Glucose Drink Resources

- Instructions For Use -

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.

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 1.75 grams of glucose per kg of body weight up to a total of 75 grams of glucose.

Interfering Factors, Substances: The following conditions should be communicated to the healthcare provider since they may influence the accuracy of an OGTT.

Known drugs that may cause glucose intolerance include:

Beverage Storage: Oral Glucose Tolerance 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.

Downloadable Resources

• Ingredients List
• Product Flyer
• Instructions For Use
• SDS Exempt Letter