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Guideline Summary
Guideline Title
VA/DoD clinical practice guideline for the management of diabetes mellitus.
Bibliographic Source(s)
Department of Veteran Affairs, Department of Defense. VA/DoD clinical practice guideline for the management of diabetes mellitus. Washington (DC): Department of Veteran Affairs, Department of Defense; 2010 Aug. 146 p.
Guideline Status

This is the current release of the guideline.

This guideline updates a previous version: Veterans Health Administration, Department of Defense. VA/DoD clinical practice guideline for the management of diabetes mellitus. Washington (DC): Veterans Health Administration, Department of Defense; 2003 Sep. Various p.

FDA Warning/Regulatory Alert

Note from the National Guideline Clearinghouse: This guideline references a drug(s) for which important revised regulatory and/or warning information has been released.

  • November 25, 2013 – Rosiglitazone-containing Diabetes Medicines External Web Site Policy: The U.S. Food and Drug Administration (FDA) has determined that recent data for rosiglitazone-containing drugs, such as Avandia, Avandamet, Avandaryl, and generics, do not show an increased risk of heart attack compared to the standard type 2 diabetes medicines metformin and sulfonylurea. As a result, FDA is requiring removal of the prescribing and dispensing restrictions for rosiglitazone medicines that were put in place in 2010. This decision is based on FDA review of data from a large, long-term clinical trial and is supported by a comprehensive, outside, expert re-evaluation of the data conducted by the Duke Clinical Research Institute (DCRI).

Scope

Disease/Condition(s)
  • Diabetes mellitus (type 1 and type 2)
  • Pre-diabetes
  • Complications of diabetes mellitus, including hypertension, dyslipidemia, kidney disease, retinopathy, and foot problems
Guideline Category
Counseling
Diagnosis
Evaluation
Management
Prevention
Risk Assessment
Screening
Treatment
Clinical Specialty
Cardiology
Endocrinology
Family Practice
Internal Medicine
Nephrology
Nutrition
Ophthalmology
Optometry
Podiatry
Preventive Medicine
Intended Users
Advanced Practice Nurses
Dietitians
Health Care Providers
Nurses
Optometrists
Pharmacists
Physician Assistants
Physicians
Podiatrists
Social Workers
Students
Guideline Objective(s)
  • To provide recommendations for the management of diabetes mellitus
  • To provide education and guidance to primary care clinicians and coordinate and standardize care within subspecialty teams and to serve as a teaching tool for students and house staff
Target Population

Adult patients (18 years or older) with diabetes mellitus receiving treatment in the Department of Veterans Affairs (VA) or Department of Defense (DoD) healthcare system

Interventions and Practices Considered

Core Assessment

  1. Biochemical tests for diagnosis, including fasting blood glucose (FBG) and hemoglobin marker (HbA1c)
  2. Evaluation of symptoms and risk factors
  3. Assessment of the risk of maternal fetal complications and screening of pregnant women for autoimmune thyroid disease, hypertension, and renal disease
  4. Identification of comorbid conditions and/or complications requiring special attention
  5. Referral of pediatric patients
  6. Patient stabilization (medically, psychologically, and socially)
  7. Annual medical evaluation (including patient/family history, physical examination, laboratory tests, nutritional assessment, educational assessment)
  8. Determination of diabetes type (Type 1 or 2, age, body mass index [BMI], urinary ketones)
  9. Consideration of aspirin therapy to prevent cardiovascular disease
  10. Management of hypertension*
    • Angiotensin-converting enzyme inhibitor (ACEI)
    • Angiotensin receptor blockers (ARBs)
    • Calcium channel blockers
    • Beta-blockers
    • Diuretics
  11. Evaluation and management of lipids
    • Screening for lipid abnormalities (fasting lipid profile)
    • Lifestyle counseling
    • Drug therapy when indicted (statins, niacin, bile acid resin, fibrates, ezetimibe)
  12. Management of kidney disease
    • Screening for chronic kidney disease (CKD)
    • Screening for proteinuria
    • Assessment of urine albumin/creatinine levels and estimated glomerular filtration rate (eGFR)
    • Lifestyle modifications
    • Pharmacologic interventions (ACEIs, ARBs)

*For complete management, see VA/DoD guideline at www.oqp.med.va.gov/cpg/cpg.htm External Web Site Policy.

Screening for Diabetes

  1. Recognizing risk factors for developing diabetes mellitus
  2. Obtaining fasting plasma glucose in patients with risk factors
  3. Counseling for interventions to prevent diabetes mellitus (e.g., lifestyle modifications, weight loss)
  4. Repeated screening at regular intervals

Glycemic Control

  1. Assessment of glycemic control (HbA1c), and the determination of optimal target HbA1c using risk stratification criteria
  2. Adjustment of HbA1c target and target range according to individual risk, benefit, and preference
  3. Identification of high risk patients and patients requiring insulin therapy
  4. Insulin replacement therapy (Type 1)
  5. Pharmacological therapy (Type 2)
    • Sulfonylureas
    • Biguanides (metformin)
    • Insulin, including continuous subcutaneous insulin infusion (CSII)
    • Alpha-glucosidase inhibitor (miglitol, acarbose)
    • Meglitinides
    • Thiazolidinediones (rosiglitazone, pioglitazone)
    • GLP-1 agonists
    • Amylin analogs
    • Dipeptidyl peptidase-4 (DPP-4) inhibitors
  6. Follow-up and patient monitoring
  7. Patient education and practices to improve patient adherence
  8. Referral to specialist, if necessary
  9. Glycemic control for hospitalized patients

