Diabetes Treatments

Diabetes is a chronic illness that requires continuing medical care and patient Diabetes care is complex and requires that many issues, beyond glycemic …

Standards of Medical Care in Diabetes
American Diabetes Association

Diabetes Care 27:S15-S35, 2004
INTRODUCTION
Diabetes is a chronic illness that requires continuing medical care and
patient self-management education to prevent acute complications and to
reduce the risk of long-term complications Diabetes care is complex and
requires that many issues, beyond glycemic control, be addressed A large
body of evidence exists that supports a range of interventions to improve
diabetes outcomes
These standards of care are intended to provide clinicians, patients,
researchers, payors, and other interested persons with the components of
diabetes care, treatment goals, and tools to evaluate the quality of care
While individual preferences, comorbidities, and other patient factors may
require modification of goals, targets that are desirable for most patients
with diabetes are provided These standards are not intended to preclude
more extensive evaluation and management of the patient by other
specialists as needed For more detailed information, refer to Bode Ed:
Medical Management of Type 1 Diabetes 1, Zimmerman Ed: Medical
Management of Type
2 Diabetes 2, and Klingensmith Ed: Intensive
Diabetes Management 3
The recommendations included are diagnostic and therapeutic actions that
are known or believed to favorably affect health outcomes of patients with
diabetes A grading system Table 1, developed by the American Diabetes
Association ADA and modeled after existing methods, was utilized to
clarify and codify the evidence that forms the basis for the
recommendations The level of evidence that supports each recommendation is
listed after each recommendation using the letters A, B, C, or E
Table 1- ADA evidence grading system for clinical practice recommendations
|Level of evidence |
|Description |
| |
| |
| |
|A |
|Clear evidence from well-conducted, generalizable, randomized |
|controlled trials that are adequately powered including: |
|Evidence from a well-conducted
multicenter trial |
|Evidence from a meta-analysis that incorporated quality ratings |
|in the analysis |
|Compelling nonexperimental evidence, ie, all or none rule |
|developed by Center for Evidence Based Medicine at Oxford |
| |
| |
|Supportive evidence from well-conducted randomized controlled |
|trials that are adequately powered including: |
|Evidence from a well-conducted trial at one or more institutions |
|Evidence from a meta-analysis that incorporated quality ratings |
|in the analysis |
| |
|B |
|Supportive evidence from well-conducted cohort studies |
|Evidence from a well-conducted prospective cohort study or |
|registry |
|Evidence from a well-conducted prospective cohort study |
|Evidence
from a well-conducted meta-analysis of cohort studies |
| |
| |
|Supportive evidence from a well-conducted case-control study |
| |
|C |
|Supportive evidence from poorly controlled or uncontrolled |
|studies |
|Evidence from randomized clinical trials with one or more major |
|or three or more minor methodological flaws that could invalidate|
|the results |
|Evidence from observational studies with high potential for bias |
|such as case series with comparison to historical controls |
|Evidence from case series or case reports |
| |
| |
|Conflicting evidence with the weight of evidence supporting the |
|recommendation
|
| |
|E |
|Expert consensus or clinical experience |
| |

CLASSIFICATION, DIAGNOSIS, AND SCREENING
Classification
In 1997, the ADA issued new diagnostic and classification criteria 4; in
2003, modifications were made regarding the diagnosis of impaired fasting
glucose IFG 5 The classification of diabetes includes four clinical
classes:
Type 1 diabetes results from ß-cell destruction, usually leading to
absolute insulin deficiency
Type 2 diabetes results from a progressive insulin secretory defect
on the background of insulin resistance
Other specific types of diabetes due to other causes, eg, genetic
defects in ß-cell function, genetic defects in insulin action,
diseases of the exocrine pancreas, drug or chemical induced
Gestational diabetes mellitus GDM diagnosed during pregnancy
Diagnosis
Criteria for the diagnosis of diabetes in nonpregnant adults are shown in
Table 2 Three ways to diagnose diabetes are
available, and each must be
confirmed on a subsequent day unless unequivocal symptoms of hyperglycemia
are present Although the 75-g oral glucose tolerance test OGTT is more
sensitive and modestly more specific than fasting plasma glucose FPG to
diagnose diabetes, it is poorly reproducible and rarely performed in
practice Because of ease of use, acceptability to patients, and lower
cost, the FPG is the preferred screening and diagnostic test It should be
noted that the vast majority of people who meet diagnostic criteria for
diabetes by OGTT, but not by FPG, will have an A1C value 70 The use of
the A1C for the diagnosis of diabetes is not recommended at this time
Table 2- Criteria for the diagnosis of diabetes
|1 |
|Symptoms of diabetes and a casual plasma glucose 200 mg/dl 111 |
|mmol/l Casual is defined as any time of day without regard to |
|time since last meal The classic symptoms of diabetes include |
|polyuria, polydipsia, and unexplained weight loss |
| |
|OR |
|
|
| |
|2 |
|FPG 126 mg/dl 70 mmol/l Fasting is defined as no caloric |
|intake for at least 8 h |
| |
|OR |
| |
| |
|3 |
|2-h PG 200 mg/dl 111 mmol/l during an OGTT The test should be|
|performed as described by the World Health Organization, using a |
|glucose load containing the equivalent of 75-g anhydrous glucose |
|dissolved in water |
| |

In the absence of unequivocal hyperglycemia, these criteria should be
confirmed by repeat testing on a different day The OGTT is not recommended
for routine clinical use, but may be required in the evaluation of
patients
with IFG or when diabetes is still suspected despite a normal FPG
Hyperglycemia not sufficient to meet the diagnostic criteria for diabetes
is categorized as either IFG or impaired glucose tolerance IGT, depending
on whether it is identified through FPG or an OGTT:
IFG FPG 100 mg/dl 56 mmol/l to 125 mg/dl 69 mmol/l
IGT 2-h plasma glucose 140 mg/dl 78 mmol/l to 199 mg/dl 110
mmol/l
Recently, IFG and IGT have been officially termed pre-diabetes Both
categories, IFG and IGT, are risk factors for future diabetes and
cardiovascular disease CVD Recent studies have shown that modest weight
loss and regular physical activity can reduce the rate of progression of
IGT to type 2 diabetes Drug therapy metformin, acarbose, and orlistat and
troglitazone [no longer clinically available] has been shown to be
effective in reducing progression to diabetes, though generally not as
effectively as intensive lifestyle interventions
Screening
Generally, people with type 1 diabetes present with acute symptoms of
diabetes and markedly elevated blood glucose levels Type 2 diabetes is
frequently not diagnosed until complications appear, and approximately one-
third of all people
with diabetes may be undiagnosed Although the burden
and natural history of diabetes is well known and although there is good
evidence for benefit from treating cases diagnosed in the context of usual
clinical care, there are no randomized trials demonstrating the benefits of
early diagnosis through screening of asymptomatic individuals
Nevertheless, there is sufficient indirect evidence to justify
opportunistic screening in a clinical setting of individuals at high risk
Criteria for testing for diabetes in asymptomatic, undiagnosed adults are
listed in Table 3 The recommended screening test for nonpregnant adults is
the FPG The OGTT is more sensitive for the diagnosis of diabetes and pre-
diabetes, but is impractical and expensive as a screening procedure
Table 3- Criteria for testing for diabetes in asymptomatic adult
individuals
|1 |Testing for diabetes should be considered in all individuals at|
| |age 45 years and above, particularly in those with a BMI 25 |
| |kg/m2, and, if normal, should be repeated at 3-year intervals|
|2 |Testing should be considered at a younger age or be carried out|
| |more frequently in individuals who are overweight BMI 25 |
| |kg/m2
and have additional risk factors: |
| |are habitually physically inactive |
| |have a first-degree relative with diabetes |
| |are members of a high-risk ethnic population eg, African |
| |American, Latino, Native American, Asian American, Pacific |
| |Islander |
| |have delivered a baby weighing 9 lb or have been diagnosed |
| |with GDM |
| |are hypertensive 140/90 mmHg |
| |have an HDL cholesterol level 35 mg/dl 090 mmol/l and/or a |
| |triglyceride level 250 mg/dl 282 mmol/l |
| |have PCOS |
| |on previous testing, had IGT or IFG |
| |have other clinical conditions associated with insulin |
| |resistance eg PCOS or acanthosis nigricans |
| |have a history of vascular disease |

May not be correct for all ethnic groups PCOS, polycystic ovary syndrome
The incidence of type 2 diabetes in
children and adolescents has increased
dramatically in the last decade Consistent with screening recommendations
for adults, only children and youth at increased risk for the presence or
the development of type 2 diabetes should be tested Table 4
Table 4- Testing for type 2 diabetes in children
| Criteria |
|Overweight BMI 85th percentile for age and sex, weight for |
|height 85th percentile, or weight 120 of ideal for height |
|Plus |
|Any two of the following risk factors: |
| Family history of type 2 diabetes in first- or second-degree |
|relative |
| Race/ethnicity Native American, African American, Latino, Asian |
|American, Pacific Islander |
| Signs of insulin resistance or conditions associated with insulin|
|resistance acanthosis nigricans, hypertension, dyslipidemia, or |
|PCOS |
| Age of initiation: age 10 years or at onset of puberty, if |
|puberty occurs at
a younger age |
| Frequency: every 2 years |
| Test: FPG preferred |

Clinical judgment should be used to test for diabetes in high-risk patients
who do not meet these criteria PCOS, polycystic ovary syndrome

