Diabetes Mellitus

  • Diagnosis
  • Screening
  • Monitoring
  • Background
  • Pediatrics
  • Lab Tests
  • References
  • Related Content

Indications for Testing

  • Known risk factors for type 2 diabetes mellitus (DM)
    • Obesity (BMI ≥25 kg/m2 or ≥23 kg/m2 in Asian Americans)
    • Family history of type 2 DM in first- or second-degree relative
    • At risk race/ethnicity – Native American, African American, Latino, Asian American, Pacific Islander
    • Signs of insulin resistance or conditions associated with insulin resistance (eg, acanthosis nigricans, hypertension, dyslipidemiaPCOS, low birthweight)
    • Maternal history of DM or gestational diabetes mellitus (GDM) during pregnancy

Criteria for Diagnosis

Laboratory Testing

  • Initial testing – HbA1c, FPG, 2-hr OGTT, or random PG are the preferred tests to diagnose diabetes in nonpregnant adults (see Criteria for Diagnosis)
    • If tests are normal, repeat at minimum of 3 year intervals (ADA, 2015)
  • Insulin antibodies
    • Not recommended for routine evaluation or management of DM (ADA, 2014)
    • For evaluation of type 1 DM – recommended to order at least two antibodies when pursuing this testing (Insel, 2015)
  • C-peptide testing – not recommended to diagnose DM
    •  Low concentrations are suggestive of type 1 DM, but are not indicative

Differential Diagnosis

  • Type 2 DM
  • Type 1 DM (ketoacidosis)
  • GDM
    • Infection
    • Acute surgical abdomen
      • Appendicitis
      • Cholecystitis/cholelithiasis
      • Pregnancy-related abdominal problem
        • Intrauterine infection
    • Thyroid disease

Adults (one of the following)

Pregnant women (gestational DM)

  • All pregnant females 24-28 weeks gestation should be screened for gestational DM (GDM) (ADA, 2015; ACOG, 2013; AACE/ACE, 2015)
    • Screen if GDM identified 6-12 weeks postpartum using OGTT according to nonpregnant criteria (ADA, 2015)
  • Two approaches may be utilized – two-step or one-step

Approach

Criteria

Fasting mg/dL

1-hr mg/dL

2-hr mg/dL

3-hr mg/dL

Two-step (50-g, 100-g load) (NIH consensus)

Carpenter & Coustan

95 (5.3 mmol/L)

180 (10.0 mmol/L)

155 (8.6 mmol/L)

140 (7.8 mmol/L)

NDDG

105 (5.8 mmol/L)

190 (10.6 mmol/L)

165 (9.2 mmol/L)

145 (8.0 mmol/L)

One-step (75-g load) (IADPSG consensus)

IADPSG

≥92 (5.1 mmol/L)

≥180 (10 mmol/L)

≥153 (8.5 mmol/L)

n/a

NDDG = National Diabetes Data Group; IADPSG = International Association of Diabetes and Pregnancy Study Groups

