Comparative Performance Analysis of Manual and Updated Optional Calibration Algorithms for the CareSens Air CGM System.

Background: The CE-marked CareSens Air continuous glucose monitoring (CGM) system (CSAir) features a 15-day sensor lifetime, a 2-hour warm-up period and mandatory manual calibrations. During subsequent product development, the algorithm was updated to reduce the warm-up period to 30 minutes and make user-entered calibrations optional. This study compared the CSAir's performance between the manual and updated algorithms.

Feasibility of a Glucose Manipulation Procedure for the Standardized Performance Evaluation of Continuous Glucose Monitoring Systems.

Background: In continuous glucose monitoring (CGM) system performance studies, it is common to implement specific procedures for manipulating the participants' blood glucose (BG) levels during the collection of comparator BG measurements. Recently, such a procedure was proposed by a group of experts, and this study assessed its ability to produce combinations of BG levels and rates of change (RoCs) with certain characteristics.

Methods: During three separate in-clinic sessions conducted over 15 days, capillary BG measurements were carried out every 15 minutes for 7 hours.

Performance of Three Continuous Glucose Monitoring Systems in Adults With Type 1 Diabetes.

Background: The performance of continuous glucose monitoring (CGM) systems is difficult to compare due to different study designs and a lack of head-to-head studies. This study evaluated the performance of FreeStyle Libre 3 (FL3), Dexcom G7 (DG7), and Medtronic Simplera (MSP) against different comparator methods and during clinically relevant glycemic scenarios.

Method: Twenty-four adult participants with type 1 diabetes mellitus wore one sensor of each CGM system in parallel for up to 15 days.

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.

Performance Assessment of Three Continuous Glucose Monitoring Systems in Adults With Type 1 Diabetes.

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.

Continuous Glucose Profiles in Healthy People With Fixed Meal Times and Under Everyday Life Conditions.

Background: The increased use of continuous glucose monitoring (CGM) and automated insulin delivery systems raises the question about therapeutic targets for glucose profiles in people with diabetes. This study aimed to assess averaged pre- and postprandial glucose profiles in people without diabetes to provide guidance for normal glucose patterns in clinical practice. For that, number and timing of meal intake were predefined.

Variation of Mean Absolute Relative Differences of Continuous Glucose Monitoring Systems Throughout the Day.

Background: There is an increasing use of continuous glucose monitoring (CGM) by people with diabetes. Measurement performance is often characterized by the mean absolute relative difference (MARD). However, MARD is influenced by a number of factors and little is known about whether MARD is stable throughout the day.

Choice of Continuous Glucose Monitoring Systems May Affect Metrics: Clinically Relevant Differences in Times in Ranges.

Background: Continuous glucose monitoring-derived parameters are becoming increasingly important in the treatment of people with diabetes. The aim of this study was to assess whether these parameters, as calculated from different continuous glucose monitoring systems worn in parallel, are comparable. In addition, clinical relevance of differences was investigated.

Impact of Two Different Reference Measurement Procedures on Apparent System Accuracy of 18 CE-Marked Current-Generation Blood Glucose Monitoring Systems.

Background: Measurement accuracy has been assessed for many different blood glucose monitoring systems (BGMS) over the years by different study groups. However, the choice of the comparison measurement procedure may impact the apparent level of accuracy found in such studies.

Materials And Methods: Measurement accuracy of 18 different BGMS was assessed in a setting based on ISO 15197 using two different comparison methods in parallel: a glucose oxidase (GOD)-based and a hexokinase (HK)-based method.

Proof of Concept for a New Raman-Based Prototype for Noninvasive Glucose Monitoring.

Background: Noninvasive glucose monitoring (NIGM) in diabetes is a long-sought-for technology. Among the many attempts Raman spectroscopy was considered as the most promising because of its glucose specificity. In this study, a recently developed prototype (GlucoBeam, RSP Systems A/S, Denmark) was tested in patients with type 1 diabetes to establish calibration models and to demonstrate proof of concept for this device in real use.

Time in Specific Glucose Ranges, Glucose Management Indicator, and Glycemic Variability: Impact of Continuous Glucose Monitoring (CGM) System Model and Sensor on CGM Metrics.

Background: International consensus recommends a set of continuous glucose monitoring (CGM) metrics to assess quality of diabetes therapy. The impact of individual CGM sensors on these metrics has not been thoroughly studied yet. This post hoc analysis aimed at comparing time in specific glucose ranges, coefficient of variation (CV) of glucose concentrations, and glucose management indicator (GMI) between different CGM systems and different sensors of the same system.

Skin Reaction Report Form: Development and Design of a Standardized Report Form for Skin Reactions Due to Medical Devices for Diabetes Management.

Background: Skin reactions due to medical devices for diabetes management have become a common problem in diabetes technology. There is a varying degree in how detailed skin reactions are described in scientific literature and diabetes practice, and no uniform structured documentation is given. Whereas most articles only describe findings, some others already document final diagnoses, such as contact dermatitis.

System accuracy evaluation of 18 CE-marked current-generation blood glucose monitoring systems based on EN ISO 15197:2015.

Objective: Accuracy of 18 current-generation blood glucose monitoring systems (BGMS) available in Europe was evaluated applying criteria adapted from EN ISO 15197:2015 with one reagent system lot. BGMS were selected based on market research data.

