PRESENTATION

Diagnosis of Diabetes
Mellitus
Presented by:
Kanwal Amjad

Ground Rules
Please hold questions until the

end of presentation.

Please put cell phones on vibrate

or turn them off.

If you must take a cell phone

call, please leave the room

quietly.

LOs
1.Urine Test
2.Blood Test
>Random plasma glucose test
>Fasting plasma glucose test
>OGTT
>HbA1c
What is Prediabetes?

Urine Analysis

Glucosuria

Ketonuria

Microalbuminuria

 1.Urine test

Glucose :
By dipstick method
Screening procedure<lack

of resources

1-2 hrs. after meal to

maximize sensitivity

Convenient

LIMITATIONS
Lacks sensitivity
Poor specificity
Individual variation in renal threshold

6-15mmol/L High Renal threshold may

mask hyperglycemia
Negative Test does not differentiate

between normal and low levels of glucose

KETONES
(acetoacetate (AcAc),

acetone, hydroxybutyric
acid (HBA)
present in urine & blood in

very low concentrations

(total serum ketones <0.5

mmol/L)
Normally>fasting,strenous

exercise, repeated
vomiting, high fat diet

LIMITATIONS
Not pathognomic of diabetes
False + >> sulf-hydral containing drugs
False ->>ascorbic acid intake>acidic

urine

 Proteins:

Standard dipstick testing detects albumin >300mg/L

Specific albumin dipstick/biochemical measurements

detect microalbuminuria

(30-300mg/L) 24 h urine

Microalbuminuria in absence of UTI >imp. indicator of

diabetic nephropathy/macrvascular dis.

Blood Biochemistry
Blood glucose
o

Fasting plasma glucose

Random plasma glucose

Oral glucose tolerance test

Glycated hemoglobin (Hb1c) measurements

Serum fructosamine estimation
Serum insulin or c-peptide levels

Random Plasma Glucose Test

Use:
Diagnosis of diabetes : used only with classic

symptoms of hyperglycemia--- polyuria , polydipsia ,

polyphagia

>200mg/dL
Technical Features:
o Sample any time, no fast
o Sample Stability low requires processing in <2hrs.

 Pros:
o Convenient
o Part of basic metabolic panel screen
Cons:
o Indicates single point blood glucose level
o Used only in symptomatic patients,not

recommended for screening

o Greater within patient variability depending on

meals, exercise, sickness, and stress.

o Affected by short term lifestyle changes and

prandial state

Fasting Plasma Glucose Test

Use:
o Screening & diagnosis of Prediabetes or Impaired

Fasting Glucose(100-125mg/dL)
o Screening & diagnosis of Diabetes (>126mg/DL)
o Repeat for confirmation of diagnosis

* Any test used to diagnose diabetes requires

confirmation with a second measurement unless
clearSYMPTOMS OF DIABETESexist.

 Technical Features:
Diagnosis requires a lab

test not a meter

Sampling in morning after

8hr fast

Sample Stability low

requires processing within

30minutes

Sensitivity greater than

A1c test,less then OGTT

 Pros:
oLow cost
oAssay is widely available & automated
Cons:
oIndicates single point blood glucose level
oAffected by short term lifestyle changes stress/illness
oLess tightly linked to diabetes complications than HbA1c
oNot convenient for patient/healthcare provider <requires return

visit>
oDiurnal variation & sample not stable after collection
oHigh within patient variability
oInadequate standardization of Assay

OGTT
Use:
Screening & diagnosis of Prediabetes or

impaired glucose tolerance (140-199mg/dL at

2hr.)

Screening & diagnosis of Diabetes (200mg/dL

at 2hr.)

Repeat for confirmation of diagnosis

Screening & diagnosis of GDM

Technical Features:
Sampling in morning after 8hr.

Fast & 2hr. After glucose

load
Sample stability low requires

processing within 30mins.

