DisforDiabetes: VA/DoD clinical practice guideline for the management of diabetes mellitus

VA/DoD clinical practice guideline for the management of diabetes mellitus

[Editor's Note: The information in this webpage has been extracted from a discussion by the Agency for Healthcare Research Quality about the Department of Veterans Affairs (VA) and The Department of Defense (DoD) clinical practice guideline for diabetes. The complete guideline is available on-line from the VA as a PDF.]

Module D - Core

The core module provides an overview of the important components of diabetes care that should be considered at each visit and the interventions that should be performed at appropriate intervals. This module will assist the provider to organize and prioritize a care plan for persons with diabetes mellitus (DM).

Patient with Diabetes Mellitus
Diabetes mellitus is a state of absolute or relative insulin deficiency resulting in hyperglycemia. This algorithm applies to adults only (age ≥17), both type 1 and type 2 (formerly referred to as insulin-dependent and non-insulin dependent diabetes mellitus), but not to gestational diabetes mellitus (GDM).

Table. Diagnosis of Diabetes Mellitus

Status Fasting Plasma Glucose (FPG) ^a,b
or Hemoglobin A₁c^c Casual Plasma Glucose^d

Diabetes Mellitus FPG ≥126 mg/dL (7.0 mmol/L) on two occasions

OR

HbA₁c is ≥6.5% and FPG ≥126 mg/dL (7.0 mmol/L)

OR

HbA₁c ≥7% on two occasions Casual plasma glucose ≥200 mg/dL (11.1 mmol/L) plus symptoms of diabetes

Pre-diabetes FPG ≥100 and <126 mg/dL on two occasions

OR

HbA₁c ≥5.7% and FPG ≥100 and <126 mg/dL (7.0 mmol/L) —

Normal FPG <100 mg/dL
HbA₁c <5.7% —

Fasting is defined as no caloric intake for at least 8 hours.

FPG is the preferred test for diagnosis, but either of the two listed is acceptable. In the absence of unequivocal hyperglycemia with acute metabolic decompensation, one of these two tests should be done on different days.

Using a clinical laboratory (not a Point of Care) methodology standardized to the National Glycohemoglobin Standardization Program (NGSP)

Casual means any time of day without regard to time since last meal; classic symptoms include polyuria, polydipsia, and unexplained weight loss.

Oral glucose tolerance testing (OGTT) is no longer recommended in routine clinical practice because it is an imprecise test with poor reproducibility. The World Health Organization suggests continued use of the OGTT for patients with blood glucose values in the "uncertain range." Also, the OGTT does seem to better predict macrovascular complications.

Refer to Pediatric Diabetes Management
Objective

Provide appropriate management for children with diabetes.

Recommendations

Children with diabetes should be referred for consultative care to a pediatric diabetic team that is knowledgeable and experienced in meeting the medical, psychosocial, and developmental needs of children with diabetes.

The pediatric diabetic team should include a pediatric endocrinologist, if available, and/or a pediatrician, certified diabetes educator, registered nurse, registered dietitian, and social worker, all with expertise and specialized training in the comprehensive care of children with diabetes.

Is Patient a Female of Reproductive Potential?
Objective

Assess the risk of maternal and fetal complications of an unintended pregnancy and implement prevention strategies.

Recommendations

All female patients with pre-existing diabetes and reproductive potential should be educated about contraceptive options, and strongly encouraged to plan and prepare for pregnancy, and to optimize their glycemic control prior to attempting to conceive.

Women with diabetes who are planning pregnancy should be educated about the different options of diabetes management during the pregnancy and referred to maternal fetal medicine provider before, or as early as possible, once pregnancy is confirmed.

Women with gestational diabetes mellitus (GDM) should be screened for diabetes 6 to 12 weeks postpartum and should follow-up with subsequent screening for diabetes or prediabetes (See Module S - Screening)

For additional information on the management of diabetes during pregnancy, refer to the NGC summary of the Va/DoD clinical practice guideline for the management of pregnancy.

Identify Comorbid Conditions
Objective

Evaluate DM management in the context of the patient's total health status.

Annotation

DM may not be the patient's only disease, nor is it necessarily the condition that needs to be prioritized for immediate treatment. Persons with DM are at risk of multiple comorbid conditions including:

Coronary artery disease (CAD)

Peripheral vascular disease (PVD)

Hypertension (HTN)

Hyperlipidemia

Overweight and abdominal obesity

The following are examples of conditions that affect the management of DM:

Chronic obstructive pulmonary disease (COPD)

Substance use disorder (SUD)

Depression

Among the more frequently encountered precipitating factors resulting in secondary diabetes are:

Pancreatic disease (e.g., due to alcoholism, pancreatic insufficiency secondary to chronic pancreatitis, malignancy, and hemochromatosis)

Drug induced disease (especially thiazide diuretics, steroids, and phenytoin)

Cushing's Disease

Acromegaly

Is the Patient Medically, Psychologically, and Socially Stable?
Objective

Stabilize the patient before initiating long-term disease management.

Recommendations

Urgent or semi-urgent medical conditions, including hypo- or hyperglycemia, and deficient renal function, must be treated before long-term disease management principles are applied.

The urgency of medical treatment, including the necessity for hospitalization, will depend upon the presence of ketoacidosis, dehydration, hyperosmolarity, infections, and other life threatening conditions.

Psychiatric illness and marked socioeconomic hardship (e.g., homelessness, absence of support system or reliable transportation, and unemployment) pose significant barriers to diabetic management. If such circumstances are identified, involvement of behavioral health, social services, and case management professionals may enhance patient compliance with treatment and follow-up.

The determination of stability is up to the judgment of the provider.

Identify/Update Related Problems from Medical Record, History, Physical Examination, Laboratory Tests, Nutritional and Educational Assessment
Objective

Obtain and document a complete medical evaluation for the patient with DM annually.

Recommendations

In addition to a general medical examination, a complete evaluation of patients with DM will include:

Information regarding the onset and duration of DM

History of hospitalization(s) for diabetic events

Review of glycemic control

Measurement of serum lipids

Identification of foot complications

Identification of eye complications

Screening for hypertension

Screening for kidney disease

Identification of macrovascular disease

Identification of neurovascular disease

Assessment of psychosocial status (including family support)

Appraisal of self-management skills

On a follow-up visit, the evaluation should focus on updating of new information and/or changes to the patient record. The components of evaluation are summarized in the table below.

Table. Evaluation of the Patient with Diabetes

Evaluation Component History-Patient/Family Physical Examination Laboratory

Glycemia

Home glucose monitoring records

Hyperglycemia

Ketoacidosis

Hypoglycemia

Lifestyle

Nutrition

Current and past medications

Also consider secondary etiologies:

Cushing's disease

Acromegaly

Hemochromatosis

Medications

Weight

Height

Body mass index (BMI)

HbA₁c

Fasting glucose

Eye

Changes in vision

Laser treatment

Glaucoma

Dilated retinal exam by eye care provider within last year

Visual acuity, if changes in vision are reported

N/A

Foot

Symptoms of neuropathy:

Pain

Paresthesia

Symptoms of peripheral vascular disease

Symptoms of systemic or local infection

Previous episodes of foot complications:

Foot deformity

Skin breakdown

Ulcers

Amputations

Visual inspection including:

Nails

Web spaces

Ulcers

Calluses

Deformities

Palpation of pulses and determination of sensation (consider using a 5.07 monofilament)

N/A

Kidney

Known history of diabetic disease

Family history of hypertension and kidney disease

Edema

Routine urinalysis

Test for micro-albuminuria and serum creatinine level if indicated

Hypertension

Previous diagnosis of hypertension

Current and previous medications

Blood pressure

N/A

Coronary and Peripheral Arterial Disease/Dyslipidemia Atherosclerotic disease:

Myocardial infarction (MI)/angina

Stroke

Transient ischemic attack (TIA)

Claudication

Surgical history of revascularization

Atherosclerotic risks other than diabetes:

Smoking history

Family history

Previous diagnosis of hyperlipidemia; triglycerides

Current and previous medications:

Aspirin

Estrogen therapy

Hypolipidemics

Cardiac examination:

Heart

Peripheral circulation including pulses and bruits

Cutaneous or tendinous xanthomata

Electro-cardiogram (EKG)

Fasting lipid profile, if not done within last year

Other modalities as indicated

Neurovascular Sensory state of:

Hands and feet

Interosseous muscle wasting

Deep tendon reflexes

N/A

Self-management Education Knowledge, understanding, and self-described behaviors of:

Use of medication

Goals of treatment

Diet and self-management skills

What to do in case of complications

Observation:

Home glucose monitoring if indicated

Foot self-examination

N/A

Other

Dental history and oral exam

Dental and gingival health

Oral examination

N/A

Infections

Insulin injection sites

Immunizations: flu and pneumovax

N/A N/A

Educational Assessment

The patient's general knowledge and ability to adequately self-manage his or her diabetes can be assessed by asking questions such as:

Is there anything you do or have been advised to do because of your diabetes that you have difficulty with or are unable to do?

