JAH Lab Bulletin No.

1, Feb 2010

Excerpts from Standards of Medical Care in Diabetes—2010

(AMERICAN DIABETES ASSOCIATION)

Download Link of complete document http://care.diabetesjournals.org/content/33/Supplement_1/S11.full.pdf

Originally approved 1988. Most recent review/revision October 2009.

Diagnosis of diabetes - Recommendations

For decades, the diagnosis of diabetes has been based on plasma glucose (PG) criteria, either fasting PG (FPG) or 2-h 75-g oral
glucose tolerance test (OGTT) values.
In 1997, the first Expert Committee on the Diagnosis and Classification of Diabetes Mellitus revised the diagnostic criteria using the
observed association between glucose levels and presence of retinopathy as the key factor with which to identify threshold FPG and 2-
h PG levels. The committee examined data from three cross-sectional epidemiologic studies that assessed retinopathy with fundus
photography or direct ophthalmoscopy and measured glycemia as FPG, 2-h PG, and HbA1c (A1C). The studies demonstrated
glycemic levels below which there was little prevalent retinopathy and above which the prevalence of retinopathy increased in an
apparently linear fashion.
The deciles of FPG, 2-h PG, and A1C at which retinopathy began to increase were the same for each measure within each population.
The analyses helped to inform a then-new diagnostic cut point of >= 126 mg/dl (7.0 mmol/l) for FPG and confirmed the long-
standing diagnostic 2-h PG value of >=200 mg/dl (11.1mmol/l)…………………………..

The established glucose criteria for the diagnosis of diabetes (FPG and 2-h PG) remain valid. Patients with severe hyperglycemia such
as those who present with severe classic hyperglycemic symptoms or hyperglycemic crisis can continue to be diagnosed when a
random (or casual) PG of >=200 mg/dl (11.1 mmol/l) is found.

Table 2—Criteria for the diagnosis of diabetes

1. A1C >=6.5%. The test should be performed in a laboratory using a method that is NGSP certi fied and
standardized to the DCCT assay.*
OR
2. FPG >=126 mg/dl (7.0 mmol/l). Fasting is defined as no caloric intake for at least 8 h.*

OR
3. Two-hour plasma glucose >=200 mg/dl (11.1 mmol/l) during an 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.*

OR
4. In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose 2200
mg/dl (11.1 mmol/l).

*In the absence of unequivocal hyperglycemia, criteria 1–3 should be confirmed by repeat testing.

Table 3—Categories of increased risk for diabetes*

• FPG 100–125 mg/dl (5.6–6.9 mmol/l) [Impaired fasting glucose, IFG]
• 2-h PG on the 75-g OGTT 140–199 mg/dl (7.8–11.0 mmol/l) [Impaired glucose tolerance IGT]
• A1C 5.7–6.4%
•
*For all three tests, risk is continuous, extending below the lower limit of the range and becoming disproportionately
greater at higher ends of the range.
JAH Lab Bulletin No. 1, Feb 2010

TESTING FOR DIABETES IN ASYMPTOMATIC PATIENTS

Table 4—Criteria for testing for diabetes in asymptomatic adult individuals

2
1. Testing should be considered in all adults who are overweight (BMI >=25 kg/m *) and have additional risk factors:
• physical inactivity
• first-degree relative with diabetes
• members of a high-risk ethnic population (e.g., African American, Latino, Native American, Asian American,
Pacific Islander)
• women who delivered a baby weighing >9 lb or were diagnosed with GDM
• hypertension (>=140/90 mmHg or on therapy for hypertension)
• HDL cholesterol level <35 mg/dl (0.90 mmol/l) and/or a triglyceride level >250 mg/dl (2.82 mmol/l)
• women with polycystic ovary syndrome
• A1C >=5.7%, IGT, or IFG on previous testing
• other clinical conditions associated with insulin resistance (e.g., severe obesity, acanthosis nigricans)
• history of CVD

2. In the absence of the above criteria, testing diabetes should begin at age 45 years

3. If results are normal, testing should be repeated at least at 3-year intervals, with consideration of more frequent
testing depending on initial results and risk status.

*At-risk BMI may be lower in some ethnic groups.

________________________________________________________________________________
……………Because age is a major risk factor for diabetes, testing of those without other risk factors should begin no later
than at age 45 years.

Either A1C, FPG, or 2-h OGTT is appropriate for testing.

The 2-h OGTT identifies people with either IFG or IGT and thus more people at increased risk for the development
of diabetes and CVD. It should be noted that the two tests do not necessarily detect the same individuals. The efficacy
of interventions for primary prevention of type 2 diabetes has primarily been demonstrated among individuals
with IGT, but not for individuals with IFG (who do not also have IGT) or those with specific A1C levels.

The appropriate interval between tests is not known.

The rationale for the 3-year interval is that false negatives will be repeated before substantial time elapses, and there is
little likelihood that an individual will develop significant complications of diabetes within 3 years of a negative test
result………

Table 5—Testing for type 2 diabetes in asymptomatic children

Criteria: Overweight (BMI >85th percentile for age and sex, weight for height >85th percentile, or
weight >120% of ideal for height)
Plus any two of the • Family history of type 2 diabetes in first-or second-degree relative
following risk • Race/ethnicity (Native American, African American, Latino, Asian American, Paci fic
factors: Islander)
• Signs of insulin resistance or conditions associated with insulin resistance (acanthosis
nigricans, hypertension, dyslipidemia, polycystic ovary syndrome, or small for
gestational age birthweight)
• Maternal history of diabetes or GDM during the child’s gestation
Age of initiation: Age 10 years or at onset of puberty, if puberty occurs at a younger age
Frequency: Every 3 years
JAH Lab Bulletin No. 1, Feb 2010

DETECTION AND DIAGNOSIS OF Gestational DM

Recommendations

● Screen for GDM using risk factor analysis and, if appropriate, an OGTT.

