Professional Documents
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Diabetes 2002
Diabetes 2002
Developed by the
American Association of Clinical Endocrinologists
and the American College of Endocrinology—2002
INTRODUCTION
Stanley Feld, MD, FACP, MACE
Chairman, Diabetes Medical Guidelines Task Force
In 1994, the American Association of Clinical Endo- initial diagnosis and to recommend optimal treatment of
crinologists (AACE) developed a System of Intensive diabetes.
Diabetes Self-Management. This system remains the cen- During the past 5 years, many published studies have
terpiece of the AACE Medical Guidelines for the confirmed the importance of intensive diabetes self-man-
Management of Diabetes Mellitus. A key component of agement, not only for type 1 but also for type 2 diabetes.
the AACE system of care is a patient-physician contract, There is now no doubt that control of diabetes is of utmost
which maintains the preeminence of the patient-physician importance. Furthermore, many new pharmacologic
relationship and the importance of the patient’s participa- agents have been developed, some with unique mecha-
tion in personal care. As stated therein, the duties of the nisms of action. The use of combinations of older and new
physician and the diabetes management team are to teach pharmacologic agents enables the patient to achieve near-
and to help direct the patient’s own self-management. normalization of blood glucose levels.
The System of Intensive Diabetes Self-Management Evidence continues to accumulate in support of the
includes the concepts of care, the responsibilities of the importance of intensive diabetes self-management early
patient and the physician, and the appropriate intervals of during the course of the disease as well as intensive con-
follow-up assessment. Also included are the timing of trol of comorbid states, such as hypertension, dyslipi-
required laboratory testing, determined by evidence-based demia, and obesity. The early control of comorbid states
and consensus clinical experience. As indicated in the decreases the occurrence of complications of diabetes.
original publication of the guidelines, the intensive self- Moreover, comorbid states can be precipitated or
management system applies to patients with type 1 and worsened by the occurrence of diabetes.
type 2 diabetes. The 2000 revision of the AACE medical practice
AACE brought these concepts directly to the public guidelines focuses on the system of care provided in the
with two highly successful patient initiatives. These dia- original guidelines but adds new evidence for manage-
betes initiatives were called “Patients First” and “Patients ment and treatment of type 1 and type 2 diabetes mellitus.
First 1998.” The names of these initiatives emphasize that The AACE System of Intensive Diabetes Self-Manage-
the treatment of the patient should be the first priority for ment remains intact. In this revision, we have emphasized
the patient, the physician, and all those providing health- type 2 diabetes because it is our conviction that type 2
care coverage. Access to appropriate care and durable diabetes is an underrecognized but very serious disease
medical equipment should not be restricted. AACE that must be treated as aggressively as type 1 diabetes
emphasizes that the patient should demand access to mellitus.
appropriate care. As chairman, I wish to thank the Diabetes Medical
In addition, the patient, with a focus on self-manage- Guidelines Task Force, Drs. Richard Hellman, Richard
ment, must become a “Professor of Diabetes.” The physi- Dickey, Paul Jellinger, John Janick, Helena Rodbard,
cian and the diabetes management team are responsible for Rhoda Cobin, David Bell, Om Ganda, Eugene Davidson,
helping the patient achieve this expertise, and the clinical and John Seibel, for their valuable contributions to these
endocrinologist is the physician best trained to make the revised, expanded guidelines.
2002 UPDATE
The American College of Endocrinology (ACE) held a Diabetes Mellitus Consensus Conference, August
20-21, 2001. The outcome of this ground breaking conference included new guidelines for HbA1c levels.
Pre and postprandial targets, and a universal term for hemoglobin A1c. These guidelines have been revised
to reflect these outcomes. Also included in the 2002 version are changes in treatment that have occurred
since the publication of the 2000 version.
Committee Members
Reviewers
normoglycemia during severe infections, cerebral for inpatient care and complications of diabetes, clearly
ischemia, or perioperative periods. Therefore, the clinical the beneficial effects of intensive therapy on reducing both
endocrinologist serves an important role not only in the the complications of diabetes and their progression
day-to-day care of the patient with diabetes but also in the provide strong support for the increased use of an inten-
acute-care setting. sive and comprehensive approach to diabetes care.
Although the benefit of a more comprehensive and Although formidable barriers to the implementation
intensive approach for diabetes care is evident at any point of widespread, intensive programs of diabetes care still
in the course of patient care (6), it is particularly important remain, the benefits may be even greater in higher risk
early during the course of the disease (1). The greatest groups, such as minority populations (6). It is reasonable
benefits have been noted in patients with less advanced to expect, and should be a goal, to have most patients with
disease (1,5,6). Thus, prompt initial care and early referral diabetes in a community setting participate in an intensive
to a clinical endocrinologist for preventive care in both treatment program and achieve an excellent outcome
type 1 and type 2 diabetes are not only logical and appro- (3,4,6).
priate but key to achieving the best clinical outcome
possible. SECTION 2: THE CLINICAL
ENDOCRINOLOGIST IN CONTINUING CARE
Diabetes Management Team
The value of diabetes management teams is also Continuing Care
becoming clearer. The concept of active involvement of The patient with diabetes mellitus has a chronic but
the patient in a self-management program is important; highly treatable disease, which can have devastating and
excellent results have been achieved when the patient costly complications. The health-care needs of such a
actively participates as a member of the diabetes care patient are predicated on the control of the diabetes. A
team. Adherence to complex regimens of care is consider- comprehensive diabetes team approach yields the best
ably enhanced by this method. Of note, however, the health-care outcomes. The team approach, however,
patient’s personal goals, particularly at the outset, may dif- requires continuity of care and management.
fer substantially from the physician’s treatment goals. The care of diabetes mellitus has become progres-
Nevertheless, with increased interactions with the physi- sively more complex and demanding of both the patient
cian, the goals can converge. The patient is often besieged and the physician. Comprehensive and intensive care of
by information and misinformation from various sources. diabetes has been confirmed to yield important benefits by
As a result, an important component of continuing care is delaying or preventing complications (1,3-5). For achieve-
the opportunity to continue a dialogue with the physician ment of these benefits, complex pharmacotherapeutic reg-
so that the patient’s questions, level of understanding of imens, as well as insulin pumps or even pancreas trans-
diabetes care, and misconceptions can be addressed in a plantation, may be needed. The clinical endocrinologist
way that would be beneficial to and protective of the can best coordinate this complex continuing care to
patient. For achievement of optimal results, a close work- achieve the optimal outcome.
ing relationship among the diabetes team members is most Thus, it is particularly critical for avoidance of com-
useful. plications that continuity of care be maintained for the
Where the arrangement is possible, a clinical endocri- development of long-term goals that can be shared and
nologist is most effective as the head of a comprehensive pursued by the patient, the physician, and other members
diabetes care program. Two reports have concluded that an of the diabetes care team. When patients regularly share
endocrinologist’s involvement offers advantages in the information with the physician, the special training and
care, cost-effectiveness, and outcomes for patients with knowledge of the clinical endocrinologist can help to iden-
diabetes (9,10). Educational programs alone have not been tify factors that may improve or disrupt diabetes control.
demonstrated to improve major clinical outcomes, but pro- For example, identification of improper habits can lead to
grams integrating both education and sophisticated, direct the formulation of solutions and the implementation of
care of the patients have been effective. Optimally, the beneficial changes, such as alterations in diet and nutrition
clinical endocrinologist should be the principal-care physi- practices, physical activity or exercise patterns, and
cian for patients with either type 1 or type 2 diabetes. responses to stress in the environment; use and adjustment
Alternatively, the clinical endocrinologist and the primary- of medications; careful attention to foot care; and adher-
care physician can comanage a program for their patients ence to a system of intensive diabetes self-management
with diabetes. Whatever the arrangement, the relationship (11).
between the patient’s physicians should be collegial so that
the particular roles of both specialist and generalist can be Intercurrent Illness
used to maximize the benefit to the patient. When the patient with diabetes needs to be hospital-
ized or has an intercurrent illness, the management of the
Cost-Effective Comprehensive Care patient’s diabetes and of its effect on the course of the
Intensive therapy has been shown to be cost-effective intercurrent illness often is the most important determinant
in both type 1 and type 2 diabetes (9,10). Because two- of the outcome of the intercurrent illness (for example,
thirds of the costs of diabetes management are currently infection, renal impairment, or hypertension). Therefore,
AACE Diabetes Guidelines, Endocr Pract. 2002;8(Suppl 1) 45
the clinical endocrinologist can provide the patient with extremely important and the most cost-effective therapeu-
the best care for the diabetes as well as ensure the most tic interventions. The AACE System of Intensive Diabetes
favorable outcome for the intercurrent illness (2). Self-Management promotes the concept of the patient
being in control and responsible for self-management. An
Education and Preventive Measures important element in self-management of diabetes
Diabetes care is best focused on the prevention of mellitus is the lifestyle changes necessary to adhere to
related complications and comorbid conditions, so that nutrition and exercise programs.
hospitalizations and cost of care are minimized. The most In recent years, it has become clear that the prescrip-
costly aspect of the care of diabetes is the hospitalizations tions for diet and physical activity must be individualized
that result from complications. The acute and chronic in order to improve patient adherence. The control over
complications occur because of either the lack of under- dietary intake and the effort to engage in physical activity
standing in long-term and short-term control of the blood correlates with the achievement of more normal blood glu-
glucose or the patient’s refusal to control the blood glu- cose levels. The principles and strategies of nutrition and
cose levels. The educational responsibilities are shared by exercise for type 1 diabetes differ from those for type 2
many members of the diabetes care team, each of whom diabetes. Patients must understand and measure the effect
has been specifically trained to understand and impart to of diet and physical activity in order to be expected to
the patient the value of preventive measures (12). As a adhere to these necessary lifestyle changes. In type 2 dia-
leader of the team, the clinical endocrinologist is able to betes, nutrition and exercise can help maintain near-nor-
educate and train not only the patient but also other team mal blood glucose and optimal lipid levels, achieve desir-
members, as well as other physicians and nonphysicians, able weight, and improve physical condition.