Do you know what to do when your sugar is high/low (describe both hyperglycemia and hypoglycemia symptoms)? Who and when do you call?

Do you remember your target goals: HbA₁c, low-density lipoprotein (LDL), weight, exercise, blood pressure (BP)?

Which food affects your blood sugar the most: chicken breast, salad, or potato?

The patient's inability to answer these questions indicates possible deficiency in knowledge and self-management skills. (Module M - Self-Management/Education provides the clinician with additional assessment tools).

Patients with DM who have more immediate medical or psychiatric problems should still undergo an educational needs assessment. This evaluation will determine whether they have sufficient skills to manage their glycemic control during a period of concurrent illness, with a goal of avoiding symptomatic hypo- or hyperglycemia.

Determine and Document if Diabetes Mellitus is Type 1 or 2
Objective

Determine if insulin is a necessary component of treatment for the particular patient.

Annotation

Patients with type 1 DM are insulinopenic (i.e., virtually absent insulin secretion), often due to autoimmune or toxic (e.g., alcohol) destruction of the pancreatic beta cells. Patients with type 2 DM have underlying insulin resistance and relative insulin deficiency.

Patients with type 1 DM may initially present with diabetic ketoacidosis (DKA). However, it is not uncommon for these patients to present to primary care with hyperglycemia alone, without symptoms of ketoacidosis.

In a primary care setting, the patient's age at the time diabetes is diagnosed, plus the BMI, and level of urinary ketones and autoimmune markers, are usually sufficient to classify the type of DM. In case of uncertainty, a consultation with specialty care may be considered.

Clinical Classification of DM

Likely Type 1 Indeterminate Likely Type 2

Age <30 years 30–40 years >40 years

BMI <25 BMI* 25–27 >27

Urinary ketones Moderate to large Low to moderate None to low

*For Asian/Pacific Islanders the BMI threshold should be 23.

The increasing prevalence of obesity has translated to an earlier onset for type 2 diabetes. Therefore, using age alone as a discriminator for the diagnosis of type 1 or type 2 diabetes may be misleading.

Consider Aspirin Therapy
Objective

Prevent cardiovascular disease.

Recommendations

Prescribe aspirin therapy (75 to 325 mg/day) for all adult patients with type 2 diabetes and evidence of cardiovascular disease. [A]

Consider beginning aspirin therapy (75 to 325 mg/day) for primary prevention in patients age ≥40 with type 2 diabetes and one or more other cardiovascular risk factors. [B]

Consider individual evaluation for aspirin therapy for patients age 30 to 40 years with type 2 DM, with other cardiovascular risk factors or with type 1 DM for duration of disease longer than 2 years. [I]

When considering the value of antiplatelet therapy, the risks of hemorrhagic stroke or gastrointestinal bleeding must be balanced against the benefits of prevention of adverse cardiovascular outcomes. [I]

Review All Diabetes-Related Complications and Set Priorities
Objective

Identify DM-related complications requiring special attention.

Recommendations

If the individualized HbA₁c is not on target, refer to Module G – Glycemic Control.

Measure blood pressure on every diabetes visit. If systolic blood pressure (SBP) ≥140 mmHg or diastolic blood pressure (DBP) is ≥90 mmHg, refer to the VA/DoD clinical practice guideline for the management of hypertension. (Also see Annotation J).

Measure fasting lipids (total cholesterol [TC], high-density lipoprotein cholesterol [HDL-C], triglycerides [TG] and calculated low-density lipoprotein cholesterol [LDL-C] if not done within one year. If the patient has elevated cholesterol or lipids, refer to the VA/DoD clinical practice guideline for the diagnosis and management of dyslipidemia. (Also see Annotation K).

Screen for proteinuria and assess kidney function if not done within one year. If the patient develops micro- or macroalbuminuria or decline in estimated glomerular filtration rate (eGFR), refer to the NGC summary of the VA/DoD clinical practice guideline for management of chronic kidney disease in primary care. (Also see Annotation L).

Screen for retinopathy if not done within two years. If the patient has symptoms, or a previous exam showed a high-risk for visual loss or retinopathy, refer to Module E – Eye Care.

Complete a foot-risk assessment if not done within one year. If the patient has risk factors or an active lesion, refer to Module F – Foot Care.

If the patient needs additional nutritional or lifestyle education, refer to Module M – Self Management and Education.

If the patient is a candidate for an influenza vaccine, administer it in season. (See Centers for Disease Control and Prevention [CDC] recommendations)

Administer pneumococcal pneumonia vaccine, if indicated. (See CDC recommendations)

If the patient is using tobacco, refer to the VA/DoD clinical practice guideline for treating tobacco use and dependence.

Management of Hypertension in Diabetes Mellitus
For complete management of hypertension see the VA/DoD Clinical Practice Guideline for the Diagnosis and Management of Hypertension in the Primary Care Setting at http://www.healthquality.va.gov/Hypertension_Clinical_Practice_Guideline.asp.

Patients with Diabetes with SBP ≥140 or DBP ≥90 mm Hg

Recommendations

Patients with diabetes with hypertension (systolic BP ≥140 or diastolic ≥90 mm Hg) should:

Begin antihypertensive therapy with an angiotensin converting enzyme inhibitor (ACEI) or a diuretic [A]

If ACEI induced side-effects occur, consider switching to an angiotensin receptor blocker (ARB) [A]

Use other preferred agents (beta blockers, long acting calcium channel blockers) as necessary, depending on other co-morbid conditions or compelling indications to achieve a blood pressure <140/80 mm Hg. [A]

Patients with diabetes with initial SBP <140 mm Hg and DBP between 80 and 89 mm Hg (within the "pre-hypertensive" category identified by JNC 7) may benefit from lowering diastolic blood pressure to <80 mm Hg. [A]

Individuals with diabetes whose blood pressure is <140/80 mm Hg who have clinical cardiovascular disease may benefit from ACEI therapy even without a reduction in blood pressure. [A]

In patients with diabetes and kidney insufficiency (i.e., eGFR <60 mL/min/1.73m² ) and proteinuria (i.e., >1 g/24h) there are some data suggesting that further BP lowering (<125/75 mm Hg) may further slow progression of renal disease. Lower BP should be achieved, if feasible and practical, depending on the tolerance of medications and side effects of BP lowering. [B]

Management of Dyslipidemia in Diabetes Mellitus
For complete management of lipids see the VA/DoD clinical practice guideline for the diagnosis and management of dyslipidemia.

Patients with Diabetes and Elevated Cholesterol Or Lipids (Dyslipidemia)

Recommendations

Patients with diabetes and patients with established coronary heart disease (CHD) should be screened for lipid abnormalities with fasting lipid profile (triglycerides and HDL-C or LDL-C).

