Diabetes Mellitus

Type 2 Diabetes, Impaired Glucose Tolerance

  • Diagnosis
  • Screening
  • Monitoring
  • Background
  • Pediatrics
  • Lab Tests
  • References
  • Related Topics
  • Videos

Indications for Testing

  • Polyuria, polydipsia, polyphagia, weight loss, fatigue
  • Overweight/obesity (BMI ≥25 kg/m2 or ≥23 kg/m2 in Asian Americans)
  • Family history of type 2 diabetes mellitus (T2DM) 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, dyslipidemiapolycystic ovarian syndrome (PCOS), low birthweight)
  • Maternal history of DM or gestational DM (GDM) during pregnancy

Criteria for Diagnosis

Laboratory Testing

  • Initial testing – hemoglobin A1c (HbA1c), fasting plasma glucose (FPG), 2-hour oral glucose tolerance test (OGTT), or plasma glucose (PG) are all acceptable tests to diagnose DM in nonpregnant adults (refer to Criteria for Diagnosis) (American Diabetes Association [ADA], 2017)
  • HbA1c – glycosylated hemoglobin, glycolated hemoglobin
    • Advantages
      • Not dependent on fasting (convenient)
      • Point of care testing available
      • Less daily variation
    • Limitations
      • Cost
      • Lower sensitivity
      • May be less available in some regions of world (usually not issue in U.S.)
      • Indirect measure
        • Impacted by age, race/ethnicity, anemia, and hemoglobinopathies
      • Point of care assays limited by proficiency of person conducting test
      • Cutoffs determined for adults; unclear whether these are transferrable to children
  • Autoimmune antibody testing
    • Use
      • Testing for autoantibodies should be performed
        • After diabetes diagnosis AND
        • If there is a concern for type 1 DM (T1DM) (aids in confirmation)
      • Individual antibody tests should not be ordered; instead, ≥2 antibodies should be ordered (Insel, 2015)
      • Most useful in newly diagnosed DM in children <18 years to establish autoimmune etiology (American Association of Clinical Endocrinologists [AACE], 2015)
      • May be useful in difficult adult cases when it is unclear if patient has T1DM or T2DM (Bingley, 2010)
      • Lack of antibodies suggests a genetic etiology (eg, monogenic DM, maturity-onset diabetes of the young [MODY]) in patients with DM  (Bingley, 2010; National Institutes of Health [NIH], 2014)
    • Tests
      • Demonstration of glutamic acid decarboxylase antibodies (GADA) and ≥1 of the following antibodies is highly suggestive of autoimmune T1DM
        • GADA/GAD 65
          • Also a marker for other autoimmune diseases
        • Islet antigen 2 (IA-2)
          • More specific than GAD 65 for diabetes
        • Islet cell cytoplasmic antibody (ICA), IgG
        • Zinc transporter 8 (ZnT8) 
        • Insulin antibody (IA) – less useful; essentially all individuals receiving insulin will develop insulin antibodies

Differential Diagnosis

  • T2DM
  • T1DM (ketoacidosis)
  • GDM
    • Infection
    • Acute surgical abdomen
      • Appendicitis
      • Cholecystitis/cholelithiasis
      • Pregnancy-related abdominal problem
        • Intrauterine infection
    • Thyroid disease
  • Tests that are used for diagnosis are also used for screening
    • Hemoglobin A1c (HbA1c), fasting plasma glucose (FPG), 2-hour oral glucose tolerance test (OGTT), or plasma glucose (PG)
    • Not all tests will detect diabetes mellitus (DM) in same individual
    • Imperfect concordance between these 3 tests 

Adults (1 of the Following Criteria)

Pregnant Women (Gestational DM)

  • All pregnant females not previously known to have diabetes should be screened for gestational DM (GDM) at 24-28 weeks gestation (American Diabetes Association [ADA], 2017; American Congress of Obstetricians and Gynecologists [ACOG], 2013; American Association of Clinical Endocrinologists [AACE]/American College of Endocrinology [ACE], 2015)
    • Screen if GDM identified 4-12 weeks postpartum using OGTT according to nonpregnant criteria (ADA, 2017)
    • Test for DM at least every 3 years thereafter (ADA, 2017)