Research Design And Methods: The BGMS ABRA, Accu-Chek Guide, AURUM, CareSens Dual, CERA-CHEK 1CODE, ContourNext One, eBsensor, FreeStyle Freedom Lite, GL50 evo, GlucoCheck GOLD, GlucoMen areo 2K, GluNEO, MyStar DoseCoach, OneTouch Verio Flex, Pic GlucoTest, Rightest GM700S, TRUEyou, and WaveSense JAZZ Wireless were tested using capillary blood from 100 different subjects and assessing the percentage of results within ±15 mg/dL (0.

Comparative Accuracy Analysis of a Real-time and an Intermittent-Scanning Continuous Glucose Monitoring System.

Background: Currently, two different types of continuous glucose monitoring (CGM) systems are available: real time (rt) CGM systems that continuously provide glucose values and intermittent-scanning (is) CGM systems. This study compared accuracy of an rtCGM and an isCGM system when worn in parallel.

Methods: Dexcom G5 Mobile (DG5) and FreeStyle Libre (FL) were worn in parallel by 27 subjects for 14 days including two clinic sessions with induced glucose excursions.

Performance and Usability of Three Systems for Continuous Glucose Monitoring in Direct Comparison.

Background: To be able to compare continuous glucose monitoring (CGM) systems, they have to be worn in parallel by the same subjects. This study evaluated the performance and usability of three different CGM systems in direct comparison.

Method: In this open, prospective study at two sites, 54 patients with diabetes wore three CGM systems each (Dexcom G5™ Mobile CGM system [DG5], Guardian™ Connect system [GC], and a Roche CGM system [RCGM]) in parallel for 6 or 7 days in a mixed inpatient and outpatient setting.

Measurement Performance of Two Continuous Tissue Glucose Monitoring Systems Intended for Replacement of Blood Glucose Monitoring.

Background: Currently, two systems for continuous tissue glucose monitoring (CGM) (Dexcom G5 [DG5] and FreeStyle Libre [FL]) are intended to replace blood glucose monitoring (BGM) and, according to manufacturer labeling, are distributed as such in some jurisdictions, including the United States and the European Union.

Methods: The measurement performance of these two systems in comparison with a BGM system was analyzed in a 14-day study with 20 participants comprising study site visits, which included phases of induced rapid glucose changes, and home use phases. Performance analysis was mainly based on deviations between CGM readings and BGM results.

Prediction Quality of Glucose Trend Indicators in Two Continuous Tissue Glucose Monitoring Systems.

Background: Continuous interstitial glucose monitoring (CGM) systems often provide glucose trend indicators (e.g., arrows) in addition to current glucose values.

Flash Glucose Monitoring: Differences Between Intermittently Scanned and Continuously Stored Data.

The flash glucose monitoring system FreeStyle Libre (Abbott Diabetes Care Ltd., Witney, UK) measures interstitial glucose concentrations and continuously stores measurement values every 15 minutes. To obtain a current glucose reading, users have to scan the sensor with the reader.

Acceptability of Implantable Continuous Glucose Monitoring Sensor.

Background: Real-time continuous glucose monitoring is associated with significant benefits for diabetes management. Implantable sensors could overcome some challenges reportedly associated with device visibility, psychosocial functioning and sensor durability.

Methods: A psychosocial assessment was conducted to determine acceptability and impact of an implantable continuous glucose monitoring (CGM) sensor as part of the PRECISE trial.

Improved Glycemic Control in a Patient Group Performing 7-Point Profile Self-Monitoring of Blood Glucose and Intensive Data Documentation: An Open-Label, Multicenter, Observational Study.

Introduction: Regular self-monitoring of blood glucose (SMBG) is recommended as an integral part of therapy for all patients with diabetes treated with insulin. In the current study, the effects on glycemic control of taking 7-point SMBG profiles and using a diabetes management system (DMA) on a smartphone were investigated.

Methods: In a 12-week, open-label, multicenter, observational study, 51 patients [26 with type 1 diabetes mellitus (T1DM) and 25 with type 2 diabetes mellitus (T2DM)] were instructed to perform SMBG at least seven times a day using DMA combined with the iBGStar SMBG system.

Accuracy and Longevity of an Implantable Continuous Glucose Sensor in the PRECISE Study: A 180-Day, Prospective, Multicenter, Pivotal Trial.

Objective: It is known that continuous glucose monitoring (CGM) systems can lower mean glucose compared with episodic self-monitoring of blood glucose. Implantable CGM systems may provide additional benefits.

Research Design And Methods: We studied the Eversense (Senseonics Inc.

System Accuracy Evaluation of Different Blood Glucose Monitoring Systems Following ISO 15197:2013 by Using Two Different Comparison Methods.

Background: Adherence to established standards (e.g., International Organization for Standardization [ISO] 15197) is important to ensure comparable and sufficient accuracy of systems for self-monitoring of blood glucose (SMBG).

Accuracy Evaluation of Four Blood Glucose Monitoring Systems in Unaltered Blood Samples in the Low Glycemic Range and Blood Samples in the Concentration Range Defined by ISO 15197.

Introduction: Systems for self-monitoring of blood glucose (SMBG) are expected to be accurate enough to provide reliable measurement results. Especially in the low glycemic range, adequate therapeutic decisions based on reliable results can alleviate complications associated with hypoglycemia.

Materials And Methods: The accuracy of four SMBG systems (system 1 was the ACCU-CHEK(®) Aviva [Roche Diagnostics GmbH, Mannheim, Germany], system 2 was the Contour(®) XT [Bayer Consumer Care AG, Basel, Switzerland], system 3 was the GlucoCheck XL [aktivmed GmbH, Augsberg, Germany], and system 4 was the GlucoMen(®) LX PLUS [A.