Patients with Type 2 DM are at significant increased risk of CVD compared with non-diabetic patients of similar age and should, therefore, be treated more aggressively according to secondary prevention protocols. [A]

LDL-C Target in Patients with History of CHD or Cardiovascular (CVD) Equivalent (DM with or without other risk factors)

LDL should be lowered to less than 100 mg/dL for patients with previous documented CHD or CVD equivalent (DM with other major risk factors) for secondary prevention. [A]

LDL should be lowered to less than 130 mg/dL for patients with DM without other major risk factors for secondary prevention. [C]

All patients with diabetes should be given lifestyle counseling. Lifestyle change is indicated in all patients with LDL-C >100 mg/dL. Strategies include diet (dietary/nutritional management of fat and/or cholesterol intake or medical nutrition therapy [MNT] consult), exercise, smoking cessation, cessation of excessive use of alcohol, and weight control.

Elevated TG level (>400 mg) may be due to poor glycemic control. The most common secondary causes of hypertriglyceridemia are alcohol, diabetes, and hypothyroidism. Addressing these underlying conditions can improve or normalize triglyceride levels and failing to address these conditions can render therapy ineffective. Once glycemic control is improved, the TG level should be reassessed and addressed.

Statin drug therapy should be initiated for patients with previous documented CHD or CVD equivalent (diabetes with other major risk factors) if baseline LDL-C is greater than or equal to 100 mg/dL. [A]

Statin drug therapy should be initiated for patients with documented DM with no major risk factors if baseline LDL-C is greater than or equal to 130 mg/dL. [C]

Statin drug therapy should be considered for all patients with CHD or CVD equivalent (diabetes with other major risk factors) regardless of LDL-C baseline. [B]

Treatment

Appropriate lipid lowering therapy should be initiated based on LDL-C baseline level and other risk factors for CVD.

Non-Pharmacotherapy

Therapeutic lifestyle changes (TLC) should be recommended for ALL patients with dyslipidemia, regardless of risk or baseline LDL-C level. [C]

For secondary prevention of recurrent CVD events, non-pharmacologic therapy is always indicated, but it should not delay appropriate pharmacotherapy.

Emphasis on TLC is an important component of primary prevention and is effective in reducing CVD risk by lowering LDL-C and blood pressure. [B]

Diet intervention should be the first step in lipid lowering therapy. [B]

Patients whose initial treatment is TLC should be given 3-6 months of dietary therapy prior to beginning medication and longer, if lipids are improving and nearing LDL thresholds. [B]

TLC is provided in a step-wise approach focused on initiating TLC components and followed by subsequent evaluation of the effect on LDL-C and moving to intensify MNT as indicated.

Lipid Pharmacotherapy

Statins are first line agents in primary and secondary prevention of CVD regardless of HDL-C or TG level. [A]

Moderate doses of formulary statins (to achieve an LDL-C reduction of 25% or greater) should be initiated unless a patient is considered to be at greater than usual risk for adverse events from statins (e.g., myopathy). [A]

For patients who cannot tolerate statins, niacin or resins should be considered for treatment. [A]

There is insufficient clinical outcome evidence to recommend ezetimibe monotherapy for reduction of CV risk. [I]

Ezetimibe can be considered for lowering LDL-C in patients who are unable to tolerate other lipid-lowering drugs, or in combination with other drugs. [A]

The dose of statin should be adjusted at 6 to 12 week intervals until individual LDL-C goals are achieved or statin doses have been maximized. [I]

Isolated Hypertriglyceridemia

Niacin, fibrates, or fish oil (omega-3 fatty acids) supplements may be used in treatment of isolated hypertriglyceridemia. [B]

Isolated Low HDL-C

For secondary prevention gemfibrozil or niacin may be used in patients with isolated low HDL-C and normal LDL-C. [A-Gemfibrozil; B-Niacin]

Management of Kidney Disease in Diabetes Mellitus
For complete management of Chronic Kidney Disease (CKD) see the NGC summary of the VA/DoD clinical practice guideline for management of chronic kidney disease in primary care.

Recommendations

Screening for CKD

Patients with diabetes should be screened periodically for the presence of kidney disease. [C]

Testing for kidney disease includes urinalysis and estimation of the glomerular filtration rate (eGFR). [B]

Patients with diabetes who have a negative urine protein by dipstick should be tested for the presence of microalbuminuria. [B]

Definitions of Chronic Kidney Disease includes any of the following:

Persistent decreased eGFR <60 ml/min/1.73m² on two tests at least three months apart

Proteinuria (>1+) on dipstick or urine protein-to-creatine ratio >0.2, confirmed on two tests at least three months apart

Microalbuminuria defined as albumin-to-creatine ratio >30, confirmed on two out of three urine tests in patients with diabetes mellitus

Known structural kidney disease defined by imaging or pathologic examination (e.g., polycystic kidney disease [PCKD])

Estimated glomerular filtration rate (eGFR) is the preferred method to assess kidney function.

The severity of CKD should be classified based on the level of the glomerular filtration rate (GFR) (see Table D-9 in the original guideline document). Kidney function should be assessed by formula-based estimation of GFR (eGFR), preferably using the 4-variable Modification of Diet in Renal Disease (MDRD) equation. [A]

Screening for Proteinuria

Microalbuminuria – in patients with diabetes – should be assessed using a laboratory method expressed as an albumin-to-creatinine ratio. If dipsticks designed to detect urinary microalbumin are used, positive tests should be followed by laboratory confirmation.

The diagnosis of microalbuminuria cannot be reliably made in the presence of an acute medical condition. As far as it is practicable, the best possible metabolic control of diabetes should be achieved before evaluating for microalbuminuria. Patients should not be screened during intercurrent illness or after heavy exercise.

It is important to consider other causes of increased albumin excretion, especially in the case of Type 1 diabetes present for <5 years. In addition to the previously mentioned conditions, other causes can include menstrual contamination, vaginal discharge, uncontrolled hypertension, and heart failure.

A 24-hour urine collection for protein and creatinine is not needed for quantitation of proteinuria, as it is more cumbersome for patients and prone to collection errors.

24-hour urine collection may be considered for: pregnant women, extreme age and weight, malnutrition, skeletal muscle disease, paraplegia or quadriplegia, patients with a vegetarian diet and rapidly changing kidney function.

Assessment and Diagnosis

Obtain Serum Creatinine and Estimate Glomerular Filtration Rate (eGFR)

Serum creatinine level should be used to estimate the GFR to identify patients at risk and develop appropriate management plans.

Patients with diabetes with urine albumin/creatinine levels of ≥30 μg/mg in the random specimen should repeat the test to ensure that the level was not transiently elevated (by heavy exercise, urinary tract infection, acute febrile illness, or heart failure).

If a second test is ≥30 μg/mg, the patient has persistent microalbuminuria; if the second test is <30μg/mg, repeat the test a third time.

Persons with diabetes and macroalbuminuria (i.e., urine Alb/creatinine ratio ≥300 μg/mg or 24-hour urine protein ≥300 mg/dL) should be assessed for level of kidney function as these levels of albuminuria indicate established to advanced diabetic kidney disease:

Document the course of the albuminuria. It would be unusual to go from having normal urine to macroalbuminuria in less than one year in diabetic kidney disease

Document if the blood pressure has been rising. As diabetic kidney disease progresses from micro- to macroalbuminuria, the blood pressure usually rises

Document the presence of other diabetic complications, such as retinopathy. All patients with diabetes with macroalbuminuria should undergo an eye exam to screen for retinopathy (findings include microaneurysm, flame hemorrhage, and soft/hard exudates) (see Module E, Eye Care) because >90 percent of patients with macroalbuminuria from diabetes will also have at least mild retinopathy

If the course has been atypical (i.e., rapidly progressive or no evidence of retinopathy), refer or consult with nephrology for further work-up

Consider alternative explanations for reduced kidney function including pre-renal, renal, and post-renal causes

Consider obtaining other tests and referral to specialists in nephrology or urology as indicated.