Physical Examination

Laboratory Testing

    • Dyslipidemia
      • Lipid panel (fasting)
        • Premise of testing
          • Patients with DM have an increased incidence of lipid abnormalities, creating risk for CVD
          • Lipid-lowering therapies have been demonstrated to reduce macrovascular disease; therefore, identification of dyslipidemia is important
        • Target goals (ADA, 2015; AACE/ACE, 2015)
          • LDL
            • <100 mg/dL – low, moderate risk patient
            • <70 mg/dL  – high risk patient
          • HDL
            • >40 mg/dL (men)
            • >50 mg/dL (women)
          • Triglycerides <150 mg/dL
        • Laboratory testing recommendations
          • Initial evaluation and annually thereafter if goals are met
            • More frequently if goals are not met
            • Adult with low values (LDL <100 mg/dL, HDL >50 mg/dL, triglycerides <150 mg/dL) – assessments up to two years apart
          • Treat aggressively with statins based on initial risk assessment (ACC/AHA 2013 guidelines)
            • No target goals set by ACC/AHA
    • Hepatic function
      • Premise of testing
        • Patients with DM are at risk for steatohepatitis
      • Laboratory testing recommendations
        • Liver function tests –  AST, ALT, alkaline phosphatase, and bilirubin
        • Initial evaluation and annually thereafter if values are normal on initial testing
    • Renal function
      • Creatinine and estimated glomerular filtration rates (eGFR)
        • Premise of testing
          • Many drugs require adjusted dosing based on creatinine, creatinine clearance or eGFR and DM may affect renal function in the course of the disease
          • Absolute creatinine values do not reflect glomerular filtration rates in many patients
            • Diabetic nephropathy diminishes creatinine clearance
            • Renal function thereby diminishes clearance and glomerular filtration rate
          • Creatinine and eGFR are broad measures of renal function
        • Laboratory testing recommendations
          • Serum creatinine and eGFR annually
            • More frequent monitoring necessary for abnormal eGFRs (ADA, 2015)
            • KIDGO guidelines are useful for deciding intervals for abnormal values (KIDGO, 2011)
      • Albuminuria
        • Premise of testing
          • Diabetic nephropathy occurs in 20-40% of patients with DM and is the single leading cause of end-stage renal disease – adding angiotensin converting enzyme (ACE) inhibitors reduces progression
          • Persistent albuminuria (range 30-299 mg/24 hours and concentrations ≥300 mg/24 hours) signifies the earliest stage of diabetic nephropathy
        • Target goal
          • <30 mg/24 hour urine (ADA, 2015; AACE/ACE, 2015)
        • Laboratory testing recommendations
          • Spot urine or 24-hour urine for microalbumin annually
    • Thyroid function
      • TSH, autoimmune antibodies
        • Premise of testing
        • Laboratory testing recommendations
          • Initial evaluation using TSH/antibody testing (for type 1 DM) and, if normal, TSH every 3 years thereafter (ADA, 2015)

Diabetes mellitus (DM) is a group of metabolic diseases resulting from defects in insulin secretion and/or insulin resistance that can lead to significant morbidity and mortality in affected patients.

Classification of Diabetes Mellitus

  • Type 1 DM – 90-95% in pediatric population; absolute insulin deficiency
  • Type 2 DM – most are teenagers or older; insulin resistance with or without insulin deficiency
  • Gestational diabetes mellitus (GDM) – exclusive to pregnant females
  • Other types of DM due to other causes (eg, cystic fibrosis, drug-induced)

Diabetes Mellitus Type 1

  • See Pediatrics tab

Diabetes Mellitus Type 2

Gestational Diabetes Mellitus

Type 1 DM

Clinical Background

Epidemiology

  • Prevalence
    • Varies by nationality – common in Northern European populations; uncommon in Chinese, Indian populations
    • 1/400-600 children and adolescents
  • Age
    • Majority diagnosed before or during adolescence
    • Peaks at 5-7 years and adolescence
  • Sex – M>F (slightly)
  • Inheritance
    • Interplay between genetic susceptibility and environmental factors
      • HLA class II haplotypes most common (DRB-DQ2, DR4-DQ8)
      • Stages (Scientific statement JDF, Endocrine Society ADA, Insel, 2015)
        • Stage 1 – autoimmunity +/normoglycemia/presymptomatic type 1 DM
        • Stage 2 – autoimmunity +/dysglycemia/presymptomatic type 1 DM
        • Stage 3 – autoimmunity +/dysglycemia/symptomatic type 1 DM

Pathophysiology

  • Autoimmune mediated destruction of insulin-producing β-cells of the islets of Langerhans in the pancreas with diminished or absent circulating insulin
  • Absolute insulin deficiency of type 1 DM is a result of the following
    • Chronic inflammatory response mediated against the islet cells
    • Cell-mediated destruction of islet cells accompanied by production of islet cell antibodies
      • Autoantibodies – order of appearance appears related to HLA-DQ genotype
        • Islet cell antibodies (ICA)
          • May be detected years prior to clinical symptoms
        • Glutamic acid decarboxylase (GAD65)
        • Insulinoma antigen 2 (IA-2)
        • Insulin autoantibodies (IAA)
        • Zinc transporter 8 (ZnT8)
      • Presence of two or more of these antibodies is a major criteria for stage 1 DM 1 (presymptomatic stage)
      • Number of autoantibodies appears to correlate with risk of DM 1 development (Insel, 2015)

Clinical Presentation

  • Polydipsia, polyuria, polyphagia
  • Nonspecific symptoms
    • Fatigue
    • Nausea, emesis
    • Weight loss
    • Blurred vision
  • Length of time from clinical presentation to diagnosis is typically a few weeks
  • Complications

