Real-world data from Europe and Africa suggest that accuracy of systems for self-monitoring of blood glucose is frequently impaired by low hematocrit

Rolf Hinzmann,Daniel Militz,Tomáš Zima,Martin Špaček,Huib Storm,Zivanai Chapanduka,Oliver Hauss

doi:10.1016/j.diabres.2021.108860

Rolf Hinzmann, Daniel Militz + Show 5 more

Open Access

https://doi.org/10.1016/j.diabres.2021.108860

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Abstract

AimsCertain systems for self-monitoring of blood glucose (SMBG) demonstrate inaccuracy at low and high hematocrit (HCT). Manufacturers define HCT ranges for accurate performance. Our objective was to assess the frequency of HCT values that can lead to clinically relevant errors. MethodsIn this cross-sectional study, we collected real-world data representing over 360,000 outpatients from the Netherlands (NL), the Czech Republic (CZ), and South Africa (ZA). These were subsequently stratified by sex and age and compared to commonly specified HCT range limits, reference intervals, and data from 1780 healthy Czech subjects. ResultsHCT values were comparably distributed in NL and CZ. Outpatients had a higher dispersion of values than healthy subjects. Low HCT values in Europe were common in age groups with a high prevalence of diabetes. All ZA age groups showed a higher prevalence of low HCT than in Europe. ConclusionsReal-world data indicate that SMBG systems specified to perform only within the frequently used 30–55% HCT range would leave 3% of outpatients in Europe and 18% in South Africa at risk of false SMBG results, with individual age strata being substantially higher. This could affect their diabetes management. Adequate SMBG systems should thus be chosen.

Highlights

Studies have demonstrated that the inaccuracy of systems for self-monitoring of blood glucose (SMBG) may result in overlooking hypoglycemia, increased frequency of hypo- and hyperglycemia, increased glycemic variability and increased HbA1c [1,2,3,4,5,6]
We assessed the frequency of medical episodes with HCT values outside commonly used specified HCTranges by evaluating outpatient samples from the Czech Republic, the Netherlands, and South Africa
Our results suggest that SMBG systems with a specified range of 30% HCT and above leave a significant number of patients at risk of clinically relevant inaccurate readings, while specified ranges of 20% HCT and especially 10% HCT minimize that risk

Summary

Introduction

Studies have demonstrated that the inaccuracy of systems for self-monitoring of blood glucose (SMBG) may result in overlooking hypoglycemia, increased frequency of hypo- and hyperglycemia, increased glycemic variability and increased HbA1c [1,2,3,4,5,6]. It is well-known that a low hematocrit (HCT) can lead to inaccurately high blood glucose values in certain SMBG systems. This can result in insulin overdosing, which in turn can lead to hypoglycemia, even in a hospital setting [7]. We wanted to assess the likelihood of real-world hematocrit distributions having an impact on the accuracy of SMBG systems

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