Detection and diagnosis of GDM
Risk assessment for GDM should be undertaken at the first prenatal visit
Women with clinical characteristics consistent with a high risk for GDM
those with marked obesity, personal history of GDM, glycosuria, or a
strong family history of diabetes should undergo glucose testing as soon
as possible An FPG 126 mg/dl or a casual plasma glucose 200
mg/dl meets the threshold for the diagnosis of diabetes and needs to be
confirmed on a subsequent day unless unequivocal symptoms of hyperglycemia
are present High-risk women not found to have GDM at the initial screening
and average-risk women should be tested between 24 and 28 weeks of
gestation Testing should follow one of two approaches:
One-step approach: perform a diagnostic 100-g OGTT
Two-step approach: perform an initial screening by measuring the
plasma or serum
glucose concentration 1 h after a 50-g oral glucose
load glucose challenge test [GCT] and perform a diagnostic 100-g
OGTT on that subset of women exceeding the glucose threshold value on
the GCT When the two-step approach is used, a glucose threshold value
140 mg/dl identifies 80 of women with GDM, and the yield is
further increased to 90 by using a cutoff of 130 mg/dl
Diagnostic criteria for the 100-g OGTT are as follows: 95 mg/dl
fasting, 180 mg/dl at 1 h, 155 mg/dl at 2 h, and 140
mg/dl at 3 h Two or more of the plasma glucose values must be met or
exceeded for a positive diagnosis The test should be done in the
morning after an overnight fast of 8-14 h The diagnosis can be made
using a 75-g glucose load, but that test is not as well validated for
detection of at-risk infants or mothers as the 100-g OGTT
Low-risk status requires no glucose testing, but this category is
limited to those women meeting all of the following characteristics:
o Age 25 years
o Weight normal before pregnancy
o Member of an ethnic group with a low prevalence of GDM
o No known diabetes in
first-degree relatives
o No history of abnormal glucose tolerance
o No history of poor obstetric outcome

Recommendations
The FPG is the preferred test to screen for and diagnose diabetes in
children and nonpregnant adults E
Screen for diabetes in high-risk, asymptomatic, undiagnosed adults and
children within the health care setting E
In those with pre-diabetes IFG/IGT, lifestyle modification should
bestrongly recommended and progression of glycemic abnormalities
followed by screening at least yearly A
Screen for diabetes in pregnancy using risk factor analysis and
screening tests as noted; the OGTT is the preferred screening test in
pregnancy E

|[p| INITIAL EVALUATION |
|ic| |
|] | |

A complete medical evaluation should be performed to classify the patient,
detect the presence or absence of diabetes complications, assist in
formulating a management plan, and provide a basis for continuing care If
the diagnosis of diabetes has already been
made, the evaluation should
review the previous treatment and the past and present degrees of glycemic
control Laboratory tests appropriate to the evaluation of each patients
general medical condition should be performed A focus on the components of
comprehensive care Table 5 will assist the health care team to ensure
optimal management of the patient with diabetes
Table 5- Components of the comprehensive diabetes evaluation
|Medical history |
|Symptoms, results of laboratory tests, and special examination |
|results related to the diagnosis of diabetes |
|Prior AIC records |
|Eating patterns, nutritional status, and weight history; growth |
|and development in children and adolescents |
|Details of previous treatment programs, including nutrition and |
|diabetes self-management education, attitudes, and health beliefs|
| |
|Current treatment of diabetes, including medications, meal plan, |
|and results of glucose monitoring and patients use of data |
|Exercise history
|
|Frequency, severity, and cause of acute complications such as |
|ketoacidosis and hypoglycemia |
|Prior or current infections, particularly skin, foot, dental, and|
|genitourinary infections |
|Symptoms and treatment of chronic eye; kidney; nerve; |
|genitourinary including sexual, bladder, and gastrointestinal |
|function including symptoms of celiac disease in type 1 diabetic|
|patients; heart; peripheral vascular; foot; and cerebrovascular |
|complications associated with diabetes |
|Other medications that may affect blood glucose levels |
|Risk factors for atherosclerosis: smoking, hypertension, obesity,|
|dyslipidemia, and family history |
|History and treatment of other conditions, including endocrine |
|and eating disorders |
|Assessment for mood disorder |
|Family history of diabetes and other endocrine disorders |
|Lifestyle, cultural, psychosocial, educational, and economic
|
|factors that might influence the management of diabetes |
|Tobacco, alcohol, and/or controlled substance use |
|Contraception and reproductive and sexual history |
| |
| |
| |
|Physical examination |
|Height and weight measurement and comparison to norms in |
|children and adolescents |
|Sexual maturation staging during pubertal period |
|Blood pressure determination, including orthostatic measurements |
|when indicated, and comparison to age-related norms |
|Fundoscopic examination |
|Oral examination |
|Thyroid palpation |
|Cardiac examination |
|Abdominal examination eg, for hepatomegaly |
|Evaluation of pulses by palpation and with
auscultation |
|Hand/finger examination |
|Foot examination |
|Skin examination for acanthosis nigricans and insulin-injection |
|sites |
|Neurological examination |
|Signs of diseases that can cause secondary diabetes eg, |
|hemochromatosis, pancreatic disease |
| |
|Laboratory evaluation |
|A1C |
|Fasting lipid profile, including total cholesterol, HDL |
|cholesterol, triglycerides, and LDL cholesterol |
|Test for microalbuminuria in type 1 diabetic patients who have |
|had diabetes for at least 5 years and in all patients with type 2|
|diabetes; some advocate beginning screening of pubertal children |
|before 5 years of diabetes |
|Serum creatinine in adults in children if proteinuria is |
|present
|
|Thyroid-stimulating hormone TSH in all type 1 diabetic |
|patients; in type 2 if clinically indicated |
|Electrocardiogram in adults, if clinically indicated |
|Urinalysis for ketones, protein, sediment |
| |
|Referrals |
|Eye exam, if indicated |
|Family planning for women of reproductive age |
|MNT, as indicated |
|Diabetes educator, if not provided by physician or practice staff|
| |
|Behavioral specialist, as indicated |
|Foot specialist, as indicated |
|Other specialties and services as appropriate |
| |

|[p| MANAGEMENT |
|ic| |
|] |
|

People with diabetes should receive medical care from a physician-
coordinated team Such teams may include, but are not limited to,
physicians, nurse practitioners, physicians assistants, nurses,
dietitians, pharmacists, and mental health professionals with expertise and
a special interest in diabetes It is essential in this collaborative and
integrated team approach that individuals with diabetes assume an active
role in their care
The management plan should be formulated as an individualized therapeutic
alliance among the patient and family, the physician, and other members of
the health care team Any plan should recognize diabetes self-management
education as an integral component of care In developing the plan,
consideration should be given to the patients age, school or work schedule
and conditions, physical activity, eating patterns, social situation and
personality, cultural factors, and presence of complications of diabetes
orother medical conditions A variety of strategies and techniques should
be used to provide adequate education and development of problem-solving
skills in the various aspects of diabetes
management Implementation of the
management plan requires that each aspect is understood and agreed on by
the patient and the care providers and that the goals and treatment plan
are reasonable
Glycemic control
Glycemic control is fundamental to the management of diabetes Prospective
randomized clinical trials such as the Diabetes Control and Complications
Trial DCCT 15 and the UK Prospective Diabetes Study UKPDS 16,17
have shown that improved glycemic control is associated with sustained
decreased rates of retinopathy, nephropathy, and neuropathy 18 In these
trials, treatment regimens that reduced average A1C to 7 1
above the upper limits of normal were associated with fewer long-term
microvascular complications; however, intensive control was found to
increase the risk of severe hypoglycemia and weight gain 19,20
Epidemiological studies support the potential of intensive glycemic control
in the reduction of CVD 15-20
Recommended glycemic goals for nonpregnant individuals are shown in Table
6 A major limitation to the available data are that they do not identify
the optimum level of control for particular patients, as there are
individual differences in the risks of hypoglycemia,
weight gain, and other
adverse effects Furthermore, with multifactorial interventions, it is
unclear how different components eg, educational interventions, glycemic
targets, lifestyle changes, and pharmacological agents contribute to the
reduction of complications There are no clinical trial data available for
the effects of glycemic control in patients with advanced complications,
the elderly 65 years of age, or young children 13 years of age
Less stringent treatment goals may be appropriate for patients with limited
life expectancies, in the very young or older adults, and in individuals
with comorbid conditions Severe or frequent hypoglycemia is an indication
for the modification of treatment regimens, including setting higher
glycemic goals
Table 6- Summary of recommendations for adults with diabetes
|Glycemic control |
| |
| |
| AIC |
|70 |
|
|
| Preprandial plasma glucose |
|90-130 mg/dl 50-72 mmol/l |
| |
| Postprandial plasma glucose |
|180 mg/dl 100 mmol/l |
| |
|Blood pressure |
|130/80 mmHg |
| |
|Lipids |
| |
| |
| LDL |
|100 mg/dl 26 mmol/l |
| |
| Triglycerides |
|150 mg/dl 17 mmol/l |
|
|
| HDL |
|40 mg/dl 11 mmol/l |
| |
|Key concepts in setting glycemic goals: |
|Goals should be individualized |
|Certain populations children, pregnant women, and elderly |
|require special considerations |
|Less intensive glycemic goals may be indicated in patients with |
|severe or frequent hypoglycemia |
|More stringent glycemic goals ie a normal A1C, 6 may |
|further reduce complications at the cost of increased risk of |
|hypoglycemia particularly in those with type 1 diabetes |
|Postprandial glucose may be targeted if AIC goals are not met |
|despite reaching preprandial glucose goals |
| |
| |

Referenced to a nondiabetic range of 40-60 using a DCCT-based assay
Postprandial glucose measurements should be made
1-2 h after the
beginning of the meal, generally peak levels in patients with diabetes
Current NCEP/ATP III guidelines suggest that in patients with
triglycerides 200 mg/dl, the non-HDL cholesterol total cholesterol minus
HDL be utilized The goal is 130 mg/dl 61
For women, it has been suggested that the HDL goal be increased by 10
mg/dl

