Welcome to BETACHEK_ the trusted and reliable name in Diabetes

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Welcome to BETACHEK_ the trusted and reliable name in Diabetes Powered By Docstoc
					Welcome to BETACHEK, the trusted and reliable name in
Diabetes management. BETACHEK products improve the
lives of people with Diabetes, making blood glucose testing
simpler and easier.
What is Diabetes?
Diabetes is a chronic disease characterised by elevated levels of glucose
in the blood (hyperglycaemia). Diabetes occurs when the body does not
produce enough insulin or is not using it properly. Insulin is a hormone
required for glucose to enter the cells and be converted to energy.
     The 3 main types of Diabetes
Type 1 (Also known as juvenile onset Diabetes)
Usually diagnosed in children, teenagers, or young adults, representing 10 to 15% of cases.
This form of Diabetes is not caused by lifestyle factors; the beta cells of the pancreas no
longer produce insulin because the body’s immune system has attacked and destroyed them.
Type 2 (Also known as adult-onset Diabetes)
The most common form, representing 85 to 90% of cases and approx. 50% don’t know they
have it. This form of Diabetes is due to lifestyle factors & generic predispositions; the
pancreas produces insulin but there is insulin resistance, a condition in which muscle, liver,
and fat cells do not use insulin properly, so it must make more. Eventually the pancreas loses
the ability to secrete enough to keep the glucose balance right, especially in response to
Develops in women during late stages of pregnancy and should disappear after the birth,
occurring in up to 9% of pregnancies. It not only increases the risk of pregnancy
complications, but increases the woman’ risk of type 2 Diabetes later in life. This form of
Diabetes is caused by the hormones of pregnancy or a shortage of insulin.
    The symptoms of Diabetes
   Chronic excessive thirst
   Dry mouth
   Frequent urination
   Great hunger
   Unexplained Weight Loss
   Fatigue
   Irritability
   Blurred Vision
   Skin infections
   Slow healing
   Tingling and numbness in the feet
   In Type 2 Diabetes sometimes no symptoms at all
    Stages of blood glucose levels in Diabetes

           Stages           Normoglycemia                              Hyperglycemia

                                                      Impaired Glucose Tolerance                 Diabetes Mellitus
                          Normal glucose regulation               or
   Types                                               Impaired Fasting Glucose    Not insulin   insulin requiring   Insulin requiring
                                                                                   Requiring      for control        for survival

Type 1 *

Type 2

Other specific Types**

Gestational Diabetes**

  Source: Report of the Expert Committee on the diagnosis and classification
  of Diabetes Mellitus, Diabetes Care, Vol 26, Suppl. 1 Jan 2003
  Diagnostic criteria for Diabetes
  The following are the diagnostic levels of glucose in the blood for Diabetes:
  1. Random Blood Glucose > 10 mmol/l (180 mg/dl)
  2. Fasting Blood Glucose > 6 mmol/l (108 mg/dl)1

