AACE GUIDELINES FOR THE MANAGEMENT OF DIABETES MELLITUS --------------------------------------------------------------------------- DEVELOPED BY THE AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND THE AMERICAN COLLEGE OF ENDOCRINOLOGY © 1995, AACE * Introduction * Our Mission * Phase 1 1. Initial Assessment 2. Patient History 3. Physical Examination 4. Laboratory Evaluation 5. Patient Knowledgebase and Motivation 6. Diabetes Self-Management System 7. Patient/Physician Contract * Phase 2 1. Interim Patient History 2. Physical Examination 3. Laboratory Evaluation 4. Patient Knowledge Base and Self-Management Skills * Phase 3 1. Assessment of Complications 2. Retinal Module 3. Cardiac/Peripheral Vascular Module 4. Neuropathy Module * Conclusion --------------------------------------------------------------------------- Introduction To Guidelines Stanley Feld, M.D., F.A.C.E President, American Association of Clinical Endocrinologists The AACE Guidelines for the Management of Diabetes Mellitus were the first guidelines developed by the American Association of Clinical Endocrinologists. The guidelines were released May 1, 1994 at our Third Annual Meeting in New Orleans. They were AACE's translation of the Diabetes Control and Complications Trial (DCCT). AACE believes that the DCCT results not only apply to Insulin Dependent Diabetes Mellitus but to Non-Insulin Dependent Diabetes Mellitus as well. A System of Intensive Diabetes Self-Management is presented. The clinical endocrinologist should be is the captain of the diabetes treatment team and is the primary care diabetes physician in the system of care developed. This self- management system is complex. The clinical endocrinologist is most suitably trained to affect this system of care. The centerpiece of the system of care is the patient-physician contract which defines the central role of the patient in his/her own care and outlines the patient's responsibility for that care. The guidelines highlight a system of surveillance to detect the early onset of diabetic complications in order to provide rapid intervention. I wish to thank the Diabetes Guidelines Task Force members Richard A. Dickey, M.D., F.A.C.E.; John J. Janick, M.D., F.A.C.E.; Paul S. Jellinger, M.D., F.A.C.E.; Yank D. Coble Jr., M.D., F.A.C.E.; Eugene T. Davidson, M.D., F.A.C.E.; Stephen F. Hodgson, M.D., F.A.C.E.; Helena W. Rodbard, M.D., F.A.C.E.; and John A. Seibel, M.D., F.A.C.E. for their great intellectual contributions to the guidelines and the many long hours they devoted to help craft this document. I also wish to thank Lifescan, Novo Nordisk and Pratt for the educational grant they provided for the development and distribution of AACE Guidelines for the Management of Diabetes Mellitus. Diabetes Guidelines Task Force Stanley Feld, M.D., F.A.C.E., Chairman Richard A. Dickey, M.D., F.A.C.E. John J. Janick, M.D., F.A.C.E. Paul S. Jellinger, M.D., F.A.C.E. Yank D. Coble, Jr, M.D., F.A.C.E. Eugene T. Davidson, M.D., F.A.C.E. Stephen F. Hodgson, M.D., F.A.C.E. Helena W. Rodbard, M.D., F.A.C.E. John A. Seibel, M.D., F.A.C.E. Reviewers Doris G. Bartuska, M.D., F.A.C.E. H. Jack Baskin, M.D., F.A.C.E. Lynn J. Bennion, M.D., F.A.C.E. Donald Bergman, M.D., F.A.C.E. George A. Bray, M.D., F.A.C.E. C. Wayne Callaway, M.D., F.A.C.E. Rhoda Cobin, M.D., F.A.C.E. George E. Dailey, M.D., F.A.C.E. Gilbert H. Daniels, M.D., F.A.C.E. Jaime Davidson, M.D., F.A.C.E. William W. Fore, M.D., F.A.C.E. Michael Garcia, M.D., F.A.C.E. Conrad Johnston, JR, M.D., F.A.C.E. Ann Lawrence, M.D., F.A.C.E. Howard R. Nankin, M.D., F.A.C.E. Edward Paloyan, M.D., F.A.C.E. William F. Price, M.D., F.A.C.E. Victor E. Silverman, M.D., F.A.C.E. --------------------------------------------------------------------------- Mission Statement The results of the Diabetes Control and Complications Trial (DCCT), announced in June 1993, confirmed that the near normalization of blood glucose levels in patients with insulin-dependent diabetes mellitus (IDDM) can significantly delay the onset and slow the progress of complications associated with this disease (1). Near normalization of blood glucose can be achieved by intensive control of diabetes (1). It has been established that the complications of diabetes are related to abnormalities in blood glucose (1). Many endocrinologists contend that intensive control could also reduce the complications associated with non-insulin-dependent diabetes mellitus (NIDDM) (2,10). The American Association of Clinical Endocrinologists (AACE) agrees that a system of intensive control of diabetes mellitus will likely decrease the rate of complications, improve patientsí quality of live, and decrease the total cost of care associated with both IDDM and NIDDM (3). A systematic multidisciplinary approach is developed to help clinical endocrinologists or other