to understand and keep in mind the special needs of the
patient with diabetes and optimal management practices Diet in Type 1 Diabetes
(12). With use of insulin therapy for control of blood glu-
cose, the patient must understand the action and the dura-
SECTION 3: NUTRITION AND EXERCISE tion of the insulin being used as well as the effect of the
timing of the intake of food on the insulin action. It is
Nutrition and exercise are major interventions in the unreasonable to expect the patient to maintain a constant
treatment of diabetes mellitus. Their importance and effect meal plan and insulin regimen. Flexibility of insulin dos-
in both type 1 and type 2 diabetes, however, have been ing and timing must be taught to the patient. This flexibil-
inadequately emphasized. The result has been unsatisfac- ity can be adapted by using the result of the blood glucose
tory patient adherence. determination and the response to intake and timing of
With the introduction of an increasing number of oral- food. The DCCT demonstrated that patients who adjusted
ly administered drugs for the treatment of type 2 diabetes, their food intake and insulin dosage in response to blood
the focus has shifted to the use of these drugs rather than glucose levels achieved lower glycosylated hemoglobin
tackling the difficult problem of helping the patient imple- values than did the control group (15). The flexibility
ment the necessary lifestyle changes for adherence to empowered those patients to adhere more willingly. The
nutritional recommendations and exercise programs. use of carbohydrate counting to determine the appropriate
A recent study showed that newer pharmaceutical bolus premeal dose of rapidly acting insulin has made the
agents cost, on the average, $1,700 per year per drug (13). use of intensive insulin therapy regimens even easier.
In a recently completed survey of AACE member clinical
endocrinologists about prescribing practices for type 2 Diet in Type 2 Diabetes
diabetes, 90% of the 348 respondents reported pre- Weight loss and maintenance of weight loss result in
scribing three or more agents in combination to achieve a decrease in the insulin resistance that is the hallmark of
control. Sixty-five percent used four agents in combina- most patients with type 2 diabetes. Simply, a negative
tion. Of the survey participants, 95% reported that the oral caloric balance can decrease insulin resistance. The end-
combinations currently available allow better glycemic point does not have to be weight loss. In the process of
control than was ever achievable in the past. The problems attaining a decrease in weight, blood glucose levels will
reported with use of drug combinations, however, improve. By monitoring the blood glucose levels and the
included expense (75%), side effects (66%), monitoring caloric intake and output, the patient can understand the
difficulties (61%), hypoglycemia (54%), and aversion to effect of a negative caloric balance on the blood glucose.
polypharmacy (30%) (14). These measurements and observations will help promote
The notion of achieving blood glucose levels as near adherence. Patients do not have to achieve ideal body
normal as possible in patients with type 2 diabetes is the weight to improve control of blood glucose, control of
underlying prevailing goal for the clinical endocrinologist. hypertension, and lipid levels. Loss of as few as 10 to 20
The clinical endocrinologist views type 2 diabetes as a lb (4.5 to 9 kg) will be helpful, but the weight loss must
serious disease with potentially severe complications. In then be maintained and exercise programs must be
patients with type 2 diabetes, nutrition and exercise are continued (16-18).
46 AACE Diabetes Guidelines, Endocr Pract. 2002;8(Suppl 1)
glucose level of 250 mg/dL or higher at the time of exer- ered, HDL increases because the relationship of VLDL to
cise will experience a further increase in glycemia and HDL has been shown to be reciprocal (34).
development of ketosis. Exercise evaluation studies with a stress electrocar-
The effects of exercise on the relationship of diet and diogram should be done before a program of physical
insulin have been well studied in type 2 diabetes and must activity is prescribed for any patient with diabetes who is
be understood by the patient and the physician (33). In 40 years old or older or who has possible cardiovascular
type 2 diabetes, physical activity has been shown to help disease. Evaluation for autonomic neuropathy can reveal
decrease peripheral insulin resistance, plasma triglyceride the value of calculating maximal heart rate, predicting the
levels, and very-low-density lipoproteins (VLDL). potential occurrence of exercise-induced hypertension and
Because cardiovascular risk is high in most patients with of orthostatic hypotension after exercise. If either occurs
type 2 diabetes at the onset, the risk of cardiovascular or the patient experiences discomfort during such studies,
complications with physical activity must be constantly the possibility of continued adherence to an exercise pro-
considered (34). Therefore, exercise must be viewed dif- gram precipitously decreases. Anticipation and crafting an
ferently in type 2 diabetes than in type 1 diabetes. exercise program to avoid these complications can
In patients with either type 1 or type 2 diabetes, exer- increase the possibility of successful adherence. Because
cise can create a general sense of well-being. Exercise is of subtle autonomic dysfunction, the pulse rate should not
generally credited with promoting physical fitness, which be used as a measure of intensity of physical activity.
in turn prevents or decreases the onset of cardiovascular Patients should exercise to perceived exertion only and not
disease. Unfortunately, no controlled studies have been based on pulse rate percent of maximal exertion for age
conducted in patients with type 1 diabetes to prove this (37).
point (35). The Malmo study, however, demonstrated the The goal should be to promote physical fitness with
value of intervention with physical activity and nutritional consistent use of an exercise program. The level of fitness
therapy in controlling the progression of type 2 diabetes may be more important than weight loss to decrease mor-
(36). Exercise promotes flexibility and motor strength, tality. The timing of the onset of an exercise program
which are also thought to promote a sense of well-being might be important because postprandial physical activity
(37). seems to lower postprandial blood glucose levels (39).
Every exercise prescription should be tailored to the
Principles of Exercise as Therapy in Type 2 Diabetes individual patient’s capacity and coexistent conditions,
Of all patients with diabetes, 90% have type 2 dia- such as hypertension or prior myocardial infarction or
betes. The major complication of type 2 diabetes is neuropathy. Flexibility exercises are important for helping
macrovascular disease. There is now consensus that the patients to participate in conditioning exertion without
macrovascular complications are attributable to the hyper- pulling or tearing muscles. The duration of exercise should
glycemia and the accompanying comorbid conditions of be a minimum of 20 minutes every 48 hours (39). At the
hypertension and dyslipidemia (see Section 5). start of the exercise program, the patient should not push
Type 2 diabetes is usually the result of increased to achieve ideal duration but should stop as soon as fatigue
insulin resistance and eventual decrease in insulin secre- is experienced.
tion because of beta cell failure. Physical activity
improves blood glucose levels, the result of a decrease in Principles of Exercise as Therapy in Type 1 Diabetes
insulin resistance as well as weight loss. Insulin resistance In normal persons, physical activity causes insulin
has been shown to decrease even without loss of weight. levels to decrease because of an increase in glucose uptake
The increased sensitivity to insulin that results in by peripheral muscles and an increase in glucagon output
increased peripheral utilization of glucose occurs not only to defend a declining blood glucose level. The blood glu-
during physical activity but for up to 48 hours after exer- cose then increases as a result of increased output of
cise (38). Therefore, exercise should be repeated at least glucose from the liver (40). The increase in peripheral
every 48 hours to maintain this effect. blood glucose is a function of the individual person’s con-
Any therapy that will reduce insulin resistance has the ditioning and is matched by the reciprocal hepatic glucose
potential to improve blood glucose control. Another bene- output.
ficial effect of an exercise program is the promotion of In patients with type 1 diabetes, the glycemic response
self-discipline necessary for controlling a chronic disease. to exercise is dependent on the metabolic control of the
Furthermore, in an era of increasing treatment options and blood glucose, the physical conditioning of the patient, the
complexity of orally administered medications for type 2 integrity of the autonomic nervous system, the prior phys-
diabetes, any therapeutic maneuver that decreases the ical activity and food intake, the intensity and duration of
complexity of treatment at low economic cost is cost- the activity, and the timing of the peak insulin action.
effective. For example, if intermediate-acting insulin peaks at
Physical activity consistently decreases plasma the time of exercise and there is an increase in glucose
triglyceride levels and VLDL levels in type 2 diabetes. uptake by the muscle, the high plasma insulin level can
High-density lipoprotein (HDL) effects have not been well neutralize the ability of the patient’s counterregulatory
studied; however, if triglycerides are significantly low- mechanisms to respond and defend the declining blood
48 AACE Diabetes Guidelines, Endocr Pract. 2002;8(Suppl 1)
glucose level with a surge of glucose output from the liver. United States. Drugs in several new classes have been
The resulting hypoglycemia can be severe (40). If the approved by the Food and Drug Administration, includ-
patient has poorly controlled diabetes, is poorly condi- ing the new biguanides, thiazolidinediones, meglitinides,
tioned, and is stressed by the exercise, counterregulatory α-glucosidase inhibitors, and new shorter acting insulin.