More stringent goals ie, a normal A1C, 6 can be considered in
individual patients based on epidemiological analyses that suggest that
there is no lower limit of A1C at which further lowering does not reduce
risk of complications, at the risk of increased hypoglycemia particularly
in those with type 1 diabetes However, the absolute risks and benefits of
lower targets are unknown The risks and benefits of an A1C goal of 6 are
currently being tested in an ongoing study ACCORD [Action to Control
Cardiovascular Risk in Diabetes] in type 2 diabetes 21 Elevated
postchallenge 2-h OGTT glucose values have been associated with increased
cardiovascular risk independent of FPG in some epidemiological studies
Postprandial plasma glucose PPG levels 140 mg/dl are unusual in
nondiabetic individuals, although large evening meals can be followed by
plasma glucose
values up to 180 mg/dl There are now pharmacological agents
that primarily modify PPG and thereby reduce A1C in parallel Thus, in
individuals who have premeal glucose values within target but who are not
meeting A1C targets, consideration of monitoring PPG 1-2 h after the start
of the meal and treatment aimed at reducing PPG values 180 mg/dl may lower
A1C However, it should be noted that the effect of these approaches on
micro- or macrovascular complications has not been studied 22
For information on glycemic control for women with GDM, refer to the ADA
position statement Gestational Diabetes Mellitus 14 For information on
glycemic control during pregnancy in women with preexisting diabetes, refer
to Medical Management of Pregnancy Complicated by Diabetes 3rd ed 23
Referral for diabetes management
For a variety of reasons, some people with diabetes and their health care
providers do not achieve the desired goals of treatment Table 6 In such
instances, additional actions suggested include enhanced diabetes self-
management education, comanagement with a diabetes team, change in
pharmacological therapy, initiation of or increase in self-monitoring of
blood glucose SMBG, more frequent
contact with the patient, and referral
to an endocrinologist
Intercurrent illness
The stress of illness frequently aggravates glycemic control and
necessitates more frequent monitoring of blood glucose and urine or blood
ketones A vomiting illness accompanied by ketosis may indicate diabetic
ketoacidosis DKA, a life-threatening condition that requires immediate
medical care to prevent complications and death; the possibility of DKA
should always be considered 24 Marked hyperglycemia requires temporary
adjustment of the treatment program and, if accompanied by ketosis,
frequent interaction with the diabetes care team The patient treated with
oral glucose-lowering agents or medical nutrition therapy MNT alone may
temporarily require insulin Adequate fluid and caloric intake must be
assured Infection or dehydration is more likely to necessitate
hospitalization of the person with diabetes than the person without
diabetes The hospitalized patient should be treated by a physician with
expertise in the management of diabetes, and recent studies suggest that
achieving very stringent glycemic control may reduce mortality in the
immediate postmyocardial infarction period 25 Aggressive
glycemic
management with insulin may reduce morbidity in patients with severe acute
illness 26
For information on management of patients in the hospital, refer to the ADA
position statement titled Hyperglycemic Crises in Diabetes 24
Recommendations
Lowering A1C has been associated with a reduction of microvascular and
neuropathic complications of diabetes A
Develop or adjust the management plan to achieve normal or near-normal
glycemia with an A1C goal of 7 B
More stringent goals ie, a normal A1C, 6 can be considered in
individual patients B
Lowering A1C may lower the risk of myocardial infarction and
cardiovascular death B
Aggressive glycemic management with insulin may reduce morbidity in
patients with severe acute illness, perioperatively and following
myocardial infarction B
Less stringent treatment goals may be appropriate for patients with a
history of severe hypoglycemia, patients with limited life
expectancies, very young children or older adults, and individuals
with comorbid conditions E

|[p| ASSESSMENT OF GLYCEMIC CONTROL |
|ic|
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|] | |

Techniques are available for health providers and patients to assess the
effectiveness of the management plan on glycemic control
SMBG
The ADAs consensus statements on SMBG provide a comprehensive review of
the subject 27,28 Major clinical trials assessing the impact of glycemic
control on diabetes complications have included SMBG as part of
multifactorial interventions, suggesting that SMBG is a component of
effective therapy SMBG allows patients to evaluate their individual
response to therapy and assess whether glycemic targets are being achieved
Results of SMBG can be useful in preventing hypoglycemia and adjusting
medications, MNT, and physical activity
The frequency and timing of SMBG should be dictated by the particular needs
and goals of the patients Daily SMBG is especially important for patients
treated with insulin to monitor for and prevent asymptomatic hypoglycemia
For most patients with type 1 diabetes and pregnant women taking insulin,
SMBG is recommended three or more times daily The optimal frequency and
timing of SMBG for patients with type 2 diabetes is not
known but should be
sufficient to facilitate reaching glucose goals When adding to or
modifying therapy, type 1 and type 2 diabetic patients should test more
often than usual The role of SMBG in stable diet-treated patients with
type 2 diabetes is not known
Because the accuracy of SMBG is instrument- and user-dependent 29, it is
important for health care providers to evaluate each patients monitoring
technique, both initially and at regular intervals thereafter In addition,
optimal use of SMBG requires proper interpretation of the data Patients
should be taught how to use the data to adjust food intake, exercise, or
pharmacological therapy to achieve specific glycemic goals Health
professionals should evaluate at regular intervals the patients ability to
use SMBG data to guide treatment
Recommendations
SMBG is an integral component of diabetes therapy B
Include SMBG in the management plan E
Instruct the patient in SMBG and routinely evaluate the patients
technique and ability to use data to adjust therapy E
A1C
By performing an A1C test, health providers can measure a patients average
glycemia over the preceding 2-3 months 29 and, thus, assess
treatment
efficacy A1C testing should be performed routinely in all patients with
diabetes, first to document the degree of glycemic control at initial
assessment and then as part of continuing care Since the A1C test reflects
mean glycemia over the preceding 2-3 months, measurement approximately
every 3 months is required to determine whether a patients metabolic
control has been reached and maintained within the target range Thus,
regular performance of the A1C test permits detection of departures from
the target Table 6 in a timely fashion For any individual patient, the
frequency of A1C testing should be dependent on the clinical situation, the
treatment regimen used, and the judgment of the clinician
Glycemic control is best judged by the combination of the results of the
patients SMBG testing as performed and the current A1C result The A1C
should be used not only to assess the patients control over the preceding
2-3 months but also as a check on the accuracy of the meter or the
patients self-reported results and the adequacy of the SMBG testing
schedule Table 7 contains the correlation between A1C levels and mean
plasma glucose levels based on data from the DCCT 30
7-
Correlation between A1C level and mean plasma glucose levels
|AIC |
|Mean plasma glucose |
| |
| |
| |
|mg/dl |
|mmol/l |
| |
| |
| |
|6 |
|135 |
|75 |
| |
| |
|7 |
|170
|
|95 |
| |
| |
|8 |
|205 |
|115 |
| |
| |
|9 |
|240 |
|135 |
| |
| |
|10 |
|275 |
|155 |
| |
|
|
|11 |
|310 |
|175 |
| |
| |
|12 |
|345 |
|195 |
| |
| |

Recommendations
Perform the A1C test at least two times a year in patients who are
meeting treatment goals and who have stable glycemic control and
quarterly in patients whose therapy has changed or who are not meeting
glycemic goals E

|[p| MNT |
|ic| |
|] | |

MNT is an integral
component of diabetes management and diabetes self-
management education A review of the evidence and detailed information can
be found in the ADA technical review and position statement in this area
31,32 People with diabetes should receive individualized MNT as needed
to achieve treatment goals, preferably provided by a registered dietitian
familiar with the components of diabetes MNT Goals of MNT that apply to
all persons with diabetes are as follows:
Attain and maintain recommended metabolic outcomes, including glucose
and A1C levels; LDL cholesterol, HDL cholesterol, and triglyceride
levels; blood pressure; and body weight see Table 6
Prevent and treat the chronic complications and comorbidities of
diabetes Modify nutrient intake and lifestyle as appropriate for the
prevention and treatment of obesity, dyslipidemia, CVD, hypertension,
and nephropathy
Improve health through healthy food choices and physical activity
Address individual nutritional needs, taking into consideration
personal and cultural preferences and lifestyle while respecting the
individuals wishes and willingness to change
Goals of MNT that apply to
specific situations include the following:
For youth with type 1 diabetes, provide adequate energy to ensure
normal growth and development; integrate insulin regimens into usual
eating and physical activity habits
For youth with type 2 diabetes, facilitate changes in eating and
physical activity habits that reduce insulin resistance and improve
metabolic status
For pregnant and lactating women, provide adequate energy and
nutrients needed for optimal outcomes
For older adults, provide for the nutritional and psychosocial needs
of an aging individual
For individuals treated with insulin or insulin secretagogues, provide
self-management education for treatment and prevention of
hypoglycemia, acute illnesses, and exercise-related blood glucose
problems
For individuals at risk for diabetes, decrease risk by encouraging
physical activity and promoting foods choices that facilitate moderate
weight loss or at least prevent weight gain
Achieving nutrition-related goals requires a coordinated team effort that
includes the person with diabetes Because of the complexity of nutrition
issues, it is
recommended that a registered dietitian, knowledgeable and
skilled in implementing nutrition therapy into diabetes management and
education, is the team member who provides MNT However, it is essential
that all team members are knowledgeable about nutrition therapy and are
supportive of the person with diabetes who needs to make lifestyle changes

MNT involves a nutrition assessment to evaluate the patients food intake,
metabolic status, lifestyle and readiness to make changes, goal setting,
dietary instruction and evaluation To facilitate adherence, the plan
should be individualized and take into account cultural, lifestyle, and
financial considerations Monitoring of glucose and A1C, lipids, blood
pressure, and renal status is essential to evaluate nutrition-related
outcomes If goals are not met Table 6, changes must be made in the
overall diabetes care and management plan
Recommendations
People with diabetes should receive individualized MNT as needed to
achieve treatment goals, preferably provided by a registered dietitian
familiar with the components of diabetes MNT B

|[p| PHYSICAL ACTIVITY |
|ic|
|
|] | |

ADA technical reviews on exercise in patients with diabetes have summarized
the value of exercise in the diabetes management plan 33,34 Regular
exercise has been shown to improve blood glucose control, reduce
cardiovascular risk factors, contribute to weight loss, and improve well-
being Furthermore, regular exercise may prevent type 2 diabetes in high-
risk individuals 6-8
Before beginning a physical activity program, the patient with diabetes
should have a detailed medical evaluation with appropriate diagnostic
studies This examination should screen for the presence of macro- and
microvascular complications that may be worsened by the physical activity
program see next section regarding coronary heart disease [CHD]
screening Identification of areas of concern will allow the design of an
individualized physical activity plan that can minimize risk to the
patient
All levels of physical activity, including leisure activities, recreational
sports, and competitive professional performance, can be performed by
people with diabetes who do not have complications and have good
glycemic
control The ability to adjust the therapeutic regimen insulin therapy and
MNT to allow safe participation is an important management strategy
Recommendations
A regular physical activity program, adapted to the presence of
complications, is recommended for all patients with diabetes who are
capable of participating B