Referral to Nephrology

Nephrology consultation for help in diagnosis and treatment is indicated in:

Patients with eGFR <30 ml/min/1.73m²) to facilitate education and planning for renal replacement therapy (dialysis or kidney transplant).

Patients with kidney function that is deteriorating rapidly (e.g., eGFR decline of 50 percent eGFR from previous measure over 6 months or less).

Patients with metabolic complications of CKD (e.g., anemia, secondary hyperparathyroidism).

Patients with CKD of unclear etiology after the initial work up, or a known or suspected kidney condition requiring specialized care (e.g., a glomerulonephritis).

Treatment

Strategies to Slow the Progression of the Disease

Treatment of high blood pressure in DM-CKD should include identification of target blood pressure levels, nonpharmacologic therapy, and specific antihypertensive agents for the prevention of progression of kidney disease and development of cardiovascular disease.

Antihypertensive therapy should be adjusted to achieve blood pressure of <130/80 mm Hg. [C]

Non-Pharmacologic Interventions

All patients with CKD with hypertension should be offered life-style advice, including maintenance of normal body weight (body mass index 18.5 to 24.9 kg/m²), reduction in dietary sodium intake (<2 g/day), regular aerobic physical exercise, smoking cessation, and limitation of alcohol intake. [B]

There is insufficient evidence to recommend the routine implementation of a low protein diet (<0.6g/kg/day) to slow the loss of GFR in patients with CKD. [D]

A low protein diet may delay the onset of uremic symptoms in patients close to needing dialysis but this benefit must be weighed against the risk of protein malnutrition. [B]

Pharmacologic Interventions

ACEIs or ARBs are the preferred agent for patients with kidney disease and hypertension. ACEIs may be preferred based on cost. ARBs may be substituted for patients with an ACEI induced cough. [A]

Many patients will require two or more medications to achieve their target blood pressure control. A diuretic should be used when a second blood pressure medication is needed, or if hyperkalemia occurs. Thiazide diuretics may be used if estimated GFR >30 ml/min/1.73m², but loop diuretics are usually needed for patients with lower eGFR. Potassium-sparing diuretics should be used with caution in patients with CKD.

An increase of serum creatinine, as much as 30 percent above baseline, after ACEI or ARB initiation is common. ACEIs or ARBs should not be discontinued for this situation, since these medications are renoprotective.

Patients with refractory hypertension, defined as inability to achieve goal blood pressure despite combination therapy with three drugs from complementary classes (including a diuretic), may benefit from an evaluation by a specialist in hypertension.

Use of an ACEI OR ARB

Patients with non-DM CKD with hypertension or diabetes with macroalbuminuria should be treated with an ACEI or ARB to slow the progression of kidney disease [A] and reduce proteinuria [A].

Patients with diabetes and microalbuminuria should be treated with an ACEI or ARB to slow the progression from microalbuminuria to macroalbuminuria, considered a surrogate for progression to CKD. [A]

ACEIs and ARBs should be initiated at low doses and titrated to moderate to high doses as used in clinical trials. [A]

There is insufficient evidence to recommend combination therapy with an ACEI and ARB to slow the progression of kidney disease except in a limited population of non-DM CKD. [I]

Creatinine and potassium levels should be monitored one to two weeks after initiation or after a change in dose of ACEI or ARB therapy and periodically to maintain a normal range. [C]

Treatment with an ACEI or ARB should not be initiated in patients with hyperkalemia (>5.5). [D]

People who develop cough on an ACEI should be switched to an ARB. Some people who develop angioedema on an ACEI may be switched to an ARB but require careful monitoring since some may also develop angioedema on an ARB. [C]

In most patients, an ACEI or ARB should be continued unless:

There is an acute GFR decline of >30 percent within the first two weeks after initiation. [B]

Serum potassium is ≥6 mEq/L, despite appropriate treatment. [B]

Follow-Up Monitoring

Patients with CKD should be monitored for complications of CKD: disorders of potassium balance, calcium and phosphate metabolism, acid base abnormalities, hematologic abnormalities, volume overload, and exposure to nephrotoxic drugs.

Patients may benefit from a dietary evaluation by a medical nutrition therapist and should be advised about a healthy diet and the preferred range of sodium, phosphate, and potassium in their diet. [C]

Patients with CKD and an eGFR >30 ml/min/1.73m² with no associated co-morbidities should be followed up every 6 to 12 months.

Patients with more advanced CKD should be referred to a nephrologist for consultation and/or continued follow-up.

Module S – Screening for Diabetes

Screening for Diabetes Mellitus
Objective

Diagnose type 2 diabetes mellitus at a stage early enough that effective treatment can minimize the risk of severe microvascular and macrovascular complications.

Recommendations

Screening for pre-diabetes or diabetes should be considered for all adults age ≥45 [B]

Screening for pre-diabetes or diabetes should be considered in younger non-pregnant adults who are overweight or obese (BMI ≥25 kg/m²) or are at high risk for DM based upon established risk factors (see Table S-1 in the original guideline document) at 1 to 3 year intervals. [B]

Screening for pre-diabetes or diabetes should occur at a frequency of 1 to 3 years. More frequent screening can be performed depending upon prior HbA₁c or fasting plasma glucose (FPG) results, and patient or clinician preferences. [I]

Fasting plasma glucose is the preferred screening test for pre-diabetes and DM and is also a component of diagnostic testing.

HbA₁c can be used to screen for pre-diabetes or diabetes, when obtaining a blood sample in a fasting state is undesirable, but fasting plasma glucose test is required for the purpose of diagnosis. [B] The HbA₁c test should be performed using clinical laboratory methodology standardized to the net splanchnic glucose production (NSGP) (not a Point of Care).

A diagnosis of DM is made if any of the following: [B]

Fasting plasma glucose (FPG) is ≥126 mg/dL on at least two occasions, or

A single HbA₁c reading of ≥6.5%, confirmed with a FPG ≥126 mg/dL. These tests can be done on the same or different days; or

HbA₁c is ≥7% on two occasions using a clinical laboratory methodology standardized to the NSGP (not a Point of Care); or

Symptoms of hyperglycemia and a casual (random) glucose ≥200 mg/dL on two occasions. However, casual (random) plasma glucose is not recommended as a routine screening test.

A diagnosis of pre-diabetes is made if any of the following: [B]

Fasting plasma glucose readings with result <126 mg/dL, but ≥100mg/dL on two occasions.

HbA₁c readings with result ≥5.7%, and confirmed with a FPG ≥100 mg/dL and <126 mg/dl. The FPG can be obtained at the same time as the HbA₁c.

Although the oral glucose tolerance test can also be used for the diagnosis of diabetes, it is not recommended in the primary care setting. [C]

Random plasma glucose is not recommended as a routine screening test. [C]

Prevention of Diabetes
Objective

Prevent or delay the onset of type 2 DM in high-risk patients.

Recommendations

Patients with pre-diabetes should be counseled about the risks of progression to diabetes and the rationale for implementing preventive strategies. [A] Individuals with risk factors for diabetes who are not diagnosed with pre-diabetes should also be counseled and educated about how to reduce risks.

Lifestyle modifications to prevent diabetes, including regular aerobic exercise and a calorie-restricted diet to promote and maintain weight loss, should be instituted in patients with pre-diabetes. [A]

An individualized goal to achieve and sustain weight loss of ≥5 percent of body weight should be set for patients with risk factor for diabetes and a BMI ≥25. [A]

When lifestyle modifications have been ineffective at preventing a sustained rise in glucose, the patient may be offered pharmacologic therapy with a metformin or an alpha-glucosidase inhibitor (e.g., acarbose) to delay progression from pre-diabetes to a diagnosis of diabetes. [A]

Module G - Glycemic Control

Patient with Diabetes Mellitus
Every patient with DM, regardless of its duration, needs to negotiate an appropriate goal for glycemic control target with his or her provider, and plan a treatment strategy to achieve this goal.

