Product/Service

Point Of Care: Blood Glucose Testing

Source: Blinded Diagnostics
Blood Glucose Testing at the point of care include Glucose and HBA1C, in adaptive clinical trials involving dose adjustment and in blinded studies.

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Point Of Care Solutions For Pharmaceutical Clinical Trials

Blinded Diagnostics specializes in the application of point-of-care diagnostic platforms for testing patients enrolled in clinical trials.

Glucose testing at the point of care has been used frequently in adaptive clinical trials involving dose adjustment and in blinded studies. Most common tests include Glucose and HBA1C. CLIA-Waived and moderately complex platforms use small blood volumes of whole or venous samples. Time to results in minutes. See an expanded list of POC tests at www.pointofcaresearch.com

The blood glucose test may be used to:

  • Screen for both high blood glucose (hyperglycemia) and low blood glucose (hypoglycemia)
  • Help diagnose diabetes
  • Monitor glucose levels in persons with diabetes
Depending on the purpose of testing, glucose may be measured on a fasting basis (collected after an 8- to 10-hour fast), randomly (anytime), post prandial (after a meal), and/or as part of an oral glucose challenge or tolerance test (OGTT / GTT).

Screening:
Comprehensive Metabolic Panel (CMP)
Blood glucose is often measured as part of a group of tests, such as a CMP, during routine physicals. This is done to screen for diabetes, which often causes no symptoms early in its course, and for pre-diabetes – moderately increased blood glucose levels that indicate an increased risk of developing type 2 diabetes. For screening purposes, a CMP or blood glucose test is performed on a fasting basis (fasting blood glucose, FBG).

Oral Glucose Challenge Test (OGTT)
Many pregnant women are screened for gestational diabetes, a temporary form of hyperglycemia, between their 24th and 28th week of pregnancy using a version of the OGTT. The American Congress of Obstetricians and Gynecologists recommend that the woman take a standard amount of a glucose solution to drink, and after 1 hour her glucose level is measured and if the level is higher than a defined value, then a longer OGTT (usually 2 or 3 hours) is performed to clarify the woman's status. The American Diabetes Association recommends that the women take 75-grams of a glucose solution to drink and if one or more of her glucose levels at fasting, 1 hour, or 2 hours are above a certain level, then she is diagnosed as having gestational diabetes.

A1c & eAG Tests
The A1c test and eAG calculation are used to monitor the glucose control of diabetics over time. The goal of those with diabetes is to keep their blood glucose levels as close to normal as possible and the A1c test and eAG results give a picture of the average amount of glucose in the blood over the last few months. They can help you and your doctor know if the measures you are taking to control your diabetes are successful or need to be adjusted.

A1c Test can be used to:
  • Minimize the complications caused by chronically elevated glucose levels, such as progressive damage to body organs like the kidneys, eyes, cardiovascular system, and nerves.
  • Help newly diagnosed diabetics determine how elevated their uncontrolled blood glucose levels have been. It may be ordered several times while control is being achieved, and then several times a year to verify that good control is being maintained.
  • Screen for and diagnose diabetes.

Only A1c tests have been referenced to an accepted laboratory method (standardized) should be used for diagnostic or screening purposes. In these cases, a fasting plasma glucose or oral glucose tolerance test may be used for screening or diagnosis. Currently, point-of-care tests, such as those that may be used at a doctor's office or a patient's bedside, are too variable for use in diagnosis but can be used to monitor treatment (lifestyle and drug therapies).

A1c should not be used for diagnosis in pregnant women, people who have had recent severe bleeding or blood transfusions, those with chronic kidney or liver disease, and people with blood disorders such as iron-deficiency anemia, vitamin B12 anemia, and hemoglobin variants.

See an expanded list of POC tests at www.pointofcaresearch.com

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Point Of Care Solutions For Pharmaceutical Clinical Trials