathy are all greatly decreased. It is possible that these complications may even be prevented by early normalization of metabolic status.
    • Near normalization of blood glucose is associated with a reduced atherogenic lipid profile.

Rationale for criteria/quality indicators and supporting scientific evidence

  • The Diabetes Control and Complications Trial (DCCT), a large multicenter randomized clinical trial with 1441 type 1 diabetics, showed that lowering blood glucose concentration slows or prevents the development of diabetic complications (1). While no randomized studies have been completed with type 2 diabetics, "there are some observational studies showing fewer cardiovascular events and less mortality in better controlled type 2 diabetes . . . It is reasonable to expect that therapy that achieves glycemic goals similar to those in the DCCT will provide similar benefits with regard to long-term microvascular and neurological complications (1)."

    When setting treatment goals for type 2 diabetes, the same individual patient characteristics should be considered as for type 1 diabetes: the patient's capacity to understand and carry out the treatment regimen; the patient's risk for severe hypoglycemia; and other factors that may increase risk or decrease benefit (e.g., advanced age, end-stage renal disease, advanced cardiovascular or cerebrovascular disease, or other coexisting diseases).

    Type 2 diabetes treatment methods should emphasize nutrition therapy, exercise, and weight reduction, supplemented when indicated by oral agents and/or insulin.

    Continuing care is essential in the management of every patient with diabetes. At each visit, the patient's progress in achieving treatment goals should be evaluated by the health care team. Problems should be reviewed. If goals are not being met, the management plan needs to be reassessed.

Definition of the condition

  • Approximately 700,000 Americans have type 1 diabetes (formerly known as insulin-dependent diabetes mellitus), a disease characterized by destruction of the pancreatic beta-cells that produce insulin, usually leading to absolute insulin deficiency. The cause of beta-cell destruction is a cellular-mediated autoimmune reaction. In this form of diabetes, the rate of beta-cell destruction is quite variable, being rapid in some individuals (mainly infants and children) and slow in others (mainly adults)(2). Some patients, particularly children and adolescents, may present with ketoacidosis as the first manifestation of the disease. Others have modest fasting hyperglycemia that can rapidly change to severe hyperglycemia and/or ketoacidosis in the presence of infection or other stress. Adults, in particular, may retain residual beta-cell function sufficient to prevent ketoacidosis for many years. These individuals eventually become dependent on insulin and are at risk for ketoacidosis. At this latter stage of the disease, there is little or no insulin secretion, as manifested by low or undetectable levels of plasma C-peptide. Immune-mediated diabetes commonly occurs in childhood and adolescence, but it can occur at any age, even in the eighth and ninth decades of life(2).

    Type 2 diabetes (formerly known as non-insulin-dependent diabetes mellitus) reflects insulin resistance, in which the body fails to use insulin properly, combined with relative (rather than absolute) insulin deficiency. This type of diabetes ranges from predominantly insulin resistant, with relative insulin deficiency, to predominantly an insulin secretory defect with insulin resistance. It typically occurs in those who are over 45 years old, overweight, sedentary, and with a family history of diabetes. Approximately 16 million Americans have type 2 diabetes (2). At least initially, and often throughout their lifetime, these patients do not need insulin treatment to survive. There are many different causes of this form of diabetes, and most likely the proportion of patients in this category will decrease in the future as identification of specific pathogenic processes and genetic defects permits better differentiation among them into more definitive subclassifications.

    Obesity itself causes some degree of insulin resistance. Patients who are not obese by traditional weight criteria may have an increased percentage of body fat distributed predominantly in the abdominal region (2). Ketoacidosis seldom occurs spontaneously in this type of diabetes and, when seen, usually arises from stress of another illness (e.g., infection). At earlier stages, this form of diabetes frequently goes undiagnosed for many years because the hyperglycemia develops gradually without the classic diabetic symptoms. Insulin levels may appear normal or elevated while the higher blood glucose levels in these patients would be expected to result in even higher insulin values had their beta-cell function been normal (2). Thus, insulin secretion is defective in these patients and insufficient to compensate for the insulin resistance. This resistance may improve with weight reduction and/or pharmacological treatment of hyperglycemia but is seldom restored to normal (2). It occurs more frequently in women with prior gestational diabetes mellitus and in individuals with hypertension or dyslipidemia, and its frequency varies in different racial/ethnic subgroups (2).

Instructions for completion of the condition template

    1. Brief your staff on the reasons for your participation in this quality improvement project and acknowledge their important role in the successful completion of the project.
    2. Identify 25 patients who have a diagnosis of type 1 or type 2 diabetes.

      • NOTE: Only identify charts of patients who have been continuously treated by you for the past 12 months. Fill in before or at time of office visit!

    4. Follow the instructions on the Diabetes Mellitus Template for data abstraction.

Scope of the template

  • Diabetes is a chronic illness that requires continuing medical care and education to prevent acute complications and to reduce the risk of long-term complications.