Glycemic control should be reevaluated at every regular interim visit or in the context of visits that relate to other concurrent problems that could affect glycemic control.

Assess Glycemic Control
Objective

Determine the patient's level of glycemic control.

Recommendations

HbA₁c should be measured in patients with diabetes at least annually, and more frequently (up to 4 times per year) if clinically indicated, to assess glycemic control over time.

Self-monitoring of blood glucose (SMBG) may be used to monitor glycemic control and adjust treatment [B]

Patients for whom SMBG is appropriate should receive instruction on the proper procedure, the importance of documenting results, and basic interpretation and application of results to maximize glycemic control.

SMBG results should be discussed with the patient to promote understanding, adjust treatment regimens, and facilitate treatment adherence. [B]

Remote electronic transmission of SMBG data should be considered as a tool to assess glycemic patterns. [C]

The frequency of SMBG in patients using insulin should be individualized based on the frequency of insulin injections, hypoglycemic reactions, level of glycemic control, and patient/provider use of the data to adjust therapy. [C]

A combination of pre-and postprandial tests may be performed, up to 4 times per day. [C]

The schedule of SMBG in patients on oral agents (not taking insulin) should be individualized, and continuation justified based upon individual clinical outcomes. Consider more frequent SMBG for the following indications:

Initiation of therapy and/or active adjustment of oral agents

Acute or ongoing illness

Detection and prevention of hypoglycemia when symptoms are suggestive of such, or if there is documented hypoglycemia unawareness

Detection of hyperglycemia when fasting and/or post-prandial blood glucose (PPG) levels are not consistent with HbA₁c.

Determine Recommended Glycemic Control Target Using Risk Stratification Criteria
Objective

Determine an appropriate target for HbA₁c based upon the patient's risk for developing microvascular complications of diabetes mellitus (retinopathy, nephropathy, and neuropathy) in the context of his or her co-morbidities, life expectancy, risk of causing hypoglycemia, presence or absence of pre-existing microvascular complications, and the patient's preferences.

Recommendations

Treat diabetes more aggressively early in its course. [B]

The target range for glycemic control should be individualized, based on the provider's appraisal of the risk-benefit ratio and discussion of the target with the individual patient. [C]

Providers should recognize the limitations of the HbA₁c measurement methodology reconciling the differences between HbA₁c readings and self-monitoring results on a case-by-case basis.

Setting the initial target range should consider the following: (see Table below)

The patient with either none or very mild microvascular complications of diabetes, who is free of major concurrent illnesses, and who has a life expectancy of at least 10 to 15 years, should have an HbA₁c target of <7 percent, if it can be achieved without risk. [A]

Any patient with diabetes should have a HbA₁c target of <9 percent to reduce symptoms of hyperglycemia. [C]

The patient with longer duration diabetes (more than 10 years) or with comorbid conditions, and who require combination medication regimen including insulin, should have an HbA₁c target of <8 percent. [A]

The patient with advanced microvascular complications and/or major comorbid illness, and/or a life expectancy of less than 5 years is unlikely to benefit from aggressive glucose lowering management and should have a HbA₁c target of 8 to 9 percent. [A]

Risk of hypoglycemia should be considered in recommending a target goal. [B]

Table. Determination of Target HbA₁c Level ^1,2

Major Comorbidity ^(d)
or
Physiologic Age Microvascular Complications

Absent or Mild^(a) Moderate ^(b) Advanced^(c)

Absent

(>10 years of life expectancy) <7% <8% 8-9%*

Present ^(e)

5 to 10 years of life expectancy <8% <8% 8-9%*

Marked ^(f)

<5 years of life expectancy 8-9%* 8-9%* 8-9%*

Based upon the DCCT referent standard. Clinicians need to evaluate the methodology used at their site.

Reflects a "goal" over time. Intensification of therapy should be undertaken based upon individual clinical circumstances and treatment option.

Mild microvascular disease is defined by early background retinopathy, and/or microalbuminuria, and/or mild neuropathy.

Moderate microvascular disease is defined by preproliferative (without severe hemorrhage, intraretinal microvascular anomalies [IRMA], or venous bleeding) retinopathy or persistent, fixed proteinuria (macroalbuminuria) and/or demonstrable peripheral neuropathy (sensory loss).

Advanced microvascular disease is defined by severe nonproliferative (with severe hemorrhage, IRMA, or venous bleeding) or proliferative retinopathy and/or renal insufficiency (serum creatinine level >2.0 mg/dl) and/or insensate extremities or autonomic neuropathy (e.g., gastroparesis, impaired sweating, orthostatic hypotension).

Major comorbidity includes, but is not limited to, any or several of the following active conditions: significant cardiovascular disease, severe chronic kidney disease, severe chronic obstructive pulmonary disease, severe chronic liver disease, recent stroke, and life-threatening malignancy.

Major co-morbidity is present, but is not end-stage and management achievable.

Major co-morbidity is present and is either end-stage or management is significantly challenging.

*Further reductions may be appropriate, balancing safety and tolerability of therapy.

Adjust the Glycemic Target According to Patient Factors
Objective

Determine a target range for HbA₁c that can be safely achieved taking into consideration individual risk, benefit, and patient's preference.

Recommendations

Risks of a proposed therapy should be balanced against the potential benefits, based upon the patient's medical, social, and psychological status.

Set a Glycemic Target Range after Discussion with the Patient
Objective

Establish the patient's readiness and willingness to achieve the target.

Recommendations

The patient and provider should agree on a specific target range of glycemic control after discussing the risks and benefits of therapy.

The patient should be assessed for knowledge, performance skills, and barriers (e.g., psychosocial, personal, or financial), and if necessary referred to a primary care case manager or endocrine/diabetes clinic to address barriers for achieving treatment goals.

Is Patient High Risk?
Objective

Identify the patient for whom consultation with, or referral to a subspecialty multi-disciplinary team would be appropriate to assist in the development of a treatment plan and/or to supervise ongoing care.

Recommendations

The indications to consider a consultation or referral to specialty include patients who:

Have type 1 DM (especially patients with history of hospitalizations for metabolic complications and/or patients who are receiving intensive insulin therapy)

Have new-onset insulin-requiring DM

Have marked insulin resistance

Have contraindications or intolerances to medications typically used in managing diabetes

Have recurrent episodes of incapacitating hypo- and/or hyperglycemia

Have poor recognition of hypoglycemia and who have history of severe hypoglycemic reactions (including coma, seizures, or frequent need for emergency resuscitation)

Have visual and/or renal impairment

Have psychosocial problems (including alcohol or substance abuse) that complicate management

Have HbA₁c >9.0 percent and are considered for aggressive management on an expedited basis

Are not achieving glycemic control despite comprehensive treatment with complex regimen of combination pharmacotherapy including insulin

Require evaluation or management beyond the level of expertise and resource level of the primary team.

Does Patient Require Insulin?
Objective

Identify the patient for whom insulin treatment is necessary.

Recommendations

The patient with type 1 DM must receive insulin replacement therapy.

Patients with type 2 diabetes or diabetes of undetermined cause who exhibit significant or rapid weight loss and/or persistent nonfasting ketonuria, have at least severe relative insulin deficiency and will require insulin therapy on an indefinite basis.

Institute/Adjust Insulin, Consider Referral
Objective

Achieve glycemic control using insulin.

Recommendations

All patients with type 1 DM should be managed by a provider experienced in managing type 1 DM in a multidisciplinary approach or by a clinic team with multidisciplinary resources (e.g., diabetologist, diabetes nurse, educator/manager, and registered dietitian) for institution and adjustment of insulin therapy.

When expeditious referral is not possible, the primary care provider should institute "survival" insulin therapy comprised of total daily insulin (TDI) 0.5 units/kg/day; half as basal insulin and half as meal time insulin.

See Annotation J-3: Insulin Therapy in the original guideline document.