Eye Care

  1. Assessment of ocular risk factors and referral of high risk patients expediently for a dilated eye examination
  2. Follow-up eye examination intervals
  3. Patient education, including the need for periodic eye examination, compliance, and the significance of new visual symptoms

Foot Care

  1. Visual inspection and peripheral sensation testing at routine primary care visits, and annual foot risk assessment to identify patients at high risk for the development of foot ulcers and lower extremity amputations
  2. Assessment of limb threatening conditions (e.g., systematic infection, acute ischemia or rest pain, foot ulceration, puncture wound, ingrown toenail, hemorrhagic callus with or without cellulitis)
  3. Wound assessment and the identification of any minor wound or lesion that can be treated by primary care physician
  4. Referral to foot care specialist, when necessary
  5. Patient and family education for foot care

Self-Management and Education

  1. Education on basic concepts, core competency (survival skills), self-management, nutrition, and/or other patient needs
  2. Referral for comprehensive diet consultation, risk-focused intervention, or to appropriate specialist
  3. Assessment of patient's knowledge and self-management skills
Major Outcomes Considered
  • Blood glucose level
  • Blood pressure
  • Vision change
  • Rates of foot wounds
  • Lipid levels
  • Identification of renal disease
  • Level of patient knowledge of disease

Methodology

Methods Used to Collect/Select the Evidence
Hand-searches of Published Literature (Primary Sources)
Hand-searches of Published Literature (Secondary Sources)
Searches of Electronic Databases
Description of Methods Used to Collect/Select the Evidence

Formulation of Questions

The Working Group developed ten researchable questions and associated key terms after orientation to the seed guidelines and to goals that had been identified by the Working Group. Following the template suggested by the Evidence-Based Medicine toolbox, Centre for Evidence-Based Medicine, the questions specified:

  • Population - characteristics of the target patient population
  • Intervention - exposure, diagnostic, or prognosis
  • Comparison - intervention, exposure, or control used for comparison
  • Outcome - outcomes of interest

These specifications served as the preliminary criteria for selecting studies.

Selection of Evidence

Published, peer-reviewed, randomized controlled trials (RCTs) were considered to constitute the strongest level of evidence in support of guideline recommendations. This decision was based on the judgment that RCTs provide the clearest, scientifically sound basis for judging comparative efficacy. The Working Group made this decision recognizing the limitations of RCTs, particularly considerations of generalizability with respect to patient selection and treatment quality. Meta-analyses that included randomized controlled studies were also considered to be the strongest level of evidence, as well as reports of evidence-based systematic reviews.

A systematic search of the literature was conducted. It focused on the best available evidence to address each key question and ensured maximum coverage of studies at the top of the hierarchy of study types: evidence-based guidelines, meta-analyses, and systematic reviews. When available, the search sought out critical appraisals already performed by others that described explicit criteria for deciding what evidence was selected and how it was determined to be valid. The sources that have already undergone rigorous critical appraisal include Cochrane Reviews, Best Evidence, Technology Assessment, and Evidence-based Practice Center (EPC) reports.

The search continued using well-known and widely available databases that were appropriate for the clinical subject. In addition to Medline/PubMed, the following databases were searched: Database of Abstracts of Reviews of Effectiveness (DARE) and Cochrane Central Register of Controlled Trials (CCTR). For Medline/PubMed, limits were set for language (English), date of publication (2002 through May 2009), and type of research (RCT and meta-analysis). For the CCTR, limits were set for date of publication (2002 through 2009).

Once definitive reviews or clinical studies that provided valid relevant answers to the question were identified, the search ended. The search was extended to studies/reports of lower quality (observational studies) only if there were no high quality studies.

Exclusion criteria included reviews that omitted clinical course or treatment. Some retrieved studies were rejected on the basis of published abstracts, and a few were rejected after the researchers scanned the retrieved citation for inclusion criteria. Typical exclusions included studies with physiological endpoints or studies of populations that were not comparable to the population of interest (e.g., studies of diabetes in children or pregnancy).

The results of the search were organized and reported using reference manager software. At this point, additional exclusion criteria were applied. The bibliographies of the retrieved articles were hand-searched for articles that may have been missed by the computer search. Additional experts were consulted for articles that may also have been missed.

Number of Source Documents

Not stated

Methods Used to Assess the Quality and Strength of the Evidence
Weighting According to a Rating Scheme (Scheme Given)
Rating Scheme for the Strength of the Evidence

Quality of Evidence (QE)

I At least one properly done randomized controlled trial
II-1 Well-designed controlled trial without randomization
II-2 Well-designed cohort or case-control analytic study
II-3 Multiple time series, dramatic results of uncontrolled experiment
III Opinion of respected authorities, case reports, and expert committees

Overall Quality

Good High grade evidence (I or II-1) directly linked to health outcome
Fair High grade evidence (I or II-1) linked to intermediate outcome; or
Moderate grade evidence (II-2 or II-3) directly linked to health outcome
Poor Level III evidence or no linkage of evidence to health outcome

Net Effect of the Intervention

Substantial More than a small relative impact on a frequent condition with a substantial burden of suffering;
or
A large impact on an infrequent condition with a significant impact on the individual patient level
Moderate A small relative impact on a frequent condition with a substantial burden of suffering;
or
A moderate impact on an infrequent condition with a significant impact on the individual patient level
Small A negligible relative impact on a frequent condition with a substantial burden of suffering;
or
A small impact on an infrequent condition with a significant impact on the individual patient level
Zero or Negative Negative impact on patients;
or
No relative impact on either a frequent condition with a substantial burden of suffering;
or
An infrequent condition with a significant impact on the individual patient level
Methods Used to Analyze the Evidence
Review of Published Meta-Analyses
Systematic Review with Evidence Tables
Description of the Methods Used to Analyze the Evidence

Preparation of Evidence Tables

The results of the searches were organized in evidence reports, and copies of the original studies were provided to the Working Group (WG) for further analysis. Each reference was appraised for scientific merit, clinical relevance, and applicability to the populations served by the Department of Veterans Affairs (VA) and Department of Defense (DoD) healthcare systems.