|[p| PREVENTION AND MANAGEMENT OF DIABETES COMPLICATIONS |
|ic| |
|] | |

I CVD: management of risk factors and screening for coronary artery
disease
CVD is the major cause of mortality for persons with diabetes It is also a
major contributor to morbidity and direct and indirect costs of diabetes
Type 2 diabetes is an independent risk factor for macrovascular disease,
and its common coexisting conditions eg, hypertension and dyslipidemia
are also risk factors
Studies have shown the efficacy of reducing cardiovascular risk factors in
preventing or slowing CVD Evidence is summarized in the following sections
and reviewed in detail in the ADA technical reviews on hypertension 35,
dyslipidemia 36, aspirin therapy 37,
and smoking cessation 38 and in
the consensus statement on CHD in people with diabetes 39 Emphasis
should be placed on reducing cardiovascular risk factors, when possible,
and clinicians should be alert for signs and symptoms of atherosclerosis
A Blood pressure control
Hypertension blood pressure 140/90 mmHg is a common comorbidity of
diabetes, affecting the majority of people with diabetes, depending on type
of diabetes, age, obesity, and ethnicity Hypertension is also a major risk
factor for CVD and microvascular complications such as retinopathy and
nephropathy In type 1 diabetes, hypertension is often the result of
underlying nephropathy In type 2 diabetes, hypertension may be present as
part of the metabolic syndrome ie, obesity, hyperglycemia, dyslipidemia
that is accompanied by high rates of CVD
Randomized clinical trials have demonstrated the benefit reduction of CHD
events, stroke, and nephropathy of lowering blood pressure to 140 mmHg
systolic and 80 mmHg diastolic in persons with diabetes 40-43
Epidemiologic analyses show that blood pressures 115/75 mmHg are
associated with increased cardiovascular event rates and mortality in
persons with diabetes 40,44,45 Therefore, a
target blood pressure goal
of 130/80 mmHg is reasonable if it can be safely achieved
Although there are no well-controlled studies of diet and exercise in the
treatment of hypertension in persons with diabetes, reducing sodium intake
and body weight when indicated, increasing consumption of fruits,
vegetables, and low-fat dairy products, avoiding excessive alcohol
consumption, and increasing activity levels have been shown to be effective
in reducing blood pressure in nondiabetic individuals 46a These
nonpharmacological strategies may also positively affect glycemia and lipid
control Their effects on cardiovascular events have not been well
measured
Lowering of blood pressure with regimens based on antihypertensive drugs,
including ACE inhibitors, angiotensin receptor blockers ARBs, ß-blockers,
diuretics, and calcium channel blockers, has been shown to be effective in
lowering cardiovascular events Several studies suggest that ACE inhibitors
may be superior to dihydropyridine calcium channel blockers DCCBs in
reducing cardiovascular events 47,48 Additionally, recent data in people
with diabetic nephropathy indicate that ARBs may be superior to DCCBs for
reducing cardiovascular
events 49 Conversely, in the recently completed
International Verapamil Study INVEST of more than 22,000 people with
coronary artery disease and hypertension, the nondihydropyridine calcium
channel blocker, verapamil, demonstrated a similar reduction in
cardiovascular mortality to a ß-blocker Moreover, this relationship held
true in the diabetic subgroup 49a
ACE inhibitors have been shown to improve cardiovascular outcomes in high-
cardiovascular-risk patients with or without hypertension 50,51 In
patients with congestive heart failure, ACE inhibitors are associated with
better outcomes when compared with ARBs ARBs also improve cardiovascular
outcomes in the subset of patients with hypertension, diabetes, and end-
organ injury 52 The compelling effect of ACE inhibitors or ARBs in
patients with albuminuria or renal insufficiency provide additional
rationale for use of these agents see section II below
The ALLHAT Antihypertensive and Lipid-Lowering Treatment to Prevent Heart
Attack Trial, a large randomized trial of different initial blood pressure
pharmacological therapies, found no large differences between initial
therapy with a chlorthalidone, amlodipine and lisinopril
Diuretics
appeared slightly more effective than other agents, particularly for
reducing heart failure 53 The -blocker arm of the ALLHAT was
terminated after interim analysis showed that doxazosin was substantially
less effective in reducing congestive heart failure than diuretic therapy
54
Before beginning treatment, patients with elevated blood pressures should
have their blood pressure reexamined within 1 month to confirm the presence
of hypertension A systolic blood pressure 160 mmHg or a diastolic
blood pressure 100 mmHg, however, mandates that immediate
pharmacological therapy be initiated Patients with hypertension should be
seen as often as needed until the recommended blood pressure goal is
obtained and then seen as necessary 40 In these patients, other
cardiovascular risk factors, including obesity, hyperlipidemia, smoking,
presence of microalbuminuria assessed before initiation of treatment, and
glycemic control, should be carefully assessed and treated Many patients
will require three or more drugs to reach target goals
Recommendations
Screening and diagnosis
Blood pressure should be measured at every routine diabetes visit
Patients found to have systolic
blood pressure 130 or diastolic
blood pressure 80 mmHg should have blood pressure confirmed on a
separate day C
Goals
Patients with diabetes should be treated to a systolic blood pressure
130 mmHg B
Patients with diabetes should be treated to a diastolic blood pressure
80 mmHg B
Treatment
Patients with hypertension systolic blood pressure 140 or
diastolic blood pressure 90 mmHg should receive drug therapy in
addition to lifestyle and behavioral therapy A
Multiple drug therapy two or more agents at proper doses is
generally required to achieve blood pressure targets B
Patients with a systolic blood pressure of 130-139 mmHg or a diastolic
blood pressure of 80-89 mmHg should be given lifestyle and behavioral
therapy alone for a maximum of 3 months and then, if targets are not
achieved, in addition, be treated with pharmacological agents that
block the renin-angiotensin system E
Initial drug therapy for those with a blood pressure 140/90 mmHg
should be with a drug class demonstrated to reduce CVD events in
patients with diabetes ACE inhibitors, ARBs, ß-blockers, diuretics,

and calcium channel blockers A
All patients with diabetes and hypertension should be treated with a
regimen that includes either an ACE inhibitor or ARB If one class is
not tolerated, the other should be substituted If needed to achieve
blood pressure targets, a thiazide diuretic should be added E
If ACE inhibitors, ARBs, or diuretics are used, monitor renal function
and serum potassium levels E
While there are no adequate head-to-head comparisons of ACE inhibitors
and ARBs, there is clinical trial support for each of the following
statements:
o In patients with type 1 diabetes, with hypertension and any
degree of albuminuria, ACE inhibitors have been shown to delay
the progression of nephropathy A
o In patients with type 2 diabetes, hypertension, and
microalbuminuria, ACE inhibitors and ARBs have been shown to
delay the progression to macroalbuminuria A
o In those with type 2 diabetes, hypertension, macroalbuminuria,
and renal insufficiency, ARBs have been shown to delay the
progression of nephropathy A

In elderly hypertensive
patients, blood pressure should be lowered
gradually to avoid complications E
Patients not achieving target blood pressure despite multiple drug
therapy should be referred to a physician experienced in the care of
patients with hypertension E
Orthostatic measurement of blood pressure should be performed in
people with diabetes and hypertension when clinically indicated E
B Lipid management
Patients with type 2 diabetes have an increased prevalence of lipid
abnormalities that contributes to higher rates of CVD Lipid management
aimed at lowering LDL cholesterol, raising HDL cholesterol, and lowering
triglycerides has been shown to reduce macrovascular disease and mortality
in patients with type 2 diabetes, particularly those who have had prior
cardiovascular events
In studies using HMG hydroxymethylglutaryl CoA reductase inhibitors
statins, patients with diabetes achieved significant reductions in
coronary and cerebrovascular events 55-58 In two studies using the
fibric acid derivative gemfibrozil, reductions in cardiovascular end points
were also achieved 59,60
Target lipid levels are shown in Table 6 Lifestyle intervention including
MNT, increased
physical activity, weight loss, and smoking cessation should
allow some patients to reach these lipid levels Nutrition intervention
should be tailored according to each patients age, type of diabetes,
pharmacological treatment, lipid levels, and other medical conditions and
should focus on the reduction of saturated fat, cholesterol, and
transunsaturated fat intake Glycemic control can also beneficially modify
plasma lipid levels Particularly in patients with very high triglycerides
and poor glycemic control, glucose lowering maybe necessary to control
hypertriglyceridemia
Pharmacological treatment is indicated if there is an inadequate response
to lifestyle modifications and improved glucose control However, in
patients with clinical CVD and LDL 100 mg/dl, pharmacological therapy
should be initiated at the same time that lifestyle intervention is
started
The first priority of pharmacological therapy is to lower LDL cholesterol
to a target goal of 100 mg/dl 260 mmol/l For LDL lowering, statins are
the drugs of choice 61
The Heart Protection Study demonstrated that in people with diabetes over
the age of 40 with a total cholesterol 135 mg/dl, LDL reduction of
30 from baseline with
the statin, simvastatin was associated with an
25 reduction in the first event rate for major coronary artery events
independent of baseline LDL, preexisting vascular disease, type or duration
of diabetes, or adequacy of glycemic control 58 Therefore, in patients
over the age of 40, statin therapy should be routinely considered In
patients with LDL 130 mg/dl, initial therapy with both lifestyle
intervention and a statin is indicated In patients with LDL between 100
mg/dl 260 mmol/l and 129 mg/dl 330 mmol/l, a variety of treatment
strategies are available, including more aggressive nutrition intervention
or pharmacological treatment with a statin If the HDL is 40 mg/dl and the
LDL is between 100 and 129 mg/dl, a fibric acid derivative or niacin might
be used
Niacin is the most effective drug for raising HDL but can significantly
increase blood glucose at a high dose More recent studies demonstrate that
at modest doses 750-2,000 mg/day, significant benefit with regards to
LDL, HDL, and triglyceride levels are accompanied by modest changes in
glucose that are generally amenable to adjustment of diabetes therapy
62,63
Combination therapy, with a statin and a fibrate or statin and
niacin, may
be efficacious for patients needing treatment for all three lipid
fractions, but this combination is associated with an increased risk for
abnormal transaminase levels, myositis, or rhabdomyolysis The risk of
rhabdomyolysis seems to be lower when statins are combined with fenofibrate
than gemfibrozil
In children and adolescentswith diabetes, LDL cholesterol should be lowered
to 100 mg/dl 260 mmol/l using diet and medications based on LDL level
and other cardiovascular risk factors in addition to diabetes 64,65
Recommendations
Screening
In adult patients, test for lipid disorders at least annually and more
often if needed to achieve goals In adults with low-risk lipid values
LDL 100 mg/dl, HDL 50 mg/dl, and triglycerides 150 mg/dl, repeat
lipid assessments every 2 years E
In children 2 years of age, perform a lipid profile after diagnosis
of diabetes and when glucose control has been established
o Type 1 diabetes: Begin prior to puberty, if positive family
history of CVD or if family history is unknown, and at
puberty, if family history is known and is negative
o Type 2 diabetes: Begin at
diagnosis, regardless of pubertal
status
o If lipid values are considered low risk, repeat lipid profile
every 2-5 years based on CVD risk status