Assure Appropriate Intervention to Address Patient Adherence
Objective

Assure proper patient monitoring and contact with the healthcare team.

Recommendations

Patients with diabetes should be regularly assessed for knowledge, performance skills, and barriers to self-management.

Patients with recurrent or severe hypoglycemia should be evaluated for precipitating factors that may be easily corrected (e.g., missed meals, incorrect administration of insulin [dosage or timing], and exercise).

If psychosocial, personal, or financial barriers are identified, additional resources should be consulted, as applicable (e.g., mental health, medical social work, or financial counselors).

Initiate/Adjust Therapy
Objective

Achieve glycemic target goals by the most cost-effective and least invasive means.

Recommendations

Individual treatment goals must be established with the patient based on the extent of the disease, comorbid conditions, and patient preferences.

Institution of dietary modifications and exercise alone is usually the appropriate initial management in patients with new onset type 2 diabetes, depending upon severity of symptoms, psychosocial evaluation, and overall health status. Encourage diet and exercise and lifestyle modification.

Use various approaches (e.g., individual or group, counseling, coaching, motivational interviewing) to promote healthful behaviors, such as healthful diet, adequate physical activity, and smoking cessation.

If treatment goals are not achieved with diet and exercise alone, drug therapy should be initiated while encouraging lifestyle modifications.

The concept of sequential treatment is commonly employed in clinical management of chronic diseases. The sequential steps for glycemic control therapy are summarized in Diagram G1 in the original guideline document.

J.1 Monotherapy (initial therapy)

Recommendations

When selecting an agent, consideration must be given to efficacy, contraindications, drug interactions, and side effects. Educate patient about treatment options and arrive at a shared treatment plan with consideration for patient preferences. [I]

Insulin should be considered in any patient with extreme hyperglycemia or significant symptoms; even if transition to therapy with oral agents is intended as hyperglycemia improves. (See section on insulin for further details.) [B]

Metformin (preferred) or sulfonylureas (SU) should be given as first line agents unless there are contraindications. [A]

Alternative monotherapy agents such as thiazolidinediones (TZDs), alpha-glucosidase inhibitors (AGIs), meglitinides, dipeptidyl peptidase-4 (DPP-4) inhibitors, and glucagon-like peptide-1 (GLP-1) agonists should be reserved for patients who have contraindications to or are unable to tolerate metformin or SU. [B]

Patients and their families should be instructed to recognize signs and symptoms of hypoglycemia and its management. [I]

J.2 Combination Therapy (add-on)

Recommendations

Metformin plus sulfonylurea is the preferred oral combination for patients who no longer have adequate glycemic control on monotherapy with either drug. [A]

Other combinations (TZDs, AGIs, meglitinides, DPP-4 inhibitors, and GLP-1 agonists) can be considered for patients unable to use metformin or a sulfonylurea due to contraindications, adverse events, or risk for adverse events (see Appendices G-2 and G-3 in the original guideline document). [B]

Addition of bedtime neutral protamine Hagedorn insulin (NPH) or daily long-acting insulin analog to metformin or sulfonylurea should be considered, particularly if the desired decrease in HbA₁c is not likely to be achieved by use of combination oral therapy. [A]

Patients and their families should be instructed to recognize signs and symptoms of hypoglycemia and its management. [I]

J.3 Insulin Therapy

Recommendations

Use of insulin therapy should be individualized, and managed by a healthcare team experienced in managing complex insulin therapy for patients with type 1 DM. [I]

Use intermediate- or long-acting insulin to provide basal insulin coverage. [B]

Insulin glargine or detemir may be considered in the NPH insulin-treated patient with frequent or severe nocturnal hypoglycemia. [B]

Use regular insulin or short-acting insulin analogues for patients who require mealtime coverage.

Alternatives to regular insulin (aspart, lispro, or glulisine) should be considered in the following settings: [B]

Demonstrated requirement for pre-meal insulin coverage due to postprandial hyperglycemia AND concurrent frequent hypoglycemia

Patients using insulin pump.

J.4 Continuous Subcutaneous Insulin Infusion (CSII)

Recommendations

CSII therapy should only be initiated and managed by an endocrinologist/diabetes team with expertise in insulin pump therapy.

CSII therapy should only be considered in patients who have either documented type 1 diabetes (history of DKA, low c-peptide or evidence of pancreatic autoimmunity) or be insulin deficient with a need for intensive insulin therapy to maintain glycemic control and are not able to maintain it using multiple daily injections (MDI) therapy. This may include patients with:

Poor glycemic control (including wide glucose excursions with hyperglycemia and serious hypoglycemia and those not meeting HbA₁c goal) despite an optimized regimen using MDI in conjunction with lifestyle modification. [A]

Marked dawn phenomenon (fasting AM hyperglycemia) not controlled using NPH at bedtime, glargine or detemir. [B]

Recurrent nocturnal hypoglycemia despite optimized regimen using glargine or detemir. [B]

Circumstances of employment or physical activity, for example shift work, in which MDI regimens have been unable to maintain glycemic control. [I]

Patients using CSII should have:

Demonstrated willingness and ability to play an active role in diabetes self-management to include frequent self-monitoring of blood glucose (SMBG), and to have frequent contact with their healthcare team.

Completed a comprehensive diabetes education program.

The use of CSII over MDI regimens is not recommended in most patients with type 2 diabetes. [D]

J.5 Glycemic Control for Hospitalized Patients

Recommendations

In patients with known DM, it is reasonable to document the DM diagnosis in the medical record. Because of the potential harm from omission of insulin in patients with type 1 DM, it is suggested that the type of DM also be documented. [I]

In order to identify potentially harmful hyperglycemia and hypoglycemia, blood glucose monitoring may be ordered in hospitalized patients with diagnosed DM and/or hyperglycemia (blood glucose [BG] >180 mg/dl) on admission. There is no evidence to support a given frequency of monitoring. Therefore, the frequency of monitoring should be based upon clinical judgment taking into account the management of diabetes, the reason for admission, and the stability of the patient. [I]

Due to safety concerns related to potential adverse events with oral anti-hyperglycemic medications, it is prudent to thoughtfully review these agents in the majority of hospitalized patients. It may be reasonable to continue oral agents in patients who are medically stable and have good glycemic control on oral agents at home. [I]

For patients with DM and/or hyperglycemia who are not medically stable or who are poorly controlled with oral anti-hyperglycemic medications at home, initiating insulin therapy should be considered. It is appropriate to continue pre-hospitalization insulin regimens, but reasonable to reduce the dose in order to minimize the risk of hypoglycemia. In the intensive care unit (ICU), continuous intravenous insulin infusion is recommended. Scheduled subcutaneous insulin is appropriate in the non-ICU setting and may include a long-acting basal insulin as well as a nutritional insulin for those eating discrete meals or receiving enteral nutrition. A supplementary correction (sliding) scale is also recommended but correction scale insulin regimens as sole therapy are discouraged. [B]

Insulin should be adjusted to maintain a BG <180 mg/dl with the goal of achieving a mean glucose around 140 mg/dl. Evidence is lacking to support a lower limit of target blood glucose but based on a recent trial suggesting that blood glucose <110 mg/dl may be harmful, the guideline developers do not recommend blood glucose levels <110 mg/dl. [A]

Insulin therapy should be guided by local protocols and preferably "dynamic" protocols that account for varied and changing insulin requirements. A nurse-driven protocol for the treatment of hypoglycemia is highly recommended to ensure prompt and effective correction of hypoglycemia. [I]

To minimize the risk of hypoglycemia and severe hyperglycemia after discharge it is reasonable to provide hospitalized patients who have DM and knowledge deficits, or patients with newly discovered hyperglycemia, basic education in "survival skills". [I]

Patients who experienced hyperglycemia during hospitalization but who are not known to have DM should be re-evaluated for DM after recovery and discharge. [B]

Determine If There Are Side Effects or Contraindications to Current Treatment
Objective

Modify therapy due to side effects of drug therapy.