physicians provide intensive therapy for patients with diabetes mellitus in an effort to achieve normal or near normal blood glucose levels. Requirements for the successful implementation of this system include, most of all, active patient participation, a committed health care team, and adherence to the schedule of interactions recommended between the patient and the health care team. The health care team should be managed and led by a clinical endocrinologist or other physician, and ideally includes a diabetes nurse and/or dietitian skilled in diabetes education, and, as needed, a pharmacist, psychologist, and exercise physiologist (3). The team should be led by a clinical endocrinologist or other physician whose expertise and experience most qualify him or her to oversee and direct this integrated system of care (3). Of course, marked improvements in patient care will be achieved when physicians of all specialties are more aware of the relationship between blood glucose control and diabetic complications and are familiar with the steps associated with implementing a program of intensive diabetes treatment. The Diabetes Self-Management System is divided into three phases. Phase I provides the opportunity for the initial patient assessment. Patient education and a customized therapeutic approach may require several outpatient visits over a few weeks. Phase II, the follow-up phase, provides for interim assessments of the patient's physical condition, him or her reaction to intensive therapy, and his or her understanding of the tools for diabetes self-management. Phase III calls for the ongoing assessment of the complications of diabetes mellitus, as well as re-educating the patient and helping his or her maintain enthusiasm for the very difficult task of intensively managing blood glucose levels. The system is ongoing, with patient-intensive participation being the key to intensive control. It is the responsibility of the clinical endocrinologist/physician and the health care team to facilitate this participation. Phase I. Initial Assessment The primary goal of Phase I is the assessment of the patient's disease status and risk factors for complications of diabetes. This may be accomplished by a thorough patient history, a complete physical examination by the clinical endocrinologist/physician, and appropriate laboratory evaluation. During Phase I, which may require multiple patient visits over 3 to 4 weeks, the clinical endocrinologist/physician will gather information, develop initial recommendations for the patient, and begin a Diabetes Self-Management System with the help of the diabetes health care team. The educational program will include appropriate nutrition, exercise, medication, record-keeping systems, and self-monitoring of blood glucose (SMBG). As the patient begins to understand the rationale for intensive control of blood glucose, the regimen can be modified and the patient taught the reasons for modification. At this time, the clinical endocrinologist/physician can schedule the appropriate evaluations and/or referrals for complications and specific risk factors. Another goal of Phase I is to assess the patient's knowledge base regarding diabetes mellitus and to evaluate his or her ability to learn new skills and techniques. This can be done using a combination of objective knowledge tests, psychological adjustment tests, and interview questions. After this assessment has been completed, the clinical endocrinologist/physician and other team members should be able to initiate the appropriate level of education regarding diabetes self-management skills. During Phase I, the clinical endocrinologist/physician should evaluate the patient's commitment to a program of intensive treatment for diabetes and elicit the patient's written agreement to participate in the Diabetes Self-Management System. The clinical endocrinologists/physician, patient, and health care team can develop a set of individualized instructions regarding the patient's care. Patient History The patient's responses to the following areas of questioning should help the physician confirm the diagnosis and duration of diabetes mellitus, establish the success or failure of previous treatment regimens, evaluate the presence of existing diabetic complications, and determine the patient's risk for the future development of complications. 1. What is the patient's chief complaint? How long has the patient had diabetes? 2. Did onset of diabetes include: 1. Polydipsia? 2. Polyuria? 3. Polyphagia? 4. Unexplained weight loss or gain? 3. Is there a family history of diabetes or other endocrine disorders? 4. Did the patient have a gestational history of diabetes? 1. Hyperglycemia? 2. Delivery of an infant weight >9 lb? 3. Toxemia? 4. Stillbirth? 5. Other complications of pregnancy? 