The GlycoMark test is FDA-cleared for the intermediate monitoring of glucose control in people with diabetes. Clinical research is for educational purposes and GlycoMark, Inc. does not promote the intended use of the GlycoMark test outside its labeling.
The GlycoMark 1,5-anhydroglucitol test is a robust clinical trial marker that can provide additional insights beyond A1C in any research relating to diabetes medications, glycemic impact of food and nutraceuticals, diabetes medical devices and lifestyle changes. The benefits it provides to researchers include:
- Clinically proven measure of mean daily maximum glucose and glycemic variability
- Correlates well with Continuous Glucose Monitor and glycemic variability measures including AUC 180 (time spent over 180 mg/dL)
- Correlates well with blood glucose after 75g glucose load
- Shows statistically significant therapy effects in as little as 2 weeks
- Can show dosing effect differences sooner than A1C
- May help distinguish if severe adverse events (SAEs) are linked to hyperglycemic excursions or are drug-related
- Recent ACCORD trial analysis of SBGM data found CVD deaths in intensive control group were not related to hypoglycemia, but rather patterns of hyperglycemic excursions and lack of attainment of 6% A1C. View Study
- Recent Diabetes Care study showed glycemic variability was more important than glucose and A1C in predicting major adverse cardiovascular events after acute MI. View Study
- 1,5-AG levels have been linked to increased risk of complications and of developing diabetes
- FDA cleared and CE marked for use in Europe
Over 40 studies have been conducted with more than 12,000 subjects – many of which involve therapy monitoring.
Many CRO reference labs already offer the GlycoMark test