Physical Examination

Laboratory Testing

  • Dyslipidemia
    • Lipid panel (fasting)
      • Premise of testing
        • Patients with diabetes mellitus (DM) have an increased incidence of lipid abnormalities, creating risk for atherosclerotic cardiovascular disease (ASCVD)
        • Lipid-lowering therapies have been demonstrated to reduce macrovascular disease; therefore, identification of dyslipidemia is important
        • ASCVD risk tracks more closely with LDL-P when there is discordance between LDL-C and LDL-P
      • Target goals (ADA, 2017)
      • Recommendations for Statin and Combination Treatment in People with Diabetes (ADA, 2017)


        Risk Factors

        Recommended Statin Intensitya

        <40 yrs



        ASCVD risk factor(s)b Moderate or high
        ASCVD High

        40-75 yrs



        ASCVD risk factors High
        ASCVD High
        ACS and LDL cholesterol >50 mg/dL (1.3 mmol/L) in patients who cannot tolerate high-dose statins Moderate plus ezetimibe

        >75 yrs



        ASCVD risk factors Moderate or high
        ASCVD High
        ACS and LDL cholesterol >50 mg/dL (1.3 mmol/L) in patients who cannot tolerate high-dose statins Moderate plus ezetimibe
      • Laboratory testing recommendations
        • Initial evaluation every 5 years in DM for those not taking statins
        • Lipid profile at initiation of statins and periodically thereafter
        • Treat aggressively with statins based on initial risk assessment (American College of Cardiology [ACC]/American Heart Association [AHA], 2013)
          • No target goals set by ACC/AHA
  • LipoFit and LipoFit particle count only by quantitative nuclear magnetic resonance spectroscopy (emerging testing)
    • Premise of testing
      • High risk patients with DM who have abnormal LDL levels
    • Laboratory testing recommendations
      • Monitor LDL particle number to guide therapy
  • 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 (elevated urinary albumin-to–creatinine ratio >30 mg/g creatinine) signifies the earliest stage of diabetic nephropathy
    • Target goal
      • <30 mg/24-hour urine (ADA, 2017; AACE/ACE, 2015)
    • Laboratory testing recommendations
      • Spot urine or 24-hour urine for microalbumin at least annually for the following patients
        • Type 1 DM (T1MD) ≥5 years
        • All patients with type 2 DM (T2DM)
        • All patients with hypertension
  • Antiplatelet agents (ADA, 2017)
    • Premise of testing
      • Patients with DM are at increased risk for stroke and heart attack
      • Consider acetylsalicylic acid in those with >10% 10-year cardiovascular risk
    • Laboratory testing recommendations
      • None
  • Hepatic function
    • Premise of testing
      • Patients with DM are at risk for steatohepatitis
    • Laboratory testing recommendations
      • Liver function tests –  aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, and bilirubin
      • Initial evaluation and annually thereafter if values are normal on initial testing
  • Renal function (ADA, 2017)
    • 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 at least annually
          • For the following patients
            • T1DM ≥5 years
            • All patients with T2DM
            • All patients with hypertension
          • More frequent monitoring necessary for abnormal eGFRs (ADA, 2017)
          • Kidney Disease: Improving Global Outcomes (KIDGO) guidelines are useful for deciding intervals for abnormal values (KIDGO, 2011)
  • Thyroid function (ADA, 2017)
    • Thyroid-stimulating hormone (TSH), autoimmune antibodies
      • Premise of testing
      • Laboratory testing recommendations
        • Initial evaluation using TSH/antibody testing (for T1DM) and, if normal, TSH every 1-2 years thereafter (ADA, 2017)
  • Celiac testing (ADA, 2017)
    • tTG or DPG with documentation of normal IgA
    • Premise of testing
      • Other autoimmune diseases occur more frequently in individuals with T1DM
    • Laboratory testing recommendations
      • At initial diagnosis
      • If symptoms develop after diagnosis

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 (T1DM)
    • 90-95% in pediatric population; absolute insulin deficiency due to autoimmune destruction of islet cells
  • Type 2 DM (T2DM)
    • Most are teenagers or older; insulin resistance with or without insulin deficiency
  • Gestational DM (GDM)
    • Exclusive to pregnant females
  • Other types of DM due to other causes