5. Has the patient lost or gained weight? What is the patient's current nutritional regiment? 6. What is the patient's exercise history and ability to exercise? 7. What are the patient's current, non-diabetes-related medications? 8. What is the patient's alcohol intake? 9. Is there a history of recreational drug use? 10. Has the patient ever been hospitalized or undergone surgery? 11. If the patient has already been diagnosed as suffering from diabetes mellitus: 1. When and how was the diabetes diagnosed? 2. Which medications have been used to treat the diabetes, and in which order? Establish the current treatment regimen, including diet and exercise. 3. How has the patient had his or her glucose levels monitored in the past? Has the patient monitored blood glucose at home? How frequently was the patient's glycosylated hemoglobin moni- tored? Were the results of these tests used to maximize the patient's degree of diabetic control? 12. Does the patient have symptoms of existing diabetic complications of any of the following types? 1. Ophthalmologic (including retinopathy)? 2. Neuropathy? 3. Renal? 4. Vascular (including cardiovascular, cerebrovascular, peripheral vascular system)? 5. Sexual dysfunction (men and women)? 6. Ketoacidosis? 7. Hypoglycemia? 8. Infections (eg, skin, foot, gynecologic)? 13. Does the patient have any identifiable risk factor for diabetic complications, such as: 1. Family history of diabetes or coronary artery disease? 2. Hypertension (systolic, diastolic)? 3. Smoking history? 4. Lipid abnormalities? 5. Central obesity? Physical Examination Phase I should include a complete physical examination for each patient. Special attention should be paid to those aspects of the examination that focus on specific areas of risk for the diabetes patient, including: 1. Height and weight measurements 2. Blood pressure determination, including orthostatic evaluation 3. Ophthalmoscopic examination 4. Thyroid palpation 5. Cardiac examination 6. Evaluation of pulses, including respiratory variation 7. Foot examination 8. Skin examination 9. Neurologic examination, with particular attention to reflexes, vibratory sensation, touch, and proprioception Laboratory Evaluation Laboratory tests should be ordered to establish the diagnosis of diabetes and to determine the current level of glycemic control. In addition, Phase I laboratory testing should provide an evaluation of the patient's general medical condition and identify associated risk factors. Laboratory tests that should be used during Phase I include: 1. Fasting or random plasma glucose* 2. Glycosylated hemoglobin/fructosamine (HbA1c) 3. Fasting lipid profile (cholesterol, triglycerides, HDL/LDL calculation) 4. Serum electrolytes* 5. Serum creatinine* 6. Urinalysis 7. Sensitive or ultrasensitive thyroid-stimulating hormone (TSH) 8. Microalbuminuria and creatinine clearance 9. Electrocardiogram (ECG) and/or stress test (*Commonly available as part of a chemistry profile.) Patient Knowledge Base and Motivation The results of objective testing regarding the physiology and treatment of diabetes mellitus will help the clinical endocrinologist/physician assess the level of diabetes education to be initiated. Psychological tests and a subjective evaluation of the patient's psychological support systems will help predict patient compliance with a system of intensive therapy. These evaluations will help the clinical endocrinologist/physician determine which team referrals are most necessary, and set priorities for educating the patient regarding diabetes self-management. 1. The following evaluation forms may be used to assess the patient's understanding of the physiological aspects of diabetes mellitus: 1. Diabetes Assessment and Teaching Record 2. AACE Knowledge Evaluation Forms 2. The following psychological tests may be used to evaluate the patient's motivation for participating in a diabetes self-management system: 1. Michigan Diabetes Research and Training Center Diabetes Care Profile (Available from MDRTC University of Michigan Medical Center, G1111 Towsley Center, Ann Arbor, MI 48109-0201. 2. Millon Behavioral Health Inventory (MBHI) Available to licensed professionals from National Computer Systems, P..O. Box 1294 Minneapolis, MN 55440 3. Evaluate the patient's resources and support systems in the following areas, to help assess the patient's motivation for complying with intensive diabetes treatment: 1. Family 2. Financial (including medical insurance status) 3. Job 4. Patient may be reassessed and re-evaluated at 6 months to see the level of knowledge retained after training and education. Diabetes Self-Management System Patient empowerment is vital to a system of intensive diabetes therapy. For the system to be successful, the patient must learn to understand and manage his or her own disease and its treatment (6). Traditional patient education is just one aspect of diabetes intensive self-management. An intensive self- management system must also help the patient with diabetes assume responsibility for the self-monitoring and problem solving that are critical to the successful implementation of a system of intensive diabetes therapy. Although this educational process will be initiated during Phase I, the information is so vital, and the material so extensive, that the educational process should be continued on an ongoing basis during all phases of treatment. Because each patient participating in the system will have different educational needs, it is important that the members of the health care team individualize the system for each patient. The results of the initial patient assessment will help health care team members establish a system of priorities for scheduling each of the topics to be covered. A series of ongoing patient assessments, to take place during all subsequent phases of treatment, will help health care team members revise these priorities as needed to ensure that the individual needs of each patient are being met, and to facilitate patient compliance. Topics to be covered during the overall course of treatment may be divided into the following categories(4): 1. The pathophysiology of diabetes 2. The rationale for the intensive treatment of diabetes mellitus o Complications that may be associated with diabetes o The relationship between control and complications 3. SMBG o Use of a glucose self-monitor o Schedule for use (minimum of twice daily) o Instructions for record keeping 4. Medication o Description o Dosing instructions o Dosage adjustment algorithms o Suggestions for record keeping 5. Nutrition o Importance o Prescribed meal plan o Dealing with nutrition-related fluctuations in blood glucose o Suggestions for record keeping 6. Exercise o Importance o Prescribed exercise plan o Dealing with activity-related fluctuations in blood glucose o Suggestions for record keeping 7. Recognizing and treating potentially dangerous complications o Hypoglycemia o Diabetic ketoacidosis o Hypoglycemic unawareness o Infection o Vascular disease 8. Instructions for special situations o Sick day rules o Travel instructions o Use of glucagon 9. Preventive care o Foot care o Skin care 10. Psychological aspects o Effect on relationships and family dynamics o Effect on self-image o Importance of support o Denial 11. Instructions for family members Patient/Physician Contract For intensive diabetes management to succeed, the patient and the clinical endocrinologist/physician must have mutual, frequently communicated treatment goals. This requires regularly scheduled communication and frequent visits between the patient and members of the health care team. The frequency of these interactions will be determined based on individual patient needs. Patients must be encouraged to comply with the specified schedule. This may require the implementation of a follow-up system by the clinical endocrinologist/physician or, in some cases, the intervention of a third-party payer. To maximize patient compliance with the Diabetes Self-Management System, it may be helpful to elicit the patient's written commitment to participate. The document, which should be signed by both the patient and the clinical endocrinologist/physician, should specify the responsibilities of both parties and contain the prescribed schedule of follow-up visits and communications. The risks of assuming or declining intensive therapy need to be defined in the contract. Phase II: Follow-up Assessments A goal of each follow-up assessment is to evaluate the patient's physical condition, level of blood glucose control, and degree of compliance. This requires an interim history, physical examination, laboratory evaluation, and a review of the patient's SMBG results. Based on the results of this evaluation, the clinical endocrinologist/physician and patient may elect to revise any or all aspects of the patient's treatment plan or the schedule for the complications modules described in Phase III of this system. Because the diabetic patient is at significantly increased risk of coronary artery and peripheral arterial disease, dyslipidemia, and hypertension,(7) lipid levels and blood pressure must be rigidly monitored and controlled. The diabetic patient should be viewed comparably to a nondiabetic patient who has had a coronary event. It is evident that the reduction of high blood pressure in the diabetes patient significantly reduces the risk of nephropathy and retinopathy (8). Other goals of Phase II are to assess the patient's understanding of diabetes mellitus and the rationale for intensive self-management and to check the patient's self-management skills. This periodically requires the administration of follow-up objective and psychological tests and a re- evaluation of the patient's support systems. Depending on the results of this interim assessment, the clinical endocrinologist/physician may reinstitute intensive diabetes education in the deficient areas. Follow-up assessments should be scheduled at intervals of no longer than 3 months (4) and may be combined with the complications modules. Interim Patient History The patient's responses to the following areas of questioning should help in the development of a revised treatment plan, assessment of existing diabetic complications, and re-evaluation of the patient's risk for future complications. 