The clinical experts and other researchers in healthcare independently read and coded each article that met inclusion criteria. Each article was turned into a one-page summary of the critical appraisal by the research team and added to a central electronic database. Each of the evidence reports covered:

  • Summary of findings
  • Methodology
  • Search terms
  • Resources searched
  • Summary table of findings
  • Critical appraisal of each study

The quality rating procedure used in this update was different from the rating scale used in the development of the original guideline in 1999. Where adjustments to the update process were made, articles from the original process were re-graded to reflect the changed rating scale (e.g., the strength of recommendation [SR] was assigned for each recommendation, based on study design and significance of the quality of the evidence).

Evidence-based practice involves integrating clinical expertise with the best available clinical evidence derived from systematic research. The Working Group reviewed the evidence and graded it using the rating scheme developed by the U.S. Preventive Services Task Force (USPSTF) (2007). The experts themselves, after an orientation and tutorial on the evidence grading process, formulated Quality of Evidence ratings, a rating of Overall Quality, a rating of the Net Effect of the Intervention (see the "Rating Scheme for the Strength of the Evidence" field), and an overall Recommendation (see the "Rating Scheme for the Strength of the Recommendations" field).

Methods Used to Formulate the Recommendations
Expert Consensus
Description of Methods Used to Formulate the Recommendations

This Department of Veterans Affairs/Department of Defense (VA/DoD) Diabetes Mellitus guideline update builds on the 2003 version. The development process follows a systematic approach described in "Guideline-for-Guidelines," an internal working document of the VA/DoD Evidence-Based Practice Working Group that requires an ongoing review of the work in progress.

The development of the 2010 Diabetes Mellitus Guideline Update (version 4.0) was initiated in January 2009 and continued through June 2010.

The Offices of Quality and Performance and Patient Care Services of the VA and the Army Medical Command of the DoD identified clinical leaders to champion the guideline development process. During a preplanning conference call, the clinical leaders defined the scope of the guideline and identified a group of clinical experts from the VA and DoD to form the Working Group (WG). For this guideline update, the WG participants were drawn from the fields of primary care, endocrinology, internal medicine, nursing and diabetes education who were also from diverse geographic regions, and both VA and DoD healthcare systems.

At the start of the update process, the clinical leaders, guideline panel members, outside experts, and experts in the field of guideline and algorithm development were consulted to determine which aspects of the 2003 guideline required updating. These consultations resulted in the determinations that guided the update efforts: (1) update any recommendations from the original guideline likely to be affected by new research findings; (2) provide information and recommendations on health systems changes relevant to diabetes care; (3) address content areas and models of treatment for which little data existed during the development of the original guideline; and (4) review the performance and lessons learned since the implementation of the original guideline.

After orientation to the guideline scope and to goals that had been identified, the WG developed ten (10) researchable questions within the focus area of the guideline and identified associated key terms. This ensured that the guideline development work outside of meetings focused on issues that practitioners considered important. This also produced criteria for the literature search and selection of included studies that formed the body of evidence for this guideline update.

The previous version of the guideline and the result of literature searches were reviewed by the WG through numerous conference calls and individual contributions to the document. The WG participated in a face-to-face session to reach a consensus about the guideline recommendations and to prepare a draft document. The draft was revised by the experts and by individual contributions to the document.

This 2010 Guideline Update is the product of many months of diligent effort and consensus building among knowledgeable individuals from the Veterans Administration, Department of Defense, academia, and guideline facilitators from the private sector. An experienced moderator facilitated the multidisciplinary Working Group. The list of participants is included in the introduction to the original guideline update (see also "Composition of Group That Authored the Guideline" field).

Lack of Evidence – Consensus of Experts

The majority of the literature supporting the science for these guidelines is referenced throughout the document and is based upon key randomized controlled trials (RCTs) and longitudinal studies published from 2002 through May 2009. Following the independent review of the evidence, a consensus meeting was held to discuss discrepancies in ratings and formulate recommendations. Where existing literature was ambiguous or conflicting, or where scientific data was lacking on an issue, recommendations were based on the clinical experience of the WG. These recommendations are indicated in the evidence tables as based on "Working Group Consensus."

Rating Scheme for the Strength of the Recommendations

Final Grade of Recommendation

  The Net Benefit of the Intervention
Quality of Evidence Substantial Moderate Small Zero or Negative
Good A B C D
Fair B B C D
Poor I I I I

A - A strong recommendation that the intervention is always indicated and acceptable

B - A recommendation that the intervention may be useful/effective

C - A recommendation that the intervention may be considered

D - A recommendation that a procedure may be considered not useful/effective, or may be harmful

I - Insufficient evidence to recommend for or against – the clinician will use clinical judgment

Cost Analysis

The guideline developers reviewed published cost analyses.

