The Need for Standardization of Continuous Glucose Monitoring Performance Evaluation: An Opinion by the International Federation of Clinical Chemistry and Laboratory Medicine Working Group on Continuous Glucose Monitoring.

Metrics derived from continuous glucose monitoring (CGM) systems are often discordant between systems. A major cause is that CGM systems are not standardized; they use various algorithms and calibration methods, leading to discordant CGM readings across systems. This discordance can be addressed by standardizing CGM performance assessments: If manufacturers aim their CGM systems at the same target, then CGM readings will align across systems.

Consensus Considerations and Good Practice Points for Use of Continuous Glucose Monitoring Systems in Hospital Settings.

Continuous glucose monitoring (CGM) systems provide frequent glucose measurements in interstitial fluid and have been used widely in ambulatory settings for diabetes management. During the coronavirus disease 2019 (COVID-19) pandemic, regulators in the U.S.

An SMS-Guided Basal Insulin Titration in People with Type 2 Diabetes New on Insulin.

Introduction: The shortage of general practitioners (GPs) and the increasing prevalence of type 2 diabetes create significant pressure on primary healthcare services. To enable that medical services are available to all that need it, innovative solutions are needed. One of those, a Short Message Service (SMS)-supported basal insulin titration service is investigated in this study.

Nocturnal Hypoglycemia in the Era of Continuous Glucose Monitoring.

Nocturnal hypoglycemia is a common acute complication of people with diabetes on insulin therapy. In particular, the inability to control glucose levels during sleep, the impact of external factors such as exercise, or alcohol and the influence of hormones are the main causes. Nocturnal hypoglycemia has several negative somatic, psychological, and social effects for people with diabetes, which are summarized in this article.

Performance of a Novel Continuous Glucose Monitoring Device in People With Diabetes.

Background: In this multicenter study, performance of a novel continuous glucose monitoring (CGM) system was evaluated.

Methods: Adult participants with diabetes were included in the study. They each wore three sensors of the CGM system on the upper arms for up to 14 days.

Characteristics of Nocturnal Hypoglycaemic Events and Their Impact on Glycaemia.

Background: Nocturnal hypoglycaemia is a burden for people with diabetes, particularly when treated with multiple daily injections (MDI) therapy. However, the characteristics of nocturnal hypoglycaemic events in this patient group are only poorly described in the literature.

Method: Continuous glucose monitoring (CGM) data from 185 study participants with type 1 diabetes using MDI therapy were collected under everyday conditions for up to 13 weeks.

Unlocking Potential: Personalized Lifestyle Therapy for Type 2 Diabetes Through a Predictive Algorithm-Driven Digital Therapeutic.

Background: We present a digital therapeutic (DTx) using continuous glucose monitoring (CGM) and an advanced artificial intelligence (AI) algorithm to digitally personalize lifestyle interventions for people with type 2 diabetes (T2D).

Method: A study of 118 participants with non-insulin-treated T2D (HbA ≥ 6.5%) who were already receiving standard care and had a mean baseline (BL) HbA of 7.

Point-of-care testing: state-of-the art and perspectives.

Point-of-care testing (POCT) is becoming an increasingly popular way to perform laboratory tests closer to the patient. This option has several recognized advantages, such as accessibility, portability, speed, convenience, ease of use, ever-growing test panels, lower cumulative healthcare costs when used within appropriate clinical pathways, better patient empowerment and engagement, and reduction of certain pre-analytical errors, especially those related to specimen transportation. On the other hand, POCT also poses some limitations and risks, namely the risk of lower accuracy and reliability compared to traditional laboratory tests, quality control and connectivity issues, high dependence on operators (with varying levels of expertise or training), challenges related to patient data management, higher costs per individual test, regulatory and compliance issues such as the need for appropriate validation prior to clinical use (especially for rapid diagnostic tests; RDTs), as well as additional preanalytical sources of error that may remain undetected in this type of testing, which is usually based on whole blood samples (i.

Quality assessment of glucose measurement with regard to epidemiology and clinical management of diabetes mellitus in Germany.

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.

A Critical Discussion of Alert Evaluations in the Context of Continuous Glucose Monitoring System Performance.

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.

Benefits of Usability Evaluation in the Development Process of Diabetes Technologies Using the Example of a Continuous Glucose Monitoring System Prototype.

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.

A Proposal for the Clinical Characterization of Continuous Glucose Monitoring Trend Arrow Accuracy.

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.

Investigation of the Effect of 70 Potential Interferents on Measurement Results of Two Blood Glucose Monitoring Systems.

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.

Plasma Glucose Concentrations in Different Sampling Tubes Measured on Different Glucose Analysers.

Introduction: The German Diabetes Association recommends using sampling tubes with citrate and fluoride additives to diagnose 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 on 41 participants without anamnestically known diabetes.

Comparator Data Characteristics and Testing Procedures for the Clinical Performance Evaluation of Continuous Glucose Monitoring Systems.

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.

Effect of Arterialization on Venous Blood Glucose Concentrations and Implications for Observed Continuous Glucose Monitoring Accuracy.

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. A heating pad set to 50°C (122°F) was used with 20 participants to heat either the dominant or nondominant arm and hand.

Evaluation of System Accuracy, Precision, Hematocrit Influence, and User Performance of Two Blood Glucose Monitoring Systems Based on ISO 15197:2013/EN ISO 15197:2015.

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.

Use of smartphone application versus written titration charts for basal insulin titration in adults with type 2 diabetes and suboptimal glycaemic control (My Dose Coach): multicentre, open-label, parallel, randomised controlled trial.

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.