● Women with GDM should be screened for diabetes 6–12 weeks postpartum and should be followed up with
subsequent screening for the development of diabetes or pre-diabetes.

Table 6—Screening for and diagnosis of GDM

First prenatal visit_____________________________________

Carry out diabetes risk assessment at the first prenatal visit.
Women at very high risk should be screened for diabetes as soon as possible after the con firmation of
pregnancy. Criteria for very high risk are:
• Severe obesity
• Prior history of GDM or delivery of large-for-gestational-age infant
• Presence of glycosuria
• Diagnosis of PCOS
• Strong family history of type 2 diabetes
* Screening/diagnosis at this stage of pregnancy should use standard diagnostic testing (Table 2)

24-28 weeks gestation_______________________________________

All women of greater than low risk of GDM, including those above not found to have diabetes early in pregnancy,
should undergo GDM testing at 24–28 weeks of gestation. Low-risk status, which does not require GDM
screening, is defined as women with ALL of the following characteristics:
• Age <25 years
• Weight normal before pregnancy
• Member of an ethnic group with a low prevalence of diabetes
• No known diabetes in first-degree relatives
• No history of abnormal glucose tolerance
• No history of poor obstetrical outcome
Two approaches may be followed for GDM screening at 24–28 weeks:
1. Two-step approach:
A. Perform initial screening by measuring plasma or serum glucose 1 h after a 50-g load of >=140 mg/dl identifies
80% of women with GDM, while the sensitivity is further increased to 90% by a threshold of >=130 mg/dl.
B. Perform a diagnostic 100-g OGTT on a separate day in women who exceed the chosen threshold on 50-g
screening.

2. One-step approach (may be preferred in clinics with high prevalence of GDM): Perform a diagnostic 100-g OGTT
in all women to be tested at 24–28 weeks. The 100-g OGTT should be performed in the morning after an overnight
fast of at least 8 h.
To make a diagnosis of GDM, at least two of the following plasma glucose values must be found:
• Fasting >= 95 mg/dl
• 1-h >= 180 mg/dl
• 2-h >= 155 mg/dl
• 3-h >= 140 mg/dl
JAH Lab Bulletin No. 1, Feb 2010

Glycohemoglobin
……………….American Diabetes Association has not previously recommended the use of A1C for diagnosing
diabetes, in part due to lack of standardization of the assay. However, A1C assays are now highly standardized, and their results can
be uniformly applied both temporally and across populations. In a recent report , after an extensive review
of both established and emerging epidemiological evidence, an international expert committee recommended the use of
the A1C test to diagnose diabetes with a threshold of >= 6.5%, and ADA affirms this decision .
The diagnostic test should be performed using a method certified by the National Glycohemoglobin Standardization
Program (NGSP) and standardized or traceable to the Diabetes Control and Complications Trial (DCCT) reference
assay.

Our laboratory is now performing A1C with NYCOCARD READER

NycoCard HbA1c has successfully completed the National

Glycohemoglobin Standardization Program (NGSP, USA) manufacturer
certification.
NycoCard HbA1c is now considered to be traceable to the Diabetes
Control and Complications Trial (DCCT) reference method. NycoCard
HbA1c has been certified every year since the first application in 2000.
This certificate of traceability expires 1 September, 2010.

Glucose tolerance test

Preparation and cautions
The patient is instructed not to restrict carbohydrate intake in the days or weeks before the test. The test should not be done during an
illness, as results may not reflect the patient's glucose metabolism when healthy. A full adult dose should not be given to a person
weighing less than 43 kg (94 lb), or exaggerated glucoses may produce a false positive result.

Procedure for OGTT

The patient should have been fasting for the previous 8-14 hours (water is allowed).
Usually the OGTT is scheduled to begin in the morning (0700-0800) as glucose tolerance exhibits a diurnal rhythm with a significant
decrease in the afternoon. A zero time (baseline) blood sample is drawn.
The patient is then given a glucose solution to drink. In the US, dosing is by weight, and since the late 1970s has been 1.75 grams
of glucose per kilogram of body weight, to a maximum dose of 75 g. Prior to 1975 a dose of 100 g was often used. The WHO
recommendation is for a 75g oral dose in all adults: the dose is adjusted for weight only in children. The dose should be drunk within 5
minutes.
For simple diabetes screening, the most important sample is the 2 hour sample and the 0 and 2 hour samples may be the only
ones collected..
If renal glycosuria (sugar excreted in the urine despite normal levels in the blood) is suspected, urine samples may also be collected
for testing along with the fasting and 2 hour blood tests.

Interpretation of OGTT results

WHO Diabetes criteria - Interpretation of Oral Glucose Tolerance Test

Glucose impaired fasting glycaemia impaired glucose tolerance Diabetes Mellitus
NORMAL
levels (IFG) (IGT) (DM)
Venous
Fasting 2hrs Fasting 2hrs Fasting 2hrs Fasting 2hrs
Plasma
(mg/dl) <100 <140 >100 & <126 <140 <126 >140 >126 >200