Method of Guideline Validation
Internal Peer Review
Description of Method of Guideline Validation

Experts from the Veterans Administration (VA) and Department of Defense (DoD) internal medicine, endocrinology, and primary care reviewed the final draft. Diabetes educators and other professionals involved in diabetes education teams also reviewed the draft. Finally the draft was posted on the Internet to solicit comment from providers from the VA and DoD healthcare system at large. Their feedback was integrated into the final document.

Recommendations

Major Recommendations

Note from the Department of Veterans Affairs and the Department of Defense (VA/DoD) and the National Guideline Clearinghouse (NGC): The recommendations for the management of diabetes in the primary care setting are organized into 6 modules with 6 algorithms. The modules with accompanying recommendations are provided below. See the original guideline document External Web Site Policy for the algorithms and evidence tables associated with selected recommendations, including level and quality of evidence, strength of recommendation, and supporting evidence citations.

The strength of recommendation grading (A, B, C, D, I) is defined at the end of the "Major Recommendations" field.

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).

  1. 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 A1cc
    Casual Plasma Glucosed
    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%
    1. Fasting is defined as no caloric intake for at least 8 hours.
    2. 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.
    3. Using a clinical laboratory (not a Point of Care) methodology standardized to the National Glycohemoglobin Standardization Program (NGSP)
    4. Casual means any time of day without regard to time since last meal; classic symptoms include polyuria, polydipsia, and unexplained weight loss.
    5. 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.
  1. Refer to Pediatric Diabetes Management

    Objective

    Provide appropriate management for children with diabetes.

    Recommendations

    1. 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.
    2. 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.
  1. 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

    1. 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.
    2. 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.
    3. 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.

  1. 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
  1. Is the Patient Medically, Psychologically, and Socially Stable?

    Objective

    Stabilize the patient before initiating long-term disease management.

    Recommendations

    1. 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.
    2. 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.
    3. 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.
    4. The determination of stability is up to the judgment of the provider.
  1. 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

    1. 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
    1. 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.

  1. 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.

  1. Consider Aspirin Therapy

    Objective

    Prevent cardiovascular disease.

    Recommendations

    1. Prescribe aspirin therapy (75 to 325 mg/day) for all adult patients with type 2 diabetes and evidence of cardiovascular disease. [A]
    2. 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]
    3. 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]
    4. 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]
  1. Review All Diabetes-Related Complications and Set Priorities

    Objective

    Identify DM-related complications requiring special attention.

    Recommendations

    1. If the individualized HbA1c is not on target, refer to Module G – Glycemic Control.
    2. 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 External Web Site Policy. (Also see Annotation J).
    3. 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).
    4. 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 VA/DoD clinical practice guideline for management of chronic kidney disease in primary care External Web Site Policy. (Also see Annotation L).
    5. 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.
    6. 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.
    7. If the patient needs additional nutritional or lifestyle education, refer to Module M – Self Management and Education.
    8. If the patient is a candidate for an influenza vaccine, administer it in season. (See Centers for Disease Control and Prevention [CDC] recommendations)
    9. Administer pneumococcal pneumonia vaccine, if indicated. (See CDC recommendations External Web Site Policy)
    10. If the patient is using tobacco, refer to the VA/DoD clinical practice guideline for treating tobacco use and dependence External Web Site Policy.
  1. 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 External Web Site Policy.

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

    Recommendations

    1. Patients with diabetes with hypertension (systolic BP ≥140 or diastolic ≥90 mm Hg) should:
      1. Begin antihypertensive therapy with an angiotensin converting enzyme inhibitor (ACEI) or a diuretic [A]
      2. If ACEI induced side-effects occur, consider switching to an angiotensin receptor blocker (ARB) [A]
      3. 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]
    1. 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]
    2. 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]
    3. 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]
  1. 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

    1. 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).
    2. 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)

    1. 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]
    2. LDL should be lowered to less than 130 mg/dL for patients with DM without other major risk factors for secondary prevention. [C]
    3. 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.
    4. 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.
    5. 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]
    6. 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]
    7. 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

    1. Therapeutic lifestyle changes (TLC) should be recommended for ALL patients with dyslipidemia, regardless of risk or baseline LDL-C level. [C]
    2. For secondary prevention of recurrent CVD events, non-pharmacologic therapy is always indicated, but it should not delay appropriate pharmacotherapy.
    3. 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]
    4. Diet intervention should be the first step in lipid lowering therapy. [B]
    5. 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]
    6. 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

    1. Statins are first line agents in primary and secondary prevention of CVD regardless of HDL-C or TG level. [A]
    2. 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]
    3. For patients who cannot tolerate statins, niacin or resins should be considered for treatment. [A]
    4. There is insufficient clinical outcome evidence to recommend ezetimibe monotherapy for reduction of CV risk. [I]
    5. 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]
    6. 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

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

    Isolated Low HDL-C

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

    For complete management of Chronic Kidney Disease (CKD) see the VA/DoD clinical practice guideline for management of chronic kidney disease in primary care External Web Site Policy.