  Expected Results (Fasting Blood Glucose Test):
  Normal Values:   3.9 – 5.6 mmol/L (70 – 100 mg/dL)
  Abnormal Values: If your testing strip reactive pad is darker in colour than the 6 mmol/L
                   (108mg/dl)1 then your result is abnormal and you should see a doctor
  for a            second test to confirm the diagnosis2. Low or high blood glucose
  readings         may indicate a potentially serious medical condition. If your blood
  glucose          reading is unusually low or high, or if you do not feel the way your
  reading          indicates, repeat the test with a new strip. If your reading is not
  consistent       with your symptoms or if your blood glucose result is less than
  2.8mmol/L        (50 mg/dL), you should contact your health care professional and
  follow           their treatment advice.
1. Definition, Diagnosis and Classification of Diabetes Mellitus and its Complications, Report of a WHO Consultation, Part 1: Diagnosis and
Classification of Diabetes Mellitus. World Health Organisation, Department of Non-communicable Disease surveillance Geneva 1999. (It is
important to keep in mind that this value is for diagnosis and not for monitoring treatment or a goal of therapy.) 2. The diagnosis of Diabetes in an
asymptomatic subject should never be made on the basis of one single abnormal blood glucose value. For the asymptomatic person, at least one
additional plasma/blood glucose test result with a value in the diabetic range is essential, either fasting, from a random (casual) sample, or from the
oral glucose tolerance test (OGTT). Source see endnote 1.
The Diabetes Epidemic
⋅   The number of type 2 Diabetics will increase worldwide from 314 million to 472
⋅   million in 2025.
⋅   50% of all type 2 Diabetics have not been diagnosed - late diagnosis has severe
    effects on
⋅   healthcare expenditures on Diabetes and its health related problems.
⋅   Type 2 Diabetes occurs in 4.1/1000 children.
⋅   The average age of type 2 is decreasing and the number of type 2 Diabetics is
⋅   The number of type 2 Diabetics in industrialised nations has doubled.
⋅   34% of all kidney insufficiencies result from type 2 Diabetes
⋅   1 out of 5 Diabetics will develop a diabetic foot syndrome; 40% of these will have
⋅   an amputation

For diagnosed type 2 Diabetics:
15% develop a retinopathy
 34% of all kidney insufficiencies result from type 2 Diabetes
 50% develop macro angiopathy
 50% have coronary disease
Targets of Diabetes therapy
To keep random blood glucose levels between 3mmol/l (54 mg/dl) &
8 mmol/l (144 mg/dl)
To achieve a maximum fasting blood glucose level of 6.7mmol
(120mg dl); 2h after eating of 7.8mmol (140mg/dl) for diagnosed
HbA1C should be at 6.5% and less
To reduce severe hypoglycaemia and high levels of hyperglycaemia
To reduce or avoid further consequent diseases caused by Diabetes

It is your individual responsibility to keep both yourself and your family

Source: NIDDM consensus of 1999; criteria of ADA and WHO 1997
Self-control for Diabetics
   Weight control
   Blood pressure ideally below 140/90, best under 130/80
   Feet – in particular patients with neuropathies
   Regular blood glucose level control
   Motivation to have self-control over Diabetes
   Regular consultation of the doctor
Types of Diabetes tests
For use among the general population - for individuals at
risk of developing Diabetes

For diagnosed Diabetics to monitor their Diabetes
Product information
   and benefits
     Why is screening for Diabetes so important?
   Diabetes is a major cause of heart disease and stroke and the main cause of kidney
    failure, limb amputations and blindness in adults (NIH)
   Early detection will save peoples lives. If individuals have Diabetes and are
    diagnosed early, they can be treated before illness develops, preventing or delaying
    the onset of Diabetes (Source: United Kingdom Prospective Diabetes Study)
   Most cases of Diabetes can be treated with dietary measures and oral medication.
   Enhanced length and/or quality of life which might result from a reduction in the
    severity and frequency of the immediate effects of Diabetes, heart disease or other
    related conditions; and the prevention or delay of its long-term complications.
   Any saving or redistribution of health care resources which might be possible as a
    result of reduced levels of care required for Diabetes, heart disease or other related
    conditions (reduced hospital admissions and lengths of stay etc).
   Descriptive data on costs suggest that the health care costs of the screening itself
    are relatively lower than the treatment cost of Diabetes and other related heart
How can you screen for Diabetes?