hormonal output resulting from the stress induced by In addition, new sulfonylureas and newer forms of avail-
physical activity along with the high blood glucose level able sulfonylureas have been developed and approved. All
attributable to poor control of the diabetes can result in an these agents have tissue-specific sites of action to improve
even higher blood glucose level (33). glycemia. They can be used in combination to take advan-
The clinical endocrinologist and the diabetes self- tage of the respective mechanisms of action to reverse the
management team can teach the patient all the variables multifactorial pathophysiology of beta cell dysfunction,
that can result from exercise and, as part of the self-man- insulin resistance, increased hepatic glucose production,
agement process, teach the patient to use the therapy of and decreased peripheral glucose utilization.
physical activity and conditioning to control the blood glu- The increase in choice and enhanced effectiveness of
cose level more effectively (33,34). these new therapeutic compounds make possible the
Effective blood glucose control can occur when the improved control of blood glucose in patients with type 2
patient learns to vary the dose of insulin appropriately, diabetes. With this array of options, however, treatment
anticipate the need for intake of food before or after regimens have become increasingly complex and confus-
physical activity, and monitor the effect of the physical ing. A trial-and-error approach is not acceptable. The use
activity by appropriate blood glucose measurement after of these new drugs alone as monotherapy and in com-
participation in exercise. This monitoring is the responsi- bination must be directed by the physician, preferably a
bility of the patient. The responsibility of the physician clinical endocrinologist.
and the diabetes self-management team is to teach the Type 2 diabetes is a serious disease in which severe
patient the principles and effects of physical activity and complications may occur, even in relatively asymptomatic
help make the patient a diabetes expert. In general, 15 g of persons. Newly available drugs are quite effective. Ideally,
carbohydrate should be added before or after physical to optimize the effect of these drugs, patients with diabetes
activity, depending on the blood glucose level. If the activ- taking them should become involved with the ongoing
ity will be very strenuous, 30 g might be needed. The management of their disease rather than simply taking the
anticipated effect of exercise and the regulation of this drugs and assuming that they are “working.” By measur-
effect can and should be learned by the patient in order to ing the blood glucose at various times of day, the effect of
take advantage of the benefits of exercise (37). In addition, the drug in relationship to activities such as meals, exer-
the short-term and long-term effects of physical activity cise, and stress can be judged. This information can lead to
could necessitate a decrease in insulin dosage. With the intelligent variations in therapy. Intensive diabetes self-
patient gaining the experience of the effect of exercise, management, as recommended by AACE, will improve
adjustment of the insulin dosage can result in more effec- blood glucose control and lower the glycosylated hemo-
tive control of the blood glucose level. The process of globin level. Only then will the risk of devastating and
physical conditioning through exercise training can result costly complications of diabetes be reduced.
in a 20 to 30% decrease in the daily subcutaneous insulin The cornerstones of therapy for type 2 diabetes
requirement (39). remain proper nutrition, exercise, and education. These
components of care should be implemented at the outset of
Summary the diagnosis of type 2 diabetes. Many patients with type
Nutrition and exercise programs are important, cost- 2 diabetes are immediately given medications without ini-
effective therapeutic maneuvers to assist patients with tial optimal therapeutic use of a program of appropriate
both type 1 and type 2 diabetes achieve effective metabol- nutrition and physical activity. Frequently, this approach
ic control. The patient must understand the effects and leads to a never-ending spiral of treatment with more and
importance of these therapeutic modalities in order to be more medication but little resulting improvement.
motivated to adhere to a beneficial nutrition and exercise The choices of oral drug therapy for type 2 diabetes
plan. The patient must be empowered not only to monitor have become extremely complex. The physician must be
the blood glucose level but also to initiate the needed positioned to use clinical judgment about the best combi-
changes in medication. When the patient becomes an nations of drugs for the patient with diabetes. This discre-
active participant in diabetes management, adherence to tion is particularly important in the long-term treatment of
effective therapy will increase and diabetes-related com- a chronic disease that is unrelenting and progressive and in
plications will decrease. which the response to therapy changes over time.
The following material is a summary of information
SECTION 4: PHARMACOLOGIC THERAPY FOR about pharmacologic options available for the treatment of
TYPE 2 DIABETES type 2 diabetes mellitus. See the current Physicians’ Desk
Reference (41) and package inserts (42-48) for detailed
Major advances have occurred in the pharmacologic information about specific drugs and for additional
treatment of type 2 diabetes during the past 5 years in the complete information.
AACE Diabetes Guidelines, Endocr Pract. 2002;8(Suppl 1) 49
Contraindications
Table 1 Known hypersensitivity to the drug
Commonly Used Sulfonylureas: Type 1 diabetes, diabetic ketoacidosis
Dosage Data Sulfa allergy
Table 3 Table 4
α-Glucosidase Inhibitors: Dosage Data Thiazolidinediones: Dosage Data
*Begin with lowest dose (25 mg three times a day with †Initiate therapy at 4 mg/day.
meals) and titrate at 2- to 4-week intervals, as needed, ‡Initiate therapy at 15 mg/day.
to maximal dose (100 mg three times a day with
meals).
†Take with first bite of each meal.
Contraindications Contraindications
Major gastrointestinal disorders, including inflammatory Known hypersensitivity or allergy to the drug or any of its
bowel disease, chronic ulceration, malabsorption, or components
partial intestinal obstruction Clinical evidence of active liver disease
Available Duration of
Table 5 Drug strengths action (h)
Meglitinides: Dosage Data
Regular U-100, 100 units/mL 3-6
Daily dose Doses/ U-500, 500 units/mL
Drug (mg) day (Lilly only)
Humalog U-100, 100 units/mL 1-2
Repaglinide (Prandin) 0.5-16* 2-4†
(lispro)
0.5 mg
Novolog U-100, 100 units/mL 1-2
1 mg
2 mg (insulin aspart)
NPH U-100, 100 units/mL 18-24
Nateglinide (Starlix) Lente U-100, 100 units/mL 18-24
120 mg 360mg* 2-4†
Ultralente U-100, 100 units/mL 24-36
*Taken 15 minutes before meals. Lantus U-100, 100 units/mL 24
†Based on number of meals. (glargine)
50/50† U-100, 100 units/mL …
Meglitinides: Profile 70/30† U-100, 100 units/mL …
Repaglinide (Prandin), in the meglitinide class of benzoic 75/25†† U-100, 100 units/mL …
acid derivatives, is an insulin secretagogue
*Daily dose and number of doses/day must be
Requires the presence of functioning beta cells
individualized.
Can be used as monotherapy or in combination with †NPH/regular mixture.
metformin ††Lispro protamine suspension (NPL)/lispro pen, taken
Similarly, nateglinide is phenyladanine derivative, insu- 15 minutes before the meal.
line secretion
52 AACE Diabetes Guidelines, Endocr Pract. 2002;8(Suppl 1)
Clinical Expectations
Table 7
Fasting and Postprandial Blood Glucose and Glycosylated Hemoglobin Responses
to Pharmacologic Treatment in Patients With Type 2 Diabetes*
*BG = blood glucose; HbA 1c = glycosylated hemoglobin; PPBG = postprandial blood glucose.
Table 8
Effect of Pharmacologic Treatment of Type 2 Diabetes on
Insulin Secretion and Glucose Production and Uptake
Hepatic Peripheral
Insulin glucose glucose
Drug secretion production uptake
SECTION 5: INTENSIVE TREATMENT OF high triglyceride levels and VLDL, lowered HDL levels,
COMORBID CONDITIONS and elevated LDL, especially small dense LDL. Because
of the association of atherogenic small dense LDL with
Substantial evidence indicates that treatment of hypertriglyceridemia and the increase in atherosclerosis,
comorbid conditions is critically important for achieving patients with diabetes have an added risk that must be con-
optimal outcomes in patients with diabetes mellitus. trolled. Additionally, lipid abnormalities and hypertension
Cardiovascular disease accounts for 80% of mortality in are accelerated with the advent of early renal disease (see
patients with diabetes mellitus. Therefore, control of other discussion of lipids, obesity, and insulin resistance in
risk factors such as dyslipidemia, hypertension, renal dis- Section 8 of these guidelines).
ease, obesity, and smoking is essential. The lesions of atherosclerosis occur primarily in large
and medium-sized elastic and muscular arteries. The result
Atherosclerosis is insufficiency of the coronary, cerebrovascular, mesen-
In many patients, the first symptom of type 2 diabetes teric, and peripheral circulations. Patients with diabetes
is a myocardial infarction attributable to coronary artery have a high absolute risk for coronary mortality and mor-
atherosclerosis. Atherosclerosis is well known to be asso- bidity and a worse prognosis than the general population.
ciated with high plasma concentrations of cholesterol, par- Furthermore, women with diabetes mellitus lose their rel-
ticularly low-density lipoprotein (LDL), whereas HDL ative protection against coronary artery disease.
cholesterol exerts a protective effect. Patients with uncon- Aggressive treatment, in accordance with the National
trolled type 2 diabetes have dyslipidemia, characterized by Cholesterol Education Program guidelines, is advised
AACE Diabetes Guidelines, Endocr Pract. 2002;8(Suppl 1) 53
(23). Most myocardial infarctions may be caused by patients with type 1 and type 2 diabetes (56). ACE
lesions that are considered hemodynamically insignifi- inhibitors also may slow the progression of microalbu-
cant. Therefore, additional maneuvers such as plaque sta- minemia to macroalbuminemia, even in normotensive
bilization (with use of aspirin or angiotensin-converting patients with type 2 diabetes (57). Recently, another
enzyme [ACE] inhibitors) may be important. potential beneficial effect of ACE inhibitors has been
reported. Endothelial dysfunction is common in patients
Dyslipidemia with type 2 diabetes. ACE inhibitors have been shown to
Although numerous clinical studies have demonstrat- improve endothelial function in type 2 diabetes (58). Other
ed the beneficial effects of lipid-lowering agents, no pub- renal protective measures include prevention and prompt
lished clinical trials have assessed the protective effect of treatment of urinary tract infections, institution of a low-
lipid-lowering agents on coronary artery disease exclu- protein diet, and avoiding or minimizing the use of
sively in patients with diabetes. Analysis of subgroups of radiographic contrast media.