    Recommendations

    Screening for CKD

    1. Patients with diabetes should be screened periodically for the presence of kidney disease. [C]
    2. Testing for kidney disease includes urinalysis and estimation of the glomerular filtration rate (eGFR). [B]
    3. Patients with diabetes who have a negative urine protein by dipstick should be tested for the presence of microalbuminuria. [B]
    4. Definitions of Chronic Kidney Disease includes any of the following:
      1. Persistent decreased eGFR <60 ml/min/1.73m2 on two tests at least three months apart
      2. Proteinuria (>1+) on dipstick or urine protein-to-creatine ratio >0.2, confirmed on two tests at least three months apart
      3. Microalbuminuria defined as albumin-to-creatine ratio >30, confirmed on two out of three urine tests in patients with diabetes mellitus
      4. Known structural kidney disease defined by imaging or pathologic examination (e.g., polycystic kidney disease [PCKD])
      5. Estimated glomerular filtration rate (eGFR) is the preferred method to assess kidney function.
    5. 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

    1. 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.
    2. 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.
    3. 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.
    4. 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.
    5. 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)

    1. Serum creatinine level should be used to estimate the GFR to identify patients at risk and develop appropriate management plans.
    2. 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).
    3. 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.
    4. 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

    1. Nephrology consultation for help in diagnosis and treatment is indicated in:
      1. Patients with eGFR <30 ml/min/1.73m2) to facilitate education and planning for renal replacement therapy (dialysis or kidney transplant).
      2. Patients with kidney function that is deteriorating rapidly (e.g., eGFR decline of 50 percent eGFR from previous measure over 6 months or less).
      3. Patients with metabolic complications of CKD (e.g., anemia, secondary hyperparathyroidism).
      4. 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

    1. 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.
    2. Antihypertensive therapy should be adjusted to achieve blood pressure of <130/80 mm Hg. [C]

    Non-Pharmacologic Interventions

    1. 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]
    2. 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]
    3. 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

    1. 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]
    2. 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.
    3. 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.
    4. 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

    1. 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].
    2. 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]
    3. ACEIs and ARBs should be initiated at low doses and titrated to moderate to high doses as used in clinical trials. [A]
    4. 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]
    5. 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]
    6. Treatment with an ACEI or ARB should not be initiated in patients with hyperkalemia (>5.5). [D]
    7. 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]
    8. In most patients, an ACEI or ARB should be continued unless:
      1. There is an acute GFR decline of >30 percent within the first two weeks after initiation. [B]
      2. Serum potassium is ≥6 mEq/L, despite appropriate treatment. [B]

    Follow-Up Monitoring

    1. 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.
    2. 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]
    3. 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.
    4. Patients with more advanced CKD should be referred to a nephrologist for consultation and/or continued follow-up.

Module S – Screening for Diabetes

  1. 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

    1. Screening for pre-diabetes or diabetes should be considered for all adults age ≥45 [B]
    2. 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]
    3. 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]
    4. Fasting plasma glucose is the preferred screening test for pre-diabetes and DM and is also a component of diagnostic testing.
    5. 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).
    6. A diagnosis of DM is made if any of the following: [B]
      1. Fasting plasma glucose (FPG) is ≥126 mg/dL on at least two occasions, or
      2. 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
      3. HbA1c is ≥7% on two occasions using a clinical laboratory methodology standardized to the NSGP (not a Point of Care); or
      4. 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.
    1. A diagnosis of pre-diabetes is made if any of the following: [B]
      1. Fasting plasma glucose readings with result <126 mg/dL, but ≥100mg/dL on two occasions.
      2. 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.
    1. 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]
    2. Random plasma glucose is not recommended as a routine screening test. [C]
  1. Prevention of Diabetes

    Objective

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

    Recommendations

    1. 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.
    2. 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]
    3. 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]
    4. 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

  1. 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.

  1. Assess Glycemic Control

    Objective

    Determine the patient's level of glycemic control.

    Recommendations

    1. 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.
    2. Self-monitoring of blood glucose (SMBG) may be used to monitor glycemic control and adjust treatment [B]
    3. 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.
    4. SMBG results should be discussed with the patient to promote understanding, adjust treatment regimens, and facilitate treatment adherence. [B]
    5. Remote electronic transmission of SMBG data should be considered as a tool to assess glycemic patterns. [C]
    6. 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]
    7. A combination of pre-and postprandial tests may be performed, up to 4 times per day. [C]
    8. 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.
  1. 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

    1. Treat diabetes more aggressively early in its course. [B]
    2. 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]
    3. 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.
    4. Setting the initial target range should consider the following: (see Table below)
      1. 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]
      2. Any patient with diabetes should have a HbA1c target of <9 percent to reduce symptoms of hyperglycemia. [C]
      3. 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]
      4. 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]
      5. 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%*
    1. Based upon the DCCT referent standard. Clinicians need to evaluate the methodology used at their site.
    2. Reflects a "goal" over time. Intensification of therapy should be undertaken based upon individual clinical circumstances and treatment option.
    1. Mild microvascular disease is defined by early background retinopathy, and/or microalbuminuria, and/or mild neuropathy.
    2. 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).
    3. 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).
    4. 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.
    5. Major co-morbidity is present, but is not end-stage and management achievable.
    6. 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.

    1. 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

      1. Risks of a proposed therapy should be balanced against the potential benefits, based upon the patient's medical, social, and psychological status.
    1. Set a Glycemic Target Range after Discussion with the Patient

      Objective

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

      Recommendations

      1. The patient and provider should agree on a specific target range of glycemic control after discussing the risks and benefits of therapy.
      2. 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.
    1. 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

      1. 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.
    1. Does Patient Require Insulin?

      Objective

      Identify the patient for whom insulin treatment is necessary.

      Recommendations

      1. The patient with type 1 DM must receive insulin replacement therapy.
      2. 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.
    1. Institute/Adjust Insulin, Consider Referral

      Objective

      Achieve glycemic control using insulin.

      Recommendations

      1. 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.
      2. 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.

    1. Assure Appropriate Intervention to Address Patient Adherence

      Objective

      Assure proper patient monitoring and contact with the healthcare team.

