100 gram glucose loads are typically administered for the diagnosis of gestational diabetes. Gestational Diabetes (GDM): Women not at high risk for GDM …
Established Name: Oral Glucose Tolerance Drink
Intended Use: Accessory to an In Vitro Diagnostic Oral Glucose Tolerance
Test OGTT in the evaluation of diabetes mellitus and related disease
conditions Oral Glucose Tolerance Drinks provide a premeasured glucose
load of either 50 grams, 75 grams or 100 grams After the glucose load is
consumed, measurements of blood glucose are drawn at specific time
intervals to determine potential defects in insulin secretion and/or
insulin action Insulin is the hormone produced by the pancreas that moves
glucose from the bloodstream into cells 50 gram glucose loads are
typically administered for the initial screening of gestational diabetes
75 gram glucose loads are typically administered for the diagnosis of
diabetes mellitus 100 gram glucose loads are typically administered for
the diagnosis of gestational diabetes
Summary and Explanation of the Test: Oral Glucose Tolerance Drinks have
been used for over thirty years to help diagnose Diabetes Type 2,
Gestational Diabetes and Impaired Glucose Tolerance IGT Clinical
studies have led to the establishment of
generally accepted criteria for
diagnosis of diabetes In the absence of unequivocal hyperglycemia with
acute metabolic decompensation, the use of an OGTT should be confirmed on a
different day by a second OGTT, the measurement of Fasting Plasma Glucose
FPG or casual plasma glucose measurement as outlined by the WHO or the
American Diabetes Association Expert Committee on Diagnosis and
Classification of Diabetes Mellitus [1,2,3,10]
Specimen Collection: The Oral Glucose Tolerance Drink 10 fluid ounce
bottle should be consumed within a 2-5 minute time period When
administering the beverage for the diagnosis of Gestational Diabetes or
Diabetes Mellitus, the test should be done after an overnight fast of
between 8 and 14 hours, during which water may be consumed and after at
least three days of unrestricted diet 150 g carbohydrate per day and
unlimited physical activity Consult test administrator for any
restrictions before the consumption of Oral Glucose Tolerance Drink 50 g
when initially screening for gestational diabetes Individuals should
refrain from smoking, eating or strenuous activity
during the test period
Healthcare providers can provide specific preparations required for
individuals under the age of 18 Blood samples shall be drawn at specific
time intervals based upon the test being performed For children, the test
load should be 175 grams of glucose per kg of body weight up to a total of
75 grams of glucose [2,3,4,5,11]
Interfering Factors, Substances: The following conditions should be
communicated to the healthcare provider since they may influence the
accuracy of an OGTT [2,6,7,8]
Acute stress Nausea
Recent illness Caffeine
Vigorous exercise Smoking
Known Drugs that may cause glucose intolerance include:
Thiazide diuretics eg, hydrochlorothiazide Steroids
Beta -blockers eg, propranolol Phenytoin
Oral contraceptives Oestrogens
Corticosteroids eg, prednisone Thyroxine
Some psychiatric medications
Beverage Storage: Oral Glucose Test Drink should be stored at room
temperature and may be chilled before administering Beverage
should be
kept out of direct sunlight and high heat and humidity areas Excessive
exposure to high heat and humidity or direct sunlight may affect the taste
and product stability If product is frozen during shipping or storage the
product must be thoroughly thawed before use Product should be discarded
if cap is missing or not properly sealed Product should be free from
precipitate Contact distributor if product contents do not match label
color Product certification is available upon request Please provide
product lot number when requesting certification Lot number and
expiration date are printed on individual bottles
Expected Test Values:
Gestational Diabetes GDM: Women not at high risk for GDM typically
undergo OGTT screening at 24-28 weeks of gestation The initial screening
is performed by measuring the plasma or serum glucose concentration 1 hour
after a 50 gram glucose load The diagnosis of GDM is based upon the
administering of 100 gram glucose load The initial screen with a
threshold value 140 mg/dl 78 mmol/l identifies approximately 80 of
women with GDM The yield is increased to 90 by using a
cutoff of 130
ml/dl 72 mmol/l The most accepted cutoff values for the diagnosis of
GDM after administering the 100 gram glucose load are 1 hour 180 mg/dl
100 mmol/l, 2 hour 155 mg/dl 86 mmol/l and 3 hour 140 mg/dl 78
mmol/l Diabetes Mellitus DM and Impaired Glucose Tolerance IGT:
Accepted values for the diagnosis of DM and IGT are based upon the
administering of a 75 gram glucose load
2-h postload glucose 140 mg/dl 78 mmol/l normal glucose
tolerance
2-h postload glucose 140 gm/dl 78 mmol/l and 200 mg/dl 111
mmol/l IGT
2-h postload glucose 200 mg/dl 111 mmol/l provisional
diagnosis of diabetes diagnosis must be confirmed on a different
day as previously described [3,4,5,9]
Performance Characteristics: Sensitivity and Specificity of OGTT screening
2-h OGTT venous glucose test with a cutoff point of 111 mmol/l has a
sensitivity of 90-93 and specificity of 100
2-h OGTT capillary glucose test with a cutoff point of 111 mmol/l
has a sensitivity of 69 and a specificity of 93 [4]
Adverse Reactions and Warnings: Glucose load may cause nausea, vomiting,
diarrhea or fainting
Product should be consumed under the direct
supervision of a trained medical professional Healthcare professionals
should be contacted for further information regarding procedures and test
results Ingredients are listed on individual bottles
Bibliography
[1] National Diabetes Data Group Classification and Diagnosis of Diabetes
Mellitus Diabetes 28, 1039-57, 1979
[2] WHO Definition, Diagnosis and Classification of Diabetes Mellitus and
its Complications World Health Organization, Geneva 1999
[3] Gavin JR, et al: Report of the Expert Committee on the Diagnosis and
Classification of Diabetes Mellitus Diabetes Care 26:S5-S20, 2003
[4] Engelgau MM, Vankat Narayan KM, Herman WH: Screening for Type 2
Diabetes Diabetes Care 23:1563-1580, 2000
[5] Coustan DR: Gestational Diabetes National Institute of Health, 703-
717
[6] Nettina S: Diabetes Mellitus The Lippincott Manual of Nursing
Practice 6th ed Lippincott-Raven, 1996, p 736-737
[7] Diagnostic Tests Handbook, Springhouse, 1987, p 114-117
[8] Brown TT: Glucose Tolerance Test Medline Medical Encyclopedia 2002
[9] Harris, MI: Classification, Diagnostic Criteria, and Screening
for
Diabetes National Institute of Health, 15-36
[10] Lebovitz: Diagnosis and Classification of Diabetes Mellitus and
Related Disorders 1999 p 6-7
[11] Jeffeat, L: Diabetes for Nurses The Diagnosis and Classification of
Diabetes Mellitus 1999 p 4-7
Product Distributor: Ever Scientific, 337 Gordon Drive, Exton, PA 19341
6105245810 01/18/05
MPL 0831
