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Cardio IQ Diabetes Risk Panel with Score

Cardio IQ Diabetes Risk Panel with Score

Test Summary

Cardio IQ® Diabetes Risk Panel with Score

  

Clinical Use

  • Diagnose prediabetes
  • Assess risk for developing type 2 diabetes mellitus
  • Identify patients suitable for lifestyle interventions and/or pharmacotherapy

Clinical Background

Type 1 diabetes mellitus is defined as a deficiency of insulin secretion, typically caused by an autoimmune response leading to β-cell destruction. Type 2 diabetes, which accounts for >90% of all diabetes cases, is caused by a combination of insulin resistance and an inadequate compensatory insulin secretion.1 Type 2 diabetes frequently goes undiagnosed, because it has no classic symptoms of diabetes and it progresses slowly from a prediabetic state. The American Diabetes Association (ADA) defines prediabetes as: 1) impaired fasting glucose (100 to 125 mg/dL), 2) impaired glucose tolerance (140 to 199 mg/dL at 2 hours after 75g glucose), or 3) elevated hemoglobin A1c (5.7% to 6.4%).1

The U.S. Centers for Disease Control and Prevention estimates that 37% of individuals ≥20 years old and 51% of those ≥65 years old had prediabetes in 2012.2 These individuals are at high risk for progression to type 2 diabetes and are candidates for preventive therapy. Therapy options include lifestyle modification, such as weight loss and increased physical activity, and metformin.3 In clinical trials, these interventions reduced the rate of progression to type 2 diabetes by 43% at 7 years4 and also at 20 years.5

This test (Cardio IQ Diabetes Risk Panel with Score) provides an 8-year risk of developing type 2 diabetes based on fasting glucose level and lipid measurements combined with the patient's body mass index (BMI), blood pressure, and parental history of diabetes.6 In addition, the panel includes hemoglobin A1c measurement which, like blood glucose, can be used to diagnose prediabetes. The risk score is calculated by adding points (Table 1) for each risk parameter the patient has and using the total to calculate 8-year risk.7 Applying this algorithm to over 3,100 individuals age 30 to 79 years yielded an area under the receiver operating characteristic (ROC) curve of 0.85.6  The area under the ROC curve is a measure of accuracy; a "perfect" test would have an area of 1.0.

Table 1. Point Designation for Risk Parameters Used to Calculate 8-Year Risk of Type 2 Diabetesa

Parameter

Points

Fasting glucose level 100-126 mg/dL

10

BMI 25.0-29.9 kg/m2

2

BMI ≥30.0 kg/m2

5

HDL-cholesterol <40 mg/dL in men or <50 mg/dL in women

5

Parental history of diabetes mellitus

3

Triglycerides ≥150 mg/dL

3

Blood pressure ≥130/85 mm Hg or receiving treatment

2

BMI, body mass index.
a Adapted from Framingham Offspring Study, reference 6.

A related test, the Cardio IQ Diabetes and ASCVD Risk Panel with Scores (92063), provides a risk for diabetes and a risk for atherosclerotic cardiovascular disease.

Individuals Suitable for Testing

  • Individuals 45 to 79 years old
  • Individuals 30 to <45 years old who meet the screening criteria shown in Table 2

Table 2. Screening Criteria for Individuals 30 to <45 Years Olda

BMI ≥25 kg/m2 plus 1 or more risk factors:

  • Physical inactivity
  • First-degree relative with diabetes
  • High-risk ethnic group (eg, African American, Latino, Asian American, Native American)
  • History of GDM or delivering a baby >9 lb
  • Hypertension (≥140/90 mm Hg) or under treatment
  • Dyslipidemia (HDL cholesterol <35 mg/dL and/or triglycerides >250 mg/dL)
  • Impaired fasting glucose, impaired glucose tolerance, or elevated hemoglobin A1c
  • Signs of insulin resistance (eg, acanthosis nigricans, PCOS, severe obesity)
  • History of cardiovascular disease

BMI, body mass index; GDM, gestational diabetes mellitus; and PCOS, polycystic ovary syndrome.
a Adapted from reference 3.

Method

For panel components and methods used, see Table 3. A risk estimate will not be calculated if hemoglobin A1c is ≥6.5% and/or glucose is ≥126 mg/dL. These levels meet the criteria for the diagnosis of diabetes.1 Risk will be calculated only on individuals 30 to 79 years old.

Table 3. Individual Tests Included in the Cardio IQ Diabetes Risk Panel with Score

Test Code

Test Name

Method

91947

Cardio IQ Glucose

Spectrophotometry

91732

Cardio IQ Hemoglobin A1c

Immunoturbidimetry

91717

Cardio IQ Cholesterol, Total

Spectrophotometry

91719

Cardio IQ HDL Cholesterol

Spectrophotometry

91718

Cardio IQ Triglycerides

Spectrophotometry

91723

Cardio IQ Direct LDLa

Enzymatic

NAb

Cardio IQ Cholesterol/HDL Ratio

Calculation

NAb

Cardio IQ LDL Cholesterol

Calculation

NAb

Cardio IQ Non-HDL Cholesterol

Calculation

NAc

Cardio IQ 8-year diabetes risk

Calculation

a Test performed at an additional charge if triglycerides are >400 mg/dL.
b Not applicable; cannot be ordered separately; can be obtained as part of the Cardio IQ Lipid Panel (test code 91716).
c Not applicable; cannot be ordered separately.

Interpretive Information

A higher 8-year diabetes risk suggests a need for preventive therapy. Management options for patients at high risk of type 2 diabetes include3:

  • Weight loss of 7% of body weight and physical activity of ≥150 min/week
  • Consideration of metformin therapy, especially for those with BMI >35 kg/m2, aged <60 years old; and women with prior gestational diabetes mellitus
  • Follow-up counseling
  • Testing at least once a year for diabetes and screening for, and treatment of, cardiovascular disease risk factors

References

  1. American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2014;37(suppl 1):S81-S90.

  2. Centers for Disease Control and Prevention. National Diabetes Statistics Report, 2014. Available at: http://www.cdc.gov/diabetes/pubs/estimates14.htm#2. Accessed July 14, 2014.

  3. American Diabetes Association. Standards of medical care in diabetes-2014. Diabetes Care. 2014;37(suppl 1):S14-S80.

  4. Lindström J, IIanne-Parikka P, Peltonen M, et al. Finnish Diabetes Prevention Study Group. Sustained reduction in the incidence of type 2 diabetes by lifestyle intervention: follow-up of the Finnish Diabetes Prevention Society. Lancet. 2006;368:1673-1679.     

  5. Li G, Zhang P, Wang J, et al. The long-term effect of lifestyle interventions to prevent diabetes in the China Da Qing Diabetes Prevention Study: A 20-year follow-up. Lancet. 2008;371:1783-1789.

  6. Wilson PWF, Meigs JB, Sullivan L, et al. Prediction of incident diabetes mellitus in middle-aged adults. The Framingham Offspring Study. Arch Intern Med.2007;167:1068-1074.

  7. Framingham Heart Study. Available at : http://www.framinghamheartstudy.org/risk-functions/diabetes/index.php#. Accessed July 14, 2014.
     

 Content reviewed 09/2014
 

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