Clinical Validity of a Self-Test Fructosamine in Outpatient Diabetic Management

Diabetes Technol Ther. Winter 1999;1(4):435-41. doi: 10.1089/152091599316964.

Abstract

Background: Measurement of glycated hemoglobin and hemoglobin A1c (HbA1c) is now well established as the best means of measuring overall glucose control in managing diabetes. Other glycated serum protein assays reflecting recent glycemic control, e.g., glycated albumin and glycated protein (fructosamine), have also been validated in clinical studies. Regardless of the method, the expense and inconvenience of laboratory testing of blood samples may contribute to the well-documented underutilization of clinical glycated protein assessment. Accordingly, a rapid, inexpensive fingerstick test of fructosamine has been developed. This study cross-sectionally and prospectively assesses the clinical validity of fingerstick fructosamine versus laboratory determination.

Methods: Fifty-one subjects (18 control, 33 with diabetes) participated in a cross-sectional study and 20 subjects with type 2 diabetes participated in a prospective, 6-week study with clinical intervention consisting of glipizide gits or metformin in mono- and combination therapy. Subjects had weekly laboratory determination of serum fructosamine, glycated hemoglobin, and fasting glucose; fingerstick fructosamine was obtained at each clinic visit.

Results: Fingerstick fructosamine was shown to correlate highly to laboratory fructosamine (r = 0.80, p < 0.001) and glycated hemoglobin (r = 0.81, p < 0.001). In the clinical intervention study subjects, significant decreases in fasting glucose (p < 0.001), laboratory fructosamine (p < 0.001), and fingerstick fructosamine (p < 0.001) were noted compared to baseline. The subject's self-test fingerstick fructosamine mirrored laboratory testing of fructosamine in detection of changes in clinical glucose control.

Conclusions: This study demonstrates that fingerstick fructosamine correlates well to laboratory assessment of fructosamine and glycated hemoglobin. The patient self-test fructosamine provides the same clinical information as laboratory assessment.

MeSH terms

  • Adult
  • Biomarkers / blood
  • Blood Specimen Collection / methods
  • Cross-Sectional Studies
  • Diabetes Mellitus / blood*
  • Diabetes Mellitus, Type 1 / blood
  • Diabetes Mellitus, Type 2 / blood
  • Fructosamine / blood*
  • Glycated Hemoglobin A / analysis
  • Humans
  • Middle Aged
  • Monitoring, Ambulatory / methods
  • Monitoring, Physiologic / methods*
  • Reference Values
  • Regression Analysis
  • Self Care*
  • Time Factors

Substances

  • Biomarkers
  • Glycated Hemoglobin A
  • Fructosamine