Treatment recommendations and goals
Lifestyle modification focusing on the reduction of saturated fat and
cholesterol intake, weight loss, increased physical activity, and
smoking cessation has been shown to improve the lipid profile in
patients with diabetes A
Patients who do not achieve lipid goals with lifestyle modifications
require pharmacological therapy A
Lower LDL cholesterol to 100 mg/dl 26 mmol/l as the primary goal
of therapy for adults B
Lowering LDL cholesterol with a statin is associated with a reduction
in cardiovascular events A
In people with diabetes over the age of 40 with a total cholesterol
135 mg/dl, statin therapy to achieve an LDL reduction of 30
regardless of baseline LDL levels may be appropriate A
In children and adolescents with diabetes, LDL cholesterol should be
lowered to 100 mg/dl 260 mmol/l using diet as well as medications
based on LDL level and other cardiovascular risk factors in
addition
to diabetes E
Lower triglycerides to 150 mg/dl 17 mmol/l and raise HDL
cholesterol to 40 mg/dl 115 mmol/l In women, an HDL goal 10 mg/dl
higher may be appropriate C
Lowering triglycerides and increasing HDL cholesterol with a fibrate
are associated with a reduction in cardiovascular events in patients
with clinical CVD, low HDL and near-normal levels of LDL A
Combination therapy employing statins and fibrates or niacin may be
necessary to achieve lipid targets, but have not been evaluated in
outcomes studies for either event reduction or safety E
C Anti-platelet agents in diabetes
The use of aspirin in diabetes is reviewed in detail in the ADA technical
review 37 and position statement 66 on aspirin therapy Aspirin has
been recommended as a primary 66a,66b and secondary therapy to prevent
cardiovascular events in diabetic and nondiabetic individuals One large
meta-analysis and several clinical trials demonstrate the efficacy of using
aspirin as a preventive measure for cardiovascular events, including stroke
and myocardial infarction Many trials have shown an 30 decrease in
myocardial infarction and a 20 decrease in
stroke in a wide range of
patients, including young and middle-aged patients, patients with and
without a history of CVD, males and females, and patients with
hypertension
Dosages used in most clinical trials ranged from 75 to 325 mg/day There is
no evidence to support any specific dose, but using the lowest possible
dosage may help reduce side effects There is no evidence for a specific
age at which to start aspirin, but at ages below 30 years, aspirin has not
been studied
Clopidogrel has been demonstrated to reduce CVD rates in diabetic
individuals 67 Adjunctive therapy in very high-risk patients or as
alternative therapy in aspirin-intolerant patients should be considered
Recommendation
Use aspirin therapy 75-162 mg/day as a secondary prevention strategy
in those with diabetes with a history of myocardial infarction,
vascular bypass procedure, stroke or transient ischemic attack,
peripheral vascular disease, claudication, and/or angina A
Use aspirin therapy 75-162 mg/day as a primary prevention strategy
in those with type 2 diabetes at increased cardiovascular risk,
including those who are over 40 years of age or who have additional

risk factors family history of CVD, hypertension, smoking,
dyslipidemia, albuminuria A
Use aspirin therapy 75-162 mg/day as a primary prevention strategy
in those with type 1 diabetes at increased cardiovascular risk,
including those who are over 40 years of age or who have additional
risk factors family history of CVD, hypertension, smoking,
dyslipidemia, albuminuria C
People with aspirin allergy, bleeding tendency, receiving
anticoagulant therapy, recent gastrointestinal bleeding, and
clinically active hepatic disease are not candidates for aspirin
therapy Other antiplatelet agents may be a reasonable alternative for
patients with high risk E
Aspirin therapy should not be recommended for patients under the age
of 21 years because of the increased risk of Reyes syndrome
associated with aspirin use in this population People under the age
of 30 have not been studied E
D Smoking cessation
Issues of smoking in diabetes are reviewed in detail in the ADA technical
review 38 and position statement 68 on smoking cessation A large body
of evidence from epidemiological, case-control, and cohort studies
provides
convincing documentation of the causal link between cigarette smoking and
health risks Cigarette smoking contributes to one of every five deaths in
the US and is the most important modifiable cause of premature death
Much of the prior work documenting the impact of smoking on health did not
separately discuss results on subsets of individuals with diabetes,
suggesting that the identified risks are at least equivalent to those found
in the general population Other studies of individuals with diabetes
consistently found a heightened risk of morbidity and premature death
associated with the development of macrovascular complications among
smokers Smoking is also related to the premature development of
microvascular complications of diabetes and may have a role in the
development of type 2 diabetes
A number of large randomized clinical trials have demonstrated the efficacy
and cost-effectiveness of counseling in changing smoking behavior Such
studies, combined with others specific to individuals with diabetes,
suggest that smoking cessation counseling is effective in reducing tobacco
use 69,70
The routine and thorough assessment of tobacco use is important as a means
of
preventing smoking or encouraging cessation Special considerations
should include assessment of level of nicotine dependence, which is
associated with difficulty in quitting and relapse
Recommendations
Advise all patients not to smoke A
Include smoking cessation counseling and other forms of treatment as a
routine component of diabetes care B
E CHD screening and treatment
CHD screening and treatment are reviewed in detail in the ADA consensus
statement on CHD in people with diabetes 39 To identify the presence of
CHD in diabetic patients without clear or suggestive symptoms of coronary
artery disease CAD, a risk factor-based approach to the initial
diagnostic evaluation and subsequent follow-up is recommended At least
annually, cardiovascular risk factors should be assessed These risk
factors include dyslipidemia, hypertension, smoking, a positive family
history of premature coronary disease, and the presence of micro- or
macroalbuminuria Abnormal risk factors should be treated as described
elsewhere in these guidelines Patients at increased CHD risk should
receive aspirin and may warrant an ACE inhibitor
Candidates for a diagnostic cardiac stress test include those
with 1
typical or atypical cardiac symptoms and 2 an abnormal resting
electrocardiogram ECG Candidates for a screening cardiac stress test
include those with 1 a history of peripheral or carotid occlusive disease;
2 sedentary lifestyle, age 35 years, and plans to begin a vigorous
exercise program; and 3 two or more of the risk factors noted above
Current evidence suggests that noninvasive tests can improve assessment of
future CHD risk There is, however, no current evidence that such testing
in asymptomatic patients with risk factors improves outcomes or leads to
better utilization of treatments
Patients with abnormal exercise ECG and patients unable to perform an
exercise ECG require additional or alternative testing Currently, stress
nuclear perfusion and stress echocardiography are valuable next-level
diagnostic procedures A consultation with a cardiologist is recommended
regarding further work-up
Recommendations
Perform exercise stress testing in asymptomatic diabetic patients
based on the criteria outlined above Consider a risk factor-based
strategy for the diagnosis of CAD that might include stress ECG and/or
stress echocardiography and/or perfusion
imaging E
Refer patients with signs and symptoms of CVD or with positive
noninvasive test for CAD to a cardiologist for further evaluation E

In patients with treated congestive heart failure, metformin use is
contraindicated The thiazolidinediones are associated with fluid
retention, and their use can be complicated by the development of
congestive heart failure Caution in prescribing thiazolidinediones in
the setting of known congestive heart failure or other heart diseases
as well as in patients with preexisting edema or concurrent insulin
therapy is required E
In patients 55 years of age, with or without hypertension but with
another cardiovascular risk factor history of CVD, dyslipidemia,
microalbuminuria, smoking, an ACE inhibitor if not contraindicated
should be considered to reduce the risk of cardiovascular events A
In patients with a prior myocardial infarction or in patients
undergoing major surgery, ß-blockers, in addition, should be
considered to reduce mortality A
II Nephropathy screening and treatment
Diabetic nephropathy occurs in 20-40 of patients with diabetes and is
the
single leading cause of end-stage renal disease ESRD Persistent
albuminuria in the range of 30-299 mg/24 h microalbuminuria has been
shown to be the earliest stage of diabetic nephropathy in type 1 diabetes
and a marker for development of nephropathy in type 2 diabetes
Microalbuminuria is also a well-established marker of increased CVD risk
71
Patients with microalbuminuria who progress to macroalbuminuria 300
mg/24 h are likely to progress to ESRD over a period of years 72,73
Over the past several years, a number of interventions have been
demonstrated to reduce the risk and slow the progression of renal disease
Intensive diabetes management with the goal of achieving near normoglycemia
has been shown in large prospective randomized studies to delay the onset
of microalbuminuria and the progression of micro- to macroalbuminuria in
patients with type 1 74,75 and type 2 diabetes 16 The UKPDS provided
strong evidence that control of blood pressure can reduce the development
of nephropathy 41 In addition, large prospective randomized studies in
patients with type 1 diabetes have demonstrated that achievement of lower
levels of systolic blood pressure 140 mmHg achieved with
treatment using
ACE inhibitors provides a selective benefit over other antihypertensive
drug classes in delaying the progression from micro- to macroalbuminuria
and can slow the decline in glomerular filtration rate GFR in patients
with macroalbuminuria 41,76-78
In addition, ACE inhibitors have been shown to reduce severe CVD ie,
myocardial infarction, stroke, death, thus further supporting the use of
these agents in patients with microalbuminuria 50 ARBs have also been
shown to reduce the rate of progression from micro- to macroalbuminuria as
well as ESRD in patients with type 2 diabetes 79-81 Some evidence
suggests that ARBs have a smaller magnitude of rise in potassium compared
with ACE inhibitors in people with nephropathy 82 With regards to
slowing the progression of nephropathy, the use of DCCBs as initial therapy
is not more effective than placebo Their use in nephropathy should be
restricted to additional therapy to further lower blood pressure in
patients already treated with ACE inhibitors or ARBs 49 In the setting
of albuminuria or nephropathy, in patients unable to tolerate ACE
inhibitors and/or ARBs, consider the use of non-DCCBs, ß-blockers, or
diuretics for the
management of blood pressure 83,84
A meta-analysis of several small studies has shown that protein restriction
may be of benefit in some patients whose nephropathy seems to be
progressing despite optimal glucose and blood pressure control 85
Screening for microalbuminuria can be performed by three methods: 1
measurement of the albumin-to-creatinine ratio in a random, spot collection
preferred method; 2 24-h collection with creatinine, allowing the
simultaneous measurement of creatinine clearance; and 3 timed eg, 4-h
or overnight collection
The analysis of a spot sample for the albumin-to-creatinine ratio is
strongly recommended by most authorities 86,87 The other two
alternatives 24-h collection and a timed specimen are rarely necessary
Measurement of a spot urine microalbumin by immunoassay or by using a
dipstick test specific for microalbumin without simultaneously measuring
urine creatinine is less expensive than the recommended methods, but is
susceptible to false-negative and false-positive determinations as a result
of variation in urine concentration due to hydration and other factors
At least two of three tests measured within a 6-month period should show
elevated levels
before a patient is designated as having microalbuminuria
Abnormalities of albumin excretion are defined in Table 8
Table 8- Definitions of abnormalities in albumin excretion
|Category |Spot collection g/mg creatinine |
| |
|Normal |30 |
|Microalbuminuria |30-299 |
|Macro clinical albuminuria |300 |

