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Standard criteria for the diagnosis of diabetes Hemoglobin A1c > 6.5%. PAML uses the recommended laboratory method for measuring hemoglobin A1c, which is in compliance with the National Glycohemoglobin Standardization Program (NGSP) and the Diabetes Control and Complications Trial (DCCT). Fasting plasma glucose (FPG) > 126 mg/dL. Fasting is defined as no caloric intake for at least 8 hours. 2-hour plasma glucose > 200 mg/dL during an oral glucose tolerance test (OGTT). The test should be performed as described by the World Health Organization, using a glucose load containing the equivalent of 75 g anhydrous glucose dissolved in water. In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose > 200 mg/dL. In the absence of unequivocal hyperglycemia, results should be confirmed by repeat testing. Laboratory Testing Guidelines for Diagnosis and Monitoring of Diabetes Testing for diabetes in asymptomatic patients Testing to detect Type 2 diabetes and assess risk for future diabetes in asymptomatic people should be considered in adults of any age who are overweight or obese (BMI > 25 kg/m2) and who have one or more additional risk factors. Physical inactivity First-degree relative with diabetes High-risk race/ethnicity (e.g., African American, Latino, Native American, Asian American, Pacific Islander) Women who delivered a baby weighing > 9 lbs or were diagnosed with gestational diabetes Hypertension (> 140/90 or on therapy for hypertension) HDL cholesterol level < 35 mg/dL and/or triglyceride level > 250 mg/dL Women with polycystic ovarian syndrome (PCOS) A1C > 5.7%, impaired glucose tolerance or impaired fasting glucose on previous testing Other clinical conditions associated with insulin resistance (e.g., severe obesity, acathosis nigricans) History of cardiovascular disease In the absence of the above criteria, testing should begin at age 45 years To test for diabetes or to assess risk of future diabetes in asymptomatic individuals, consider hemoglobin A1c, fasting plasma glucose or 2-hour 75-g oral glucose tolerance testing If tests are normal, carry out repeat testing at 3-year intervals. In those identified with increased risk for future diabetes, identify and, if appropriate, treat other cardiovascular disease (CVD) risk factors. The following is a summary of current laboratory testing guidelines for the diagnosis and monitoring of diabetes. OR OR OR 061312 Diabetes Guidelines_PAML_DIAGUIDE_0001
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Page 1: Laboratory Testing Guidelines for Diagnosis and … Guidelines.pdf · Standard criteria for the diagnosis of diabetes Hemoglobin A1c > 6.5%. PAML uses the recommended laboratory method

Standard criteria for the diagnosis of diabetes

Hemoglobin A1c > 6.5%.PAML uses the recommended laboratory method for measuring hemoglobin A1c, which is in compliance with the National Glycohemoglobin Standardization Program (NGSP) and the Diabetes Control and Complications Trial (DCCT).

Fasting plasma glucose (FPG) > 126 mg/dL.

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

2-hour plasma glucose > 200 mg/dL during an oral glucose tolerance test (OGTT).

The test should be performed as described by the World Health Organization, using a glucose load containing the equivalent of 75 g anhydrous glucose dissolved in water.

In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose > 200 mg/dL.

In the absence of unequivocal hyperglycemia, results should be confi rmed by repeat testing.

Laboratory Testing Guidelines for Diagnosis and Monitoring of Diabetes

Testing for diabetes in asymptomatic patients

Testing to detect Type 2 diabetes and assess risk for future diabetes in asymptomatic people should be considered in adults of any age who are overweight or obese (BMI > 25 kg/m2) and who have one or more additional risk factors.

