Few Haemoglobine A1c Point of Care Methods for Better Diabetes

Outcome in Yogyakarta Primary Health Care.

Introduction: Diabetes mellitus (DM) is the most common endocrine problem

at present. The diagnosis of this endocrine disorder bases mainly on laboratory
investigations. Point-of-care (POC) glucose technology is one of diagnose
methode however it is currently considered to be insufficiently accurate for the
diagnosis of diabetes so resulting invalid glucose value.
Glycated end product is a specific in vivo substance that can be generated in
case of poorly controlled DM patients.This is the result from the reaction
between proteins in blood (normally hemoglobin or albumin) with excessive
glucose in blood..
The two main tests on glycated end products are hemoglobin A1C (HbA1C) and
fructosamine. HbA1C gas has a wider range of prediction, upto 3 months, while
that of fructosamine is about 1 month.
HbA1 is widely accepted as a reliable indicator of long term hyperglycaemia.
Objective: Te primary objective of our study was to investigate whether state-
of-the-art POC glucose (StatStrip glucose hospital meter, Nova Biomedical,
USA) technology could be used as a POC diagnostic tool for type 2 diabetes
mellitus and intermediate hyperglycaemia in subjects with a previous history of
dysglycaemia, undergoing a 75 g diagnostic oral glucose tolerance test (oGTT).
We hypothesized that aninnovative POC-glucose technology might have
achieved sufcient analytical accuracy for diagnostic purposes.
Method: Subjects. Adult subjects, referred to primary health for the diagnosis
of diabetes, were consecutively enrolled in this study. The subjects were either
screened by their family physicians and found to have fasting hyperglycaemia
(>6.1 mmol/L) or were diagnosed with intermediate hyperglycaemia (impaired
fasting glucose (IFG) or impaired glucose tolerance (IGT)), as assessed by
oGTT on their previous visits to our Clinic. Pregnant women, referred for the
diagnosis of gestational diabetes, and subjects receiving any kind of medication
affecting glucose metabolism (e.g., corticosteroids, oral hypoglycaemic agents)
were not included in this study.A written informed consent was obtained from
all subjects.
Laboratory Methods. All laboratory procedures (preanalytical, analytical, and
postanalytical) were performed by educated laboratory personnel according to
standard operating procedures for the accredited laboratory (ISO 15189 Medical
laboratories—particular requirements for qualityand competence).
Venous blood was sampled in heparinized tubes (Becton Dickinson, USA) at
fasting and 2 hours afer peroralingestion of 75 g glucose dissolved in 250 mL
plain water was used as the reference laboratory procedure for venous plasma
glucose measurement (RLP). Immediately afer venipuncture, at each time point
ofoGTT, capillary blood was sampled by pricking fourth fngerof nondominant
hand, and point-of-care (POC) glucose was measured in duplicate, by using two
StatStrip glucose meters and two different lots of reagent strips.
Classifcation of Glycaemia. Glycaemic status was classifed according to the
2006 WHO diagnostic criteria ford iabetes and intermediate hyperglycaemia.
Based on FPG and 2 h PG, subjects were classifed as either having normal
glucose tolerance (NGT), impaired fasting glucose (IFG), impaired glucose
tolerance (IGT), or diabetes mellitus (DM), by using sample type-related
classifcation criteria for venous and capillary plasma, respectively
Statistical Analysis. Data are presented as mean ± SD. Pearson’s correlation
and Passing-Bablok regression analysiswere used for the analytical between-
methods comparison. Afer testing for normality, differences between the
categoriesof glycaemia were evaluated with ANOVA, followed by Student-
Newman-Keuls test for pairwise comparisons, while the differences between
POC- and RLP-glucose results wereanalysed with paired samples students’s t-
test. Possible influence of hematocrit on between-method bias was assessed
with linear regression analysis.
assessed by HbA1c, could lead to substantial reductions in the risk of
developing the microvascular complication of diabete s such as retinopathy,
nephropathy, and neuropathy.
Furthermore, long-term follow-up of participants during the observational phase
of
the UKPDS demonstrated that more effective glycaemic control from the time
of diagnosis in people with type 2 diabetes conferred a long-term legacy benefit
that persisted even though glycaemic control may deteriorate over time.3 This
observation implies that strategies that facilitate early detection of diabetes
should result in improved outcomes, with major long-term health and cost
benefits The HbA1c test is attractive as it measures chronic glycaemia, rather
than instantaneous blood glucose levels. HbA1c has been used as an objective
marker of average glycaemic control for many years, has an accepted place in
the monitoring of patients with diabetes, and is relied on for significant
management decisions, such as initiation of insulin therapy. HbA1c levels were
at least as strongly related to the
presence of diabetic retinopathy as were blood glucose levels.10 It is also
strongly associated with macrovascular outcomes and mortality. HbA1c has
recently been endorsed as a diagnostic test for diabetes by the World Health
Organization, the International Diabetes Federation and the American Diabetes
Association.14

Point-of-care (POC) tests provide analytical information that can be used to

make decisions at patients’ bedside, as opposed to laboratory tests that must be
run at a central laboratory. POC testing is a widely used tool to enable
immediate determination of glucose levels in hospitalized patients and facilitate
rapid treatment decisions in response to fluctuations in glycemia. Accurate POC
glucose testing requires attention to various factors before,during, and after
performance of tests. These include 1) proper preparationof test sites to avoid
preanalytical errors, 2) proper identification of tested patients whose
physiological status permits sampled capillary specimens tocorrelate with
central venous blood glucose levels to avoid analytical errors, and 3) proper
documentation of the fidelity of meter results with the medicalrecord to avoid
postanalytical errors.
Proper inpatient glycemic management requires timely blood glucose results
with careful consideration ofsample size, patient comfort, test time, nursing
work flow, cost, and ability to
automatically transfer results into theelectronic medical record so they are
readily available to clinicians to make treatment changes. Prescription blood
glucose monitors for use by HCPs at
the bedside are already widely used for this purpose. Regulatory bodies in the
United States and Europe aren requiring progressively greater levels of accuracy
for these products. Even
with accurately performing monitors, it is necessary to follow proper procedures
to avoid errors. Preanalyticalerrors resulting from poor sampling or strip storage
can cause inaccuracy.