Patients should ingest atleast

150g/day of carbohydrates for

3 days prior
Sensitivity greater than A1c or

FPG tests

Pros:
oSensitive indicator of risk of developing diabetes
oEarly marker of Impaired Glucose Balance
oCons:
oAffected by short term lifestyle changes stress/illness
oNot convenient for patient/healthcare provider requires fasting &

scheduling a morning appointment or return visit

oExtensive patient preparation
oSample not stable after collection
oHigh within patient variablity & is expensive

Glycated hemoglobin (Hb1c) test

Use:

Screening & diagnosis of Prediabetes (5.7-

6.4%)

Screening & diagnosis of Diabetes

(6.5%)

Repeat for confirmation of diagnosis

Monitoring of diabetes

Technical Features
o Diagnosis requires a lab test

certified by NGSP (National

Glycohemoglobin Standardization
Program) not meter
o Sample :any time of day/no fast
o Sample : anticoagulated whole

blood
o Sample stability :superior
o Sensitivity less than FPG test

&OGTT

 Pros:
oReflects long term blood glucose

concentrations(~3months)
oUnaffected by acute changes in Glucose levels due to

stress/illness
oHighly correlated with risks for complications such as

retinopathy & cardiovascular disease

oConvenient for patients & healthcare providers
oMost stable sample after collection
oLow within patient variability
oEstablished international standardization of lab tests

 Cons:

oLow sensitivity : identifies few cases of

diabetes than other blood glucose tests

oINTERFERENCE resulting in falsely increased or

decreased results due to *genetic

variants(HbS,HbC,HbF) affects people of
Africa,Mediterranean,SouthEastAsian heritage
*kidney disease *liver disease *iron deficiency
anemia *heavy bleeding
oNot recommended for raidly progressing

diabetes<Type 1 in children>

Method

Interference from HbC

Interference from HbS

Interference
from HbE

Interference
from HbD

Interference
from elevated HbF

Abbott Architect/Aeroset

Yes

Yes

Arkray ADAMS A1c HA-8180V (Menarini)

No

No

HbA1c not quantified

HbA1c not quantified

No <30% HbF

Axis-Shield Afinion

No

No

No

No

Bayer A1cNOW
Beckman AU system

Yes
Yes

Yes
Yes

No
No

No
No

$
$

Beckman Synchron System

No

No

No

No

Bio-Rad D-10 (A1c program)

No

No

No

No

No <10% HbF

Bio-Rad Variant II NU

No

No

No <10% HbF

Bio-Rad Variant II Turbo

No

No

Yes

Yes

No <5% HbF

Bio-Rad Variant II Turbo 2.0

No

No

No/Yes
(conflicting reports)

No

No <25% HbF

Bio-Rad in2it
Ortho-Clinical Vitros

Yes
No

No
No

Yes
No

No
No

$
$

Roche Cobas Integra Gen.2

No

No

No

No

Roche/Hitachi (Tina Quant II)

No

No

No

No

Sebia Capillarys 2 Flex Piercing

No

No

No

No

No <15% HbF

Siemens Advia A1c (new version)

No

No

Siemens
DCA 2000/Vantage

No

No

No

No

No <10% HbF

Siemens Dimension

No

No

No

No

Tosoh G7

Yes

No

Yes

No

No 30% HbF

Tosoh G8

No

No

Yes

No

No 30% HbF

Trinity (Primus) HPLC (affinity)

No

No

No

No

No <15% HbF

PRE-DIABETES:Prediabetes is when blood glucose levels are

higher than normal but not high enough for a diagnosis of
diabetes. Prediabetes means a person is at increased risk for
developing type 2 diabetes, as well as for heart disease and
stroke. Many people with prediabetes develop type 2 diabetes
within 10 years.
Impaired Fasting Glucose:
FPG (110-126mg/dl)
Impaired Glucose Tolerance:
2-hrsPG in 75-OGTT (140-200mg/dl)

SUMMARY
Indicator

Normal

Pre-diabetes

Diabetes

Fasting plasma
glucose

< 100 mg/dl

100-125 mg/dl

126 mg/dl or
greater

OGTT 2 hr.
post glucoserich beverage

< 140 mg/dl

140-199 mg/dl

200 mg/dl or
greater

Casual or
random plasma
glucose and
symptoms
A1c

200 mg/dl or
greater

<5.7%

5.7-6.4%

6.5% or greater

 In some people, a blood glucose test may indicate a

diagnosis of diabetes even though an A1C test does not.

The reverse can also occuran A1C test may indicate a

diagnosis of diabetes even though a blood glucose test

does not.

Because of these variations in test results, health care

providers should repeat tests before making a

diagnosis. People with differing test results may be in an
early stage of the disease, where blood glucose levels
have not risen high enough to show on every test.

References
www.ngps.org
dtc.ucsf.edu
www.niddk.nih.gov
www.diabetes.org