► Physical inactivity

► First-degree relative with diabetes

► High-risk race/ethnicity (e.g., African American, Latino, Native American, Asian American, Pacifi c Islander)

► Women who delivered a baby weighing > 9 lbs or were diagnosed with gestational diabetes

► Hypertension (> 140/90 or on therapy for hypertension)

► HDL cholesterol level < 35 mg/dL and/or triglyceride level > 250 mg/dL

► Women with polycystic ovarian syndrome (PCOS)

► A1C > 5.7%, impaired glucose tolerance or impaired fasting glucose on previous testing

► Other clinical conditions associated with insulin resistance (e.g., severe obesity, acathosis nigricans)

► History of cardiovascular disease

► In the absence of the above criteria, testing should begin at age 45 years

► To test for diabetes or to assess risk of future diabetes in asymptomatic individuals, consider hemoglobin A1c, fasting plasma glucose or 2-hour 75-g oral glucose tolerance testing

If tests are normal, carry out repeat testing at 3-year intervals.

In those identifi ed with increased risk for future diabetes, identify and, if appropriate, treat other cardiovascular disease (CVD) risk factors.

The following is a summary of current laboratory testing guidelines for the diagnosis and monitoring of diabetes.

OR

OR

OR

061312Diabetes Guidelines_PAML_DIAGUIDE_0001

Page 2: Laboratory Testing Guidelines for Diagnosis and … Guidelines.pdf · Standard criteria for the diagnosis of diabetes Hemoglobin A1c > 6.5%. PAML uses the recommended laboratory method

Gestational diabetes mellitus (GDM)

A universal recommendation for the ideal approach for screening and diagnosis of GDM remains elusive. Therefore, presented here are two approaches:

• From the American Diabetes Association (ADA) and the International Association of Diabetes and Pregnancy Study Group (IADPSG)

• From the American Congress of Obstetricians and Gynecologists (ACOG). PAML offers panels that will accommodate either approach.

American Diabetes Association and International Association of Diabetes and Pregnancy Study Groups Recommendations for GDM

Screen for undiagnosed type 2 diabetes at the fi rst prenatal visit in those with risk factors, using the standard diagnostic criteria listed above.

In pregnant women not known to have diabetes, screen for GDM at 24 – 28 weeks gestation using a 75-g 2-hour OGTT.

The OGTT should be performed in the morning after an overnight fast of at least 8 hours.

The diagnosis of GDM when any one of the following diagnostic cut points is exceeded:

► Fasting > 92 mg/dl ► 1 hour > 180 mg/dl ► 2 hours > 153 mg/dL

Screen women with GDM for persistent diabetes 6 – 12 weeks postpartum.

Women with a history of GDM should have lifelong screening for the development of diabetes or prediabetes at least every 3 years.

American Congress of Obstetricians and Gynecologists Recommendations for GDM

All pregnant women should be screened for GDM, whether by patient history, clinical risk factors or a 50-gram, 1-hour loading dose test to determine blood glucose levels. The cut point for this test is > 130 mg/dL The diagnosis of GDM can be made based on the result of a 100-gram, 3-hour glucose tolerance test, when two or more of the following cut points for plasma glucose are exceeded:

► Fasting > 95 mg/dL ► 1 hour > 180 mg/dL ► 2 hours > 155 mg/dL ► 3 hours > 140 mg/dL

Hemoglobin A1c Testing

Reference Range 4.0 - 5.6%Hemoglobin A1c values of 5.7% - 6.4% indicate an increased risk for developing diabetes mellitus.Hemoglobin A1c values equal to or greater than 6.5% are diagnostic of diabetes mellitus.Diagnosis should be confi rmed by repeating the hemoglobin A1c test.

The ADA recommends A1c values of less than 7% as the goal for diabetic therapy in most patients.The A1c goal of 7% corresponds to an estimated average glucose of 154 mg/dL.PAML uses the ADA recommended formula for calculating estimated average glucose.For Type 2 diabetics, ADA recommends that more stringent A1c goals (e.g., 6.0 - 6.5%) may be consid-ered in selected patients (with short disease duration, long life expectancy no signifi cant CVD) if this can be achieved without signifi cant hypoglycemia or other adverse effects of treatment.For Type 2 diabetics, ADA recommends that less strin-gent A1c goals (e.g., 7.5 – 8.0% or even slightly higher) are appropriate for patients with a history of severe hypoglycemia, limited life expectancy, advanced com-plications, extensive comorbid conditions and those in whom the target is diffi cult to attain despite intensive self-management, education, repeated counseling and effective doses of multiple glucose-lowering agents, including insulin.Perform hemoglobin A1c testing at least two times a year in patients who are meeting treatment goals and who have stable glycemic control.Perform hemoglobin A1c testing quarterly in patients whose therapy has changed or who are not meeting glycemic goals.