    • Regular visits should be scheduled for all patients with diabetes. Insulin-treated patients should generally be seen at least quarterly and other patients quarterly or semi-annually until all treatment goals have been achieved. Thereafter, the frequency of visits may be decreased as long as the patient continues to achieve all treatment goals. (More frequent contact also may be required if the patient is undergoing intensive insulin therapy, not meeting glycemic or blood pressure goals, or has evidence of progression of microvascular or macrovascular complications.) (Questions 6-7)
    • Patients with type 1 diabetes should be screened annually for retinopathy beginning 5 years after the onset of diabetes. Patients with type 2 diabetes should have an initial examination for retinopathy shortly after the diagnosis of diabetes is made. Dilated ophthalmoscopy should be used and repeated annually by an ophthalmologist or optometrist who is knowledgeable and experienced in the management of diabetic retinopathy. (Questions 2A-2B)
    • The Glycosylated Hemoglobin (GHb) test has been shown to predict the risk for the development of many of the chronic complications in diabetes, analogous to using cholesterol determinations to predict the risk for development of cardiovascular disease. GHb testing should be performed routinely in all patients with diabetes, first to document the degree of glycemic control at initial assessment, then as part of continuing care. Since GHb reflects a mean glycemia over the preceding 2 - 3 months, measurement approximately every 3 months is required to determine whether a patient's metabolic control has remained continuously within the target range. In the absence of well-controlled studies that suggest a definite testing protocol, expert opinion recommends GHb testing at least one or two times a year in patients with a history of stable glycemic control and quarterly assessments in patients whose therapy has been changed or who show poor control. (Question 7)
    • The American Diabetes Association recommends that the goal of therapy should be a GHb of < 7% and that physicians should reevaluate the treatment regimen in patients with GHb values consistently > 8%. (Question 7) Because GHb values differ in different laboratories, GHb values should be adjusted to account for local differences in assay methodology and nondiabetic reference ranges (2,3,4).
    • The primary goal of therapy for adult patients with diabetes is to lower LDL cholesterol to < 130 mg/dl (< 3.35 mmol/l). The primary goal of therapy in people with known CHD is to lower the LDL cholesterol to < 100 mg/dl (< 2.60 mmol/l) and triglycerides to < 200 mg/dl (< 2.30 mmol/l). People with diabetes who have triglyceride levels > 1,000 mg/dl (> 11.3 mmol/l) are at risk of pancreatitis and other manifestations of the hyperchylomicronemic syndrome. These individuals need special, immediate attention to lower triglyceride levels to < 400 mg/dl (< 4.50 mmol/l). Further reduction to Adult Cholesterol Treatment Panel II goals of < 200 mg/dl (< 2.30 mmol/l) may be beneficial (5). Adult patients with diabetes should be tested for lipid disorders annually with a fasting serum cholesterol, triglyceride, HDL cholesterol, and calculated LDL cholesterol. If all values are within acceptable limits, the clinician may consider obtaining this lipid profile less frequently. (Question 3)
    • Patients' legs and feet must be examined, including between the toes and the posterior aspect of the heels. This examination should be performed by a qualified health care professional with experience in the care of diabetic foot problems at every regular visit. (Question 4)
    • Testing for microalbumin should be performed yearly in pubertal and postpubertal type 1 patients who have had diabetes for at least 5 years and in all patients with type 2 diabetes. Specific assays are needed to detect microalbuminuria because standard hospital laboratory assays for urinary protein are not sufficiently sensitive to measure such levels. Microalbuminuria is said to be present if urinary albumin excretion is > 30 mg/24 h (equivalent to 20 mg/min on a timed specimen or 30 mg/g creatinine on a random sample). There is also marked day-to-day variability in albumin excretion, so at least two of three collections done in a 3 - 6 month period should show elevated levels before designating a patient as having microalbuminuria. (Questions 5A-5B)

References

 

Bibliography

  • American Association of Clinical Endocrinologists and the American College of Endocrinology. AACE guidelines for the management of diabetes mellitus. Endocrine Practice. 1995;1:149-159.

    American Diabetes Association and National Committee for Quality Assurance. Application manual for the provider recognition program. 1997.

    The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. JAMA. 1993;329:978-986.

    The Diabetes Control and Complications Trial Research Group. Lifetime benefits and costs of intensive therapy as practiced in the diabetes control and complications trial. JAMA. 1996;276:1409-1415.

    Foundation for Accountability. Diabetes mellitus performance measures. 1996.

    Goldstein DE, Little RR, Lorenz RA, Malone JI, Nathan D, Peterson CM. Tests of glycemia in diabetes (Technical Review). Diabetes Care. 1995;18:896-909.

    Kotsanos JG. Development of performance measures for seven chronic diseases. Joint Commission Journal on Quality Improvement. 1997;23(3):150-161.

    National Committee for Quality Assurance Eye exams for people with diabetes [HEDIS 3.0]. 1996: 148-153.

    National Institutes of Health. Hypertension in diabetes. 1994, NIH Publication No. 94:3530.

    Weir GC, Nathan DM, Singer DE. Standards of care for diabetes (Technical Review). Diabetes Care. 1994;17:1514-1522.

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