186 results match your criteria difference mard

Evaluation of Accuracy and Safety of the Next-Generation Up to 180-Day Long-Term Implantable Eversense Continuous Glucose Monitoring System: The PROMISE Study.

Diabetes Technol Ther 2021 Sep 9. Epub 2021 Sep 9.

Senseonics, Inc., Germantown, Maryland, USA.

Use of continuous glucose monitoring (CGM) systems is being rapidly adopted as standard of care for insulin-requiring patients with diabetes. The PROMISE study (NCT03808376) evaluated the accuracy and safety of the next-generation implantable Eversense CGM system for up to 180 days. This was a prospective multicenter study involving 181 subjects with diabetes at 8 USA sites. Read More

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September 2021

Post-Market Surveillance Assessment of the Clinical Accuracy of a Blood Glucose Monitoring System with an Improved Algorithm for Enhanced Product Performance.

J Diabetes Sci Technol 2021 Aug 31:19322968211039465. Epub 2021 Aug 31.

LifeScan Scotland Ltd., Inverness, UK.

Background: On-going manufacturer-led post-market surveillance (PMS), assessing the clinical accuracy of blood glucose monitoring (BGM) systems, is critical to substantiate the performance of such products for people with diabetes.

Materials And Methods: Batches of Verio test-strip product were randomly and routinely selected over the period from launch of an improved-algorithm product to reporting date and sent to 3 clinic sites for clinician-led accuracy assessment. Accuracy is reported as per recently adopted FDA guidance for BGM systems, EN ISO 15197:2015 and MARD/MAD (Mean absolute relative difference/Mean absolute difference). Read More

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Continuous Glucose Monitoring in the Management of Neonates with Persistent Hypoglycaemia and Congenital Hyperinsulinism.

J Clin Endocrinol Metab 2021 Aug 18. Epub 2021 Aug 18.

Cambridge University Hospitals NHS Trust, Cambridge Biomedical Campus, Hills Road, Cambridge.

Background: Persistent hypoglycaemia is common in the newborn and is associated with poor neurodevelopmental outcome. Adequate monitoring is critical in prevention, but is dependent on frequent, often hourly blood sampling. Continuous glucose monitoring (CGM) is increasingly being used in children with type 1 diabetes mellitus, but use in neonatology remains limited. Read More

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Reliability of continuous glucose monitoring system in the inpatient setting.

J Clin Transl Endocrinol 2021 Sep 7;25:100262. Epub 2021 Jul 7.

Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, USA.

Aims/hypothesis: Hyperglycemia and hypoglycemia are associated with increased morbidity and mortality in the inpatient setting. Standard point of care capillary glucose testing (POCT) is commonly used in hospitalized patients to monitor their glucose levels. The goal of this study was to examine the relationships between the glucose readings obtained by a continuous glucose monitoring system (CGMS) (Freestyle Libre) and the capillary blood glucose results obtained by the inpatient glucose POCT meter (Accuchek Inform II) as well as between CGMS readings and the serum glucose values obtained by the hospital laboratory. Read More

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September 2021

Clinical Characteristics and Risk of Diabetic Complications in Data-Driven Clusters Among Type 2 Diabetes.

Front Endocrinol (Lausanne) 2021 30;12:617628. Epub 2021 Jun 30.

BGI Institute of Applied Agriculture, BGI-Shenzhen, Shenzhen, China.

Background: This study aimed to cluster newly diagnosed patients and patients with long-term diabetes and to explore the clinical characteristics, risk of diabetes complications, and medication treatment related to each cluster.

Research Design And Methods: K-means clustering analysis was performed on 1,060 Chinese patients with type 2 diabetes based on five variables (HbA1c, age at diagnosis, BMI, HOMA2-IR, and HOMA2-B). The clinical features, risk of diabetic complications, and the utilization of elven types of medications agents related to each cluster were evaluated with the chi-square test and the Tukey-Kramer method. Read More

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The Accuracy of Continuous Glucose Monitoring in the Medical Intensive Care Unit.

J Diabetes Sci Technol 2021 Jul 5:19322968211027590. Epub 2021 Jul 5.

Department of Medicine, Division of Endocrinology and Metabolism, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.