1. Has the patient experienced any acute health problems? 2. Have there been any changes in any chronic health problems the patient may have? 3. Has the patient experienced any symptoms or signs suggestive of hypoglycemia? 4. Is the patient suffering from any new symptoms or signs suggestive of diabetic complications? 5. Have there been any changes in risk factors? Physical Examination Phase II includes an interim physical examination for each patient. The following elements may be included, depending on patient symptoms and signs and the results of the initial physical examination: 1. Height and weight measurements* 2. Blood pressure determination, including orthostatic evaluation* 3. Ophthalmoscopic examination 4. Thyroid palpation 5. Cardiac examination 6. Evaluation of pulses, including respiratory variation 7. Foot examination* 8. Skin examination 9. Neurologic examination Every patient should have a complete physical examination at least once annually. (*Should be included with every interim physical examination.) Laboratory Evaluation During each follow-up assessment the results of the patient's SMBG should be reviewed. In addition, laboratory tests should be ordered to confirm the patient's current level of glycemic control. These analyses should include: 1. Random plasma glucose 2. Glycosylated hemoglobin (HbA1c) or fructosamine 3. Lipid profile Based on the results of the patient's SMBG and laboratory testing, the clinical endocrinologist/physician may elect to revise the recommendations regarding nutrition, exercise, medication, self-monitoring, and follow-up communication. In addition, the clinical endocrinologist/phy-sician may elect to revise the schedule for implementing any or all of the Phase III complications modules. Patient Knowledge Base and Self-Management Skills To assess the patient's current level of understanding of the pathophysiology of diabetes mellitus and the rationale for self-management, and to check his or her self-management skills, follow-up objective and psychological tests should be administered. In addition, a re-evaluation of the patient's support systems should be performed. 1. The following evaluation forms may be used to assess the patient's understanding of the physiologic aspects of diabetes mellitus: o Diabetes Assessment and Teaching Record o AACE Knowledge Evaluation Forms 2. The following psychological test may be used to evaluate the patient's motivation for participating in a diabetes self-management system: 3. Michigan Diabetes Research and Training Center Diabetes Care Profile Available from MDRTC University of Michigan Medical Center, G1111 Towsley Center, Ann Arbor, MI 48109-0201 4. Millon Behavioral Health Inventory (MBHI) Available to licensed professionals from National Computer Systems, P.O. Box 1294, Minneapolis, MN 55440 5. The patient's resources and support systems should be reevaluated in the following areas: o Family o Financial (including medical insurance status) o Job Depending on the results of the interim assessment, the clinical endocrinologist/physician may reinstitute intensive education in the deficient areas and/or refer the patient to one or more members of the health care team. Phase III: Assessment of Complications The goal of Phase III is to continually assess the presence and/or severity of the complications associated with diabetes mellitus. Each of these modules should be performed in conjunction with a Phase II follow-up assessment module. The following complications modules should be performed: 1. Retinal 2. Cardiac/peripheral vascular 3. Renal 4. Neuropathy One module may be included with each quarterly follow-up visit. Retinal Module When performed in conjunction with the retinal module, the Phase II interim history and physical examination should include any questions relevant to the assessment of retinal complications. Additional diagnostic evaluations should include: 1. Test of visual acuity (Snellen chart) 2. Funduscopic examination 3. Intraocular pressure (IOP) test In addition to educating the patient about the retinal complications that may be associated with diabetes, the clinical endocrinologist/physician should determine - based on the