Recommendations

The patient with recurrent or severe hypoglycemia should be evaluated for precipitating factors that may be easily correctable (e.g., missed meals, exercise, incorrect administration of insulin—dosage or timing).

See Appendix G3: Pharmacological Therapy, in the original guideline document.

Are There Problems with Patient Adherence?
Objective

Identify barriers to full adherence to the prescribed treatment regimen.

Recommendations

If the patient does not achieve his/her target range, the provider should identify barriers to patient adherence to the treatment regimen (e.g., miscommunication, lack of education or understanding, financial/social/psychological barriers, and cultural beliefs).

If barriers are identified, referral to a case manager or behavioral/financial counselor may be considered as appropriate.

Should Glycemic Control Target Be Adjusted?
Objective

Determine whether the recommended glycemic control goal remains appropriate for the patient.

Recommendation

Treatment goals should be periodically reassessed based upon patient specific factors, including changes in the patient's health status, adverse drug reactions, adherence to therapy, and preferences.

Follow-Up
Objective

Maintain glycemic control and ensure proper patient monitoring by the healthcare team.

Recommendations

Patient should be scheduled for appropriate follow-up to evaluate response, tolerability to therapy, goal reassessment, and management of acute and chronic problems:

The frequency of follow-up visits for the patient with diabetes who is meeting treatment goals and who has no unstable chronic complications should be individualized.

When there is a sudden change in health status or when changes are made to the treatment regimen, follow-up within one month or sooner may be appropriate.

Treatment goals should be periodically reassessed based upon patient-specific factors, including changes in the patient's health status, adverse drug reactions, adherence to therapy, and preferences.

Module E - Eye Care

Has Patient's Vision Changed Recently?
Objective

Identify patients with diabetes mellitus (DM) in need of urgent referral to an eye care provider.

Recommendation

Patients with an acute change in vision or change in ocular function should be urgently referred to an eye care provider.

Refer Patients with Type 1 DM for Initial Eye Retinal Examination
Objective

Establish the timing of the initial ocular evaluation for patients with early-onset DM or type 1 DM at a later age.

Recommendation

Patients with early diabetes onset (age <30 years) or type 1 diabetes at a later age should have an initial examination when the time from diabetes diagnosis is >3 years. [B]

Refer Patient with Type 2 DM for Initial Eye Retinal Examination
Objective

Establish the timing of the initial ocular evaluation for patients with type 2 DM.

Recommendations

Patients who are newly diagnosed with type 2 DM and have not had an eye exam within the past 12 months should have a retinal examination performed within 6 months. [B]

A retinal examination (e.g., dilated fundus examination by an eye care professional or retinal imaging with interpretation by a qualified, experienced reader) should be used to detect retinopathy. [A]

Follow-Up Examination Yearly or According to Eye Care Provider-Recommended Schedule
Objective

Establish a follow-up interval for patients based on the risk for retinopathy development or progression.

Recommendations

Patients who have had no retinopathy on all previous examinations should be screened for retinopathy at least every other year (biennial screening). More frequent retinal examinations in such patients should be considered when risk factors associated with an increased rate of progression of retinopathy are present. [B]

Patients with existing retinopathy should be managed in conjunction with an eye care professional and examined at intervals deemed appropriate for the level of retinopathy. [I]

Module F - Foot Care

Perform and Document Visual Inspection of Feet
Objective

Examine the patient's feet for any abnormal findings.

Recommendation

The patient's feet should be visually inspected for: [I]

Breaks in the skin

Erythema

Trauma

Pallor on elevation

Dependent rubor

Changes in the size or shape of the foot

Nail deformities

Extensive callous

Tinea pedis

Pitting edema

Perform Foot Risk Assessment
Objective

Identify the patient at risk for lower extremity (LE) ulcers and amputations.

Recommendation

A foot risk assessment must be performed and documented at least once a year. A complete foot risk assessment includes:

Evaluation of the skin for breakdown

Assessment of protective sensation using the Semmes-Weinstein 5.07 monofilament

Evaluation for LE arterial disease

Evaluation for foot deformity

Prior history of ulcers or amputations

In addition, the patient's footwear should be evaluated.

Are Any Limb-Threatening Conditions Present?
Objective

Identify a limb-threatening condition that may require immediate attention, referral, or hospitalization.

Recommendation

Evaluation should be performed for limb-threatening conditions, such as systemic infection, acute ischemia/rest pain, foot ulceration, puncture wound, ingrown toenail, and hemorrhagic callous with or without cellulitis.

Refer to Appropriate Level of Care for Evaluation and Treatment
Objective

Determine the appropriate intervention.

Recommendations

Patients with limb-threatening conditions should be referred to the appropriate level of care for evaluation and treatment.

If the patient's symptoms limit his/her lifestyle, a vascular specialist should determine the appropriateness of surgical intervention on a patient-specific basis. Justification of vascular procedures should be based on the outcomes of the vascular interventions.

Is Patient at High Risk for Foot Problem?
Objective

Identify the patient at high risk for LE foot ulcers and amputations.

Recommendations

Patients without limb-threatening conditions should be evaluated for their level of risk for LE foot ulcers and amputations.

The existence of one of the following characteristics is sufficient to define the patient as high risk for foot problem:

Lack of sensation to Semmes-Weinstein 5.07 monofilament at one or more noncalloused plantar sites

Evidence of LE arterial disease (absence of both dorsalis pedis and tibialis posterior pulses, dependent rubor with pallor on elevation, history of rest pain or claudication, and prior history of LE bypass surgery)

Foot deformities (specifically hammer toes, claw toe, Charcot's arthropathy, bunions, and metatarsal head deformities)

History of foot ulcer or non-traumatic lower-extremity amputation (LEA) at any level.

The patient at high risk should be referred to a foot care specialist for a more comprehensive evaluation and intensive treatment plan including patient education concerning foot care practices, hygiene, and footwear.

A foot care specialist is defined as a podiatrist, vascular surgeon, orthopedic surgeon, or other healthcare provider with demonstrated training, competence, and licensure in foot care.

Is There a Minor Wound or Lesion?
Objective

Determine the extent of the injury.

Recommendations

Minor lesions or wounds that could possibly be treated by the primary care provider are blisters, erosions, and/or minor cuts that do not extend beyond subcutaneous tissue. Pulses are present, there are no signs of acute infection, and there is no severe lower limb pain and no sign of a worsening lesion.

Patients with an ingrown toenail should be referred to a foot specialist for evaluation and treatment (see Annotation C: Ingrown Toenail).

Refer to Foot Care Specialist for Complete Evaluation and Treatment
Objective

Ensure a more intensive follow-up treatment plan.

Recommendations

High risk patients with a minor foot wound or lesion should be promptly referred to a foot care specialist (i.e., podiatrist, vascular surgeon, orthopedic surgeon, and other health care providers with demonstrated training, competence, and licensure in foot care) for evaluation and treatment.

Footwear prescriptions should be based upon individual characteristics of foot structure and function.

Perform and Document Patient Education for Preventive Foot Care and Footwear
Objective

Empower the patient to perform proper foot care practices.

Recommendation

All patients and their families should receive self-management education for preventive foot care and selection of footwear. Instruction should include recommendations for daily foot inspection and preventive foot care, skin care, and use of emollients, nail care, and treatment for callus.

Perform Visual Inspection and Peripheral Sensation Evaluation at Each Routine Primary Care Visit
Objective

Ensure ongoing screening to identify patients at risk for LE ulcers and amputation.

Recommendation

Visual inspection and peripheral sensation testing in high-risk patient should be performed at each routine primary care visit for all patients (see Annotation A).

Perform Wound Assessment
Objective

Determine the character and nature of the wound.

Recommendations

Patients with diabetes with minor wounds or foot lesions should have a wound assessment.

The wound assessment includes:

A review of anatomic, physical, and lesion characteristics including determination of circumference, depth, and involvement of deep structures.