Objective: To assess the accuracy of continuous glucose monitoring (CGM) in medical intensive care unit (MICU) patients.

Methods: A Medtronic Enlite sensor accuracy was assessed versus capillary blood glucose (CBG) and plasma glucose (PG) using the mean absolute relative difference (MARD), surveillance error grid (SEG) analysis and modified Bland-Altman plots.

Results: Using CBG as a reference, MARD was 6. Read More

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Implantable and transcutaneous continuous glucose monitoring system: a randomized cross over trial comparing accuracy, efficacy and acceptance.

J Endocrinol Invest 2021 Jul 1. Epub 2021 Jul 1.

Department of Medicine, University of Padova, Via Giustiniani 2, 35128, Padova, Italy.

Aim: To compare accuracy, efficacy and acceptance of implantable and transcutaneous continuous glucose monitoring (CGM) systems.

Methods: In a randomized crossover trial we compared 12 weeks with Eversense implantable sensor (EVS) and 12 weeks with Dexcom G5 transcutaneous sensor (DG5) in terms of accuracy, evaluated as Mean Absolute Relative Difference (MARD) vs capillary glucose (SMBG), time of CGM use, adverse events, efficacy (as HbA1c, time in range, time above and below range) and psychological outcomes evaluated with Diabetes Treatment Satisfaction Questionnaire (DTSQ), Glucose Monitoring Satisfaction Survey (GMSS), Hypoglycemia Fear Survey (HFS2), Diabetes Distress Scale (DDS).

Results: 16 subjects (13 males, 48. Read More

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Sample stability of autoantibodies: A tool for laboratory quality initiatives.

Clin Biochem 2021 Oct 23;96:43-48. Epub 2021 Jun 23.

Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, Ontario, Canada; Department of Pathology and Laboratory Medicine, Mount Sinai Hospital, Sinai Health System, Toronto, Ontario, Canada. Electronic address:

Objectives: Serum autoantibody measurement aids in diagnosing and monitoring various autoimmune conditions. Defining autoantibody stability limits can improve laboratory process quality. Here, we define short-term stability in a refrigerator, long-term stability in a freezer, and the effect of freeze-thaw cycles to improve autoantibody testing procedures. Read More

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October 2021

Accuracy of CGM Systems During Continuous and Interval Exercise in Adults with Type 1 Diabetes.

J Diabetes Sci Technol 2021 Jun 11:19322968211023522. Epub 2021 Jun 11.

Department of Medicine, Division of Endocrinology, Diabetes and Metabolism, University and Hospital of Verona, Verona, Italy.

Background: continuous glucose monitoring systems (CGMs) play an important role in the management of T1D, but their accuracy may reduce during rapid glucose excursions. The aim of study was to assess the accuracy of recent rt-CGMs available in Italy, in subjects with T1D during 2 sessions of physical activity: moderate continuous (CON) and interval exercise (IE).

Method: we recruited 22 patients with T1D, on CSII associated or integrated with a CGM, to which a second different sensor was applied. Read More

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Accuracy of Dexcom G6 Continuous Glucose Monitoring in Non-Critically Ill Hospitalized Patients With Diabetes.

Diabetes Care 2021 Jun 7. Epub 2021 Jun 7.

Division of Endocrinology, Metabolism and Lipids, Department of Medicine, Emory University School of Medicine, Atlanta, GA

Objective: Advances in continuous glucose monitoring (CGM) have transformed ambulatory diabetes management. Until recently, inpatient use of CGM has remained investigational, with limited data on its accuracy in the hospital setting.

Research Design And Methods: To analyze the accuracy of Dexcom G6, we compared retrospective matched-pair CGM and capillary point-of-care (POC) glucose data from three inpatient CGM studies (two interventional and one observational) in general medicine and surgery patients with diabetes treated with insulin. Read More

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Efficacy of Hybrid Closed-Loop Insulin Delivery System in a Hospital Setting: A Case Series.

AACE Clin Case Rep 2021 May-Jun;7(3):184-188. Epub 2021 Jan 6.

Division of Endocrinology, NYU Long Island School of Medicine, Mineola, New York.