patients in several large studies, however, provides evi- In its sixth report, the Joint National Committee on
dence of improved outcomes, especially in patients with Prevention, Detection, Evaluation, and Treatment of High
diabetes. These investigations include the Helsinki Heart Blood Pressure (59) concluded that systolic blood pressure
Study (49), the Scandinavian Simvastatin Survival Study should be reduced below 130 mm Hg and diastolic blood
(“4S”) (50), the Cholesterol and Recurrent Events (CARE) pressure below 85 mm Hg to achieve optimal risk
Trial (51), and the Air Force/Texas Coronary Atheroscle- reduction.
rosis Prevention Study (52). From these studies, one could Patients with type 2 diabetes and hypertension should
extrapolate the conclusion that intensive therapy for monitor their blood pressure frequently with home blood
dyslipidemia would be as protective as for the general pressure self-monitoring. Blood pressure can vary with
population. AACE believes that intensive treatment of food and salt intake, stress, and weight gain. Patients
dyslipidemia in patients with diabetes is important and should be taught how to judge the effect lifestyle changes
necessary for protection from the macrovascular compli- might have on the blood pressure and when to adjust their
cations of dyslipidemia. lifestyle in addition to their medication. The physician and
Currently, four major classes of lipid-lowering drugs the diabetes self-management team should empower the
are available: patient to be aware of these fluctuations. The team should
teach the patient the significance of reducing the risk com-
1. Statins (hydroxymethylglutaryl-coenzyme A reductase plications of hypertension and the importance of the data
inhibitors): lovastatin, simvastatin, pravastatin, fluva- obtained with home blood pressure self-monitoring.
statin, and atorvastatin
2. Fibric acid derivatives: gemfibrozil, fenofibrate Cardiovascular Disorders
3. Bile acid sequestrants: cholestyramine, colestipol Antioxidants such as vitamin E have been shown to
4. Nicotinic acid (which should be used with extreme decrease the incidence of myocardial infarction. In con-
caution, if at all, in patients with diabetes because of trast, β-carotene has been ineffective in decreasing the
deleterious effects on glycemic control) incidence of myocardial infarction. Prevention of vascular
events by the antiplatelet effect of daily low-dose aspirin
The most common lipid abnormality in patients with (as low as 30 mg/day) has been well established. Daily
type 2 diabetes mellitus is hypertriglyceridemia (53). The low-dose aspirin therapy is important for both primary and
relationship between hypertriglyceridemia and coronary secondary prevention of cerebral and cardiac events (60).
artery disease is complex. A recent meta-analysis suggest- Less well established is the proposal to use multivitamin
ed that triglyceride levels are an independent risk factor preparations containing folate, vitamin B12, and vitamin
for coronary artery disease (54). Triglyceride-rich lipopro- B6 to reduce the blood level of homocysteine, a known
teins tend to be associated with low HDL cholesterol lev- atherogenic agent (61,62). Outcomes of myocardial
els and small dense LDL particles. This lipid triad is often infarction (7,63,64) and stroke improve with near-normal-
associated with insulin resistance, hypertension, and ization of the blood glucose level.
prethrombotic states. Screening for asymptomatic coronary artery disease is
an important consideration in patients with diabetes
Hypertension (65,66). An appropriate protocol for such screening has
Recently, the UKPDS (55) demonstrated that inten- not been adequately tested. Increasing age, gender, cardio-
sive control of blood pressure in patients with hyperten- vascular risk factors, microalbuminuria, and retinopathy
sion reduced all diabetes complications by 24%, diabetes- may identify high-risk groups for whom such testing is
related deaths by 32%, strokes by 44%, heart failure by indicated.
56%, and microvascular complications by 37%. For
achieving control of hypertension, β-adrenergic blocking Overall
agents and ACE inhibitors were equally efficacious. Optimal care of the patient with diabetes must include
ACE inhibitors may confer an additional benefit. intensive glycemic control, proper nutrition, a physical
Studies have shown a specific effect of ACE inhibitors activity program, cessation of smoking, and weight
slowing the progression of diabetic nephropathy in control. Aggressive medical management of comorbid
54 AACE Diabetes Guidelines, Endocr Pract. 2002;8(Suppl 1)
conditions, such as dyslipidemia, hypertension, and early statistical correlation between blood glucose and
renal disease, and use of antiplatelet therapy for preven- macrovascular complications less definite; nonetheless,
tion of vascular events are critical to improved outcomes they are associated variables.
and decreased cost of care for diabetes and its complica- Although the intensive management of diabetes,
tions. which is necessary for achievement of tighter blood glu-
cose control, is associated with higher “up-front costs” of
SECTION 6: COST AND COST-EFFECTIVENESS labor, medications, and supplies, this investment has been
OF DIABETES CARE shown to be effective in reducing morbidity and mortality
as well as minimizing later expenditures for the most cost-
The cost of diabetes mellitus is enormous, not only in ly long-term complications (10,71,72). The cost benefit of
terms of human morbidity and mortality but also relative tight glucose control is most pronounced in young patients
to the economic burden it has imposed on the health-care who, in general, will have a longer subsequent duration of
system in the United States. Although patients with dia- life during which the complications of diabetes could
betes constitute only 3.1% of the total US population, they develop if normoglycemia is not achieved (10).
incur 11.9% of the total US health-care expenditures (67). The cost of treating diabetes with “intensive” therapy
within the DCCT ($4,014/yr) was 2.4 times that of “con-
Factors Contributing to Costs ventional therapy” ($1,666/yr). This cost was in a research
The economic costs of diabetes consist of direct setting. Inpatient initiation of treatment during the study
health-care expenditures as well as the loss of productivi- accounted for more than 80% of the additional cost (73).
ty because of related disability and premature death. The Outside the DCCT study participants, in physician prac-
direct medical costs of diabetes may be calculated as both tices, however, intensive therapy was much less expen-
medical expenses attributable to diabetes and total medical sive—only $2,337/yr (67). This difference was primarily
expenditures incurred among patients with diabetes. In due to less frequent and less prolonged use of hospital ser-
1997 in the United States, direct medical expenditures vices and a lower cost for outpatient visits. Dedicated dia-
attributable to diabetes totaled $44.1 billion. This overall betes management teams led by an endocrinologist have
amount consisted of $7.7 billion for diabetes and acute been shown to maintain DCCT-level control of diabetes
glycemic care, $11.8 billion due to the excess prevalence while using fewer inpatient and emergency department
of related chronic complications, and $24.6 billion due to resources (74).
the excess prevalence of general medical complications. A simulation model of disease progression and costs
Analysis of cost categories showed that 62% of costs were (75) revealed that intensively treated patients with dia-
for inpatient care, 25% were for outpatient services, and betes live 5.1 years longer than those given conventional
13% were for nursing home care. In addition, indirect therapy, with a lifetime increment in cost of only $33,746
costs included $17 billion from premature mortality and or $6,616 per year of additional life. Therefore, the inten-
$37.1 billion from disability, a total of $54.1 billion (68). sive treatment represented an extremely cost-effective
investment. In addition, with further consideration of the
Comparative Medical Expenditures reduction in complications (blindness, end-stage renal dis-
In 1997, total medical expenditures in the United ease, and lower extremity amputation) that decrease the
States for people with diabetes were $77.7 billion or quality of life, the study noted that the incremental cost per
$10,071 per capita, in comparison with $2,669 per capita “quality-adjusted life year” gained was only about
for those without diabetes (68). For 1992, Rubin and asso- $20,000 for type 1 diabetes and $16,000 for type 2
ciates (69) reported similar figures of $9,493 and $2,604, diabetes—relatively inexpensive in relationship to other
respectively, and noted that 15% of the national health- commonly accepted medical therapies.
care expenditures were spent on treating the 10.3 million Short-term outcome analysis (76) has shown that
people with overt diabetes. It has been estimated that improved glycemic control in patients with type 2 diabetes
another 5.4 million people have undiagnosed diabetes, a is associated with improved quality of life, higher retained
factor that would further increase the estimates of health- employment, greater productive capacity, and less absen-
care costs for those with diabetes (70). teeism. When these factors are considered, the cost of
intensive therapy seems offset by even greater economic
Effectiveness of Intensive Management benefit, not only to the individual patient but to society as
Since the publication of the findings of the DCCT (1) a whole.
and, more recently, of the UKPDS (3,4), it has become In the UKPDS (55), tight control of blood pressure
clear that tighter control of blood glucose in both type 1 was shown to confer additional preventive benefit.
and type 2 diabetes can result in significant reduction in Although this effort increased the average cost of drugs by
the development and progression of microvascular com- £ 613 ($977 US equivalent), a decrease in complications
plications of diabetes. Furthermore, the frequency of necessitating hospitalization accounted for a reduction of
macrovascular complications is decreased by near-nor- £ 700 ($1,116 US equivalent). Tight control was estimat-
malization of the blood glucose levels. Multiple contribut- ed to cost less than £ 3,000 ($4,784 US equivalent) per
ing causative factors of macrovascular complications, year of life gained. Thus, intensive diabetes management
including dyslipidemia and hypertension, make the makes as much sense economically as it does medically.