Use the Betachek Diabetes Test

This revolutionary test is the first
Diabetes screening test for home-

The Betachek Diabetes Test is
available in a multi language
     What is Betachek Diabetes Test?
Betachek Diabetes Test is a screening test for the general public. Betachek is a pink/blue
“visually read” test strip for the semi quantitative measurement of glucose concentration in
fresh capillary whole blood. Each test comprises two reagent zones attached to the end of
a plastic strip. The glucose concentration is estimated by comparison with a 26 colour
comparison chart for result interpretation.
The test is known as a fasting blood glucose test (FBG). The measurement range is:      1-
55mmol/L (18-991 mg/dL).
Betachek Diabetes Test has the same technological characteristics as the Betachek Visual,
the only difference is that this product contains 2 single use lancets and 2 strips.
Betachek Diabetes Test is intended for use as a rapid, in vitro method of detecting
abnormal glucose concentrations that can be a sign of Diabetes or other health problems.
Any abnormal results should be verified by a doctor using a quantitative method.
Betachek Diabetes Test is an over-the-counter in vitro diagnostic test for semi-quantitative
measurement of glucose in the whole blood samples obtained from the fingertip.
    Who should use the Betachek Diabetes Test?
Everyone should especially those with a:
 Family history of Diabetes
 Personal history of gestational Diabetes
 Members of a high risk ethnic group
 Overweight (BMI ≥ 25kg/m2)
      Physically inactive
      Age > 45 years
      Maternal age > 25 years
      Hypertension
      Polycystic ovary syndrome
      History of vascular disease
      Have high blood pressure, heart disease or have had a heart attack

    (Source: American Diabetes Association, Screening for Type 2 Diabetes, Diabetes Care, 26 (1), 2003)
The benefits of Betachek Diabetes Test as opposed to
testing performed by healthcare professionals
   Most cases of Diabetes can be treated with dietary measures and oral medication.
   The recommended test for screening purposes is one performed on a subject that has fasted
    for a minimum of 8 hours. Therefore, a patient must present to the doctor in a fasted state.
    This can be quite inconvenient and disruptive, particularly if an appointment with a health
    care professional is not first thing in the morning.
   A home test allows a person to have an evening meal and then perform the test before
    breakfast. This is more convenient and therefore compliance with the fasting requirement is
    more likely.
   Privacy
   Comfort
   Cost savings to the individual (transport to Doctor/Nurse/Pharmacist and Fees charged)
   Potential of lowering costs to the government (Diabetes is a disease that is estimated to cost
    billions of dollars annually) due to a reduction in undiagnosed Diabetics.
Diabetes testing in 3 Easy Steps:

            Apply Blood

            Wipe Off Blood

            Results in 60
    Features of Betachek Diabetes Test
   A large range from 1 mmol/l (18 mg/dl) to 55 mmol/l (991 mg/dl)
   Excellent matching results from small increments in the colour chart.
   A Pink/Blue visually read blood glucose test.
   Twin colour technology for precision in matching colours
   Instructions available in a multi language presentation
   Does not require a meter
   Fast & accurate testing – easy to use
   Independent clinical trials have shown BETACHEK to be 98% accurate in
    determining blood glucose levels when compared to a laboratory reference
How often should you test for Diabetes?

     High-risk individuals should test annually
     Individuals who are 45+ should test every three years
     Women at risk of gestational Diabetes should undertake testing
      during initial stages of pregnancy, and again at 24-28 weeks.