      Recommendations

      1. Patients with diabetes should be regularly assessed for knowledge, performance skills, and barriers to self-management.
      2. 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).
      3. 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).
    1. Initiate/Adjust Therapy

      Objective

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

      Recommendations

      1. Individual treatment goals must be established with the patient based on the extent of the disease, comorbid conditions, and patient preferences.
      2. 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.
      3. 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.
      4. 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

      1. 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]
      2. 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]
      3. Metformin (preferred) or sulfonylureas (SU) should be given as first line agents unless there are contraindications. [A]
      4. 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]
      5. 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

      1. Metformin plus sulfonylurea is the preferred oral combination for patients who no longer have adequate glycemic control on monotherapy with either drug. [A]
      2. 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]
      3. 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]
      4. Patients and their families should be instructed to recognize signs and symptoms of hypoglycemia and its management. [I]

      J.3 Insulin Therapy

      Recommendations

      1. 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]
      2. Use intermediate- or long-acting insulin to provide basal insulin coverage. [B]
      3. Insulin glargine or detemir may be considered in the NPH insulin-treated patient with frequent or severe nocturnal hypoglycemia. [B]
      4. Use regular insulin or short-acting insulin analogues for patients who require mealtime coverage.
      5. 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

      1. CSII therapy should only be initiated and managed by an endocrinologist/diabetes team with expertise in insulin pump therapy.
      2. 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:
        1. 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]
        2. Marked dawn phenomenon (fasting AM hyperglycemia) not controlled using NPH at bedtime, glargine or detemir. [B]
        3. Recurrent nocturnal hypoglycemia despite optimized regimen using glargine or detemir. [B]
        4. Circumstances of employment or physical activity, for example shift work, in which MDI regimens have been unable to maintain glycemic control. [I]
      1. Patients using CSII should have:
        1. 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.
        2. Completed a comprehensive diabetes education program.
      1. 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

      1. 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]
      2. 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]
      3. 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]
      4. 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]
      5. 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]
      6. 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]
      7. 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]
      8. 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]
    1. Determine If There Are Side Effects or Contraindications to Current Treatment

      Objective

      Modify therapy due to side effects of drug therapy.

      Recommendations

      1. 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.

    1. Are There Problems with Patient Adherence?

      Objective

      Identify barriers to full adherence to the prescribed treatment regimen.

      Recommendations

      1. 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).
      2. If barriers are identified, referral to a case manager or behavioral/financial counselor may be considered as appropriate.
    1. Should Glycemic Control Target Be Adjusted?

      Objective

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

      Recommendation

      1. 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.
    1. Follow-Up

      Objective

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

      Recommendations

      1. 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.
      1. 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

    1. Has Patient's Vision Changed Recently?

      Objective

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

      Recommendation

      1. Patients with an acute change in vision or change in ocular function should be urgently referred to an eye care provider.
    1. 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

      1. 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]
    1. 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

      1. 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]
      2. 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]
    1. 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

      1. 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]
      2. 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

    1. Perform and Document Visual Inspection of Feet

      Objective

      Examine the patient's feet for any abnormal findings.

      Recommendation

      1. 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
    1. Perform Foot Risk Assessment

      Objective

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

      Recommendation

      1. 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.

    1. Are Any Limb-Threatening Conditions Present?

      Objective

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

      Recommendation

      1. 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.
    1. Refer to Appropriate Level of Care for Evaluation and Treatment

      Objective

      Determine the appropriate intervention.

      Recommendations

      1. Patients with limb-threatening conditions should be referred to the appropriate level of care for evaluation and treatment.
      2. 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.
    1. Is Patient at High Risk for Foot Problem?

      Objective

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

      Recommendations

      1. Patients without limb-threatening conditions should be evaluated for their level of risk for LE foot ulcers and amputations.
      2. 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.
      1. 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.

    1. Is There a Minor Wound or Lesion?

      Objective

      Determine the extent of the injury.

      Recommendations

      1. 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.
      2. Patients with an ingrown toenail should be referred to a foot specialist for evaluation and treatment (see Annotation C: Ingrown Toenail).
    1. Refer to Foot Care Specialist for Complete Evaluation and Treatment

      Objective

      Ensure a more intensive follow-up treatment plan.

      Recommendations

      1. 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.
      2. Footwear prescriptions should be based upon individual characteristics of foot structure and function.
    1. Perform and Document Patient Education for Preventive Foot Care and Footwear

      Objective

      Empower the patient to perform proper foot care practices.

      Recommendation

      1. 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.
    1. 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

      1. 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).
    1. Perform Wound Assessment

      Objective

      Determine the character and nature of the wound.

      Recommendations

      1. Patients with diabetes with minor wounds or foot lesions should have a wound assessment.
      2. 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.
    1. Provide Local Wound Care; Offload Pressure and Weight, as Indicated

      Objective

      Provide care of an uncomplicated minor lesion.

      Recommendations

      1. 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.
      2. Patients with diabetes with uncomplicated minor lesions must be followed at least monthly.
    1. Has Wound Healed within 4 Weeks?

      Objective

      Determine appropriateness of the treatment outcome.

      Recommendation

      1. 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.
    1. Is There a Minor Foot Problem?

      Objective

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

      Recommendation

      1. 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).
    1. Treat as Appropriate

      Objective

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

      Recommendation

      1. Assure that patient and family members have received appropriate education regarding preventive foot care.
      2. Treat minor foot problems, as appropriate.

    Module M - Self-Management and Education

    1. 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.