AACE Diabetes Guidelines, Endocr Pract. 2002;8(Suppl 1) 55
Numerous studies have documented the importance of vascular complications. This knowledge will aid in
a diabetes management team led by a clinical endocrinolo- increasing adherence to recommendations.
gist in achieving the tight blood glucose control necessary 5. Monitor blood pressure consistently to help regulate the
to yield the benefits of reduction in human pain and suffer- blood pressure and blood pressure medication. Under-
ing. Such studies have demonstrated the cost efficiency of stand the effects of medication and stress on blood pres-
this approach to diabetes care in reducing the frequency of sure control and the risk of the lack of blood glucose
unnecessary visits to the emergency department and short control. This understanding will encourage adherence to
hospital stays (74), in decreasing the duration of hospital blood pressure monitoring and control measures and
decrease the risk of complications from hypertension, a
stay for patients with diabetes (2), in treating diabetic
serious comorbid complication of diabetes.
ketoacidosis more efficiently (77-80), and in providing
6. Recognize and understand the psychologic barriers that
ongoing care to patients with diabetes that reduced both prevent adherence to the system of intensive self-man-
cardiovascular and renal morbidity and mortality (6). agement of diabetes. Learn how to express feelings and
define the barriers to expressing feelings to the physi-
SECTION 7: PATIENT AND PHYSICIAN cian and the self-management team. This skill might
RESPONSIBILITIES FOR EFFECTIVE help increase adherence with the system of intensive
DIABETES CARE self-management of diabetes.
7. Learn the best techniques of foot care management and
In any therapeutic situation, the physician and the make a commitment to intensive foot care.
patient have specific responsibilities. During the past 3 8. Understand the reasons for the onset of retinopathy, and
decades, this concept of shared responsibility has espe- recognize the signs and symptoms for early detection.
cially been emphasized in the management of chronic dis- 9. Understand the need for establishing goals for blood glu-
eases, and type 1 diabetes mellitus is a notable example. cose, lipids, and blood pressure. Learn to participate in
Until recently, type 2 diabetes mellitus had not been the development of these goals and in their modification,
perceived as being a serious disease, perhaps because in consultation with the physician. After the goals have
patients with type 2 diabetes may be relatively asympto- been established, develop a dedication to reaching those
matic. The medical community now knows that even goals through intensive self-management of diabetes.
10. Actively participate in continuing diabetes education,
though the patient may be asymptomatic, a high blood glu-
such as support groups and physician and educator
cose level will result in unrelenting development of both
interactions, between regularly scheduled appointments.
microvascular and macrovascular disease. The microvas- Share this valuable resource, becoming a teacher to
cular disease leads to ophthalmologic, neurologic, and other patients with diabetes and thereby learning from
renal complications. The comorbid conditions of dyslipi- such interactions.
demia and hypertension have a complex relationship with 11. Adhere to proper nutrition and physical activity pro-
diabetes. They may be worsened by poorly controlled dia- grams. Understand the physiologic rationale for their
betes or, in some settings, may be a direct result of lack of effectiveness. To improve adherence, discuss barriers
glycemic control. To achieve glycemic control, the with the physician and the diabetes management team.
asymptomatic patient with type 2 diabetes must become 12. Accurately document serial blood glucose and blood
an active participant in the management of the blood glu- pressure measurements. Understand that the purpose of
cose level. The physician and the diabetes management keeping such records is to help clarify blood glucose
team must teach, nurture, and continually guide the patient and blood pressure relationships to dietary aberrations,
toward self-management of the blood glucose. stress, exercise, and acute illnesses such as infections.
The AACE Medical Guidelines for the Management This documentation will facilitate appropriate changes
of Diabetes Mellitus include a patient-physician contract. in treatment.
This contract outlines both the patient’s and the 13. Understand the importance of keeping regularly sched-
physician’s responsibilities in the management of this very uled appointments. Effective treatment of diabetes
serious and complicated disease. The summarized depends on a continuum of care, including periodic
medical consultations.
responsibilities of each stakeholder follow.
14. Adhere to the proper use of medications. Understanding
The Patient’s Responsibilities the mechanism of action of the medication will enhance
1. Perform monitoring of blood glucose consistently to adherence. If changes in the medication seem necessary,
help understand the dynamics of blood glucose changes learn to communicate with the physician between
relative to medication, diet, stress, and exercise. appointments so that appropriate alterations can be
2. Understand the importance of smoking cessation in made as a collaborative effort with the physician.
decreasing the risks of diabetes-related macrovascular 15. Understand the meaning of glycosylated hemoglobin,
and microvascular complications and, if a smoker, and know the results of personal glycosylated hemoglo-
enroll in a program of smoking cessation. bin values.
3. Learn the importance of participation in a program of 16. Appreciate that the patient-physician contract is a tool to
prescribed exercise for weight reduction and physical help both the patient and the physician uphold their
conditioning. commitments in the therapeutic plan.
4. Know the importance of and reasons for the consistent 17. Evaluate the compliance of the physician, and commu-
use of aspirin in helping to reduce the risk of macro- nicate this assessment to the physician.
56 AACE Diabetes Guidelines, Endocr Pract. 2002;8(Suppl 1)
The Physician’s Responsibilities 9. Supervise the education of the patient. The physician
For an effective diabetes self-management system, must be involved in discussing preventive methods and
the physician must also fulfill the following responsibili- explaining risk reduction so that the patient gains exper-
ties in the patient-physician contract. tise in diabetes management and is encouraged by the
entire diabetes care team.
1. Adhere to the protocol outlined in the AACE Medical 10. Ensure that the patient understands and adheres to pre-
Guidelines for the Management of Diabetes Mellitus: A ventive measures, including detailed instructions for
System of Intensive Diabetes Self-Management. foot care, diet, and physical activities, aimed at reducing
2. Appropriately collect the patient data (details of the the risk of complications.
clinical course and the laboratory findings) so that clin- 11. Utilize a process to evaluate the patient’s adherence to
ical outcomes can be measured and related to economic the system of intensive self-management. The assess-
outcomes. ment should be objective and amenable to evaluation in
3. Determine patient satisfaction and quality of life by use query format related to other variables. The program
of questionnaires at yearly intervals. should include mechanisms to determine whether the
4. Utilize a system of communication and documentation patient is taking medicines and insulins safely and cor-
of the communication with the diabetes self-manage- rectly. A continuing program should be undertaken to
ment team so that the team is truly an extension of the identify errors and misconceptions as well as to educate
physician’s care. others in the system who help care for these patients.
5. Utilize diabetes skill evaluation programs, and objec- This effort will reduce the frequency of potential mis-
tively evaluate the patient semiannually. takes in the overall process.
6. Define the frequency of patient visits, and assess the
patient’s ability and desire to adhere to the system of The Patient-Physician Contract
intensive diabetes self-management. In medical care, the social contract is between the
7. Document, evaluate, and rate the patient’s concerns patient and the physician. Both the physician and the
every 3 months in a utilizable data format. As the key patient have obligations in this therapeutic relationship.
element, the patient must feel comfortable describing The fulfillment of those obligations and responsibilities by
barriers to intensive self-management. The patient each party is critical to achieving near-normal blood glu-
should always be the focus of the diabetes self-manage- cose levels. In patients with type 1 or type 2 diabetes,
ment team. decreasing the rate of complications, enhancing the quali-
8. Evaluate the effectiveness of the documentation of care ty of life, limiting the associated morbidity, and minimiz-
of the patient. Pay particular attention to the quality of ing the economic costs can be achieved by increasing
the documentation; continuous improvement in the adherence and attaining near-normalization of the blood
quality of documentation should be an integral part of
glucose levels.
the system of care.
Table 9
Summary of Patient and Physician Responsibilities
in Intensive Diabetes Self-Management System
SECTION 8: THE INSULIN RESISTANCE early age should undergo periodic assessment for the pres-
SYNDROME ence of diabetes.
Some evidence suggests that breast cancer may be
Characterization associated with insulin resistance—because of stimulation
The insulin resistance syndrome is characterized by of tumor growth by high insulin levels or by decreased
glucose intolerance, hypertension, dyslipidemia, and vis- hepatic production of sex hormone-binding globulin and
ceral obesity (81,82). All of these findings are risk factors higher free estrogen levels (88). Moreover, many cases of
for ischemic heart disease, but insulin resistance, as polycystic ovary disease are associated with insulin resis-
assessed by the fasting insulin level, has itself been shown tance. High insulin levels stimulate the production of
to be an independent risk factor for ischemic heart disease androgens from the ovaries and adrenal gland and luteiniz-
in investigations such as the Quebec Heart Study (83). In ing hormone from the pituitary gland (89). The decreased
fact, in that study, insulin resistance was shown to be a sex hormone-binding globulin further increases the free
more important risk factor than total apolipoprotein B or androgen levels and increases the likelihood of manifesta-
HDL cholesterol levels. tions of the disease (acne, hirsutism, virilism, amenorrhea,
The dyslipidemia associated with insulin resistance is and infertility). Women with polycystic ovaries, because
characterized by a high triglyceride level and a low HDL of their underlying insulin resistance, are at high risk for
cholesterol level. In the atherogenicity of the dyslipidemia subsequent development of the other manifestations of
associated with insulin resistance, however, small dense polycystic ovary disease including diabetes mellitus and
LDL particles, postprandial hyperlipidemia, and increased vascular disease.
remnant particles may be equally important factors
(81,84). Causative Factors
Insulin resistance is a state in which insulin-sensitive
Associated Conditions tissues, such as skeletal muscle, have a reduced sensitivi-
Insulin resistance as a cause of hypertension is more ty to the effects of insulin on glucose uptake. At least 50%
prevalent in some ethnic minority groups than in others. of any patient’s insulin resistance is due to genetic factors.
