ifeabs diabetes aborator testin ervies - mdbriefcase inc....diabetes canada states that in 2018,...

Diabetes Canada states that in 2018, over 3.5 million

people (about 9% of the population) in Canada

have been diagnosed with diabetes, with as many

as 10.7 million (28% of the population) currently

at-risk, or undiagnosed.1 With increase in the rates of

obesity and large sections of the population leading

a sedentary lifestyle, the need for detailed diabetes

risk assessment, prevention, and management has

become critical.

LifeLabs offers a comprehensive array of diabetes

laboratory testing services to help healthcare

providers manage diabetes in patients of all ages,

and in all stages of the diabetes care continuum.

LifeLabs Diabetes Laboratory Testing Services

2 LifeLabs DIABETES LABORATORY TESTING SERVICES

Why Choose LifeLabs?

According to Diabetes Canada 2018 Guideline definitions:

• Diabetes Mellitus is a heterogeneous metabolic disorder where

hyperglycemia (high levels of glucose in the blood) occurs due to impaired

glucose secretion, defective insulin action, or both. Chronic hyperglycemia

of diabetes can lead to microvascular complications affecting kidney, eyes

and nerves, and increase the risk of cardiovascular disease. The diagnostic

criteria for diabetes are based on thresholds of glycemia that are associated

with microvascular disease, especially retinopathy.2

• Prediabetes is a practical and convenient term referring to impaired fasting glucose (IFG), impaired glucose tolerance (IGT)

or a glycated hemoglobin (A1c) of 6.0% to 6.4%, each of which places individuals at high risk of developing diabetes and its

complications.3

Over 360

LifeLabs locations offer diabetes test collection

services

We accept walk-ins, as well as appointments for

diabetes tests

Quick turn-around

time (TAT) allows for fast decision-making in treatment

management

Electronic reporting with direct

results integration into most EMR’s

Launchpad – an online physician portal with 24/7 remote access

to results

Consultations

with our team of pathology specialists

when required

Diabetes Risk Assessment and Early Diagnosis Tests

LifeLabs diabetes tests help you make a proactive approach to preventing, diagnosing and managing diabetes.

3LifeLabs DIABETES LABORATORY TESTING SERVICES

FASTING PLASMA GLUCOSE (FPG)

Measured in mmol/L, this test measures the level

of glucose in the blood after fasting for at least

8 hours. While FPG levels below 5.6 mmol/L are

considered normal, results between 6.1 mmol/L

and 6.9 mmol/L indicate impaired fasting glucose

and therefore, prediabetes. FPG levels over 7.0

mmol/L indicate diabetes.4

HEMOGLOBIN A1c (HB A1c)

Hemoglobin A1c, also called A1c or glycated

hemoglobin, is formed by the non-enzymatic

glycation reaction between the ß chain of

hemoglobin A0 and glucose.19

The A1c test evaluates the average amount of

glucose in the blood over the last 2 to 3 months

by measuring the percentage of glycated

(glycosylated) hemoglobin. A1c % between 6 and

6.4 may be considered prediabetes, whereas 6.5

and over indicates diabetes.5

A1c is a better predictor of microvascular

complications and risk of cardiovascular disease.

However, A1c is not recommended for type 1

diagnosis in adults, or for screening individuals

with iron, Vitamin B12, cystic fibrosis, kidney or

liver disorders, or for gestational diabetes. FPG is

the recommended test in those cases.6

The 2018 Clinical Practice Guidelines

released by Diabetes Canada state that

both FPG and Hb A1c are acceptable tests

to screen, diagnose and monitor individuals

with diabetes. If patient is asymptomatic,

and if either FPG or A1c results are in the

diabetes range, then repeat testing is

recommended for confirmation of diagnosis.

LifeLabs also offers the 75g 2-Hour Oral

Glucose Tolerance Test (OGTT) and

post-meal Random Plasma Glucose as

alternative tests in the diagnosis of diabetes.


Other Metabolic Markers to Assess Diabetes

FRUCTOSAMINE*

Also known as Glycated Serum Protein, Fructosamine is

a test used to monitor blood sugar levels over time for a

patient with diabetes mellitus. The level of fructosamine

in the blood is a reflection of glucose levels over the

previous 2-3 weeks.

GLYCOMARK*

The GlycoMark test measures 1,5-AG, a specific indicator

of hyperglycemic episodes and glycemic variability within

the past 1-2 weeks. This test is a non-fasting, FDA-cleared,

serum or plasma blood chemistry test. This test is useful

in detecting blood sugar levels over short periods of time,

which can help the healthcare provider in optimizing the

diabetes management / treatment plan.