patient history and findings of the current examination - the frequency of follow-up and/or need for referral to an ophthalmologist/retinal specialist. Cardiac/Peripheral Vascular Module Vascular risk factors should be assessed annually in adults with diabetes. When performed in conjunction with the cardiac/peripheral vascular module, the Phase II interim history and physical examination should include any questions relevant to the assessment of cardiac/peripheral vascular complications. Additional diagnostic evaluations should include: 1. ECG and rhythm strip and/or stress test (based on the patient's age and symptoms) 2. Lipid profile (cholesterol, triglycerides, HDL/LDL calculation) 3. Evaluation of peripheral pulses by physical and/or objective testing In addition to educating the patient about the vascular complications that may be associated with diabetes, the clinical endocrinologist/physician should determine - based on the patient history and findings of the current examination - the frequency of follow-up, the need for more intensive cardiac testing, and/or need for referral to a cardiologist, interventional radiologist, or vascular surgeon. Renal Module (4) When performed in conjunction with the renal module, the Phase II interim history and physical examination should include any questions relevant to the assessment of renal complications. Additional diagnostic evaluations should include: 1. Test for microalbuminuria 2. Creatinine clearance 3. SMAC In addition to educating the patient about the renal complications that may be associated with diabetes, the clinical endocrinologist/physician should determine - based on the patient history and findings of the current examination - the frequency of follow-up and/or need for referral to a nephrologist. Neuropathy Module When performed in conjunction with the neuropathy module, the Phase II interim history and physical examination should include any questions relevant to the assessment of neuropathy. Additional diagnostic evaluations should include: 1. A review of symptoms relevant to peripheral nerve and autonomic dysfunction 2. Module-specific testing (vibratory sensation, soft touch, pinprick, evaluation of autonomic dysfunction; eg, R-R interval variation with paced breathing) In addition to educating the patient about neuropathy, the clinical endocrinologist/physician should determine-based on the patient history and findings of the current examination - the frequency of follow-up and/or need for referral to a neurologist. Conclusion The clinical practice parameters for a Diabetes Self-Management System have been outlined. A diabetes self-management health care team, under the leadership of a clinical endocrinologist or other physician, teaches the most important member of the health care team - the patient - to control his or her blood glucose level in order to reduce the risk of complications. The patient is ultimately responsible for adhering to the program. Naturally, the patient who is an appropriate candidate for the Diabetes Self-Management System must have a choice; he or she can choose conventional therapy. However, the patient must recognize that this may lead to a higher rate of devastating complications, whereas intensive therapy can help maintain normal or near normal blood glucose levels and avoid many of the complications of diabetes mellitus, although the cost might be more frequent symptoms or episodes of hypoglycemia (1). --------------------------------------------------------------------------- References 1. 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. N Engl J Med. 1993; 329;977-986. 2. American Association of Clinical Endocrinol-ogists. New Recommendations for Patients with Diabetes. Undated. 3. American Association of Clinical Endocrinol-ogists. Primary Care for the Diabetes Mellitus Patient. Undated. 4. American Diabetes Association. Position statement. Standards of medical care for patients with diabetes mellitus. Diabetes Care. 1991; 14(2):10- 13. 5. Davidson MB. DiabetesMellitus: Diagnosis and Treatment. 3rd ed. New York, NY: Churchill Livingstone; 1991:330. 6. American Diabetes Association. Physician's Guide to Non-Insulin-Dependent (Type II) Diabetes: Diagnosis and Treatment. 2nd ed. 1989:62-63. 7. Nathan DM. The rationale for glucose control in diabetes mellitus. Endocrinol Metab Clin North Am. 1992; 21:221-235. 8. Arauz-Pacheco C, Raskin P. Management of hypertension in diabetes. Endocrinol Metab Clin North Am. 1992;21:371-394. 9. American Diabetes Association. Position statement. Eye care guidelines for patients with diabetes mellitus. Diabetes Care. 1991;14(2):16-17. 10. Nathan DM, Singer DE,Godine JE, Harrington CH, Perlmuter LC. Retinopathy in older type II diabetics: association with glucose control. 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