Because of variability in urinary albumin excretion, two of three specimens
collected within a 3- to 6-month period should be abnormal before
considering a patient to have crossed one of these diagnostic thresholds
Exercise within 24 h, infection, fever, congestive heart failure, marked
hyperglycemia, and marked hypertension may elevate urinary albumin
excretion over baseline values

Physicians may use the Levey modification of the Cockcroft and Gault
equation to calculate estimated GFR eGFR from serum creatinine and to
stage the patients renal disease 87,88 The eGFR can easily be
calculated by going to
wwwkidneyorg/professionals/dogi/gfr_calculatorcfm
The role of annual
microalbumuria assessment is less clear after diagnosis
of microalbuminuria and institution of ACE inhibitor or ARB therapy and
blood pressure control Most experts, however, recommend continued
surveillance to assess both response to therapy and progression of disease
Many experts suggest that managing urine microalbuminuria to reduce it to
the normal or near-normal range may improve renal and cardiovascular
prognosis; this approach has not been formally evaluated in prospective
trials
Consider referral to a physician experienced in the care of diabetic renal
disease either when the GFR has fallen to 60 ml min-1 173 m-2 or if
difficulties occur in the management of hypertension or hyperkalemia It is
suggested that consultation with a nephrologist be obtained when the GFR is
30 ml min-1 173 m-2 Early referral of such patients has been found
to reduce cost and improve quality of care and keep people off dialysis
longer 89 For a complete discussion on the treatment of nephropathy, see
the ADAs position statement Diabetic Nephropathy 90
Recommendations
General recommendations
To reduce the risk and/or slow the progression of nephropathy,
optimize glucose control A

To reduce the risk and/or slow the progression of nephropathy,
optimize blood pressure control A
Screening
Perform an annual test for the presence of microalbuminuria in type 1
diabetic patients with diabetes duration of 5 years and in all
type 2 diabetic patients, starting at diagnosis E
Treatment
In the treatment of both micro- and macroalbuminuria, either ACE
inhibitors or ARBs should be used A
While there are no adequate head-to-head comparisons of ACE inhibitors
and ARBs, there is clinical trial support for each of the following
statements:
o In patients with type 1 diabetes, with hypertension and any
degree of albuminuria, ACE inhibitors have been shown to delay
the progression of nephropathy A
o In patients with type 2 diabetes, hypertension, and
microalbuminuria, ACE inhibitors and ARBs have been shown to
delay the progression to macroalbuminuria A
o In patients with type 2 diabetes, hypertension,
macroalbuminuria, and renal insufficiency serum creatinine 15
mg/dl, ARBs have been shown to delay the progression of

nephropathy A
o If one class is not tolerated, the other should be substituted
E

With presence of nephropathy, initiate protein restriction to 08
g kg-1 body wt-1 day-1 10 of daily calories, the current
adult-recommended dietary allowance for protein Further restriction
may be useful in slowing the decline of GFR in selected patients B
With regards to slowing the progression of nephropathy, the use of
DCCBs as initial therapy is not more effective than placebo Their use
in nephropathy should be restricted to additional therapy to further
lower blood pressure in patients already treated with ACE inhibitors
or ARBs B
In the setting of albuminuria or nephropathy, in patients unable to
tolerate ACE inhibitors and/or ARBs, consider the use of non-DCCBs, ß-
blockers, or diuretics for the management of blood pressure E
If ACE inhibitors, ARBs, or diuretics are used, monitor serum
potassium levels for the development of hyperkalemia B
Consider referral to a physician experienced in the care of diabetic
renal disease when the eGFR has fallen to 60 ml min-1 173 m-2 or
if
difficulties occur in the management of hypertension or
hyperkalemia B
III Diabetic retinopathy screening and treatment
Diabetic retinopathy is a highly specific vascular complication of both
type 1 and type 2 diabetes The prevalence of retinopathy is strongly
related to the duration of diabetes Diabetic retinopathy is estimated to
be the most frequent cause of new cases of blindness among adults aged 20-
74 years
Intensive diabetes management with the goal of achieving near normoglycemia
has been shown in large prospective randomized studies to prevent and/or
delay the onset of diabetic retinopathy 15,16 In addition to glycemic
control, several other factors seem to increase the risk of retinopathy
The presence of nephropathy is associated with retinopathy High blood
pressure is an established risk factor for the development of macular edema
and is associated with the presence of proliferative diabetic retinopathy
PDR Lowering blood pressure, as demonstrated by the UKPDS, has been
shown to decrease the progression of retinopathy Several case series and a
controlled prospective study suggest that pregnancy in type 1 diabetic
patients may aggravate retinopathy 91 During
pregnancy and 1 year
postpartum, retinopathy may be transiently aggravated; laser
photocoagulation surgery can minimize this risk 92
Patients with type 1 diabetes should have an initial dilated and
comprehensive eye examination by an ophthalmologist or optometrist within 3-
5 years after the onset of diabetes Patients with type 2 diabetes should
have an initial dilated and comprehensive eye examination by an
ophthalmologist or optometrist shortly after the diagnosis of diabetes
Subsequent examinations for type 1 and type 2 diabetic patients should be
repeated annually by an ophthalmologist or optometrist who is knowledgeable
and experienced in diagnosing the presence of diabetic retinopathy and is
aware of its management Less frequent exams every 2-3 years may be
considered with the advice of an eye care professional in the setting of a
normal eye exam 93-95 Examinations will be required more frequently if
retinopathy is progressing
One of the main motivations for screening for diabetic retinopathy is the
established efficacy of laser photocoagulation surgery in preventing visual
loss Two large National Institutes of Health-sponsored trials, the
Diabetic Retinopathy Study DRS
96-100 and the Early Treatment Diabetic
Retinopathy Study ETDRS, provide the strongest support for the
therapeutic benefit of photocoagulation surgery 101-107
The DRS tested whether scatter panretinal photocoagulation surgery could
reduce the risk of vision loss from PDR Severe visual loss ie, best
acuity of 5/200 or worse was seen in 159 of untreated vs 64 of
treated eyes The benefit was greatest among patients whose baseline
evaluation revealed high-risk characteristics HRCs chiefly disc
neovascularization or vitreous hemorrhage with any retinal
neovascularization Of control eyes with HRCs, 26 progressed to severe
visual loss vs 11 of treated eyes Given the risk of a modest loss of
visual acuity and of contraction of visual field from panretinal laser
surgery, such therapy has been primarily recommended for eyes approaching
or reaching HRCs
The ETDRS established the benefit of focal laser photocoagulation surgery
in eyes with macular edema, particularly those with clinically significant
macular edema In patients with clinically significant macular edema after
2 years, 20 of untreated eyes had a doubling of the visual angle eg,
20/50 to 20/100 compared with 8 of treated eyes Other
results from the
ETDRS indicate that, provided careful follow-up can be maintained, scatter
photocoagulation surgery is not recommended for eyes with mild or moderate
nonproliferative diabetic retinopathy NPDR When retinopathy is more
severe, scatter photocoagulation surgery should be considered, and usually
should not be delayed, if the eye has reached the high-risk proliferative
stage In older-onset patients with severe NPDR or less than high-risk PDR,
the risk of severe visual loss and vitrectomy is reduced 50 by laser
photocoagulation surgery at these earlier stages
Laser photocoagulation surgery in both the DRS and the ETDRS was beneficial
in reducing the risk of further visual loss, but generally not beneficial
in reversing already diminished acuity This preventive effect and the fact
that patients with PDR or macular edema may be asymptomatic provide strong
support for a screening program to detect diabetic retinopathy
For a detailed review of the evidence and further discussion, see the ADAs
technical review and position statement on this subject 91,108,109
Recommendations
General recommendations
Optimal glycemic control can substantially reduce the risk and