References

1. Executive Summary: Standards of Medical Care in Diabetes – 2011. Diabetes Care 2011;34 Suppl I:S4 – S10.

2. Position Statement: Standards of Medical Care in Diabetes – 2011. Diabetes Care 2011;34 Suppl I:S11 – S61.

3. Position Statement: Diagnosis and Classifi cation of Diabetes Mellitus. Diabetes Care 2011;34 Suppl I;S62 – S69.

4. Committee Opinion: Screening and Diagnosis of Gestational Diabetes Mellitus. September 2011, Number 504, American Congress of Obstetricians and Gynecologists Committee on Obstetric Practice;1 – 3.

5. Management of Hyperglycemia in Type 2 Diabetes: A Patient-Centered Approach. Position Statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care 2012;35:1364-1379.

Diagnosis

Diabetic Monitoring

Page 3: Laboratory Testing Guidelines for Diagnosis and … Guidelines.pdf · Standard criteria for the diagnosis of diabetes Hemoglobin A1c > 6.5%. PAML uses the recommended laboratory method

DESCRIPTION ORDER CODE

CPTCODE SPECIMEN RANGES

Glucose Challenge1 HR (PREG)

GCTPG 82950 2 mL serum (red-top tube). Collect sample 1 hour after 50-gram glucose load. Separate serum from the cells within 30 minutes of collection and put in separate plastic tube. Store and transport refrigerated.

Note: Diet requirements are not necessary.GCTPG is to be used only to order a screening test for gestational diabetes in pregnant patients.

LT 130 mg/dLPresumptive Gestational Diabetes MellitusThis threshold value applies to a blood glucose drawn 1 hour after a 50-gram oral glucose load. An abnormal result should be verifi ed by a 3-hour (100 gram) glucose tolerance test (ACOG protocol for gestational diabetes).

Glucose, Fasting GLU 82947 2 mL serum (red-top tube). Separate serum from the cells within 30 minutes of collection and put in separate plastic tube. Store and transport refrigerated. Record patient’s fasting status.

0-2 days premature 30-80 mg/dL0-2 days full term 40-902 days - 1 month 60-105Adult 65-99Pregnant 65-92

ADA Diagnostic Categories for Nonpregnant Adults:Impaired Fasting Glucose: 100-125 mg/dLA fasting glucose result of 126 mg/dL or greater indicates diabetes if the abnormality is confi rmed on a subsequent day. A random glucose of GT 200 mg/dL indicates diabetes if the abnormality is confi rmed on a subsequent day.

Glucose, Specifi c GLUSP 82947 2 mL serum (red-top tube). Separate serum from the cells within 30 minutes of collection and put in separate plastic tube. Store and transport refrigerated. GLUSP is to be used only for an additional glucose specimen. Please be specifi c when recording the nature of the specimen.

0-2 days premature 30-80 mg/dL0-2 days full term 40-902 days - 1 month 60-105Adult 65-99Pregnant 65-92

ADA Diagnostic Categories for Nonpregnant Adults:Impaired Fasting Glucose: 100-125 mg/dLA fasting glucose result of 126 mg/dL or greater indicates diabetes if the abnormality is confi rmed on a subsequent day. A random glucose of GT 200 mg/dL indicates diabetes if the abnormality is confi rmed on a subsequent day.