Objective: We report a case series of 4 patients with type 1 diabetes who used hybrid closed-loop insulin pumps (Medtronic MiniMed 670 G) during hospitalization.

Methods: Clinical data and point-of-care glucose values are presented for each patient. Glucose values are shown graphically while in manual mode as well as in auto mode. Read More

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January 2021

Use and Accuracy of Inpatient CGM During the COVID-19 Pandemic: An Observational Study of General Medicine and ICU Patients.

J Diabetes Sci Technol 2021 May 10:19322968211008446. Epub 2021 May 10.

Weill Cornell Medicine, New York, NY, USA.

Background: Continuous glucose monitoring (CGM) is widely used in the outpatient setting for people with diabetes and has been limited to investigational use only for the inpatient population. In April 2020, the US FDA exercised enforcement discretion for the temporary use of inpatient CGM during the pandemic, thus hospitals were presented the opportunity to implement this technology.

Methods: We sought to investigate the accuracy of CGM in hospitalized patients on general care floors and the intensive care unit (ICU) in attempts to decrease healthcare professional exposure to COVID-19 and ultimately improve glycemic management of patients affected by COVID-19. Read More

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Short-term prediction of future continuous glucose monitoring readings in type 1 diabetes: Development and validation of a neural network regression model.

Int J Med Inform 2021 07 24;151:104472. Epub 2021 Apr 24.

Department of Health Science and Technology, Aalborg University, Denmark.

Background And Objective: CGM systems are still subject to a time-delay, which especially during rapid changes causes clinically significant difference between the CGM and the actual BG level. This study had the aim of exploring the potential of developing and validating a model for prediction of future CGM measurements in order to overcome the time-delay.

Methods: An artificial neural network regression (NN) approach were used to predict CGM values with a lead-time of 15 min. Read More

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Continuous Glucose Monitoring in the Intensive Care Unit Following Total Pancreatectomy with Islet Autotransplantation in Children: Establishing Accuracy of the Dexcom G6 Model.

J Clin Med 2021 Apr 27;10(9). Epub 2021 Apr 27.

Division of Endocrinology, Department of Pediatrics, Cincinnati Children's Hospital Medical Center, Cincinnati, OH 45229, USA.

Hyperglycemia is detrimental to postoperative islet cell survival in patients undergoing total pancreatectomy with islet autotransplantation (TPIAT). This makes continuous glucose monitoring (CGM) a useful management tool. We evaluated the accuracy of the Dexcom G6 CGM in pediatric intensive care unit patients following TPIAT. Read More

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A Modified CGM Algorithm Enhances Data Availability While Retaining iCGM Performance.

J Diabetes Sci Technol 2021 Apr 15:19322968211007521. Epub 2021 Apr 15.

Dexcom, Inc., San Diego, CA, USA.

The algorithm for the Dexcom G6 CGM System was enhanced to retain accuracy while reducing the frequency and duration of sensor error. The new algorithm was evaluated by post-processing raw signals collected from G6 pivotal trials (NCT02880267) and by assessing the difference in data availability after a limited, real-world launch. Accuracy was comparable with the new algorithm-the overall %20/20 was 91. Read More

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Mean Absolute Relative Difference of Blood Glucose Monitoring Systems and Relationship to ISO 15197.

J Diabetes Sci Technol 2021 Mar 24:19322968211001402. Epub 2021 Mar 24.

Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany.

Background: The analytical quality of a blood glucose monitoring system (BGMS) is often assessed according to the requirements described in the international standard ISO 15197. However, the mean absolute relative difference (MARD) is sometimes used as well. This analysis aims at providing empirical data from BGMS evaluation studies conducted according to ISO 15197 and at providing an estimation of how MARD and percentage of measurement results within ISO accuracy limits are related. Read More

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

J Diabetes Sci Technol 2021 Feb 20:1932296821992373. Epub 2021 Feb 20.

Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany.

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. Read More

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February 2021

Performance of commercially-available cholesterol self-tests.

Ann Clin Biochem 2021 07 17;58(4):289-296. Epub 2021 Feb 17.

Laboratory of Clinical Chemistry and Hematology, Jeroen Bosch Hospital, Den Bosch, the Netherlands.