25 HYDROXY VITAMIN D

Low levels of Vitamin D are associated with increased risk

of CVD events, myocardial infarction (MI), and death due

to heart failure, sudden cardiac death, and stroke. The

cardiovascular impact of low vitamin D is via activation of

the renin-angiotensin-aldosterone system, as well as via

increased parathyroid hormone levels (which predispose

individuals to increased insulin resistance associated

with diabetes, hypertension, inflammation, and increased

cardiovascular risk).

*Provincial health plan coverage for fructosamine varies by province or by specific clinical indications. The GlycoMark test is currently an uninsured test.


Diabetes Classification Tests

In cases where the type of Diabetes is not clear based

on clinical assessment (e.g. age of onset, body weight,

response to oral hypoglycemics etc.), some lab tests can

help to differentiate between types.

Type 1 diabetes encompasses diabetes that is primarily

a result of auto-immune pancreatic beta cell destruction

with consequent insulin deficiency, which is prone to

ketoacidosis. This also includes Latent Autoimmune

Diabetes in Adults (LADA) in patients that appear to

have immune-mediated loss of pancreatic beta cells.

Type 2 diabetes may range from predominant

insulin resistance with relative insulin deficiency to a

predominant secretory defect with insulin resistance.

Ketosis is not as common and no auto-immune processes

are involved.

When autoimmune type 1 diabetes is present, one or more of the diabetes autoantibodies will be present in

about 95% of those affected at the time of initial diagnosis. With type 2 diabetes, the autoantibodies are

typically absent.

ISLET CELL CYTOPLASMIC AUTOANTIBODIES (ICA) TEST

Beta cells are a type of islet cells. This test measures a group of islet cell autoantibodies targeted against a variety

of islet cell proteins. These autoantibodies are present in up 80% of type 1 diabetic adults. Islet autoantibodies may

also be seen in people with other autoimmune endocrine disorders such as Hashimoto thyroiditis or autoimmune

Addison disease.


The 2018 Clinical Practice Guidelines released by Diabetes Canada recommends an initial 50g glucose

challenge test, followed, if abnormal, with a 75g oral glucose tolerance test (2h OGTT). A diagnosis of GDM is

made if one plasma glucose value is abnormal (i.e. if fasting ≥5.3 mmol/L, or 1hour ≥10.6 mmol/L, or 2 hours

≥9.0 mmol/L). The alternate approach is a 1-step approach of a 75 g oral glucose tolerance test. A diagnosis of

GDM is made if one plasma glucose value is abnormal (i.e. if fasting ≥5.1 mmol/L, or 1 hour ≥10.0 mmol/L, or 2

hours ≥8.5 mmol/L).7

Other specific types include a wide variety of relatively uncommon conditions, primarily specific genetically

defined forms of diabetes or diabetes associated with other diseases or drug use.

INSULINOMA-ASSOCIATED-2 AUTOANTIBODIES (IA-2A)

IA-2A test detects autoantibodies directed against

beta cell antigens but is non-specific. These auto-

antibodies are found in up to 60% of type 1 diabetics.

INSULIN ANTIBODIES (IAA)

The autoantibodies seen in children are often

different than those seen in adults. Insulin Antibodies

(IAA) is usually the first marker to appear in young

children. As the disease evolves, this may disappear

and ICA, GADA and IA-2A become more important.

GLUTAMIC ACID DECARBOXYLASE AUTOANTIBODIES (GADA) TEST

GADA test detects autoantibodies directed against

beta cell protein (antigen) but is not specific to beta

cells. These autoantibodies are also detected in up to

80% of newly diagnosed type 1 diabetics.

GESTATIONAL DIABETES MELLITUS

(GDM) refers to glucose intolerance with onset or first

recognition during pregnancy.


Diabetes Genetic Laboratory Tests Monogenic diabetes is a rare disorder caused by genetic

defects of beta cell function that typically presents in

young people (<25 years of age), is noninsulin dependent

and is familial, with an autosomal dominant pattern

of inheritance. The most common form of monogenic

diabetes is maturity-onset diabetes of the young

(MODY), which represents about 2% of all diabetes

cases.8

MODY PANEL

LifeLabs offer comprehensive testing for MODY as well as

genetic testing expertise and genetic counselling through

our LifeLabs Genetics division. Several different genes

that affect the production of insulin are grouped under

the LifeLabs MODY panel. These include ABCC8, BLK,

CEL, GCK, HNF1A, HNF1B, HNF4A, INS, KLF11, NEUROD1,

PAX4, NKX2-2, PDX1, RFX6, and ZFP57.

15 different conditions are tested as part of the panel.

These include:

• Diabetes Mellitus Type 2 and insulin-dependent Type 1

• Familial hypoplastic or glomerulocystic kidney disease

• MODY type 1 to 11

• Michelle-Riley Syndrome

• Transient neonatal diabetes mellitus 1

These tests can be ordered on the LifeLabs Hereditary Testing National Requisition.

