In-office HbA1c Results Improve Diabetes Decision Making, Patient Compliance, and Outcomes

Clinical studies show that in-office HbA1c results improve decision making,1 patient compliance,2 and outcomes. “The immediate feedback of HbA1c results at the time of patient encounters resulted in a significant improvement of glycemic control at 6-month follow-up and persisted for the 12-month study.”3

Outcomes improve when healthcare providers are able to discuss A1c results with patients in real time.
Outcomes improve when healthcare providers are able to discuss A1c results with patients in real time.

In-office HbA1c testing helps you more efficiently manage your patient. It may also reduce the effort and time needed to sort, send, receive, and collate lab samples and reports.

An in-office HbA1c system should give you highly accurate results.

In addition, look for:

  • Simplified test procedure with no reagent preparation.
  • Simple and flexible specimen collection.
  • National Glycohemoglobin Standardization Program (NGSP) certified and traceable to International Federation of Clinical Chemistry (IFCC) reference materials and test methods.
  • A system that can also report out IFCC units if required.
  • A robust, easily tailored data management system that supports the way your office works.
  • Ability to enter patient and operator ID.
  • Ability to utilize QC reminders and QC lockout.
  • Minimal maintenance.

___________________
a National Glycohemoglobin Standardization Program
b Diabetes Control and Complications Trial

  • National Glycohemoglobin Standardization Program (NGSP) certified and traceable to International Federation of Clinical Chemistry (IFCC) reference materials and test methods.
  • Comparable accuracy to lab HbA1c tests.
  • Simplicity: no reagent preparation, 6 minutes to results, and self-prompting screens.
  • Flexible specimen collection: only requires 1 μL of capillary or venous blood sample.
  • Decision support: immediate results allow convenient treatment plan adjustments. Additional features include A1c trend graphs and early detection/monitoring of kidney disease (with the optional urine microalbumin/creatinine test).
  • Robust, flexible data management: enter patient and operator ID, print or transfer records to EMR/LIS, flash drive, PC, etc. — all through the easy to use touchscreen display. Stores up to 4,000 records.
  • QC reminder and lockout options: allows the user to easily and conveniently validate system and test result accuracy.
  • Excellent track record and low maintenance.

An in-house study was conducted to assess precision for the DCA HbA1c test.

  • A total of 2160 tests were conducted by testing three different levels of clinical samples in duplicate twice per day over 20 days and across three DCA Vantage analyzers using three (3) different lots of DCA HbA1c reagent.

 

   Assigned
   Value

% HbA1c
Mean Value

mmol/mol HbA1c
Mean Value

% CV    

SD     

   5.0%

 5.3

 34.4

 1.76

 0.09

   6.5%

 6.7

 49.7

 1.73

 0.11

   8.0%

 8.1

 65.0

 2.02

 0.16

  • These results demonstrate very tight precision with coefficient of variation (CVs) of 2.0% or less.

___________________
1Thaler LM, Ziemer DC, Gallina DL, et al. Diabetes in urban African-Americans. XVII. Availability of rapid HbA1c measurements enhances clinical decision-making. Diabetes Care. 1999;22:1415-1421.
2Miller CD, Barnes CS, Phillips LS, et al. Rapid A1c availability improves clinical decision-making in an urban primary care clinic. Diabetes Care. 2003;26:1158-1163.
3Cagliero E, Levina DV, Nathan DM. Immediate feedback of HbA1c levels improves glycemic control in Type 1 and insulin-treated Type 2 diabetic patients. Diabetes Care. 1999;22:1785-1789.
4 GHX Market Intelligence, market data report. 4Q 2012 report.
5 DCA System Hemoglobin A1c Reagent Kit Instructions for Use, Part Number 10698776.