"Dexcom" from_date:2012

Dexcom G6 for real-time continuous glucose monitoring Dexcom G6 for real-time continuous glucose monitoring Medtech innovation briefing Published: 3 November 2020 www.nice.org.uk/guidance/mib233 pathwaysSummary Summary • The technologytechnology described in this briefing is the Dexcom G6 real-time continuous glucose monitoring system. It measures interstitial fluid glucose levels in people with type 1 or type 2 diabetes. • The innovative aspectsinnovative aspects are that the Dexcom G6 continuously measures glucose levels using a sensor inserted under the skin instead of routine finger-prick blood glucose testing. Glucose measurements can be shared remotely with carers and family members through the connected app. Alerts sound if glucose levels fall outside of a target range. The sensor can

Continuous glucose monitoring system (Dexcom G6MC Dexcom) 1 Continuous glucose monitoring system (Dexcom G6MC, Dexcom) English summary FEBUARY 2020 Une production de l’Institut national d’excellence en santé et en services sociaux (INESSS) Direction des services de santé et de l’évaluation des technologies 1 SUMMARY The Institut national d’excellence en santé et en services sociaux (INESSS) was mandated by the Bureau de l’innovation to assess the relevance of public coverage of the Dexcom G6® Mobile System, a continuous glucose monitoring (CGM) technology, for type 1 diabetics aged 2 years or older. Evaluation process A systematic literature review was conducted to identify the evidence relevant to the evaluation and to supplement the information submitted

Accuracy of the Dexcom G7 Continuous Glucose Monitoring Sensors in People with Diabetes Undergoing Hemodialysis (ALPHA-2 Study). The accuracy of the latest generation Dexcom G7 sensors in individuals with diabetes undergoing hemodialysis has not previously been investigated. Participants with diabetes undergoing hemodialysis were recruited, with paired sensor glucose from Dexcom G7 recorded %, and 99.9% of pairs within zones A and B for lab, glucometer, and EKF methods, respectively. This, the first Dexcom G7 accuracy study conducted in people on hemodialysis, demonstrates accuracy and safety when compared with lab reference readings. These data support the accessibility of continuous glucose monitoring (CGM) and hybrid closed-loop systems for people with diabetes on hemodialysis.

Clinical outcomes of a real-world prospective study using Dexcom ONE continuous glucose monitoring in people with diabetes treated with two or more insulin injections per day. This study assessed real-world glycaemic outcomes associated with the use of Dexcom ONE in adults with suboptimally controlled diabetes. In this single-site prospective study, adults with type 1 (T1D) or type 2 diabetes (T2D) taking two or more insulin injections per day initiated Dexcom ONE CGM use and attended follow-up data collection visits after 3 and 6 months. During the study, participants received usual diabetes care. Primary outcome was a change in HbA1c at 6 months. Additional outcomes included change in participant-reported outcomes and CGM-derived time in glucose range 3.9-10 mmol/L (TIR), time above

New device, 'old' allergens. Allergic contact dermatitis caused by the Dexcom G7 glucose sensor. Allergic contact dermatitis (ACD) has been reported as an adverse effect from the use of several glucose sensors and insulin pumps from different manufacturers. Isobornyl acrylate (IBOA) has been identified as a major culprit sensitizer, but also other acrylates and (modified) colophonium have been reported as causes of ACD. To report the two first cases diagnosed with ACD caused by the Dexcom G7 (DG7) glucose sensor. Two children with suspected ACD from DG7 were patch tested with our medical device series with an addition of selected test preparations including two variants of modified colophonium - methyl hydrogenated rosinate (MHR) and glyceryl hydrogenated rosinate (GHR). Both patients were

Performance of the Dexcom G7 CGM System in Pregnant Women with Diabetes. We evaluated accuracy and safety of a seventh-generation real-time continuous glucose monitoring (CGM) system in pregnancy. Evaluable data for accuracy analysis were obtained from 96 G7 sensors (Dexcom, Inc.) worn by 96 of 105 enrolled pregnant women with type 1 (n=59), type 2 (n=21), or gestational diabetes (n=25). CGM

Cost-utility analysis of Dexcom G6 real-time continuous glucose monitoring versus FreeStyle Libre 1 intermittently scanned continuous glucose monitoring in adults with type 1 diabetes in Belgium. The aim of this study was to assess the long-term cost-effectiveness of Dexcom G6 real-time continuous glucose monitoring (rtCGM) with alert functionality compared with FreeStyle Libre 1 intermittently of hypoglycaemia. The results were robust under a wide range of one-way sensitivity analyses. In models where the price of rtCGM is €5.11/day (a price increase of 30.4%) or €12.34/day (a price increase of 214.8%), rtCGM was cost-neutral or reached an incremental cost-effectiveness ratio of €40,000 per quality-adjusted life year, respectively. When priced similarly, Dexcom G6 rtCGM with alert functionality has