Glucose Tolerance 2 HR

GTOL2 8295082947

2 mL serum (red-top tube) for each timed sample. Draw fasting sample just prior to 75-gram glucose load. Draw other sample at the 2-hour interval. Separate serum from the cells within 30 minutes of collection and put in separate plastic tube. Clearly label tubes. Store transport refrigerated. Call PAML for printed diet requirements.

Glucose, Fasting0-2 days premature 30-80 mg/dL0-2 days full term 40-902 days - 1 month 60-105Adult 65-99

Glucose, 2 HourLT 140 mg/dL Normolglycemia140-199 Increased risk for diabetes200 or more Indicates diabetes.

In the absence of unequivocal hyperglycemia, results should be confi rmed by repeat testing.

Page 4: Laboratory Testing Guidelines for Diagnosis and … Guidelines.pdf · Standard criteria for the diagnosis of diabetes Hemoglobin A1c > 6.5%. PAML uses the recommended laboratory method

DESCRIPTION ORDER CODE

CPTCODE

SEGNARNEMICEPS

Glucose Tolerance 3 HR (PREG)

GTPG 8295182952

2 mL serum (red-top tube) for each timed sample. Draw fasting sample just prior to 100-gram glucose load. Draw additional samples at 1-hour, 2-hour, and 3-hour intervals. Separate serum from the cells within 30 minutes of collection and put in separate plastic tube. Clearly label each specimen. Store and transport refrigerated. This is the ACOG recommended study for the diagnosis of gestational diabetes in pregnant patients.

Two or more of the following threshold values must be met or exceeded to diagnose gestational diabetes.

Glucose, Fasting 95 mg/dLGlucose, 1-Hour 180Glucose, 2-Hour 155Glucose, 3-Hour 140

Glucose, Random GLU 82947 2 mL serum (red-top tube). Separate serum from the cells within 30 minutes of collection and put in separate plastic tube. Store and transport refrigerated.

0-2 days premature 30-80 mg/dL0-2 days full term 40-902 days - 1 month 60-105Adult 65-99Pregnant 65-92

ADA Diagnostic Categories for Nonpregnant Adults:Impaired fasting glucose:100-125 mg/dLA fasting glucose result of 126 mg/dL or greater indicates diabetes if the abnormality is confi rmed on a subsequent day. A random glucose of 200 mg/dL or greater for a symptomatic patient indicates diabetes if the abnormality is confi rmed on a subsequent day. Confi rmation by fasting glucose is preferred.

Glucose Tolerance 2 HR (PREG)

GTT2PG 82951 2 mL serum (red-top tube) or for each timed sample. Draw fasting sample just prior to 75-gram glucose load. Draw additional samples at 1-hour and 2-hour intervals. Separate serum from the cells within 30 minutes of collection and put in separate plastic tube. Clearly label tubes. Store and transport refrigerated. This is the ADA option for the diagnosis of gestational diabetes in pregnant patients. It should not be confused with the 2-hour GTT used for nonpregnant adults in the diagnosis of type 2 diabetes.

One or more of the following threshold values must be met or exceeded to diagnose gestational diabetes.

Glucose, Fasting 92 mg/dLGlucose, 1-Hour 180Glucose, 2-Hour 153

These criteria apply to the 2-hour (75-gram) ADA glucose tolerance testing protocol for gestational diabetes.

Hemoglobin A1C(Glycohemoglobin)

GLYCO 83036 1mL whole blood (EDTA lavender tube). Store and transport refrigerated.

- Hemoglobin A1c 4.0 - 5.6%- Hemoglobin A1c values of 5.7 - 6.4% indicate an increased risk for developing diabetes mellitus.- Hemoglobin A1c values equal to or greater than 6.5% are diagnostic of diabetes mellitus.- Diagnosis should be confi rmed by repeating the hemoglobin A1c test.- The ADA recommends A1c values of less than 7% as the global for diabetic therapy. This A1c goal corresponds to an estimated average glucose of 154 mg/dL.- PAML uses the ADA recommended formula for calculating estimated average glucose.


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