 Type 2 DM

  • See Clinical Background section

Diagnosis

Indications for Testing

Criteria for Diagnosis

  • Refer to Diagnosis section

Laboratory Testing

  • HbA1c fasting plasma glucose, 2-hour oral glucose tolerance test (OGTT), and random glucose are the preferred tests to diagnose diabetes in children (ADA,2014)
    • Random glucose measures have greater variability and less reproducibility in children
  • C-peptide or insulin concentrations to diagnose type 1 DM – not recommended
    • Consider insulin antibody testing – refer to Diagnosis section

Monitoring

  • HbA1c
    • Premise of testing
      • Glycation of hemoglobin is non-linear over time and occurs over the whole lifespan of the red blood cell
      • Correlates with risk of long-term complications and with diabetes control over previous 2-3 months
    • Target goal (ADA, 2015)
      • <7.5% for all pediatric groups
    • Laboratory testing recommendations
      • 2 measurements per year for patients meeting goal of <6.5-7% (ADA, 2014), ≤6.5% (ACE/AACE, 2015)
        • If patient is not hypoglycemic, goal should be <6%
      • More frequent monitoring in patients with HbA1c ≥7%; however, not more often than every 3 months (ADA, 2015; AACE/ACE, 2015)
  • Hypoglycemia
    • Not infrequent when children are using insulin
      • Diligence required for younger children

Indications for Laboratory Testing

Tests generally appear in the order most useful for common clinical situations.
Click on number for test-specific information in the ARUP Laboratory Test Directory

Hemoglobin A1c 0070426
Method: Quantitative High Performance Liquid Chromatography/Boronate Affinity

Limitations

Unstable hemoglobins or hemolytic anemia may yield falsely low results

Iron deficiency anemia may yield falsely high results

Glucose, Plasma or Serum 0020024
Method: Quantitative Enzymatic

Glucose Tolerance Test 0020542
Method: Quantitative Enzymatic

Glucose Screen, Pregnancy 0020047
Method: Quantitative Enzymatic

Lipid Panel 0020421
Method: Quantitative Enzymatic

Microalbumin, Urine 0050203
Method: Quantitative Immunoturbidimetry

Glomerular Filtration Rate, Estimated 0020725
Method: Quantitative Enzymatic

Hepatic Function Panel 0020416
Method: Quantitative Enzymatic/Quantitative Spectrophotometry

Thyroid Stimulating Hormone with reflex to Free Thyroxine 2006108
Method: Quantitative Electrochemiluminescent Immunoassay

Thyroid Stimulating Immunoglobulin 0099430
Method: Quantitative Bioassay/Quantitative Chemiluminescent Immunoassay

Limitations

Blocking antibodies specific to TSHR may decrease TSI antibody concentrations; net response is most likely physiologic

TSH serum concentration ≥6 mU/L may cause a false-positive result

Thyroid Stimulating Hormone Receptor Antibody (TRAb) 2002734
Method: Quantitative Electrochemiluminescent Immunoassay

Fructosamine 0099012
Method: Quantitative Spectrophotometry

Limitations

Variations in concentrations of serum proteins can affect results

High concentration of ascorbic acid interferes with the assay

1,5 Anhydroglucitol Quantitative, Serum or Plasma 0081335
Method: Quantitative Enzymatic

Limitations

Do not use in poorly controlled disease because test is not sensitive

In patients with poorly controlled DM 1,5-AG is less sensitive to modest changes in glycemic control due to continuous glycosuria

Decreased in individuals with renal glucose thresholds that are markedly different from 180 mg/dL (eg, chronic renal failure, pregnancy, dialysis) and in those undergoing steroid therapy

Alpha-glucosidase inhibitors can decrease 1,5-AG by interfering with intestinal absorption

Additional Tests Available

Glutamic Acid Decarboxylase Antibody 2001771
Method: Semi-quantitative Enzyme-Linked Immunosorbent Assay

Comments

If pursuing antibody testing to determine autoimmune diabetes mellitus, perform at least 2 antibody tests

Other antibody tests include islet antigen-2 (IA-2); insulin antibody (IAA); islet cell cytoplasmic antibody, IgG (ICA); and zinc transporter 8 (ZnT8)

Most useful to establish autoimmune etiology in previously diagnosed type I DM

Do not use to differentiate type 1 versus type 2 DM, for most cases

IA-2 Antibody 0050202
Method: Quantitative Radioimmunoassay

Comments

If pursuing antibody testing to determine autoimmune diabetes mellitus, perform at least 2 antibody tests