Continuous glucose monitoring and recreational scuba diving in type 1 diabetes: head-to-head comparison between Free Style Libre 3 and Dexcom G7 performance. Background Scuba diving was previously excluded because of hypoglycemic risks for type 1 diabetic patients (T1DM). Specific eligibility criteria and a safety protocol have been defined, while continuous glucose monitoring (CGM) systems have enhanced diabetes management. This study aims to assess the feasibility and accuracy of CGM Dexcom G7 (DG7) and Free Style Libre 3 (FSL3) in a setting of repetitive scuba diving in T1DM, exploring the possibility of non-adjunctive use. Material and methods The study was conducted during an event of Diabete Sommerso® association in November 2023. Participants followed a safety protocol, with capillary

Unveiling the interplay between rational, psychological and functional factors in continuous glucose monitoring early adoption: Novel evidence from the Dexcom ONE case in Italy. The escalating prevalence of diabetes, with its multifaceted complications, poses a pressing challenge for healthcare systems globally. In response, the advent of continuous glucose monitoring (CGM) systems, offering systems. The research model was built to unveil the impacts of psychological factors, functional components and rational constructs derived from the Technology Acceptance Model (TAM) on CGM systems sustained adoption. To ensure the comparability of results, we have collected data from people who had used Dexcom ONE Dexcom (San Diego, CA) for the first time for at least one month. Employing Structural

Long-Term Improvements in Glycemic Control with Dexcom CGM Use in Adults with Noninsulin-Treated Type 2 Diabetes. The objective of this real-world, observational study was to evaluate change in continuing glucose monitoring (CGM) metrics for 1 year after CGM initiation in adults with noninsulin-treated type 2 diabetes (T2D). Data were analyzed from Dexcom G6 and G7 users who self-reported: T2D by 0.5% (1.2%) from 8.1% (0.9%) to 7.6% (1.1%) (both < 0.001). Participants who maintained or customized the high alert default setting of 250 mg/dL had a greater increase in TIR and TITR compared with participants who disabled the alert. Days of CGM use over 12 months were high in 84.7% (15.9%). In this large, real-world study of adults with suboptimally controlled T2D not using insulin, Dexcom CGM

Testing the Real-World Accuracy of the Dexcom G6 Pro CGM during the Insulin-Only Bionic Pancreas Pivotal Trial. Continuous glucose monitoring (CGM) has transformed the way people with type 1 diabetes can self-monitor glucose levels. Past studies have evaluated the accuracy of CGM devices in clinic-based studies, but few have analyzed their accuracy in real-world settings. The Insulin-Only Bionic Pancreas Trial provided the opportunity to assess real-world accuracy of the blinded Dexcom G6 Pro sensor over the first 48-60 hours of wear using a blood glucose meter (BGM) as a comparator for 1,073 CGM-BGM pairs across 53 participants. The mean absolute relative difference (MARD) was 11.0% over a median period of 50 hours (range 47-79 hours). The MARD was 13.6% in the first 12 hours, 10.5% in hours 12

Longitudinal analysis of users transitioning from the Dexcom G5 to the G6 RT-CGM system in Germany, Sweden and the United Kingdom (2018-2020). Regional variations in the adoption of diabetes technology may be reflected in population-level metrics of glycaemic control. In this observational study, we aimed to assess the glycaemic impacts of transitioning from the Dexcom G5 Real-Time Continuous Glucose Monitoring (RT-CGM) System to the Dexcom G6 in three European countries. Anonymised RT-CGM data (uploaded to the Dexcom Clarity app) were from users in Germany, Sweden, and the United Kingdom (UK) who transitioned from G5 to G6 between 9-12 months after G6 launched in 2018. Primary endpoints were percent time in hypoglycaemia, percent time in range (TIR), user retention rates, device utilisation

Performance of the Dexcom G6 Continuous Glucose Monitoring (CGM) System During Cardiac Surgery Using Hypothermic Extracorporeal Circulation. Continuous glucose monitoring (CGM) may be challenged by extreme conditions during cardiac surgery using hypothermic extracorporeal circulation (ECC). We evaluated the Dexcom G6 sensor in 16 subjects undergoing cardiac surgery with hypothermic ECC, of whom %, and -41.6%). During surgery, 86.3% pairs were in Clarke error grid zones A or B and 41.0% of sensor readings fulfilled the International Organization for Standardization (ISO) 15197:2013 norm. Postsurgery, MARD was 15.0%. Cardiac surgery using hypothermic ECC challenges the accuracy of the Dexcom G6 CGM although recovery appears to occur thereafter.

