In Response to a Previous Letter to the Editor Titled,“Accuracy of a Blood Glucose Monitoring System”

In the past, the UK MDA independently commissioned, funded, and published freely available “blue cover report” evaluations of the performance of all blood glucose meter systems entering the UK market for inclusion on the NHS DT. These provided independent, impartial, comprehensive evaluation studies undertaken in a standardized manner using protocols agreed with manufacturers. Although manufacturers were not involved in practical aspects of undertaking such independent evaluations, the manufacturers were given an opportunity to input by comment on the protocol, providing BGMS and to comment on the report and interpretation of results. These features, which are not present in many current peer-reviewed published evaluation studies, improved quality and ensured these independent studies and publications were clearly seen as balanced, valid, high-quality, and impartial.

Funding of accuracy studies by independent bodies is however currently very infrequent, and virtually all evaluation studies and publications are funded by industry. While appropriate independent evaluation of accuracy is essential and welcomed, correct evaluation is complex. In the rare occasions when high-quality independent evaluations take place, while not being directly involved in practical aspects of the studies, manufacturers should be provided with the opportunity to input by commenting on the protocol, the systems/strips used and their handling, and allowed to include summary interpretive comments.

The publication by Vanterpool ¹ discussed here warrants discussion:

• Although published in 2016, the date when the study was performed is not stated.

• Details of strip lots numbers or expiry dates are not provided.

• BGMS GlucoRx Nexus TD-4277 were purchased at a pharmacy in the UK by the funder of the study (Roche) and then transported to Germany, where the study took place. Evaluation of strips supplied via conventional supply chains is entirely valid and ISO 15197;2013 states all components of the BGMS should be representative of routine production units. However, supply of BGMS via Roche Diagnostics, a direct competitor of GlucoRx Ltd in the UK, rather than an independent intermediary, may not be perceived as impartial.

• Details of over what time the different strip lots were obtained and how they were stored and transported are not provided.

• The manufacturer was given no opportunity to observe or comment on the protocol, supply of meter/strips, or findings. Supplemental supply of one lot of strips by the manufacturers for simultaneous evaluation would have acted as a useful quality control.

• Surprisingly, no members of the expert group performing the practical aspects of the study (Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm) appear as authors.

• The article fails to reference a previous letter to the editor titled, “Accuracy Evaluation of a CE-Marked System for Self-Monitoring of Blood Glucose With Three Reagent System Lots Following ISO 15197:2013,” by Eckhard Salzsieder and Sabine Berg, J Diabetes Sci Technol. 2016;10(1):238-239. This study demonstrates that the BGMS TD-4277 fulfils and exceeds the minimum analytical and clinical accuracy requirement of ISO 15197:2013.

When taken in combination, all the points above show the study unfortunately failing to demonstrate sufficient safeguards to ensure it is truly independent and impartial.