Prof. Dr. med. Peter B. Luppa, EQAS Expert & INSTAND e.V. Board Member
gave a presentation on July 30, 2025, at the ADLM Congress in Chicago as part of the session
“34102 - Improving Analytical Quality to Meet the Growing Demand for Optimized Diabetes Therapy” on the topic of
'Quality Assessment of Laboratory Measurements of Plasma Glucose and HbA1c with Regard to Epidemiology and Clinical Management of Diabetes Mellitus in Germany'
Background:
Over the past ten to fifteen years, the prevalence of diabetes mellitus has continued to increase in Germany, leading to a shift from undiagnosed to diagnosed cases. In light of this significant epidemiological development, the number of people with documented type 2 diabetes stood at 8.7 million in 2022. In addition, there are an estimated two million undiagnosed cases.
Furthermore, the life expectancy of diabetics is increasing due to improved clinical care for people with diabetes in the German healthcare system. Possible reasons for this include improved treatment regimens, improved preventive screening of at-risk individuals with increased use of anamnestic risk scores, and the introduction of HbA1c for diagnosis in 2010. Quality aspects of laboratory analysis could also play a role. This retrospective study was conducted to clarify this.
Methods:
The epidemiology and clinical management of diabetes in Germany were reviewed based on publications from the last 13 years, which were identified through a selective search of the PubMed database. In addition, data from German EQA schemes conducted by INSTAND and RfB for the parameters plasma glucose and HbA1c in whole blood, reviewed from 2010 to 2022, were evaluated. This involved a data set of more than 25,000 individual results. Furthermore, data on the analytical performance of point-of-care blood glucose meters in accordance with ISO standard 15197:2013 were reviewed in a meta-analysis.
Results:
Various aspects of laboratory diagnostics are consistent with the observation of an increase in the prevalence of diabetes mellitus when looking back at the period from 2010 to 2022:
Firstly, the analytical performance of blood glucose meters, which diabetes patients frequently use for self-monitoring of blood glucose levels, has improved significantly during this period in accordance with ISO standard 15197:2013.
Secondly, the number of participating laboratories increased significantly in the interlaboratory tests offered by both German EQA scheme organizations. Thirdly, an analysis of the variation in the results reported by participants for HbA1c between 2010 and 2022 showed a significant reduction in the variation in results. However, this trend could not be demonstrated for the variation in plasma glucose measured with POCT devices during the same period. This indicates that the sample material used for the glucose analyte is suboptimal and is responsible for the significant differences in glucose values observed across the various point-of-care devices. However, INSTAND is now pursuing new concepts for more suitable interlaboratory test control materials.
Conclusion:
These retrospective findings demonstrate the excellent analytical quality of glucose and HbA1c laboratory diagnostics in Germany. Indirectly, it can be concluded that high-quality laboratory diagnostics contribute to better diagnostics and earlier treatment of people with diabetes mellitus and help to reduce the number of undiagnosed cases.
Literature:
Luppa PB, Zeller M, Pieper M, Kaiser P, Weiss N, Vierbaum L, Freckmann G. Quality assessment of glucose measurement with regard to epidemiology and clinical management of diabetes mellitus in Germany. Front Mol Biosci. 2024 Mar 20;11:1371426. doi: 10.3389/fmolb.2024.1371426.