Abstract:
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 was performed for different SMBG systems available in Europe with three reagent lots each. MATERIALS AND METHODS:Test procedures followed the recently published revision ISO 15197:2013. Comparison measurements were performed with a glucose oxidase (YSI 2300 STAT Plus™ glucose analyzer; YSI Inc., Yellow Springs, OH) and a hexokinase (cobas Integra(®) 400 Plus analyzer; Roche Instrument Center, Rotkreuz, Switzerland) method. Compliance with ISO 15197:2013 accuracy criteria was determined by calculating the percentage of results within ±15% or within ±0.83 mmol/L of the comparison measurement results for glucose concentrations at and above or below 5.55 mmol/L, respectively, and by calculating the percentage of results within consensus error grid Zones A and B. RESULTS:Seven systems showed with all three tested lots that 95-100% of the results were within the accuracy limits of ISO 15197:2013 and that 100% of results were within consensus error grid Zones A and B, irrespective of the comparison method used. Regarding results of individual lots, slight differences between the glucose oxidase method and the hexokinase method were found. Accuracy criteria of ISO 15197:2003 (±20% for concentrations ≥4.2 mmol/L and±0.83 mmol/L for concentrations <4.2 mmol/L) were fulfilled by eight systems with all three lots and by one system with two lots. CONCLUSIONS:In this study, seven systems complied with the accuracy criteria of ISO 15197:2013. The results also indicate that the comparison measurement method/system is important, as it may have a considerable impact on accuracy data obtained for a system.
journal_name
Diabetes Technol Therjournal_title
Diabetes technology & therapeuticsauthors
Freckmann G,Link M,Schmid C,Pleus S,Baumstark A,Haug Cdoi
10.1089/dia.2015.0085subject
Has Abstractpub_date
2015-09-01 00:00:00pages
635-48issue
9eissn
1520-9156issn
1557-8593journal_volume
17pub_type
杂志文章abstract:BACKGROUND:Continuous glucose monitoring (CGM) and sensor-augmented pump (SAP) therapy improve glucose control provided good adherence. In France, not only diabetologists, nurses, and dieticians but also nurses employed by homecare providers (HCPNs) are together involved in the initiation and/or follow-up of continuous...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,多中心研究
doi:10.1089/dia.2015.0240
更新日期:2016-03-01 00:00:00
abstract:BACKGROUND:Diabetic foot ulcer area is a basic parameter used for monitoring the wound healing and effectiveness of the treatment applied. TeleDiaFoS (developed earlier in collaboration with the Department and Clinic of Gastroenterology and Metabolic Diseases, Medical University of Warsaw, Warsaw, Poland) is one of jus...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2011.0082
更新日期:2011-11-01 00:00:00
abstract:BACKGROUND:A brief history of the field of human factors research is covered, along with how this discipline is leveraged within medical device companies, to eliminate design flaws in products, in order to make them safe and effective for human use. The way in which human factors research was used to develop the t:slim...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,多中心研究
doi:10.1089/dia.2013.0098
更新日期:2013-10-01 00:00:00
abstract:BACKGROUND:Programmable and fixed auditory and/or vibratory threshold alerts are essential features of real-time continuous glucose monitoring (rtCGM) systems that provide users time to intervene before the onset of clinical hypoglycemia or hyperglycemia. A sixth-generation rtCGM system from Dexcom, Inc. (G6) includes ...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2018.0359
更新日期:2019-04-01 00:00:00
abstract:BACKGROUND:Little information is available regarding glucose fluctuations in postprandial states and during the oral glucose tolerance test (OGTT) in Japanese people with normal glucose tolerance (NGT). METHODS:Glucose profiles of 27 Japanese people were measured for 4 days by using continuous glucose monitoring. A 75...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2008.0083
更新日期:2009-07-01 00:00:00
abstract::Patients with diabetes play with a double-edged sword when it comes to deciding glucose and A1c target levels. On the one side, tight control has been shown to be crucial in avoiding long-term complications; on the other, tighter control leads to an increased risk of iatrogenic hypoglycemia, which is compounded when h...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2005.7.3
更新日期:2005-02-01 00:00:00
abstract::There are three main issues in non-invasive (NI) glucose measurements: namely, specificity, compartmentalization of glucose values, and calibration. There has been progress in the use of near-infrared and mid-infrared spectroscopy. Recently new glucose measurement methods have been developed, exploiting the effect of ...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,评审
doi:10.1089/dia.2004.6.660
更新日期:2004-10-01 00:00:00
abstract:BACKGROUND:The Optimizing Control in Diabetes (OPTIMIZE) survey was conducted to understand the patients' perspective to achieving good glycemic control and to determine how patients' perceptions of insulin may affect their decisions to initiate or intensify their insulin therapy. METHODS:A total of 1,444 subjects wit...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,多中心研究
doi:10.1089/dia.2008.0249
更新日期:2008-02-01 00:00:00
abstract:BACKGROUND:Automated insulin management features of the MiniMed® 640G sensor-augmented pump system include suspension in response to predicted low sensor glucose (SG) values ("suspend before low"), suspension in response to existing low SG values ("suspend on low"), and automatic restarting of basal insulin delivery up...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2016.0216
