Use of the GTT@home Oral Glucose Tolerance Test Kit in Gestational Diabetes Mellitus: Performance Evaluation Study.

Abstract

Background: The 75-g oral glucose tolerance test (OGTT) remains the optimal diagnostic test for use in pregnancy but needs to be performed in the clinical setting. The GTT@home OGTT device offers the potential to enable patients to perform the test at home using capillary blood samples.

Objective: This study aimed to determine the accuracy of the GTT@home device compared to the routine National Health Service laboratory reference method using blood samples during an OGTT from pregnant women at high risk of developing gestational diabetes mellitus (GDM).

Methods: A total of 65 women (aged >18 y), at high risk for GDM (per the National Institute for Health and Care Excellence guidelines) were recruited for this performance evaluation. Following an overnight fast, participants went for a 75-g OGTT. Fasting and 2-hour capillary glucose levels were measured using the GTT@home device with corresponding venous samples measured in the laboratory.

Results: The complete data for analysis was available for 61/65 devices. The overall bias for the GTT@home device was +0.16 mmol/L. Correlation analysis of the clinical performance of the two methods using a surveillance error grid showed 79.8% of results in the lowest, 16.9% in the "slight, lower" and 2.4% in the "slight, higher" risk categories. Only 0.8% were "moderate, lower" risk, and none were in any higher risk categories. There was agreement in the classification in 54/61 cases. The GTT@home device under-classified 2 cases and over-classified 5 cases.

Conclusions: The GTT@home device worked well in a controlled, antenatal clinical setting. Differences in classification observed were generally due to small differences in glucose values close to the diagnostic cut-offs. The GTT@home device shows promise for home testing of glucose tolerance in pregnant women.