The mechanism for the increased prevalence of hyperten- Insulin resistance is worsened by aging, inactivity leading
sion is related to higher insulin levels acting on the renal to a loss of muscle mass, and the development of obesity.
tubule, increased reabsorption of sodium, and vasocon- For obesity to be associated with insulin resistance, it must
striction through stimulation of the sympathetic system by be of the android or male distribution (that is, with a high
insulin (85). In addition, the insulin resistance syndrome is waist-to-hip ratio) and not the gynoid or female distribu-
associated with endothelial dysfunction (82,86), leading to tion, with most of the adipose tissue in the lower body (a
a decrease in production of nitric oxide. The decreased decreased waist-to-hip ratio). Furthermore, subcutaneous
production of nitric oxide, in turn, leads to vasoconstric- adipose tissue is not associated with insulin resistance,
tion and stimulation of clotting factors, platelet aggrega- whereas intraperitoneal or visceral adiposity is. The ratio
tion, and decreased breakdown of fibrinogen through of intraperitoneal to subcutaneous fat can be determined
stimulation of plasminogen activator inhibitor. Endo- by computed tomographic scanning or magnetic reso-
thelial dysfunction is also associated with increased nance imaging. Increased intraperitoneal fat is suspected if
endothelial permeability to molecules such as lipoproteins. the waist circumference is more than 37 inches (94 cm) or
In addition, activation of growth factors leads to accelerat- the waist-to-hip ratio exceeds 0.85 in women or 1.00 in
ed atherosclerosis. Abnormal endothelial permeability is men (82,90).
also present in the glomerulus, in reality an arteriole, lead- Other environmental factors that increase insulin
ing to microalbuminuria and proteinuria. The level of pro- resistance are cigarette smoking and a lack of exercise.
teinuria has been shown to be inversely proportional to the Insulin resistance is lowered by a moderate alcohol intake
insulin sensitivity. In patients who are at high risk for dia- (one to two drinks per day); however, AACE does not
betes because of insulin resistance, proteinuria will often advocate the use of alcohol to achieve such a result.
be detected before fasting or postprandial blood glucose Pharmacologically, drugs such as nicotinic acid, β-adren-
levels are found to be high. ergic blocking agents, thiazide diuretics, progesterones,
Overt diabetes will develop when insulin production and short-acting dihydropyridine calcium channel block-
cannot be increased to overcome insulin resistance. In ers increase insulin resistance, whereas ACE inhibitors,
comparison with thin patients, many obese patients with- angiotensin II receptor blockers, and estrogen replacement
out diabetes produce 5 to 8 times more insulin—an therapy lower insulin resistance.
amount that can be as much as 500 U/day—to overcome Because infections and cancers may exacerbate the
insulin resistance. Thus, type 2 diabetes can be attributed insulin resistance syndrome, investigators have postulated
to a genetic failure of the pancreatic beta cells to compen- that the final common pathway of the insulin resistance
sate for insulin resistance (87). The presence of hyper- syndrome is through the action of cytokines. Although
uricemia, with or without clinical manifestations of gout, many cytokines have been shown to be increased in the
is also a feature of the metabolic syndrome which includes insulin resistance syndrome, the cytokine that could most
insulin resistance. Therefore, patients known to have reasonably be the link among all the manifestations of the
hypertension, dyslipidemia, hyperuricemia, or gout at an syndrome is tumor necrosis factor-α.
58 AACE Diabetes Guidelines, Endocr Pract. 2002;8(Suppl 1)
4. The patient may be reassessed and reevaluated at 6 7. Recognizing and managing potentially dangerous
months to determine the level of knowledge retained complications
after training and education a. Hypoglycemia
b. Diabetic ketoacidosis
Diabetes Self-Management System c. Hypoglycemia unawareness
Patient empowerment is vital to a system of intensive d. Infection
diabetes therapy. For a successful system, the patient must e. Vascular disease
understand and learn to manage the diabetes and its treat- 8. Instructions for special situations
ment (95). Traditional patient education is just one aspect a. Sick day rules
of diabetes intensive self-management. In addition, the b. Travel instructions
patient with diabetes must be taught to assume responsi- c. Use of glucagon
bility for the self-monitoring and problem solving that are 9. Preventive care
critical to the successful implementation of a system of a. Foot care
intensive diabetes therapy. b. Skin care
Although this educational process is initiated during 10. Psychologic aspects
Phase I, the information is so vital and the material is so a. Effect on relationships and family dynamics
extensive that the educational process should be continued b. Effect on self-image
during all phases of treatment. c. Importance of support
Because each participating patient will have different d. Denial
educational needs, the members of the health-care team 11. Instructions for family members
must individualize the program. The results of the initial
patient assessment will help health-care team members Patient-Physician Contract
establish a system of priorities for scheduling each topic to For successful implementation of intensive diabetes
be covered. A series of ongoing patient assessments, management, the patient and the clinical endocrinologist
undertaken during all subsequent phases of treatment, will or other physician must have mutual, frequently commu-
help health-care team members revise these priorities as nicated treatment goals. This relationship necessitates reg-
needed to ensure that the individual needs of each patient ularly scheduled communication and frequent visits
are being met and to facilitate patient adherence. between the patient and members of the health-care team.
Topics to be addressed during the overall course of The frequency of these interactions should be based on
treatment of the patient with diabetes may be divided into individual patient needs. Patients must be encouraged to
the following categories (93): adhere to the specified schedule. To achieve this goal, the
physician may need to establish a follow-up system or, in
1. Pathophysiologic features of diabetes some cases, the intervention of a third-party payer.
2. Rationale for the intensive treatment of diabetes For optimal patient adherence to the System of
mellitus Intensive Diabetes Self-Management, it may be helpful to
a. Potential complications associated with diabetes elicit the patient’s written commitment to participate. The
b. Relationship between control and complications document, which should be signed by both the patient and
3. Self-monitoring of blood glucose the physician, should specify the responsibilities of both
a. Use of a blood glucose self-monitor parties and contain the prescribed schedule of follow-up
b. Schedule for use (minimum of twice daily) visits and communications (see Appendix). The risks of
c. Instructions for record keeping assuming or declining the responsibility of intensive
4. Medication therapy need to be defined in the contract.
a. Description
b. Dosing instructions Phase II: Follow-Up Assessments
c. Dosage adjustment algorithms
d. Suggestions for record keeping A goal of each follow-up assessment is to evaluate the
5. Nutrition patient’s physical condition, level of blood glucose con-
a. Importance trol, and degree of adherence to guidelines. Such an
b. Prescribed meal plan assessment should include an interim history, physical
c. Dealing with nutrition-related fluctuations in examination, laboratory evaluation, and review of the
blood glucose levels patient’s results of self-monitoring of blood glucose. On
d. Suggestions for record keeping the basis of the results of this evaluation, the physician and
6. Exercise the patient may elect to revise any or all aspects of the
a. Importance patient’s treatment plan or the schedule for the assessment
b. Prescribed exercise plan of complications (see Phase III).
c. Dealing with activity-related fluctuations in Because the patient with diabetes has a considerably
blood glucose levels increased risk of coronary artery and peripheral arterial
d. Suggestions for record keeping disease, dyslipidemia, and hypertension, lipid levels and
AACE Diabetes Guidelines, Endocr Pract. 2002;8(Suppl 1) 61
Phase III: Assessment of Complications nation should include any questions relevant to the assess-
ment of renal complications. Additional diagnostic evalu-
The goal of Phase III is to assess the presence and ations should include the following:
severity of the complications associated with diabetes
mellitus. Each of the following four complications mod- 1. Test for microalbuminuria
ules (93,96) should be performed in conjunction with a 2. Creatinine clearance
quarterly Phase II follow-up assessment: 3. Automated serum chemistry analysis
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pressure control and risk of macrovascular and microvas- Diabetes Control and Complications Trial. Diabetes Care.
cular complications in type 2 diabetes: UKPDS 38 [pub- 1995;18:1468-1478.
lished erratum appears in BMJ. 1999;318:29]. BMJ. 1998; 74. Cobin RH. Endocrinologists provide cost effective dia-
317:703-713. betes care. First Messenger. 1997;6(No. 5):8-10.
56. Lewis EJ, Hunsicker LG, Bain RP, Rohde RD, The 75. Diabetes Control and Complications Trial Research
Collaborative Study Group. The effect of angiotensin- Group. Lifetime benefits and costs of intensive therapy as
converting-enzyme inhibition on diabetic nephropathy practiced in the Diabetes Control and Complications Trial
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[published erratum appears in JAMA. 1997;278:25]. 87. Polonsky KS, Sturis J, Bell GI. Seminars in Medicine of
JAMA. 1996;276:1409-1415. the Beth Israel Hospital, Boston: non-insulin-dependent
76. Testa MA, Simonson DC. Health economic benefits and diabetes mellitus—a genetically programmed failure of
quality of life during improved glycemic control in the beta cell to compensate for insulin resistance. N Engl
patients with type 2 diabetes mellitus: a randomized, con- J Med. 1996;334:777-783.
trolled, double-blind trial. JAMA. 1998;280:1490-1496. 88. Benson EA, Holdaway IM. Insulin receptors in human
77. May ME, Young C, King J. Resource utilization in treat- cancer. Br J Cancer. 1981;44:917-920.
ment of diabetic ketoacidosis in adults. Am J Med Sci. 89. Dunaif A, Scott D, Finegood D, Quintana B, Whitcomb
1993;306:287-294. R. The insulin-sensitizing agent troglitazone improves
78. Alsever RN. Specialist versus primary care: not an easy metabolic and reproductive abnormalities in the polycys-
question. Physician Exec. 1995;21:39-41. tic ovary syndrome. J Clin Endocrinol Metab. 1996;81:
79. Moss JM. Diabetic ketoacidosis: effective low-cost treat- 3299-3306.
ment in a community hospital. South Med J. 1987;80:875- 90. Kissebah AH. Central obesity: measurement and meta-
881. bolic effects. Diabetes Rev. 1997;5:8-20.