    1. 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

      1. 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).

    1. Refer for Comprehensive Diabetes Self-management and Diet Education

      Objective

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

      Recommendations

      1. Patients newly diagnosed with diabetes should receive comprehensive DSME and education for MNT.
      2. 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
      1. 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.
      2. The use of approaches such as group visits and telehealth should be considered in providing education.
    1. 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

      1. 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.
      2. 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.
      3. Assessment and documentation of the patient's understanding of education.
    1. 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

      1. 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.

    1. 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

      1. 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.
      2. Refer to case manager for providing ongoing, detailed coordination of care for high risk patients.
    1. 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

      1. When knowledge deficits continue to exist or a large number of lifestyle changes are necessary, frequent follow-up may be indicated.
      2. 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).
      3. 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.
    1. 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.

    1. 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.

    1. 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:

      1. Diabetes education is effective for improving clinical outcomes and quality of life, at least in the short-term.
      2. DSME has evolved from primarily didactic presentations to more theoretically based empowerment models.
      3. 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.
      4. Ongoing support is critical to sustain progress made by participants during the DSME program.
      5. Behavioral goal-setting is an effective strategy to support self-management behaviors.

    Definitions:

    Quality of Evidence (QE)

    I At least one properly done randomized controlled trial
    II-1 Well-designed controlled trial without randomization
    II-2 Well-designed cohort or case-control analytic study
    II-3 Multiple time series, dramatic results of uncontrolled experiment
    III Opinion of respected authorities, case reports, and expert committees

    Overall Quality

    Good High grade evidence (I or II-1) directly linked to health outcome
    Fair High grade evidence (I or II-1) linked to intermediate outcome; or
    Moderate grade evidence (II-2 or II-3) directly linked to health outcome
    Poor Level III evidence or no linkage of evidence to health outcome

    Net Effect of the Intervention

    Substantial More than a small relative impact on a frequent condition with a substantial burden of suffering;
    or
    A large impact on an infrequent condition with a significant impact on the individual patient level
    Moderate A small relative impact on a frequent condition with a substantial burden of suffering;
    or
    A moderate impact on an infrequent condition with a significant impact on the individual patient level
    Small A negligible relative impact on a frequent condition with a substantial burden of suffering;
    or
    A small impact on an infrequent condition with a significant impact on the individual patient level
    Zero or Negative Negative impact on patients;
    or
    No relative impact on either a frequent condition with a substantial burden of suffering;
    or
    An infrequent condition with a significant impact on the individual patient level

    Final Grade of Recommendation

      The Net Benefit of the Intervention
    Quality of Evidence Substantial Moderate Small Zero or Negative
    Good A B C D
    Fair B B C D
    Poor I I I I

    A - A strong recommendation that the intervention is always indicated and acceptable

    B - A recommendation that the intervention may be useful/effective

    C - A recommendation that the intervention may be considered

    D - A recommendation that a procedure may be considered not useful/effective, or may be harmful

    I - Insufficient evidence to recommend for or against – the clinician will use clinical judgment

    Clinical Algorithm(s)

    Algorithms are provided in the original guideline document External Web Site Policy for:

    • Management of Diabetes Mellitus, Core Algorithm
    • Screening for DM
    • Glycemic Control
    • Screening for Retinopathy
    • Foot Care
    • Self-management and Education

    Evidence Supporting the Recommendations

    Type of Evidence Supporting the Recommendations

    The type of supporting evidence is identified for selected recommendations (see "Major Recommendations").

    The guideline is based on an exhaustive review of the literature. Where existing literature was ambiguous or conflicting, or where scientific data were lacking on an issue, recommendations were based on the clinical experience of the Working Group.

    Benefits/Harms of Implementing the Guideline Recommendations

    Potential Benefits
    • Appropriate screening for pre-diabetes and diabetes mellitus
    • Appropriate management of patients with pre-diabetes and diabetes mellitus, including patient self-management, may improve quality and length of life and prevent complications of diabetes.
    Potential Harms

    General Side Effects of Pharmacotherapy

    • Side effects of pharmacological therapy can include drug-drug interactions, hypoglycemia, and specific adverse drug effects. Patients may experience side effects from medications if adjustments are not made when patients undergo medical or surgical procedures, have a change in their condition, or develop an intercurrent illness.
    • Patients may develop contraindications to continued use of a previously successful maintenance medication. Examples would include newly recognized renal insufficiency or severe congestive heart failure in a patient treated with metformin.
    • Refer to the original guideline document, including Appendix G-3, for further details regarding specific medications.

    Contraindications

    Contraindications
    • Niacin is contraindicated in patients with hepatic disease and relatively contraindicated in patients with gout and history of complicated/active peptic ulcer disease.
    • Statins are contraindicated in active liver disease, in those persons with persistent elevation of liver transaminases, and in pregnancy.
    • Fibrates are contraindicated in severe renal or hepatic disease, including primary biliary cirrhosis and preexisting gallbladder disease.

    Refer to Appendix G-3 in the original guideline document for information on contraindications to anti-diabetic drugs.

    Qualifying Statements

    Qualifying Statements
    • The Department of Veterans Affairs (VA) and The Department of Defense (DoD) guidelines are based on the best information available at the time of publication. They are designed to provide information and assist in decision-making. They are not intended to define a standard of care and should not be construed as one. Also, they should not be interpreted as prescribing an exclusive course of management.
    • Variations in practice will inevitably and appropriately occur when providers take into account the needs of individual patients, available resources, and limitations unique to an institution or type of practice. Every healthcare professional making use of these guidelines is responsible for evaluating the appropriateness of applying them in any particular clinical situation.