(Source: The Expert Committee Report on the Diagnosis and Classification of Diabetes Mellitus, Report of the Expert
Committee on the Diagnosis and Classification of Diabetes Mellitus, Diabetes Care, 26(1), 2003)
What to do if your blood glucose levels are
•   Firstly you should make an appointment to visit your Doctor for diagnosis.
•   Find out ways you can change your lifestyle through:
      – Dieting (try managing this with healthy meal pans)
      – Physical Activity (be as active as you can)
      – Medications (Be sure to take them)
•   Join your local Diabetes Association (your doctor may refer you, but this
    is not always necessary)
•   Start monitoring/testing your blood glucose levels regularly
•   Always take your insulin with you (for those who require it)
•   Keep a positive mental attitude
    Conclusion of Betachek Diabetes Test in the
Betachek offers the highest quality screening product and in many countries the only available in the
home-use test category. In most countries you are required to see a medical professional to take the test
(POCT) , this can be performed at pharmacies, clinics, medical centres, surgeries and hospitals. This
method is time consuming and difficult as a patient is required to fast for 8 hours before testing, where
home-use tests can be taken when you wake in the morning before breakfast; quick, simple, easy, private
and accurate. Busy Pharmacists are now pushing our product instead of performing the test themselves
as it relieves their time and provides higher profit margins for the same accurate results.
NDP specializes in the manufacture of Diabetes testing systems with the Betachek range of products
recognized internationally for their uncompromising quality and innovation. This single market focus has
lead to improvements in ease of use, test time and other parameters continuing to give Betachek products
the innovative advances that ensure better lives for those who use them. Our research and development
has resulted in several milestone achievements including acceptance as the most accurate visual test on
the market.
Using a strip that is calibrated to whole blood allows accuracy in comparison to urine tests which shows
approximate levels from up to 4 hours prior, not too mention, some people have glucose in their urine
even when the level of glucose in the blood is normal. Clinical trials have shown BETACHEK to be 98%
accurate in determining blood glucose levels when compared to a laboratory reference method. Results
only takes 60 seconds, which is much quicker and efficient than most if not all of our competitors.
Quality Accreditations
BETACHEK products are manufactured in Sydney, Australia to the
highest quality standards.

All products carry the CE mark and have TGA approval.

NDP is a licensed manufacturer of in vitro diagnostic medical
devices in accordance with:

    EN ISO 9001:2000
    EN ISO 13485:2000
    EN 928
    GMP code
Performance Evaluation

Laboratory studies to analyse the performance of Betachek Visual strips and
Betachek Glucose Control Solution were carried out The evaluation was
designed to measure precision in normal conditions of use i.e. by an
individual user across multiple days with the same lot of test strips. Glucose
control solutions of three different values were used. (Ref: ISO 15197:2003).

•   Linearity over the measurement range was demonstrated in a study
    n=260 with the following regression; y = 0.97x + 0.0114 / R2 = 0.9747
•   Sensitivity/Detection limit : 0.5mmol/L (9 mg/dL) – 55mmol/L (991mg/dL)
•   Specificity: The test strips react specifically with D-glucose.
•   Interferences: No interference from drugs has been found, except for a
    reduced colour reaction up to 60 minutes after i.v. injection of ascorbic
Method comparison with lay users

Betachek blood glucose test system was assessed by comparing blood
glucose results obtained by patients with those obtained using a
laboratory reference method. Patients were asked to match the
developed strip to the nearest colour standard on the label. If the result
was thought to lie between two standards the average result was
calculated in accordance with the instructions for use.

e.g. if the result was between 216 mg/dL and 270 mg/dL
216 + 270 = 243 mg/dL OR 12 + 15 = 13.5 mmol/L
     2                         2
      Final Performance Characteristics
 The accuracy of Betachek test strip visual results was evaluated. 15 batches were tested. Strip visual
results were compared with the blood glucose concentration obtained using a reference method.
Betachek results falling within ±0.83 mmol/L (±15mg/dL) at glucose concentrations <4.2 mmol/L (<75
mg/dL) and within ±20% of the reference value at glucose concentrations >4.2 mmol/L (>75 mg/dL)
were accepted as accurate.
For each batch and blood glucose concentration, all strips conformed to specification. This study
verified the accuracy of Betachek as a visual test for blood glucose measurement.

Stability of Strips:
The accuracy of test strip visual results was monitored over an extended period to verify the stability of
the product over shelf-life. For each batch and blood glucose concentration, all strips showed no
deviation from the reference value range when periodically tested prior to 14 months. The results
indicate that the Betachek strips were stable for up to 18 months after manufacture. From these results
it can be concluded that the activity of Betachek strips, determined through visual estimation, is stable
for 18 months. This study verified a test strip expiry date of 18 months.

Market Experience:
Betachek was approved for sale on the Australian market in 1992. It has since been sold in over 40
countries and is being introduced in more countries as regulatory requirements are met. There have
been no serious complaints or problems and the product has been received well.

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