Freckmann

BACKGROUND: During the last decade, Germany has seen an increased prevalence and a redistribution from undetected to diagnosed diabetes mellitus. Due to this substantial epidemiological development, the number of people with documented type 2 diabetes was 8.7 million in 2022. An estimated two million undiagnosed subjects are to be added. Beyond that, the life expectancy of diabetic subjects is increasing due to more responsive health systems in terms of care. Possible reasons include improved screening of at-risk individuals, the introduction of HbA1c for diagnosis in 2010, and the higher use of risk scores...

No abstract text is available yet for this article.

Many continuous glucose monitoring (CGM) systems provide functionality which alerts users of potentially unwanted glycemic conditions. These alerts can include glucose threshold alerts to call the user's attention to hypoglycemia or hyperglycemia, predictive alerts warning about impeding hypoglycemia or hyperglycemia, and rate-of-change alerts. A recent review identified 129 articles about CGM performance studies, of which approximately 25% contained alert evaluations. In some studies, real alerts were assessed; however, most of these studies retrospectively determined the timing of CGM alerts because not all CGM systems record alerts which necessitates manual documentation...

BACKGROUND: Usability engineering analyzes the interaction between the intended users and a device. Its implementation is mandatory for manufacturers to obtain regulatory approval for the European market. The aim of this evaluation was assessing the role of usability testing in the development process. For this purpose, a continuous glucose monitoring (CGM) device under development was investigated to determine whether it could be used safely and effectively by the intended users. METHODS: Conduct of the usability testing was based on the international standard IEC 62366-1...

The assessment and characterization of trend accuracy, that is, the ability of a continuous glucose monitoring (CGM) system to correctly indicate the direction and rate of change (RoC) of glucose levels, has received comparatively little attention in the overall evaluation of CGM performance. As such, only few approaches that examine the trend accuracy have been put forward. In this article, we review existing approaches and propose the clinical trend concurrence analysis (CTCA) which is an adaptation of the conventional trend concurrence analysis...

No abstract text is available yet for this article.

No abstract text is available yet for this article.

BACKGROUND: Reliable blood glucose (BG) measurements are important for people with diabetes to manage their therapy as well as in point-of-care testing (POCT) performed by health care professionals to monitor BG of patients or even to diagnose diabetes. Among other factors, endogenous and exogenous substances present in blood samples can impact the measurement results. To ensure and prove that blood glucose monitoring systems (BGMSs) are robust in terms of potential interferents, manufacturers have to perform extensive evaluations...

Introduction The German Diabetes Association recommends use of sampling tubes with citrate and fluoride additives in the diagnosis of diabetes by oral glucose tolerance test to inhibit glycolysis. The effect of different tubes on measurement results was assessed. Materials and Methods In a first study, an oral glucose tolerance test was performed in 41 participants without anamnestically known diabetes. Venous blood was sampled in two different tubes with citrate/fluoride additives from different manufacturers and one with only lithium-heparin additive...

No abstract text is available yet for this article.

Comparing the performance of different continuous glucose monitoring (CGM) systems is challenging due to the lack of comprehensive guidelines for clinical study design. In particular, the absence of concise requirements for the distribution of comparator (reference) blood glucose (BG) concentrations and their rate of change (RoC), that are used to evaluate CGM performance, impairs comparability. For this article, several experts in the field of CGM performance testing have collaborated to propose characteristics of the distribution of comparator measurements that should be collected during CGM performance testing...

Background Heating of the arm and/or hand ("arterialization") is sometimes used in continuous glucose monitoring (CGM) performance studies with the reported aim of reducing differences between venous and capillary glucose concentrations. In this study, the effect of heating on venous glucose concentrations and CGM accuracy was investigated. Methods A heating pad set to 50 °C (122 °F) was used with 20 participants to heat either the dominant or non-dominant arm and hand. Venous and capillary samples were obtained every 15 minutes on both arms throughout each of three 6-hour glucose challenges...

INTRODUCTION: Sufficiently high analytical quality of blood glucose monitoring systems (BGMS) is a prerequisite for efficient diabetes therapy. In this study we assessed system accuracy, measurement repeatability, intermediate measurement precision, user performance, and the influence of hematocrit on two CE-marked blood glucose monitoring systems. For one BGMS, measurement accuracy using venous samples was additionally investigated. METHODS: Study procedures were based on the International Organization of Standardization (ISO) 15197:2013/EN ISO 15197:2015 ("ISO 15197")...

BACKGROUND: The majority of people with type 2 diabetes who require insulin therapy use only basal insulin in combination with other anti-diabetic agents. We tested whether using a smartphone application to titrate insulin could improve glycaemic control in people with type 2 diabetes who use basal insulin. METHODS: This was a 12-week, multicentre, open-label, parallel, randomised controlled trial conducted in 36 diabetes practices in Germany. Eligible participants had type 2 diabetes, a BMI ≥25...

The introduction of automated insulin delivery (AID) systems has enabled increasing numbers of individuals with type 1 diabetes (T1D) to improve their glycemic control largely. However, use of AID systems is limited due to their complexity and costs associated. The user must wear both a continuously monitoring glucose system and an insulin infusion pump. The glucose sensor and the insulin catheter must be inserted at two different body sites using different insertion devices. In addition, the user must pair and manage the different systems...

BACKGROUND: FIND, the global alliance for diagnostics, identified the nonmarket-approved continuous glucose monitoring (CGM) system, FiberSense system (FBS), as a potential device for use in low- and middle-income countries. Together with two market-approved, factory-calibrated CGM systems, namely, the FreeStyle Libre 2 (FL2) and the GlucoRx AiDEX (ADX), the FBS was subjected to a clinical performance evaluation. METHODS: Thirty adult participants with type 1 diabetes were enrolled...

The use of different approaches for design and results presentation of studies for the clinical performance evaluation of continuous glucose monitoring (CGM) systems has long been recognized as a major challenge in comparing their results. However, a comprehensive characterization of the variability in study designs is currently unavailable. This article presents a scoping review of clinical CGM performance evaluations published between 2002 and 2022. Specifically, this review quantifies the prevalence of numerous options associated with various aspects of study design, including subject population, comparator (reference) method selection, testing procedures, and statistical accuracy evaluation...

Dysregulation of the PI3K/AKT pathway is a common occurrence in high-grade serous ovarian carcinoma (HGSOC), with the loss of the tumour suppressor PTEN in HGSOC being associated with poor prognosis. The cellular mechanisms of how PTEN loss contributes to HGSOC are largely unknown. We here utilise time-lapse imaging of HGSOC spheroids coupled to a machine learning approach to classify the phenotype of PTEN loss. PTEN deficiency induces PI(3,4,5)P3 -rich and -dependent membrane protrusions into the extracellular matrix (ECM), resulting in a collective invasion phenotype...

We thank Dr. Freckmann et al. [...].

In their recent article entitled "Accuracy Assessment of the GlucoMen® Day CGM System in Individuals with Type 1 Diabetes: A Pilot Study" [...].