Contact the team at [email protected] or call

1-84-GENEHELP (1-844-363-4357)


Prediabetes and type 2 diabetes are often indicative of a broader underlying disorder, including the metabolic syndrome

(MetS), a highly prevalent condition that is accompanied by obesity, hypertension, dyslipidemia and elevated blood

glucose levels. While metabolic syndrome and type 2 diabetes often coexist, those with metabolic syndrome without

diabetes are at significant risk of developing diabetes as well as cardiovascular disease (CVD).13

MetS is diagnosed when a patient has three of the following conditions14:

✓ High blood pressure (≥ 130/85 mm Hg, or receiving

medication)

✓ High blood glucose levels (≥ 5.6 mmol/L, or receiving

medication)

✓ High triglycerides (≥ 1.7 mmol/L, or receiving medication)

✓ Low HDL-Cholesterol (< 1.0 mmol/L in men or < 1.3

mmol/L in women)

✓ Large waist circumference (≥ 102 cm in men, 88 cm in

women; ranges vary according to ethnicity)

Canadian clinical practice guidelines recommend Fasting

Plasma Glucose (FPG), Lipid Assessments and regular blood

pressure measurement to diagnose and manage MetS.

METABOLICSYNDROME

Visceral Obesity

Insulin

Resistance

Hypertension

High

Triglycerides

Low HDL-

Cholesterol

METABOLIC SYNDROME TESTS

Diabetes Monitoring and Cardiac Risk Assessment Tests Monitoring - For most individuals with diabetes, Hb A1c

should be measured approximately every 3 months to

ensure that glycemic goals are being met or maintained.

The 2018 Clinical Practice Guidelines released by

Diabetes Canada recommend that the frequency of Hb

A1c testing be increased if assessing response to therapy

or during pregnancy. Additionally, Serum Ketones is a

test recommended for adults with type 1 diabetes during

periods of acute illness and if accompanied by elevated

blood glucose levels.9

Cardiac Risk - Cardiovascular disease is the leading

cause of mortality in patients with Type 2 Diabetes

Myocardial infarction (MI), stroke and amputation are all

manifestations of the aggressive atherosclerosis that can

occur with diabetes10

9

LIPID ASSESSMENT

This is a panel of blood tests that serves as an initial

broad medical assessment tool for abnormalities

in total cholesterol, HDL cholesterol (calculated),

triglycerides, LDL cholesterol (calculated), non-HDL

cholesterol and cholesterol/HDL-C ratio. A lipid panel

can used to identify hyperlipidemia, which may indicate

an increased risk for CVD.

A lipid panel may also be ordered at regular intervals

to evaluate the success of lipid-lowering lifestyle

changes such as diet and exercise or to determine the

effectiveness of drug therapy such as statins.

Studies have shown that identifying individuals

in the very early stages of kidney disease helps

people and healthcare providers adjust treatment.

Controlling diabetes and hypertension by

maintaining tight glycemic control and reducing

blood pressure delay or prevent the progression

of kidney disease.

APOLIPOPROTEIN B

Apo B is the predominant apolipoprotein attached to

LDL, intermediate-density lipoproteins (IDL), and very

low-density lipoproteins (VLDL). Guidelines support

the measurement of apo B for monitoring response to

statin therapy or those with very high triglycerides. An

elevated Apo B level is associated with an increased risk

of CVD by up to 2.5 times.12

ALBUMIN CREATININE RATIO – RANDOM URINE

Hypertension Canada guidelines recommend testing

urinary albumin excretion in patients with diabetes to

guide treatment of hypertension11. The urine albumin/

creatinine ratio (ACR) is used to screen people with

chronic conditions (such as diabetes with hypertension)

that put them at an increased risk of developing kidney

disease. Please refer to the section on monitoring

kidney function to learn more.


ALANINE AMINOTRANSFERASE (ALT)

ALT is an enzyme found mostly in the cells of the liver and kidney. When the

liver is damaged, ALT is released into the blood. ALT values are often compared

to the results of other tests such as alkaline phosphatase (ALP), total protein,

and bilirubin to help determine which form of liver disease is present.

Monitoring Liver Function in Diabetes

ASPARTATE AMINOTRANSFERASE (AST)

The test is most useful in detecting liver damage due to hepatitis,

drugs toxic to the liver, cirrhosis, or alcoholism. An AST test is often

performed along with an ALT test. A calculated AST/ALT ratio is useful

for differentiating between different causes of liver injury and in

recognizing when the increased levels may be coming from another

source, such as heart or muscle injury.

ALBUMIN

Albumin is a protein found in the blood. Since albumin is

produced by the liver, its level can decrease with loss of liver

function; however, this typically occurs only when the liver

has been severely affected. An albumin test may be ordered

as part of a liver panel to evaluate liver function or with

a creatinine, blood urea nitrogen (BUN), or renal panel to

evaluate kidney function.