Type 1 Diabetes Mellitus

Refer to Pediatrics section

Type 2 Diabetes Mellitus

Gestational Diabetes Mellitus

Type 1 Diabetes Mellitus (T1DM)

Clinical Background


  • 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, American Diabetes Association [ADA], Insel, 2015)
        • Stage 1 – autoimmunity +/normoglycemia/presymptomatic T1DM
        • Stage 2 – autoimmunity +/dysglycemia/presymptomatic T1DM
        • Stage 3 – autoimmunity +/dysglycemia/symptomatic T1DM


  • Autoimmune-mediated destruction of insulin-producing beta (β)-cells of islets of Langerhans in pancreas with diminished or absent circulating insulin
  • Absolute insulin deficiency of T1DM is a result of
    • Chronic inflammatory response mediated against 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 (GAD)
        • Insulinoma antigen 2 (IA-2)
        • Insulin autoantibodies (IAA)
        • Zinc transporter 8 (ZnT8)
      • Presence of 2 or more of these antibodies is a major criteria for stage 1 DM (presymptomatic stage)
      • Number of autoantibodies appears to correlate with risk of T1DM 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
    • Short term – diabetic ketoacidosis (~33% of affected individuals present with this)
    • Long term – refer to type 2 DM (T2DM) Clinical Background section

Type 2 Diabetes Mellitus (T2DM)


Indications for Testing

  • Overweight or obese for age and sex plus ≥2 risk factors
    • Family history of T2DM
    • Race/ethnicity
    • Signs of insulin resistance
    • Maternal history of DM or gestational DM (GDM) during child’s gestation

Criteria for Diagnosis

Cutoffs for pediatrics are the same as for adults; however, studies that form the basis for these recommendations were based on adults.

Laboratory Testing

  • Hemoglobin A1c (HbA1c), fasting plasma glucose (FPG), 2-hour oral glucose tolerance test (OGTT), and plasma glucose (PG) are the preferred tests to diagnose diabetes in children (ADA, 2017)
    • Random glucose measures have greater variability and less reproducibility in children
  • Insulin antibody testing
    • No indication for routine evaluation or management (ADA, 2016)


  • Screening advocated because of increasing prevalence of T2DM in children
  • Recommended age to begin screening – 10 years (or at onset of puberty if puberty occurs at a younger age)
    • American Association of Clinical Endocrinologists (AACE), 2011 – screen every 3 years if overweight and have 2 other risk factors
      • Risk factors include family history, race/ethnicity recognized to increase risk, signs of insulin resistance, maternal history of diabetes, or GDM during child’s gestation


  • HbA1c
    • Premise of testing
      • Glycation of hemoglobin is nonlinear over time and occurs over the whole lifespan of the red blood cell (~120 days)
      • Correlates with risk of long-term complications and with DM control over previous 2-3 months
    • Target goal (ADA, 2017)
      • <7.5% for all pediatric groups
    • Laboratory testing recommendations
      • ≥2 measurements per year for patients meeting target goal (ADA, 2017)
        • 3-month testing for those not meeting goals
        • If patient is not hypoglycemic, goal should be <7%
        • Blood glucose goals should be modified in children with frequent hypoglycemia or hypoglycemia unawareness
          • Hypoglycemia not infrequent when children are using insulin; diligence required for younger children
      • More frequent monitoring in patients with HbA1c ≥7.5%
        • Not more often than every 3 months (ADA, 2017; AACE/American College of Endocrinology [ACE], 2015)
      • False lowering – hemolytic anemias, sickle cell disease, acute blood loss
      • False elevation – splenectomy, iron deficiency anemia, hyperbilirubinemia, hypertriglyceridemia, uremia
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


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


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


Variations in concentrations of serum proteins can affect results

High concentration of ascorbic acid interferes with assay

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

LipoFit by NMR 2013716
Method: Quantitative Nuclear Magnetic Resonance Spectroscopy/ Quantitative Enzymatic/ Detergent Solubilization

LipoFit by NMR, Particle Count Only 2013715
Method: Quantitative Nuclear Magnetic Resonance Spectroscopy


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Medical Reviewers

Content Reviewed: 
May 2017

Last Update: September 2017