Accuracy and Safety of Dexcom G7 Continuous Glucose Monitoring in Adults with Diabetes. We evaluated the accuracy and safety of a seventh generation (G7) Dexcom continuous glucose monitor (CGM) during 10.5 days of use in adults with diabetes. Adults with either type 1 or type 2 diabetes (on intensive insulin therapy or not) participated at 12 investigational sites in the United States

Contact allergy to the Dexcom G6 glucose monitoring system-Role of 2,2'-methylenebis(6-tert-butyl-4-methylphenol) monoacrylate in the new adhesive. Skin reactions to the glucose monitoring systems Dexcom G5 and G6 have been rare. In 2019, the components of the adhesive were exchanged for better skin fixation. Since then, more and more patients experienced severe skin reactions. A few months ago , our aim was to examine whether IBOA is contained in the newer model adhesive and may also contribute to allergic contact dermatitis (ACD). Five patients with a newly occurred ACD caused by the glucose monitoring system Dexcom G6 were investigated. Patch testing including MBPA in three different concentrations, as well as IBOA, were performed. Gas chromatography-mass spectrometry of the newer system

Real-World Evidence and Glycemic Improvement Using Dexcom G6 Features. Optional features of continuous glucose monitoring (CGM) systems empower patients and caregivers to understand and manage diabetes in new ways. We examined associations between use of optional features, demographics, and glycemic outcomes. Retrospective cohort studies were performed with data from US-based users of the G6 CGM System (Dexcom, Inc.). For all cohorts, data included sensor glucose values (SGVs). In separate cohorts, use of alert features (for hyperglycemia, existing hypoglycemia, and impending hypoglycemia), remote data sharing feature (Share), software for retrospective pattern analysis (CLARITY), "virtual assistant" feature that announces the current SGV and trend in response to a spoken request were

Long-Term Cost-Effectiveness the Dexcom G6 Real-Time Continuous Glucose Monitoring System Compared with Self-Monitoring of Blood Glucose in People with Type 1 Diabetes in France. The aim was to determine the long-term cost-effectiveness of the Dexcom G6 real-time continuous glucose monitoring (RT-CGM) system versus self-monitoring of blood glucose (SMBG) in adults with type 1 diabetes (T1D

Reliability of the Dexcom G6 Continuous Glucose Monitor During Hyperbaric Oxygen Exposure. People with diabetes-related ulcers may benefit from hyperbaric oxygen (HBO) therapy and from continuous glucose monitors (CGM). Although blood glucose (BG) meters based on glucose oxidase (GO) report erroneously low values at high pO, BG meters based on glucose dehydrogenase (GD) do not. We therefore examined the performance of a GO-based CGM system in comparison to GO-based and GD-based BG systems in normobaric air (NBAir), hyperbaric air (HBAir), and HBO environments. Twenty-six volunteers without diabetes mellitus (DM) wore Dexcom G6 CGM systems and provided periodic blood samples before, during, and after a standard HBO treatment consisting of three 30-min intervals of HBO separated by two 5-min

Performance of the Dexcom G6 Continuous Glucose Monitoring System in Pregnant Women with Diabetes. The aim of this study was to determine the performance of the Dexcom G6 continuous glucose monitoring (CGM) system across three sensor wear sites in pregnant women with diabetes in the second or third trimesters. Participants with type 1 (T1D), type 2 (T2D), or gestational (GDM) diabetes mellitus of pregnancy. Compared with the reference, 92.5% of CGM values were within ±20%/20 mg/dL. The overall MARD and that of sensors worn on the abdomen, upper buttock, and posterior upper arm was 10.3%, 11.5%, 11.2%, and 8.7%, respectively. There were no device-related adverse events. Skin reactions at the insertion sites were absent or minor. The Dexcom G6 CGM system is accurate and safe in pregnant women

A Three-Way Accuracy Comparison of the Dexcom G5, Abbott Freestyle Libre Pro, and Senseonics Eversense Continuous Glucose Monitoring Devices in a Home-Use Study of Subjects with Type 1 Diabetes. There is a dearth of comparative accuracy studies of continuous glucose monitoring (CGM) devices in the home-use setting, and none with the Eversense implantable CGM. We evaluated the accuracy of the Dexcom G5, Abbott Freestyle Libre Pro, and Senseonics Eversense during a 6-week free-living home-use bionic pancreas study involving 23 subjects with type 1 diabetes who wore all three devices concurrently. The primary outcome was the mean absolute relative difference (MARD) between CGM readings and point-of-care (POC) plasma-glucose (PG) values obtained approximately twice daily by the subjects. We