progression of diabetic retinopathy A
Optimal blood pressure control can reduce the risk and progression of
diabetic retinopathy A
Aspirin therapy does not prevent retinopathy or increase the risks of
hemorrhage A
Screening
Adults and adolescents with type 1 diabetes should have an initial
dilated and comprehensive eye examination by an ophthalmologist or
optometrist within 3-5 years after the onset of diabetes B
Patients with type 2 diabetes should have an initial dilated and
comprehensive eye examination by an ophthalmologist or optometrist
shortly after the diagnosis of diabetes B
Subsequent examinations for type 1 and type 2 diabetic patients should
be repeated annually by an ophthalmologist or optometrist who is
knowledgeable and experienced in diagnosing the presence of diabetic
retinopathy and is aware of its management Less frequent exams every
2-3 years may be considered with the advice of an eye care
professional in the setting of a normal eye exam Examinations will be
required more frequently if retinopathy is progressing B
When planning pregnancy, women with preexisting
diabetes should have a
comprehensive eye examination and should be counseled on the risk of
development and/or progression of diabetic retinopathy Women with
diabetes who become pregnant should have a comprehensive eye
examination in the first trimester and close follow-up throughout
pregnancy and for 1 year postpartum This guideline does not apply to
women who develop GDM because such individuals are not at increased
risk for diabetic retinopathy B
Treatment
Laser therapy can reduce the risk of vision loss in patients with
HRCs A
Promptly refer patients with any level of macular edema, severe NPDR,
or any PDR to an ophthalmologist who is knowledgeable and experienced
in the management and treatment of diabetic retinopathy A
IV Foot care
Amputation and foot ulceration are the most common consequences of diabetic
neuropathy and major causes of morbidity and disability in people with
diabetes Early recognition and management of independent risk factors can
prevent or delay adverse outcomes
The risk of ulcers or amputations is increased in people who have had
diabetes 10 years, are male, have poor glucose control,
or have
cardiovascular, retinal, or renal complications The following foot-related
risk conditions are associated with an increased risk of amputation:
Peripheral neuropathy with loss of protective sensation
Altered biomechanics in the presence of neuropathy
Evidence of increased pressure erythema, hemorrhage under a callus
Bony deformity
Peripheral vascular disease decreased or absent pedal pulses
A history of ulcers or amputation
Severe nail pathology
All individuals with diabetes should receive an annual foot examination to
identify high-risk foot conditions This examination should include
assessment of protective sensation, foot structure and biomechanics,
vascular status, and skin integrity People with one or more high-risk foot
conditions should be evaluated more frequently for the development of
additional risk factors People with neuropathy should have a visual
inspection of their feet at every visit with a health care professional
Evaluation of neurological status in the low-risk foot should include a
quantitative somatosensory threshold test, using the Semmes-Weinstein 507
10-g monofilament The skin should be assessed for integrity,
especially
between the toes and under the metatarsal heads The presence of erythema,
warmth, or callus formation may indicate areas of tissue damage with
impending breakdown Bony deformities, limitation in joint mobility, and
problems with gait and balance should be assessed
People with neuropathy or evidence of increased plantar pressure may be
adequately managed with well-fitted walking shoes or athletic shoes
Patients should be educated on the implications of sensory loss and the
ways to substitute other sensory modalities hand palpation, visual
inspection for surveillance of early problems People with evidence of
increased plantar pressure eg, erythema, warmth, callus, or measured
pressure should use footwear that cushions and redistributes the pressure
Callus can be debrided with a scalpel by a foot care specialist or other
health professional with experience and training in foot care People with
bony deformities eg, hammertoes, prominent metatarsal heads, bunions
may need extra-wide shoes or depth shoes People with extreme bony
deformities eg, Charcot foot that cannot be accommodated with
commercial therapeutic footwear may need custom-molded shoes
Initial screening for
peripheral arterial disease PAD should include a
history for claudication and an assessment of the pedal pulses Consider
obtaining an ankle-brachial index ABI, as many patients with PAD are
asymptomatic Refer patients with significant or a positive ABI for further
vascular assessment and consider exercise, medications, and surgical
options 110
Patients with diabetes and high-risk foot conditions should be educated
regarding their risk factors and appropriate management Patients at risk
should understand the implications of the loss of protective sensation, the
importance of foot monitoring on a daily basis, the proper care of the
foot, including nail and skin care, and the selection of appropriate
footwear The patients understanding of these issues and their physical
ability to conduct proper foot surveillance and care should be assessed
Patients with visual difficulties, physical constraints preventing
movement, or cognitive problems that impair their ability to assess the
condition of the foot and to institute appropriate responses will need
other people, such as family members, to assist in their care Patients at
low risk may benefit from education on foot care and footwear
For
a detailed review of the evidence and further discussion, see the ADAs
technical review and position statement in this area 111,112
Problems involving the feet, especially ulcers and wound care, may require
care by a podiatrist, orthopedic surgeon, or rehabilitation specialist
experienced in the management of persons with diabetes For a complete
discussion on wound care, see the ADAs consensus statement on diabetic
foot wound care 113
Recommendations
A multidisciplinary approach is recommended for persons with foot
ulcers and high-risk feet, especially those with a history of prior
ulcer or amputation A
The foot examination can be accomplished in a primary care setting and
should include the use of a Semmes-Weinstein monofilament, tuning
fork, palpation, and a visual examination B
Educate all patients, especially those with risk factors, including
smoking, or prior lower-extremity complications, about the risk and
prevention of foot problems and reinforce self-care behavior B
Refer high-risk patients to foot care specialists for ongoing
preventive care and life-long surveillance C
Initial screening for PAD should
include a history for claudication
and an assessment of the pedal pulses Consider obtaining an ABI, as
many patients with PAD are asymptomatic C
Refer patients with significant claudication or a positive ABI for
further vascular assessment and consider exercise, medications, and
surgical options C
Perform a comprehensive foot examination annually on patients with
diabetes to identify risk factors predictive of ulcers and
amputations Perform a visual inspection of patients feet at each
routine visit E

|[p| PREVENTIVE CARE |
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I Preconception care
Major congenital malformations remain the leading cause of mortality and
serious morbidity in infants of mothers with type 1 and type 2 diabetes
Observational studies indicate that the risk of malformations increases
continuously with increasing maternal glycemia during the first 6-8 weeks
of gestation, as defined by first trimester A1C concentrations There is no
threshold for A1C values above which the risk
begins or below which it
disappears However, malformation rates above the 1-2 background rate seen
in nondiabetic pregnancies appear to be limited to pregnancies in which
first trimester A1C concentrations are 1 above the normal range
Preconception care of diabetes appears to reduce the risk of congenital
malformations Five nonrandomized studies have compared rates of major
malformations in infants between women who participated in preconception
diabetes care programs and women who initiated intensive diabetes
management after they were already pregnant The preconception care
programs were multidisciplinary and designed to train patients in diabetes
self-management with diet, intensified insulin therapy, and SMBG Goals
were set to achieve normal blood glucose concentrations, and 80 of
subjects achieved normal A1C concentrations before they became pregnant
114-118 In all five studies, the incidence of major congenital
malformations in women who participated in preconception care range 10-
17 of infants was much lower than the incidence in women who did not
participate range 14-109 of infants One limitation of these studies
is that participation in preconception care was
self-selected by patients
rather than randomized Thus, it is impossible to be certain that the lower
malformation rates resulted fully from improved diabetes care Nonetheless,
the overwhelming evidence supports the concept that malformations can be
reduced or prevented by careful management of diabetes before pregnancy
Planned pregnancies greatly facilitate preconception diabetes care
Unfortunately, nearly two-thirds of pregnancies in women with diabetes are
unplanned, leading to a persistent excess of malformations in infants of
diabetic mothers To minimize the occurrence of these devastating
malformations, standard care for all women with diabetes who have child-
bearing potential should include 1 education about the risk of
malformations associated with unplanned pregnancies and poor metabolic
control and 2 use of effective contraception at all times, unless the
patient is in good metabolic control and actively trying to conceive
Women contemplating pregnancy need to be seen frequently by a
multidisciplinary team experienced in the management of diabetes before and
during pregnancy Teams may vary but should include a diabetologist, an
internist or a family physician, an
obstetrician, a diabetes educator, a
dietitian, a social worker, and other specialists as necessary The goals
of preconception care are to 1 integrate the patient into the management
of her diabetes, 2 achieve the lowest A1C test results possible without
excessive hypoglycemia, 3 assure effective contraception until stable and
acceptable glycemia is achieved, and 4 identify, evaluate, and treat long-
term diabetic complications such as retinopathy, nephropathy, neuropathy,
hypertension, and CAD
For further discussion, see the ADAs technical review and position
statement on this subject 119,120
Recommendations
A1C levels should be normal or as close to normal as possible 1
above the upper limits of normal in an individual patient before
conception is attempted B
All women with diabetes and child-bearing potential should be educated
about the need for good glucose control before pregnancy They should
participate in family planning E
Women with diabetes who are contemplating pregnancy should be
evaluated and, if indicated, treated for diabetic retinopathy,
nephropathy, neuropathy, and CVD E
Among the drugs commonly used in the
treatment of patients with
diabetes, statins are pregnancy category X and should be discontinued
before conception if possible ACE inhibitors and ARBs are category C
in the first trimester maternal benefit may outweigh fetal risk in
certain situations, but category D in later pregnancy, and should
generally be discontinued before pregnancy Among the oral
antidiabetic agents, metformin and acarbose are classified as category
B and all others as category C; potential risks and benefits of oral
antidiabetic agents in the preconception period must be carefully
weighed, recognizing that sufficient data are not available to
establish the safety of these agents in pregnancy They should
generally be discontinued in pregnancy E
II Immunization
Influenza and pneumonia are common, preventable infectious diseases
associated with high mortality and morbidity in the elderly and in people
with chronic diseases There are limited studies reporting the morbidity
and mortality of influenza and pneumococcal pneumonia specifically in
people with diabetes Observational studies of patients with a variety of
chronic illnesses, including
diabetes, show that these conditions are
associated with an increase in hospitalizations for influenza and its
complications Based on a case-control series, influenza vaccine has been
shown to reduce diabetes-related hospital admission by as much as 79
during flu epidemics 121 People with diabetes may be at increased risk
of the bacteremic form of pneumococcal infection and have been reported to
have a high risk of nosocomial bacteremia, which has a mortality rate as
high as 50
Safe and effective vaccines are available that can greatly reduce the risk
of serious complications from these diseases 122,123 There is sufficient
evidence to support that people with diabetes have appropriate serologic
and clinical responses to these vaccinations The Centers for Disease
Controls Advisory Committee on Immunization Practices recommends influenza
and pneumococcal vaccines for all persons over 65 years of age as well as
for all persons of any age with diabetes
For a complete discussion on the prevention of influenza and pneumococcal
disease in people with diabetes, consult the technical review and position
statement on this subject 124,125
Recommendations
Annually provide an influenza
vaccine to all diabetic patients 6
months of age or older C
Provide at least one lifetime pneumococcal vaccine for adults with
diabetes A one-time revaccination is recommended for individuals 64
years of age previously immunized when they were 65 years of age if
the vaccine was administered 5 years ago Other indications for
repeat vaccination include nephrotic syndrome, chronic renal disease,
and other immunocompromised states, such as after transplantation C