Other antibody tests include glutamic acid decarboxylase antibody (GAD); insulin antibody (IAA); islet cell cytoplasmic antibody, IgG (ICA); and zinc transporter 8 (ZnT8)

Most useful to establish autoimmune etiology in previously diagnosed type I DM

Do not use to differentiate type 1 versus type 2 DM, for most cases

Insulin Antibody 0099228
Method: Quantitative Radioimmunoassay

Comments

Use to determine presence of antibodies to exogenous insulin analogues; testing not recommended for patients receiving insulin > 2 weeks, as insulin antibody formation may occur

If pursuing antibody testing to determine autoimmune diabetes mellitus, perform at least 2 antibody tests

Other antibody tests include glutamic acid decarboxylase antibody (GAD); islet antigen-2 (IA-2); islet cell cytoplasmic antibody, IgG (ICA); and zinc transporter 8 (ZnT8)

Do not use to differentiate type 1 versus type 2 DM, for most cases

Zinc Transporter 8 Antibody 2006196
Method: Semi-Quantitative Enzyme-Linked Immunosorbent Assay

Comments

If pursuing antibody testing to determine autoimmune diabetes mellitus, perform at least 2 antibody tests

Other antibody tests include glutamic acid decarboxylase antibody (GAD); islet antigen-2 (IA-2); islet cell cytoplasmic antibody, IgG (ICA); and insulin antibody (IAA)

Most useful to establish autoimmune etiology in previously diagnosed type I DM

Do not use to differentiate type 1 versus type 2 DM, for most cases

Islet Cell Cytoplasmic Antibody, IgG 0050138
Method: Semi-Quantitative Indirect Fluorescent Antibody

Comments

If pursuing antibody testing to determine autoimmune diabetes mellitus, perform at least 2 antibody tests

Other antibody tests include glutamic acid decarboxylase antibody (GAD); islet antigen-2 (IA-2); insulin antibody (IAA); and zinc transporter 8 (ZnT8)

Most useful to establish autoimmune etiology in previously diagnosed type I DM

Do not use to differentiate type 1 versus type 2 DM, for most cases

C-Peptide, Serum or Plasma 0070103
Method: Quantitative Chemiluminescent Immunoassay

Comments

Aids in the detection of insulinoma

May aid in distinguishing type 1 from type 2 DM in ambiguous cases

Do not use to diagnose DM

Insulin, Free and Total 0070155
Method: Quantitative Ultrafiltration/Quantitative Chemiluminescent Immunoassay

Comments

Not recommended to diagnose DM

Insulin, Random 0070107
Method: Quantitative Chemiluminescent Immunoassay

Comments

Aids in the detection of insulinoma

Do not use to diagnose DM

Insulin, Fasting 0070063
Method: Quantitative Chemiluminescent Immunoassay

Comments

Aids in the detection of insulinoma

Do not use to diagnose DM

Guidelines

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American Diabetes Association. Standards of medical care in diabetes-2015 abridged for primary care providers. Clin Diabetes. 2015; 33(2): 97-111. PubMed

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Committee on Practice Bulletins--Obstetrics. Practice Bulletin No. 137: Gestational diabetes mellitus. Obstet Gynecol. 2013; 122(2 Pt 1): 406-16. PubMed

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Diabetes in Pregnancy. In National Collaborating Centre for Women’s and Children’s Health. Management of Diabetes and Its Complications from Preconception to the Postnatal Period, London: RCOG Press, 2008.

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Phillip M, Battelino T, Rodriguez H, Danne T, Kaufman F, European Society for Paediatric Endocrinology, Lawson Wilkins Pediatric Endocrine Society, International Society for Pediatric and Adolescent Diabetes, American Diabetes Association, European Association for the Study of Diabetes. Use of insulin pump therapy in the pediatric age-group: consensus statement from the European Society for Paediatric Endocrinology, the Lawson Wilkins Pediatric Endocrine Society, and the International Society for Pediatric and Adolescent Diabetes, endors Diabetes Care. 2007; 30(6): 1653-62. PubMed

Qaseem A, Vijan S, Snow V, Cross T, Weiss K, Owens D, Clinical Efficacy Assessment Subcommittee of the American College of Physicians. Glycemic control and type 2 diabetes mellitus: the optimal hemoglobin A1c targets. A guidance statement from the American College of Physicians. Ann Intern Med. 2007; 147(6): 417-22. PubMed

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Medical Reviewers

Last Update: January 2016