LifeLabs offers tests to identify individuals with non-alcoholic fatty liver disease (NAFLD) who are

at a high risk of serious liver complications. While overall prevalence of NAFLD is estimated to be

anywhere from 6.3% to 33%, the rate is more than double that in people with type 2 diabetes.15 In its

most indolent form, NAFLD is characterized by the histologic accumulation of fat within hepatocytes.

In some patients, this fat accumulation is accompanied by varying degrees of inflammation and

fibrosis - which may progress to cirrhosis and associated complications.

In recent studies, NAFLD has been shown to predict the development of type 2

diabetes and vice versa.16 Each condition may serve as a progression factor for

the other, and some complications of diabetes may be directly linked to NAFLD.17


Monitoring Kidney Function in Diabetes

CHRONIC KIDNEY DISEASE (CKD) TESTS

Chronic kidney disease (CKD)is an important common

complication of diabetes. CKD due to diabetes occurs

in 20% to 40% of patients and is the most common

cause of end-stage renal disease.18 Both type 1 and type 2

diabetes patients are at risk. LifeLabs offers specific tests

to monitor chronic kidney disease (CKD) in patients with

diabetic nephropathy.

SERUM CREATININE eGFR

Glomerular filtration rate (GFR) is a measure of the

function of the kidneys. This test measures the level of

creatinine in the blood and uses the result in a formula to

calculate a number that reflects how well the kidneys are

functioning, called the estimated GFR or eGFR. The eGFR

is a calculation based on a serum creatinine test.

ALBUMIN CREATININE RATIO – RANDOM URINE

The urine albumin/creatinine ratio (ACR) is used to

screen people with chronic conditions (such as diabetes

with hypertension) that put them at an increased risk of

developing kidney disease.

ELECTROLYTES

The electrolyte panel measures the blood levels of the

main electrolytes in the body: sodium (Na+), potassium

(K+), chloride (Cl-), and bicarbonate (HCO3-; sometimes

reported as total CO2). Electrolyte measurements may be

used to help investigate conditions that cause electrolyte

imbalances such as dehydration, kidney disease, lung

diseases, or heart conditions. Repeat testing may then

also be used to monitor treatment of the condition

causing the imbalance.

URINE PROTEIN TO CREATININE RATIO (UP/CR)

This test detects not just albumin, but all types of

proteins that may be present in the urine.

PARATHYROID HORMONE (PTH)

PTH controls calcium levels in the blood, and is often

increased in kidney disease.

LifeLabs3680 Gilmore WayBurnaby, BCV5G 4V8

CORPORATE OFFICES

LifeLabs100 International BlvdToronto, ONM9W 6J6

www.LifeLabs.com

LifeLabs Genetics 175 Galaxy Blvd., Suite 105 Toronto, ON M9W 0C9

1. “Diabetes statistics in Canada are estimates generated by the Canadian Diabetes Cost Model, a forecasting model that provides projections on prevalence, incidence and economic burden of diabetes in Canada based on national data from government sources.” – Diabetes Canada media sources, updated: March 2018

2 – 7,9,10,13. 2018 Clinical Practice Guidelines for the Prevention and Management of Diabetes in Canada; Can J Diabetes 2018;42 (Suppl 1):S88-S103.

8. Naylor R, Philipson LH. Who should have genetic testing for maturity-onset diabetes of the young? Clin Endocrinol. 2011;75:422-426

11. Kara A. et al. Hypertension Canada’s 2018 Guidelines for Diagnosis, Risk Assessment, Prevention, and Treatment of Hypertension in Adults and Children. Can J Cardiol.

12. Anderson TJ, Grégoire J, Hegele RA, et al. 2012 update of the Canadian Cardiovascular Society guidelines for the diagnosis and treatment of dyslipidemia for the prevention of cardiovascular disease in the adult. Can J Cardiol. 2013;29:151-167.

14. Metabolic Syndrome Canada, web sources ‘What is Metabolic Syndrome’

15. Chalasani N, et al. The diagnosis and management of nonalcoholic fatty liver disease: practice guidelines by the American Association for the Study of Liver Diseases, American College of Gastroenterology, and the American Gastroenterological Association. Hepatology. 2012;55(6):2005-2023.

16, 17. Williams KH, et al. Diabetes and nonalcoholic fatty liver disease: a pathogenic duo. Endocr Rev. 2013;34:84-129.

18. American Diabetes Association. Standards of medical care in diabetes—2017. Diabetes Care. 2017;40(suppl 1):S1-S120.

19. Farmer, Andrew. Monitoring Diabetes. In: Holt, Richard I.G et al (eds) Textbook of Diabetes. 5th ed. Wiley Blackwell, 2017 (p 375).

ifeabs diabetes aborator testin ervies - mdbriefcase inc....diabetes canada states that in 2018,...

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