|[p| SPECIAL CONSIDERATIONS |
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I Care of older adults with diabetes
Diabetes is an important health condition for the aging population; at
least 20 of patients over the age of 65 years have diabetes The number of
older persons with diabetes can be expected to grow rapidly over the coming
decades A recent publication, Guidelines for improving the care of the
older person with diabetes, contains evidence-based guidelines produced in
conjunction with the American Geriatric Society This document contains
an
excellent discussion of this area, and specific guidelines and language
from it have been incorporated below 126 Unfortunately, there are no
long-term studies in persons over 65 years of age demonstrating the
benefits of tight glycemic control, blood pressure, and lipid control
Older persons with diabetes have higher rates of premature death,
functional disability, and coexisting illnesses such as hypertension, CHD,
and stroke than those without diabetes Older adults with diabetes are also
at greater risk than other older persons for several common geriatric
syndromes, such as polypharmacy, depression, cognitive impairment, urinary
incontinence, injurious falls, and persistent pain
The care of older adults with diabetes is complicated by their clinical and
functional heterogeneity Some older persons developed diabetes in middle
age and face years of comorbidity; others who are newly diagnosed may have
had years of undiagnosed comorbidity or few complications from the disease
Some older adults with diabetes are frail and have other underlying chronic
conditions, substantial diabetes-related comorbidity, or limited physical
or cognitive functioning, but other older persons with
diabetes have little
comorbidity and are active Life expectancies are also highly variable for
this population Clinicians caring for older adults with diabetes must take
this heterogeneity into consideration when setting and prioritizing
treatment goals
All this having been said, patients who can be expected to live long enough
to reap the benefits of long-term intensive diabetes management 10
years and who are active, cognitively intact, and willing to undertake the
responsibility of self-management should be encouraged to do so and be
treated using the stated goals for younger adults with diabetes
There is good evidence from middle-aged and older adults suggesting that
multidisciplinary interventions that provide education on medication use,
monitoring, and recognizing hypo- and hyperglycemia can significantly
improve glycemic control Although control of hyperglycemia is important,
in older persons with diabetes, greater reductions in morbidity and
mortality may result from control of all cardiovascular risk factors rather
than from tight glycemic control alone There is strong evidence from
clinical trials of the value of treating hypertension in the elderly There
is less
evidence for lipid-lowering and aspirin therapy, although as
diabetic patients have such an elevated risk for CVD, aggressive management
of lipids and aspirin use when not contraindicated are reasonable
interventions
As noted above, for patients with advanced diabetes complications, life-
limiting comorbid illness, or cognitive or functional impairment, it is
reasonable to set less intensive glycemic target goals These patients are
less likely to benefit from reducing the risk of microvascular
complications and more likely to suffer serious adverse effects from
hypoglycemia Patients with poorly controlled diabetes may be subject to
acute complications of diabetes, including hyperglycemic hyperosmolar coma
Older patients can be treated with the same drug regimens as younger
patients, but special care is required in prescribing and monitoring drug
therapy Metformin is often contraindicated because of renal insufficiency
or heart failure Sulfonylureas and other insulin secretagogues can cause
hypoglycemia Insulin can also cause hypoglycemia as well as require good
visual and motor skills and cognitive ability of the patient or a
caregiver Thiazolidinediones should not be used in
patients with
congestive heart failure New York Heart Association [NYHA] Class III and
IV Drugs should be started at the lowest dose and titrated up gradually
until targets are reached or side effects develop As well as regards blood
pressure and lipid management, the potential benefits must always be
weighed against potential risks
II Children and adolescents
Approximately three-quarters of all newly diagnosed cases of type 1
diabetes occur in individuals younger than 18 years of age Care of this
group requires integration of diabetes management with the complicated
physical and emotional growth needs of children, adolescents, and their
families
Diabetes care for children of this age-group should be provided by a team
that can deal with these special medical, educational, nutritional, and
behavioral issues
At the time of initial diagnosis, it is extremely important to establish
the goals of care and to begin diabetes self-management education A firm
educational base should be provided so that the individual and family can
become increasingly independent in the self-management of diabetes
Glycemic goals may need to be modified to take into account the fact that
most children
younger than 6 or 7 years of age have a form of hypoglycemic
unawareness, in that they lack the cognitive capacity to recognize and
respond to hypoglycemic symptoms and may be at greater risk for the
sequelae of hypoglycemia
Intercurrent illnesses are more frequent in young children Sick-day
management rules, including assessment for ketosis with every illness, must
be established and taught to prevent severe hyperglycemia and DKA that
requires hospitalization and may lead to severe morbidity and even death
24 MNT should be provided at diagnosis, and at least annually
thereafter, by an individual experienced with the nutritional needs of the
growing child and the behavioral issues that have an impact on adolescent
diets Caution must be exercised to avoid overaggressive dietary
manipulation in the very young Assessment of lifestyle needs should be
accompanied by possible modifications of the diabetes regimen For example,
an adolescent who requires more flexibility might be switched to a
basal/bolus insulin program with preprandial rapidly acting insulin
administration or continuous subcutaneous insulin injection CSII
A major issue deserving emphasis in this age-group is that of
adherence
No matter how sound the medical regimen, it can only be as good as the
ability of the family and/or individual to implement it Family involvement
in diabetes remains an important component of optimal diabetes management
throughout childhood and into adolescence Health care providers who care
for children and adolescents, therefore, must be capable of evaluating the
behavioral, emotional, and psychosocial factors that interfere with
implementation and then must work with the individual and family to resolve
problems that occur and/or to modify goals as appropriate
The incidence of type 2 diabetes in children and adolescents has been shown
to be increasing, especially in ethnic minority populations 127,128
Although there are insufficient data to make definite recommendations, a
recent ADA consensus statement provides guidance to the prevention,
screening, and treatment of type 2 diabetes in young people The ideal goal
of treatment is normalization of blood glucose and A1C values Accurate
diagnosis and classification of diabetes is crucial in determining
appropriate treatment for these patients Medical management should include
MNT, exercise, and lifestyle interventions, but
drug therapy, including
insulin in many cases, is required Successful control of comorbidities,
such as hypertension and hyperlipidemia, is also important For further
discussion, see the ADA consensus statement Type 2 Diabetes in Children
and Adolescents 13
Information should be supplied to the school or day care setting so that
school personnel are aware of the diagnosis of diabetes in the student and
of the signs, symptoms, and treatment of hypoglycemia It is desirable that
blood glucose testing be performed at the school or day care setting before
lunch and when signs or symptoms of abnormal blood glucose levels are
present Many children may require support for insulin administration by
either injection or CSII before lunch at school or in day care
For further discussion, see the ADAs position statement The Care of
Children With Diabetes in the School and Day Care Setting 129 and the
NDEP publication Helping the Student with Diabetes Succeed: A Guide for
School Personnel National Diabetes Education Program, 2003,
http://wwwndepnihgov/
Strategies for improving diabetes care
The implementation of the standards of care for diabetes is suboptimal in
the health care system The
challenge of providing effective diabetes care
has thus far defied a simple solution, yet numerous interventions have been
implemented with strategies to improve adherence to the recommended
standards Successful programs have published results showing improvement
in important outcomes such as A1C measurements as well as process measures
such as provision of eye exams The interventions have been focused at this
level of providers, the system, and patients Features of successful
programs reported in the literature include:
Improving provider education regarding the standards of care through
formal and informal provider education program
Adoption of practice guidelines, with participation of the providers
in the process Guidelines should be readily accessible at the point
of service, such as on patient charts, in examining rooms, or on
office computer systems
Use of checklists that mirror guidelines have been successful at
improving adherence to standard of care
Systems changes, such as provision of automated reminders to providers
and patients, profiling or reporting of data to providers, and
identification of patients at
risk because of abnormal target values
or a lack of reported values
Quality improvement programs combining CQI or other cycles of analysis
and intervention with provider performance data
Practice changes, such as clustering of dedicated diabetes visits and
group visits
Tracking systems either with an electronic medical record or patient
registry have been helpful at increasing adherence to standards of
care
Delivery of diabetes self-management education has been shown to
increase adherence to standard of care
Availability of case management services, usually by a nurse Nurses
using detailed protocols working under the supervision of physicians
Nurse education calls have been helpful
Availability and involvement of expert consultants, such as
endocrinologists and diabetes educators
Clustering patients with diabetes into specific times within a primary
care practice schedule
Other nonautomated systems such as mailing reminders to patients,
chart stickers, and flow sheets have been useful to prompt both
providers and patients
Because these interventions are generally
provided as components of a
multifactorial intervention, it is difficult to assess the contribution of
each component; however, it is clear that optimal diabetes management
requires an organized, systematic approach and involvement of a health care
team Further research to identify improved mechanisms to translate
research into practice is necessary Successful translation will require a
multidiscipline approach utilizing a variety of behavioral and
technological approaches
In recent years, numerous health care organizations, ranging from large
health care systems such as the US Veterans Administration to small
private practices, have implemented strategies to improve diabetes care
Successful programs have published results showing improvement in important
outcomes such as A1C measurements as well as process measures such as
provision of eye exams Features of successful programs reported in the
literature include:
Adoption of practice guidelines, with participation of the providers
in the process Guidelines should be readily accessible at the point
of service, such as on patient charts, in examining rooms, or on
office computer systems
Systems changes,
such as provision of automated reminders to providers
and patients, profiling or reporting of data to providers, and
identification of patients at risk because of abnormal target values
or a lack of reported values
Practice changes, such as scheduling of dedicated diabetes visits and
group visits
Delivery of diabetes self-management education
Availability of case management services, usually by a nurse
Availability and involvement of expert consultants, such as
endocrinologists and diabetes educators
Because these interventions are generally provided as components of a
multifactorial intervention, it is difficult to assess the
contribution of each component; however, it is clear that optimal
diabetes management requires an organized, systematic approach and
involvement of a health care team
Simple tools such as flow charts may be useful in smaller practices

Source:csun.edu