80. Levetan CS, Passaro MD, Jablonski KA, Ratner RE. 91. Ruderman N, Chisholm D, Pi-Sunyer X, Schneider S.
Effect of physician specialty on outcomes in diabetic The metabolically obese, normal-weight individual revis-
ketoacidosis. Diabetes Care. 1999;22:1790-1795. ited. Diabetes. 1998;47:699-713.
81. Reaven GM. Insulin resistance and its consequences: 92. Helmrich SP, Ragland DR, Leung RW, Paffenbarger
non-insulin-dependent diabetes mellitus and coronary RS Jr. Physical activity and reduced occurrence of non-
heart disease. In: LeRoith D, Taylor SI, Olefsky JM, eds. insulin-dependent diabetes mellitus. N Engl J Med.
Diabetes Mellitus. Philadelphia: Lippincott-Raven 1991;325:147-152.
Publishers, 1996: 509-519. 93. American Diabetes Association. Standards of medical
82. American Diabetes Association. Consensus care for patients with diabetes mellitus [position state-
Development Conference on Insulin Resistance. 5-6 ment]. Diabetes Care. 1991;14:10-13.
November 1997. Diabetes Care. 1998;21:310-314. 94. Davidson MB. Diabetes Mellitus: Diagnosis and
83. Despres JP, Lamarche B, Mauriege P, et al. Treatment. 3rd ed. New York: Churchill Livingstone,
Hyperinsulinemia as an independent risk factor for 1991: 330.
ischemic heart disease. N Engl J Med. 1996;334:952-957. 95. American Diabetes Association. Physician’s Guide to
84. Chen Y-DI, Reaven GM. Insulin resistance and athero- Non-Insulin-Dependent (Type II) Diabetes: Diagnosis and
sclerosis. Diabetes Rev. 1997;5:331-342. Treatment. 2nd ed. Alexandria, VA: American Diabetes
85. Reaven GM, Lithell H, Landsberg L. Hypertension and Association, 1989: 62-63.
associated metabolic abnormalities—the role of insulin 96. American Diabetes Association. Eye care guidelines for
resistance and the sympathoadrenal system. N Engl J Med. patients with diabetes mellitus [position statement].
1996;334:374-38l. Diabetes Care. 1991;14:16-17.
86. Hsueh WA, Quinones MJ, Creager MA. Endothelium
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1997;5:343-352.
66 AACE Diabetes Guidelines, Endocr Pract. 2002;8(Suppl 1)
Appendix
II.Current Medications
Current Problems:
AACE Diabetes Guidelines, Endocr Pract. 2002;8(Suppl 1) 67
III. Educational Objectives/Plan
1.
2.
3.
Time:
Breakfast:
Snack:
Lunch:
Snack:
Dinner:
Snack:
Food preferences/intolerances:
Breakfast:
Midmorning Snack:
Lunch:
Afternoon Snack:
Dinner:
Bedtime Snack:
Frequency of:
DKA Low BS High BS Diabetic Hospitalizations
Complications:
Retinopathy I BP Nephropathy Neuropathy PVD Other
Exercise:
Type Times/Week How Long
68 AACE Diabetes Guidelines, Endocr Pract. 2002;8(Suppl 1)
A. Basic Pathophysiology
Understands the basic pathophysiology of diabetes
B. Psychologic Adjustment
Has psychologically adjusted to diabetes
and lifestyle modifications and understands
effects of stress on management
C. Family Involvement
Family and/or significant other(s) are sufficiently
involved in diabetes management
S M W D
D. Exercise
Describes, understands, and incorporates effective
exercise habits into diabetes management
E. Medications
Demonstrates and/or verbalizes correct use of
1. P.O. Type
Dosage
Frequency
Action
2. Insulin
Type/Dose
Action
Injection Techniques
Mixing
Storage
Site Selection
F. Relationship Among
Nutrition/Exercise/Medication
Understands interrelation of nutrition, exercise,
medication, and lab values and
incorporates this into diabetes management
G. Monitoring
1 . Demonstrates accurate blood or urine
glucose monitoring
2. Frequency
3. Type
4 . Urine ketone testing
H. Hypoglycemia
Understands, describes, and appropriately reacts to
and treats the signs and symptoms of hypoglycemia
I. Illness/Hyperglycemia
Understands, describes, and appropriately responds
to the signs and symptoms of illness and/or
hyperglycemia; ketones
AACE Diabetes Guidelines, Endocr Pract. 2002;8(Suppl 1) 69
K. Care Benefits/Responsibilities
Understands the benefits and responsibilities
of appropriate diabetes management
L. Hygiene
Understands the importance of and practices routine
hygiene to prevent possible diabetes complications
Foot care
Eye care
Dental Care
General
N. Community Resources
Is aware of and appropriately uses available community
resources (ADA, MedicAlert ®, support groups)
Other:
Signatures
RN, CDE
RD/LD
AACE Diabetes Guidelines, Endocr Pract. 2002;8(Suppl 1) 71
20. Which food provides soluble fiber? 4. In general, fit patients with diabetes should exercise
a. lentils for
b. oats a. 15 minutes once a week
c. fruits b. 1 hour once a week
d. all of the above* c. 20 to 30 minutes 3 times a week*
d. 1 hour every day
21. Which of the following should not be used by
patients with diabetes? 5. Patients who need insulin should inject it into the
a. aspartame thigh muscle before running.
b. honey* a. true
c. saccharin b. false*
d. fructose
6. If blood glucose is less than 80 mg/dL during exer-
22. People with diabetes need more vitamins and miner- cise, you should
als than do people without diabetes. a. lie down
a. true b. eat a snack*
b. false* c. call your doctor immediately
d. ignore it and keep exercising
23. The number of calories eaten should be
a. greatest at breakfast 7. If blood glucose is more than 300 mg/dL, insulin
b. greatest at lunch should be adjusted or exercise should be delayed.
c. greatest at dinner a. true*
d. evenly distributed among meals* b. false
24. All patients with diabetes follow the same meal 8. For avoidance of hypoglycemia, the best time to
plan. exercise is
a. true a. any time you are hungry
b. false* b. just before dinner
c. after meals*
25. “Exchange” refers to foods that d. just before breakfast
a. can be substituted for each other*
b. must be returned because they contain sugar Monitoring
c. can be shared with friends
d. must be avoided 1. Low blood glucose can be detected accurately by
testing
Exercise a. urine
b. blood*
1. Regular exercise c. saliva
a. improves lipid levels d. all of the above
b. strengthens the heart
c. gives a sense of well-being 2. Self-monitoring of blood glucose is
d. does all of the above* a. essential for intensive therapy
b. the key to determining the right amount of med-
2. Regular exercise may ication
a. lower blood glucose c. useful even if diabetes is controlled with diet
b. reduce the amount of insulin needed and exercise
c. reduce the amount of diabetes pills needed d. all of the above*
d. do all of the above*
3. With intensive therapy, self-monitoring of blood
3. Which exercise is best for patients with “insensi- glucose should be done
tive” feet? a. only before breakfast
a. swimming* b. only before lunch
b. jogging c. only before dinner
c. running d. several times a day*
d. tap dancing
74 AACE Diabetes Guidelines, Endocr Pract. 2002;8(Suppl 1)
4. Monitoring should be done more often 3. Sources of insulin used for injections are
a. on sick days a. pigs
b. when traveling b. cows
c. when meal or exercise plans change c. synthesis by recombinant DNA
d. at all of the above times* d. all of the above*
5. Patients with diabetes should undergo assessment by 4. The insulin you are using should be stored in
their clinical endocrinologist or another physician a. the refrigerator
a. every 3 months* b. the freezer
b. every year c. the medicine cabinet
c. every 2 years d. a cool, dry place*
d. only after complications develop
5. The preferred site for an insulin injection is
6. A glycosylated hemoglobin test measures blood glu- a. the abdomen*
cose over the past b. the hips
a. hour c. the buttocks
b. day d. all of the above
c. week
d. 8 to 12 weeks* 6. Insulin should always be injected in the same site.
a. true
7. In people without diabetes, the normal glycosylated b. false*
hemoglobin value is about
a. 8 to 10% 7. When you travel, your medications and supplies
b. 3.8 to 6.0%* should be
a. checked in your luggage
c. 2.5 to 3.5%
b. carried with you*
d. 10.1 to 11.8%
c. left at home
8. During illness, blood glucose should be monitored
8. During illness, you should stop taking your medica-
every
tions.
a. 1/2 hour
a. true
b. 3 to 4 hours*
b. false*
c. 6 hours
d. 12 hours Type 1 Diabetes: Patient Evaluation
9. To treat mild hypoglycemia, you could What Is Diabetes?
a. take 3 glucose tablets
b. eat a few pieces of candy (not sugar-free) 1. In type 1 diabetes mellitus, the body does not make
c. eat 2 tablespoons of raisins enough
d. do any of the above* a. saliva
b. insulin*
10. Nighttime hypoglycemia should be treated with c. glucose
a. carbohydrate d. cholesterol
b. protein
c. fat 2. Patients with type 1 diabetes
d. first carbohydrate, then carbohydrate plus pro- a. never need insulin injections
tein* b. need insulin injections daily*
c. may occasionally need insulin injections
Medications
3. Insulin is made in the
1. Diabetes pills a. liver
a. lower blood glucose b. stomach
b. increase the release of insulin c. kidneys
c. fight insulin resistance d. pancreas*
d. do all of the above*
4. Insulin helps the body
2. For diabetes pills to work, the body must be able to a. turn sugar into energy*
make some insulin. b. get rid of sugar
a. true* c. store sugar in the blood
b. false d. make red blood cells
AACE Diabetes Guidelines, Endocr Pract. 2002;8(Suppl 1) 75
5. “Blood glucose” refers to the level of sugar 15. The most important person on your health-care team
(glucose) in the blood. is
a. true* a. you*
b. false b. the doctor
c. the diabetes educator
6. The target range for blood glucose before meals is d. the dietitian
a. 50 to 70 mg/dL
b. 70 to 120 mg/dL* Nutrition
c. 125 to 160 mg/dL
d. 160 to 200 mg/dL 1. Carbohydrates should make up what percent of your
daily calories?