Background: Hypercholesterolemia (plasma cholesterol concentration ≥5.2 mmol/L) is a risk factor for cardiovascular disease and stroke. Many different cholesterol self-tests are readily available at general stores, pharmacies and web shops. Read More

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Performance of the Intermittently Scanned Continuous Glucose Monitoring (isCGM) System during a High Oral Glucose Challenge in Adults with Type 1 Diabetes-A Prospective Secondary Outcome Analysis.

Biosensors (Basel) 2021 Jan 15;11(1). Epub 2021 Jan 15.

Cardiovascular Diabetology Research Group, Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, 8036 Graz, Austria.

To assess intermittently scanned continuous glucose monitoring (isCGM) performance for different rates of change in plasma glucose (RCPG) during glycemic challenges in type 1 diabetes (T1D). Nineteen people with T1D (7 females; age 35 ± 11 years; HbA 7.3 ± 0. Read More

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January 2021

A Comprehensive Review of Continuous Glucose Monitoring Accuracy during Exercise Periods.

Sensors (Basel) 2021 Jan 12;21(2). Epub 2021 Jan 12.

Centro de Investigación Biomédica en Red de Diabetes y Enfermedades Metabólicas Asociadas (CIBERDEM), Instituto de Salud Carlos III, 28029 Madrid, Spain.

Continuous Glucose Monitoring (CGM) has been a springboard of new diabetes management technologies such as integrated sensor-pump systems, the artificial pancreas, and more recently, smart pens. It also allows patients to make better informed decisions compared to a few measurements per day from a glucometer. However, CGM accuracy is reportedly affected during exercise periods, which can impact the effectiveness of CGM-based treatments. Read More

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January 2021

Accuracy of continuous glucose monitoring in preterm infants: a systematic review and meta-analysis.

BMJ Open 2020 12 24;10(12):e045335. Epub 2020 Dec 24.

Cochrane Netherlands, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.

Background And Objectives: Continuous glucose monitoring (CGM) could be a valuable instrument for measurement of glucose concentration in preterm neonate. We undertook a systematic review and meta-analysis to compare the diagnostic accuracy of CGM devices to intermittent blood glucose evaluation methods for the detection of hypoglycaemic or hypoglycaemic events in preterm infants.

Data Sources: A structured electronic database search was performed for studies that assessed the accuracy of CGM against any intermittent blood glucose testing methods in detecting episodes of altered glycaemia in preterm infants. Read More

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December 2020

The Association between Antidiabetic Agents and Leukocyte Telomere Length in the Novel Classification of Type 2 Diabetes Mellitus.

Gerontology 2021 15;67(1):60-68. Epub 2020 Dec 15.

Department of Endocrinology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China,

Aims: This study aimed to explore the new role of telomere length (TL) in the novel classification of type 2 diabetes mellitus (T2DM) patients driven by cluster analysis.

Materials And Methods: A total of 541 T2DM patients were divided into 4 subgroups by k-means analysis: mild obesity-related diabetes (MOD), severe insulin-deficient diabetes (SIDD), severe insulin-resistant diabetes (SIRD), and mild age-related diabetes (MARD). After patients with insufficient data were excluded, further analysis was conducted on 246 T2DM patients. Read More

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December 2020

Inaccurate Glucose Sensor Values After Hydroxyurea Administration.

Diabetes Technol Ther 2021 Jun 30;23(6):443-451. Epub 2020 Dec 30.

Division of Endocrinology, Department of Pediatrics, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.

To assess the degree, duration, mean absolute relative difference (MARD), and error analysis of discrepant values per continuous glucose monitoring (CGM) systems after hydroxyurea (HU) administration. Inpatient glucometer and CGM data from 16 total pancreatectomy/islet autotransplantation patients using Dexcom Professional G4 and 12 patients using Dexcom G6 were analyzed after daily dosing with HU. Timing of HU dosing and median of 9. Read More

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Accuracy of Flash Glucose Monitoring in Patients with Diabetes Mellitus on Hemodialysis and Its Relationship with Hydration Status.

J Diabetes Sci Technol 2020 Nov 30:1932296820975057. Epub 2020 Nov 30.

Endocrinology and Nutrition Department, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.