Assessment for signs of infection including necrosis, sinus tracts, exudate, odor, presence of fibrin, and healthy granulation tissue.

Assessment of surrounding areas for signs of edema, cellulitis, or abscess.

Provide Local Wound Care; Offload Pressure and Weight, as Indicated
Objective

Provide care of an uncomplicated minor lesion.

Recommendations

Patients with diabetes with uncomplicated minor lesions should receive local wound care. Primary care providers should attempt to offload weight-bearing on the affected extremity.

Patients with diabetes with uncomplicated minor lesions must be followed at least monthly.

Has Wound Healed within 4 Weeks?
Objective

Determine appropriateness of the treatment outcome.

Recommendation

Patients with diabetes treated for an uncomplicated wound should be assessed within four weeks from the initial wound assessment for appropriate reduction in lesion size and depth and appearance of healthy granulating tissue with no evidence of infection.

Is There a Minor Foot Problem?
Objective

Identify minor conditions that could be attended to by the patient and/or family member.

Recommendation

Minor foot problems (e.g., onychomycosis, painful corn, dry skin, athlete's foot, minor calluses, uncomplicated nail trimming, and improper foot hygiene) may be treated by a primary care provider in the office or by the patient or family members at home (see Annotation F).

Treat as Appropriate
Objective

Determine the feasibility of treating the patient at home or in the office of the primary care provider.

Recommendation

Assure that patient and family members have received appropriate education regarding preventive foot care.

Treat minor foot problems, as appropriate.

Module M - Self-Management and Education

Is This a Patient with Newly Diagnosed Diabetes Mellitus?
Module M applies to patients who have been diagnosed with DM and require diabetes self-management education (DSME) as well as knowledge and skills to facilitate implementation of their treatment plan.

Provide Information and Education on Basic Concepts, Core Competencies, Document Findings
Objective

Ensure that patients with diabetes understand the core competencies (survival skills) and other basic information so that they may safely self-manage their diabetes.

Recommendation

Ensure that patients newly diagnosed with DM are provided with core competency education. The core competencies include:

Acute complications (hyperglycemia and hypoglycemia)

Medication education

Self-monitoring of blood glucose and how to use the results

Basic diet principles

Sick day management

When to seek further assistance

(See Appendix M-1: Core Competencies [Survival Skills] for Patients with Diabetes in the original guideline document).

Refer for Comprehensive Diabetes Self-management and Diet Education
Objective

Provide or refer for comprehensive DSME and Medical Nutrition Therapy (MNT) education.

Recommendations

Patients newly diagnosed with diabetes should receive comprehensive DSME and education for MNT.

DSME, including MNT education, should be an interactive, collaborative, ongoing process involving patients with diabetes and educators and include the following four-step process:

Assessment of the patient's educational needs

Identification of the patient's specific self-management goals

Education and behavioral interventions aimed at meeting the patient's goals

Evaluation of the patient's progress towards the goals

The education component should be tailored to the patient's needs and provided by healthcare professionals who are most knowledgeable in the topic. Regardless of setting, availability of a multidisciplinary team approach is highly desirable and could include, but is not limited to, a dietitian, certified diabetes educator, registered nurse, pharmacist, psychologist, exercise physiologist, physical therapist, social worker, endocrinologist, behaviorist, ophthalmologist, optometrist, physician, podiatrist, other healthcare professionals and paraprofessionals, or other specialized physicians based on the individual patient's needs.

The use of approaches such as group visits and telehealth should be considered in providing education.

Determine Patient's Extent of Knowledge and Self-Management Skill Deficit Based on Treatment Goals
Objective

Determine the education and skills enhancement needed to enable the patient to self-manage.

Recommendations

Assessment of the following factors should be completed to determine the extent of the patient's educational and skills deficit and his/her ability for self-management: knowledge of the diabetes disease process, treatment goals, management skills, cultural influences, health beliefs/behavior, attitudes, socioeconomic factors and barriers.

Documentation of the patient's learning needs, abilities including physical and cognitive limitations, or language barriers, preferences, cultural and religious practices, emotional barriers, health literacy and numeracy, desire and motivation to learn and/or change, and the financial implications of care choices.

Assessment and documentation of the patient's understanding of education.

Does the Patient Need Referral for Further Education or Intervention?
Objective

Identify patients who are at high risk for diabetes complications or in need of further educational intervention.

Recommendations

Conditions that may warrant risk-focused intervention include:

Markedly or persistently elevated HbA₁c (For appropriate HbA₁c target based on risk stratification, see Module G: Table "Determination of Target HbA₁c Level," above)

Progression to end stage renal disease (ESRD) (e.g., stage 3-5 CKD)

Lower extremity complications

Pregnancy, or planned pregnancy, or woman of child bearing age

Impaired vision

Severe psychosocial or economic barriers

Cognitive impairment or frailty

Intensive insulin therapy

Recurrent hypoglycemia or hypoglycemia unawareness

Recent hospitalization for diabetic ketoacidosis (DKA), hyperosmolar hyperglycemic state disease complexity

The need for risk-focused education interventions may also have been identified through other modules of this guideline.

Any deficiencies in the critical areas reviewed in the medical history (see Module D) may indicate patient knowledge needs in multiple areas and should trigger a referral for comprehensive DSME.

Refer as Appropriate for Comprehensive Self-Management and Diet Education or Risk-Focused Intervention or to a Case Manager or Appropriate Specialist
Objective

Determine which referrals are appropriate based on the patient's needs and availability of providers, programs, and benefit coverage.

Recommendations

Patients at high risk may have needs beyond educational deficits and should be referred for focused attention by other services. Possible referrals could include, but are not limited to: case manager, registered nurse, registered dietitian, pharmacist, psychologist, exercise physiologist, physical therapist, social worker, endocrinologist, ophthalmologist, optometrist, physician, podiatrist, behaviorist, other healthcare professionals, or paraprofessionals.

Refer to case manager for providing ongoing, detailed coordination of care for high risk patients.

Reassess and Follow-Up as Indicated
Objective

Identify the frequency of patient appointments needed to evaluate educational effectiveness or reinforce education/self-management skills.

Recommendations

When knowledge deficits continue to exist or a large number of lifestyle changes are necessary, frequent follow-up may be indicated.

Recently learned diabetes skills or information should be reevaluated no longer than 3 months after initial instruction. One possible method involves follow-up at earlier time points (e.g., 1 month).

When appropriate, single behavioral goals should be identified and prioritized to increase the likelihood of the patient adopting lifestyle changes necessary to achieve treatment goals.

Does the Patient Want More Information?
Objective

Address patient's desire (motivation) for additional information.

Annotation

Patients often hear of developments in diabetes or have specific questions regarding newer treatment modalities. They may also decide they want to improve their glycemic control or their life style.

Provide Materials or Patient Reference List or Refer as Needed
Objective

Provide additional information in response to patients' questions about new treatments or advanced self-management skills that have been communicated from other persons with diabetes or the media.

Annotation

If the patient requests additional information it may not be essential for the caregiver to intervene professionally or refer to a specialist.

Methods for Providing DSME
Recommendations

The following overriding principles were based on existing evidence used to guide the review and revision of the DSME Standards:

Diabetes education is effective for improving clinical outcomes and quality of life, at least in the short-term.

DSME has evolved from primarily didactic presentations to more theoretically based empowerment models.

There is no one "best" education program or approach; however, programs incorporating behavioral and psychosocial strategies demonstrate improved outcomes. Additional studies show that culturally and age appropriate programs improve outcomes and that group education is effective.

Ongoing support is critical to sustain progress made by participants during the DSME program.

Behavioral goal-setting is an effective strategy to support self-management behaviors.

Clinical Algorithm(s)
Algorithms are provided in the original guideline document for:

Management of Diabetes Mellitus, Core Algorithm

Screening for DM

Glycemic Control

Screening for Retinopathy

Foot Care

Self-management and Education