    Implementation of the Guideline

    Description of Implementation Strategy
    • The guideline and algorithms are designed to be adapted by individual facilities in consideration of local needs and resources. The algorithms serve as a guide that providers can use to determine best interventions and timing of care for their patients in order to optimize quality of care and clinical outcomes.
    • Although this guideline represents the state of the art practice on the date of its publication, medical practice is evolving and this evolution requires continuous updating of published information. New technology and more research will improve patient care in the future. The clinical practice guideline can assist in identifying priority areas for research and optimal allocation of resources. Future studies examining the results of clinical practice guidelines such as these may lead to the development of new practice-based evidence.
    Implementation Tools
    Clinical Algorithm
    Quality Measures
    Quick Reference Guides/Physician Guides
    For information about availability, see the Availability of Companion Documents and Patient Resources fields below.

    Institute of Medicine (IOM) National Healthcare Quality Report Categories

    IOM Care Need
    Living with Illness
    Staying Healthy
    IOM Domain
    Effectiveness
    Patient-centeredness

    Identifying Information and Availability

    Bibliographic Source(s)
    Department of Veteran Affairs, Department of Defense. VA/DoD clinical practice guideline for the management of diabetes mellitus. Washington (DC): Department of Veteran Affairs, Department of Defense; 2010 Aug. 146 p.
    Adaptation

    Not applicable: The guideline was not adapted from another source.

    Date Released
    1999 Dec (revised 2010 Aug)
    Guideline Developer(s)
    Department of Defense - Federal Government Agency [U.S.]
    Department of Veterans Affairs - Federal Government Agency [U.S.]
    Veterans Health Administration - Federal Government Agency [U.S.]
    Source(s) of Funding

    United States Government

    Guideline Committee

    The Management of Diabetes Mellitus Guideline Update Working Group

    Composition of Group That Authored the Guideline

    Working Group Members (VA): David Aron, MD, MS; Paul Conlin, MD; John R. Downs, MD; Mercedes Falciglia, MD; Linda Haas, PhC, RN, CDE; Debbie Khachikian, Pharm D; Leonard Pogach, MS, MBA (Co-Chair); Ruth Weinstock, MD, PhD

    Working Group Members (DoD): Alan Douglass, MD; Curtis Hobbs, MD (Co-Chair); Jack E. Lewi, MD; James McCrary, D.O.; Robert Vigersky, MD; Susan Walker, PhD, RN, CDE

    Office of Quality and Performance, VHA: Carla Cassidy, RN, MSN, NP

    Quality Management Division, US Army Medical Command: Ernest Degenhardt, MSN, RN, ANP-FNP; Angela V. Klar, MSN, RN, ANP-CS

    Facilitator: Oded Susskind, MPH

    Healthcare Quality Informatics: Martha D'Erasmo, MPH; Rosalie Fishman, RN, MSN, CPHQ; Sue Radcliff

    Financial Disclosures/Conflicts of Interest

    Not stated

    Guideline Status

    This is the current release of the guideline.

    This guideline updates a previous version: Veterans Health Administration, Department of Defense. VA/DoD clinical practice guideline for the management of diabetes mellitus. Washington (DC): Veterans Health Administration, Department of Defense; 2003 Sep. Various p.

    Guideline Availability

    Electronic copies available from the Department of Veterans Affairs (VA) Web site External Web Site Policy.

    Print copies: Department of Veterans Affairs, Veterans Health Administration, Office of Quality and Performance (10Q) 810 Vermont Ave. NW, Washington, DC 20420.

    Availability of Companion Documents

    The following is available:

    • VA/DOD clinical practice guideline for the management of diabetes mellitus (DM). Guideline summary. Washington (DC): Department of Veterans Affairs (U.S.); 2010. 44 p. Electronic copies: Available in Portable Document Format (PDF) from the Department of Veterans Affairs Web site External Web Site Policy.

    Print copies: Department of Veterans Affairs, Veterans Health Administration, Office of Quality and Performance (10Q) 810 Vermont Ave. NW, Washington, DC 20420.

    Patient Resources

    None available

    NGC Status

    This summary was completed by ECRI on February 9, 2001. The information was verified by the guideline developer on November 2, 2001. This NGC summary was updated by ECRI on August 13, 2004. The information was verified by the guideline developer on November 15, 2004. This summary was updated by ECRI on January 11, 2006 following the U.S. Food and Drug Administration advisory on rosiglitazone. This summary was updated by ECRI Institute on September 5, 2007 following the U.S. Food and Drug Administration advisory on the Thiazolidinedione class of antidiabetic drugs. This summary was updated by ECRI Institute on November 28, 2007 following the U.S. Food and Drug Administration advisory on the Avandia (rosiglitazone maleate) Tablets. This summary was updated by ECRI Institute on March 10, 2008 following the U.S. Food and Drug Administration advisory on Avandia (rosiglitazone maleate). This summary was updated by ECRI Institute on March 4, 2011. This summary was updated by ECRI Institute on June 27, 2011 following the U.S. Food and Drug Administration advisory on Zocor (simvastatin). This summary was updated by ECRI Institute on April 13, 2012 following the U.S. Food and Drug Administration advisories on Statin Drugs and Statins and HIV or Hepatitis C drugs. This summary was updated by ECRI Institute on April 4, 2014 following the U.S. Food and Drug Administration (FDA) advisory on Rosiglitazone-containing Diabetes Medicines.

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