Laboratory Investigation for Diabetes Mellitus: Practical Concerns

FASTING PLASMA GLUCOSE: BASIC BUT

IMPORTANT
FPG is the very basic test for DM. FPG is useful for both
diagnosis and following up. This is a basic test but very
important. The pre-analytical factor seems to strongly affect
the FPG results. The patient preparation must be gently
controlled. It is a requirement to verify the fasting stage of
the patients.

CAPILLARY GLUCOSE DETERMINATION: POINT

OF CARE TESTING [2-4]
Capillary glucose determination by glucometer is
accepted as a very useful tool in monitoring of DM case. It is
accepted as the most widely used point of care testing at
present. This can shorten the turnaround time for the
laboratory analysis

POSTPRANDIAL GLUCOSE: AN ALTERNATIVE

MEASUREMENT FOR BLOOD GLUCOSE
Sometimes, the FPG test is not feasible hence the
postprandial glucose is examined. This might be another
alternative clue for diagnosis of DM.

GLYCATED END PRODUCT: TOOL FOR

MONITORING FOR DIABETIC COMPLICATION
Glycated end product is a specific in vivo substance that
can be generated in case of poorly controlled DM patients.
This is the result from the reaction between proteins in blood
(normally hemoglobin or albumin) with excessive glucose in
blood. The nature of energy aberration induction of the
reaction results in complications of DM [5]. The two main
tests on glycated end products are hemoglobin A1C
(HbA1C) and fructosamine. HbA1C gas has a wider range of
prediction, upto 3 months,

ORAL GLUCOSE TOLERANCE TEST AND

DIABETES IN PREGNANCY
Oral glucose tolerance test (OGTT) is the main test for
diagnosis of DM in pregnancy, which is a specific endocrine
disorder in obstetrics. OGTT is generally indicated after
positive urine glucose test and glucose challenge test

C-PEPTIDE: A NEW TEST IN DIABETIC MEDICINE

C-peptide is considered as a new test in diabetic
medicine. It is mentioned useful in follow-up of the diabetic
complication [16]. It is noted for the good diagnostic
property for diabetic neuropathy, one of the most common
complications of DM

INSULIN TEST: A DIRECT MEASUREMENT OF

HORMONE
Insulin is the major hormone in regulation of blood
glucose hemeostasis. The abnormality of insulin physiology
is mentioned as an important underlying for DM. The
measurement of insulin can be done but it is not practically
used in routine diabetic clinic.

Validation of Point-of-Care Glucose Testing for

Diagnosis of Type 2 Diabetes
Point-of-care (POC) glucose technology is currently considered to be
insufficiently accurate for the diagnosis of diabetes. The objective of this study
was to investigate the diagnostic accuracy of an innovative, interference-
resistant POC glucose meter (StatStrip glucose hospital meter, Nova
Biomedical, USA) in subjects with a previous history of dysglycaemia,
undergoing a 75 g diagnostic oral glucose tolerance test (oGTT). Venous and
capillary blood sampling for the reference laboratory procedure (RLP) and
POC-glucose measurement was carried out at fasting and 2 h oGTT, and
categories of glucose tolerance were classified
according to 2006 WHO diagnostic criteria for the respective sample type. We
found an excellent between-method correlation at fasting (𝑟 = 0.9681, 𝑃 <
0.0001) and 2h oGTT (𝑟 = 0.9768, 𝑃 < 0.0001) and an almost perfect diagnostic
agreement(weighted Kappa=0.858).Within a total of 237 study subjects, 137
were diagnosed with diabetes with RLP, and only 6 of them were reclassified as
having glucose intolerance with POC. The diagnostic performance of POC-
fasting glucose in discriminating between the normal and any category of
disturbed glucose tolerance did not differ from the RLP (𝑃 = 0.081). Results of
this study indicate that StatStrip POC glucose meter could serve as a reliable
tool for the diabetes diagnosis, particularly in primary healthcare facilities with
dispersed blood sampling services.
Statistical Analysis. Data are presented as mean } SD. Pearson’s correlation
and Passing-Bablok regression analysis were used for the analytical between-
methods comparison. After testing for normality, differences between the
categories of glycaemia were evaluated with ANOVA, followed by Student-
Newman-Keuls test for pairwise comparisons, while the differences between
POC- and RLP-glucose results were analysed with paired samples students’s t-
test. Possible influence of hematocrit on between-method bias was assessed
with linear regression analysis. Any 𝑃 value of <0.05 was considered
significant. Bland-Altman analysis was used to determine HbA1c was measured
with a commercially available immunoturbidimetric procedure (TinaQuant,
Cobas Integra-400Plus, Roche Diagnostics, Germany) traceable to the IFCC
reference system, with results reported in both International Journal of
Endocrinology 3NGSP-conventional (%) and SI (mmol/mol) units. Fasting
EDTA-blood samples were obtained for these analyses