Background: The use of flash-glucose monitoring system FreeStyle Libre (FSL) has demonstrated benefits in metabolic control and quality of life in different populations with diabetes mellitus (DM), being funded in many countries. Due to this, DM subjects on hemodialysis (HD) are using FSL despite the accuracy in this population being unclear. The aims of the present study are to assess the accuracy of FSL in DM subjects on HD, its relationship to hydration status, and patient satisfaction. Read More

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November 2020

Performance of three different continuous glucose monitoring systems in children with type 1 diabetes during a diabetes summer camp.

Pediatr Diabetes 2021 03 4;22(2):271-278. Epub 2020 Dec 4.

Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Austria.

The aim of this study was to assess accuracy of the three most commonly used continuous glucose monitoring (CGM) systems in almost real-life situation during a diabetes camp in children with type 1 diabetes (T1D) aged 9-14 years. Data was gathered during a 2-week summer camp under physicians' supervision. Out of 38 participating children with T1D (aged: 11. Read More

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Replay Simulations with Personalized Metabolic Model for Treatment Design and Evaluation in Type 1 Diabetes.

J Diabetes Sci Technol 2020 Nov 20:1932296820973193. Epub 2020 Nov 20.

Center for Diabetes Technology, University of Virginia, Charlottesville, VA, USA.

Background: The capacity to replay data collected in real life by people with type 1 diabetes mellitus (T1DM) would lead to individualized (vs population) assessment of treatment strategies to control blood glucose and possibly true personalization. Patek et al introduced such a technique, relying on regularized deconvolution of a population glucose homeostasis model to estimate a residual additive signal and reproduce the experimental data; therefore, allowing the subject-specific replay of scenarios by altering the model inputs (eg, insulin). This early method was shown to have a limited domain of validity. Read More

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November 2020

A Prospective Multicenter Clinical Performance Evaluation of the C-CGM System.

J Diabetes Sci Technol 2020 Oct 21:1932296820964574. Epub 2020 Oct 21.

WaveForm Diabetes, Inc., Wilsonville, OR, USA.

Background: Continuous glucose monitors (CGMs) have had a significant impact on the management of diabetes mellitus. We present the results of a multinational evaluation of the Cascade CGM ("C-CGM") over 14 days of in-clinic and home use.

Method: Each of the 57 enrolled type 1 diabetes mellitus and type 2 diabetes mellitus subjects wore 2 C-CGMs on the abdomen for 14 days. Read More

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October 2020

Comparison of oral glucose tolerance test and ambulatory glycaemic profiles in pregnant women in Uganda with gestational diabetes using the FreeStyle Libre flash glucose monitoring system.

BMC Pregnancy Childbirth 2020 Oct 19;20(1):635. Epub 2020 Oct 19.

Non-Communicable Diseases Theme, Medical Research Council/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine (MRC/UVRI & LSHTM) Uganda Research Unit, Plot 51-59, Nakiwogo Road, P. O. BOX 49, Entebbe, Uganda.

Background: The diagnosis of hyperglycaemia in sub-Saharan Africa (SSA) is challenging. Blood glucose levels obtained during oral glucose tolerance test (OGTT) may not reflect home glycaemic profiles. We compare OGTT results with home glycaemic profiles obtained using the FreeStyle Libre continuous glucose monitoring device (FSL-CGM). Read More

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October 2020

Continuous Glucose Monitoring in Critically Ill Patients With COVID-19: Results of an Emergent Pilot Study.

J Diabetes Sci Technol 2020 11 16;14(6):1065-1073. Epub 2020 Oct 16.

Division of Endocrinology, Diabetes and Metabolism, Houston Methodist, Weill Cornell Medical College, Texas A&M Health Sciences Center, Houston, TX, USA.

Background: Amidst the coronavirus disease 2019 (COVID-19) pandemic, continuous glucose monitoring (CGM) has emerged as an alternative for inpatient point-of-care blood glucose (POC-BG) monitoring. We performed a feasibility pilot study using CGM in critically ill patients with COVID-19 in the intensive care unit (ICU).

Methods: Single-center, retrospective study of glucose monitoring in critically ill patients with COVID-19 on insulin therapy using Medtronic Guardian Connect and Dexcom G6 CGM systems. Read More

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November 2020