Why Test?

Hyperglycemia: Glycemic Control Reduces Diabetes Complications

The American Diabetes Association (ADA) has set glucose and A1C targets to help monitor glycemic control and reduce diabetes related outcomes.

Glycemic Targets1

 Glucose: < 130 mg/dl
(or < 180 mg/dl two hours post meal)
AIC: < 7%
(Patients are considered pre-diabetic if A1C is > 5.6%.)

 

 

Current Glycemic Control Testing Has Its Limitations

A periodic finger stick glucose is not always reliably timed or performed, and may yield inaccurate results.3,4
A quarterly or bi-annual A1C glucose average is a lagging indicator of glycemic control and is incapable of detecting recent hyperglycemia and glycemic variability.

  • Up to 40% of patients considered by A1C to be in “good control” may be experiencing postprandial hyperglycemia and glycemic variability.5,6
  • Over 15% of A1C results can be affected by physiological and pharmacological factors associated with the patient’s hemoglobin.
  • The estimated blood glucose range for an A1C of 7% is 123 – 185 mg/dL.6

 

The Utility of the GlycoMark Test

ABNORMAL GlycoMark results identify patients with recent hyperglycemic excursions that are not evident with A1C.

  • In comparing two patients with similar “good” A1Cs of 7.4%, the glycemic profiles are quite different.  Without the GlycoMark test, these patients might receive the same treatment and ongoing management.
  • By incorporating the GlycoMark test, patients with a low GlycoMark test can be more closely and individually managed to reduce glycemic variability and improve their A1C.

 


INCREASING or DECREASING GlycoMark results reveal changes in glycemic control (improving or worsening).

  • Allows for timely detection of changes in glycemic control associated with health, lifestyle and/or treatment modifications
  • Used in conjunction with A1C to help guide treatment strategies and get patients to goal

Multiple studies independently link 1,5-AG with diabetes complications and outcomes.

 

Refer to the GlycoMark test package insert for additional information.

 

 

Note:

  • The GlycoMark test is not affected by hemoglobinopathies, such as anemias, sickle cell disease or malaria,  because it is not a hemoglobin glycosylation marker like A1c.
  • The GlycoMark test has been tested and found to be unaffected by hemoglobin (125 mg/dL), triglycerides (1153 mg/dL), bilirubin (40 mg/dL), glucose (1000 mg/dL),  maltose (500 mg/dL), ascorbic acid (25 mg/dL), uric acid (20 mg/dL), urea (20 mg/dL) and creatinine (10 mg/dL).

 

References:
1American Diabetes Association. Diabetes Care 2015 Jan; 38(Supplement 1): S33-S40.
2Stratton IM, et al. BMJ. 2000 Aug 12;321(7258):405-12.
3Erbach M, et al. J Diabetes Sci Technol. 2016;10:1161-1168.
4Klonoff DC, et al. J Diabetes Sci Technol. 2011;5:1529-1548.
5Erlinger TP, Branca FL. Diabetes Care. 2001 Oct;24(10):1734-8.
6Bonora E, et al. Diabetologia. 2006 May;49(5):846-54.
7Dungan KM, et al. Diabetes Care 2006 Jun; 29(6): 1214-1219.
8Selvin E, et al. Clin Chem. 2014 Nov; 60(11): 1409–1418.
9Selvin E, et al. Diabetes 2016;65:201–208.
10Lee AK, et al. Diabetes Care 2017 Dec; 40(12): 1661-1667.
11Rawlings AM, et al. Diabetes Care 2017 Jul; 40(7): 879-886.
12Nowak N, et al. Diabetologia 2013 Apr;56(4): 709–713.

The GlycoMark test is an FDA-cleared, non-fasting serum or plasma test for monitoring blood glucose variability in people with diabetes. The GlycoMark test provides quantitative measurement of 1,5-anhydroglucitol (1,5-AG) in serum or plasma. The test is for professional use, and is indicated for the intermediate term monitoring of glycemic control in people with diabetes.

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