Limitations

Although the GlycoMark test can help identify hyperglycemia and peak levels exceeding the renal threshold, it cannot provide information about the timing of high glucose levels or duration of hyperglycemic episodes. Hyperglycemia can occur in the fasting period, post-meal period, or both.

Some conditions, particularly those that may increase urine glucose output, may affect the results of the GlycoMark test.1  These conditions include:

  • GlycoMark test is to be used with serum or EDTA plasma; performance in other matrices has not been evaluated.
  • Persistently positive urinary glucose levels, or oxyhyperglycemia after gastrectomy, may result in a low 1,5-AG value. Low values have also been observed in terminal stage renal failure, dialysis patients, advanced cirrhosis, and prolonged incapability of oral ingestion of food.2,3,4
  • For some patients with severe hyperglycemia, the internal pool of 1,5-AG may tend to remain depleted as a result of persistent glycosuria. In these cases, measurements of 1,5-AG may be less indicative of initial recovery following initiation of anti-diabetic treatment.
  • 1,5-AG values may be increased when some Chinese medicines, such as Polygala Tenuifolia and Senega syrup, are administered, because these medicines contain very high concentrations of 1,5-AG. Values may be altered during intravenous hyperalimentation therapy, depending on whether the therapy contains 1,5-AG.5,6
  • The class of diabetes medications known as sodium-glucose co-transporter 2 (SGLT2) inhibitors lower blood glucose by blocking glucose reabsorption, resulting in elimination of glucose through urine. Because these medications exert their effect by producing glycosuria, abnormal 1,5-AG levels may be observed in conjunction with the use of these medications.7 SGLT2 inhibitors affect circulating 1,5-AG levels, but do not affect the performance of the GlycoMark test.
  • Some alpha-glucosidase inhibitors, such as Acarbose, may potentially reduce 1,5-AG levels due to interference with intestinal absorption of 1,5-AG.8
  • As with all diagnostic tests, GlycoMark results should be interpreted along with clinical findings and results from other diagnostic methods.

 

 

References:
1Data on file, see package insert for details.
6Yamanouchi T, et al. Diabetes Res Clin Pract 1994;24{Suppl):S261-S268.
2Emoto M, et al. Nephron 1992;61:181-186.
3Yamagishi S, et al. Acta Diabetol 1998;35:65-66.
4Kawasaki T, et al. Diabetes Res Clin Pract 2000;50:97-101.
5Minoda S. Teikyo Medical Journal 1993;16:321-333. (in Japanese)
6Balis DA, et al. J Diabetes 2014;6:378-380.
7Watanabe K, et al. J Diabetes Complications 2004;18:183-186.