7. “Hyperglycemia” means a. 5 to 10%
a. high blood glucose* b. 15%
b. low blood glucose c. 25%
c. high blood pressure d. 55 to 60%*
d. low blood pressure
2. A good source of complex carbohydrates is
8. “Hypoglycemia” means a. eggs
a. high blood pressure b. mayonnaise
b. low blood pressure c. whole-grain bread*
c. high blood glucose d. roast beef
d. low blood glucose*
3. Fat should constitute what percent of your daily
9. Which of the following is a symptom of hypo- calories?
glycemia? a. less than 30%*
a. weakness b. 45%
b. sweating c. 55 to 60%
c. shakiness d. 75%
d. all of the above*
4. Which of the following foods is high in fat?
10. The aim of intensive diabetes treatment is a. apples
a. to keep blood glucose as close to normal as b. lettuce
possible c. cheddar cheese*
b. to avoid long-term complications d. oatmeal
c. both of the above*
5. The fatty substance in food linked to heart disease is
11. Complications of diabetes include a. carbohydrates
a. kidney disease b. protein
b. eye problems c. cholesterol*
c. foot problems d. fiber
d. all of the above*
6. Which of the following foods contain cholesterol?
12. Which of the following can affect blood glucose a. eggs
control? b. Swiss cheese
a. stress c. red meat
b. eating habits d. all of the above*
c. exercise
d. all of the above* 7. To decrease dietary fat and cholesterol, which food
is the best choice?
13. Patients with diabetes have no control over the a. steak
development of complications. b. fried eggs
a. true c. broiled chicken without skin*
b. false* d. ham and cheese sandwich
14. “Tight” control of diabetes means 8. How much of your diet should be protein?
a. keeping blood glucose as close to normal as a. less than 10%
possible b. 15 to 20%*
b. frequent self-monitoring c. 50%
c. reduced complications d. 75%
d. all of the above*
76 AACE Diabetes Guidelines, Endocr Pract. 2002;8(Suppl 1)
9. Which of the following foods provides low-fat 2. Which exercise is best for patients with “insensi-
protein? tive” feet?
a. broiled flounder* a. swimming*
b. Swiss cheese b. jogging
c. carrots c. running
d. saltines d. tap dancing
10. The maximum daily amount of salt (sodium) in your 3. In general, fit patients with diabetes should exercise
diet should be for
a. less than 3 g* a. 15 minutes once a week
b. 5 g b. 1 hour once a week
c. 10 g c. 20 to 30 minutes 3 times a week*
d. 12 g d. 1 hour every day
11. One serving of alcohol equals 4. Patients who need insulin should inject it into the
a. 12 ounces of beer thigh muscle before running.
b. 2 ounces of wine a. true
c. 1.5 ounces of scotch b. false*
d. all of the above*
5. If blood glucose is less than 80 mg/dL during
12. If alcohol is allowed, you should drink it exercise, you should
a. on an empty stomach a. lie down
b. along with food* b. eat a snack*
c. call your doctor immediately
13. If alcohol is allowed, which is not a good choice? d. ignore it and keep exercising
a. dry white wine
b. sweet liqueur* 6. If blood glucose is more than 300 mg/dL, insulin
c. scotch and water should be adjusted or exercise should be delayed.
d. beer a. true*
b. false
14. A “free food”
a. has no sugar 7. For avoidance of hypoglycemia, the best time to
b. has fewer than 20 calories* exercise is
c. has no salt a. any time you are hungry
d. can be eaten in unlimited quantities b. just before dinner
c. after meals*
15. Which one of the following should not be used by d. just before breakfast
patients with diabetes?
a. aspartame Monitoring
b. honey*
c. saccharin 1. Low blood glucose can be detected accurately by
d. fructose testing
a. urine
16. “Exchange” refers to foods that b. blood*
a. can be substituted for each other* c. saliva
b. must be returned because they contain sugar d. all of the above
c. can be shared with friends
d. must be avoided 2. Self-monitoring of blood glucose is
a. essential for intensive therapy
Exercise b. the key to determining the right amount of med-
ication
1. Regular exercise c. important to see the effect of food intake
a. improves lipid levels d. all of the above*
b. strengthens the heart
c. gives a sense of well-being 3. With intensive therapy, self-monitoring of blood
d. does all of the above* glucose should be done
a. only before breakfast
b. only before lunch
c. only before dinner
d. several times a day*
AACE Diabetes Guidelines, Endocr Pract. 2002;8(Suppl 1) 77
4. Monitoring should be done more often 11. To treat mild hypoglycemia, you could
a. on sick days a. take 3 glucose tablets
b. when traveling b. eat a few pieces of candy (not sugar-free)
c. when meal or exercise plans change c. eat 2 tablespoons of raisins
d. at all of the above times* d. do any of the above*
5. If your blood glucose is more than 240 mg/dL and 12. Nighttime hypoglycemia should be treated with
your urine contains large ketones, you should a. carbohydrate
a. take a nap b. protein
b. take extra insulin, then call your doctor* c. fat
c. eat a large meal d. first carbohydrate, then carbohydrate plus pro-
d. exercise tein*
8. A glycosylated hemoglobin test measures blood glu- 3. The best site for an insulin injection is
cose over the past a. the abdomen*
a. hour b. the hips
b. day c. the buttocks
c. week d. all of the above
d. 8 to 12 weeks*
4. Insulin should always be injected in the same site.
9. In people without diabetes, the normal glycosylated a. true
hemoglobin value is about b. false*
a. 8 to 10%
b. 3.8 to 6.0%* 5. When you travel, your medications and supplies
c. 2.5 to 3.5% should be
d. 10.1 to 11.8% a. checked in your luggage
b. carried with you*
10. During illness, blood glucose should be monitored c. left at home
every
a. 1/2 hour 6. During illness, you should stop taking your medica-
b. 3 to 4 hours* tions.
c. 6 hours a. true
d. 12 hours b. false*
78 AACE Diabetes Guidelines, Endocr Pract. 2002;8(Suppl 1)
I understand that if I agree to participate in the System of Intensive Diabetes Self-Management, I will be expected to do
the following:
1. Dedicate myself to getting my blood glucose level as close to normal as possible by following the instructions of the
diabetes self-management team
2. Regularly visit the clinic for a physical examination, laboratory tests, and nutrition counseling; follow-up visits will
be scheduled every 3 months or more frequently if deemed necessary by my physician or other members of my
health-care team
3. Bring a detailed 1-day food record to each follow-up visit, provide necessary nutrition information for me and my
dietitian, and adjust my eating habits to meet the nutrition goals established by my dietitian
4. Use medications as prescribed by my health-care team
5. Monitor my blood glucose levels at home as instructed and bring the results to each follow-up visit
6. Follow my prescribed exercise plan
7. Obtain identification as a patient with diabetes, for prompt assistance in case of an emergency
8. Ask my physician and other members of my health-care team to explain any aspect of my care that I do not entirely
understand
I also understand that if I do not strive to normalize my blood glucose, I am at increased risk of developing the
complications of diabetes mellitus.
My signature indicates that I have read and understand the above agreement.
__________________________________________
Patient
________________
Date
I agree to provide the leadership for the diabetes self-management team. Team members will be available to answer
your questions and help you self-manage your diabetes. I will continue to encourage you to maintain the best possible
control of your diabetes.
__________________________________________
Physician
________________
Date
AACE Diabetes Guidelines, Endocr Pract. 2002;8(Suppl 1) 79
Schedule:
Phase I: Initial Assessment Multiple visits over 3-4 weeks
Schedule:
3-month intervals
Phase II: Follow-Up Assessments (in combination with complications modules)
Laboratory tests
•Random plasma glucose Make any necessary
•Glycosylated hemoglobin adjustments to scheduling of
•Lipids, if necessary complications modules
Results of blood glucose (see Phase III)
self-monitoring
Physical examination
•Height, weight
•Blood pressure (including
orthostatic)
•Ophthalmoscopy
•Thyroid palpation
•Cardiac assessment
•Pulses
•Feet
•Skin
•Neurologic system
6-month visit
Schedule:
Each module to be performed annually
Phase III: Assessment of Complications Initiate at 9-month visit