更新日期:2016-10-01 00:00:00
abstract:OBJECTIVES:We evaluated patterns of meal intake, insulin bolus delivery, and fingerstick glucose measurements during hybrid closed-loop and sensor-augmented pump (SAP) therapy, including associations with glucose control. METHODS:Data were retrospectively analyzed from pump-treated adults with type 1 diabetes who unde...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1089/dia.2016.0307
更新日期:2017-07-01 00:00:00
abstract::Prevalence of diabetes continues to increase in urban areas, and escalation is discernible in semi-urban and rural areas. It is reported to affect Asian Indians a decade earlier compared with other populations, and complications (e.g., nephropathy) occur earlier and are severe and more prevalent than in other races. B...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,评审
doi:10.1089/dia.2013.0373
更新日期:2014-08-01 00:00:00
abstract::It is becoming increasingly acknowledged that people with Type 2 Diabetes represent what can be termed "an enriched population": a group that has the greatest risk of morbidity and mortality from cardiovascular diseases such as myocardial infarcts and strokes. Due to the tremendous toll, both human and financial, that...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,评审
doi:10.1089/15209150050025258
更新日期:2000-07-01 00:00:00
abstract:BACKGROUND:During the proteomic era, one of the most rapidly growing areas in biomedical research is biomarker discovery, particularly using proteomic technologies. The urinary proteome is known to be a valuable field of study and has become one of the most attractive subdisciplines in clinical proteomics for human dis...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1089/dia.2010.0078
更新日期:2010-12-01 00:00:00
abstract::By the year 2030, the diabetes pandemic will likely affect more than 10% of the world's population. The personal, public health, and economic crises implicit in this trend call for decisive action. Yet, escalating dilemmas thwart full realization of current therapies. First, controversial studies, such as the Action t...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,评审
doi:10.1089/dia.2012.0132
更新日期:2012-11-01 00:00:00
abstract::Continuous glucose monitoring (CGM) systems have been available for more than 15 years by now. However, market uptake is relatively low in most countries; in other words, relatively few patients with diabetes use CGM systems regularly. One major reason for the reluctance of patients to use CGM systems is the costs ass...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2015.0296
更新日期:2016-02-01 00:00:00
abstract:: Background: We aimed to explore insulin pump settings in breastfeeding women with type 1 diabetes. Methods: Thirteen unselected breastfeeding women with type 1 diabetes on insulin pump therapy were included consecutively from A...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2019.0280
更新日期:2020-04-01 00:00:00
abstract::Laser retinal photocoagulation represents the primary therapy for the potentially blinding manifestations of diabetic retinopathy. Advances in laser therapy for diabetic eye disease have arisen from the convergence of laser technology and clinical ophthalmology. In this review, the basis of laser therapy in diabetic r...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,评审
doi:10.1089/152091599317396
更新日期:1999-07-01 00:00:00
abstract::Many people with insulin-treated diabetes continue to experience inadequate glycemic control and a high incidence of hypoglycemic events, despite improvements in therapeutic strategies. While glycated hemoglobin (HbA1c) is currently recognized as the gold-standard for assessing glycemic control, the measure reflects m...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2020.0180
更新日期:2021-01-01 00:00:00
abstract:BACKGROUND:Currently, it is still unknown whether differences in glycemic control have any effect on glucose and insulin kinetics after vildagliptin administration. The aim of this study was to evaluate the effect of vildagliptin on glucose and insulin concentrations during a 24-h period in type 2 diabetes patients wit...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1089/dia.2013.0020
更新日期:2013-07-01 00:00:00
abstract::Recent years have brought about an explosion in the number of companies offering connected diabetes care products, defined as digital diabetes management systems based around (1) smartphone apps, (2) devices with built-in connectivity, and (3) remote human and automated coaching and support. These nascent models aim t...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,评审
doi:10.1089/dia.2019.0273
更新日期:2020-01-01 00:00:00
abstract::Clustering of diseases has been appreciated by health insurers and epidemiologists for some time. Co-morbidity suggests shared pathways of disease. It is by now well agreed that common diseases have a strong genetic component. Here we present evidence that the angiotensin I-converting enzyme (ACE) deletion/deletion (D...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/152091502320798321
更新日期:2002-01-01 00:00:00
abstract:: Background: The objective of this study was to assess the safety and performance of the Omnipod® personalized model predictive control (MPC) algorithm in adults, adolescents, and children aged ≥6 years with type 1 diabetes (T1D) under free-living conditions using an invest...
journal_title:Diabetes technology & therapeutics
pub_type: 临床试验,杂志文章,多中心研究
doi:10.1089/dia.2019.0286
更新日期:2020-03-01 00:00:00
abstract:BACKGROUND:There is an unmet need for a modular artificial pancreas (AP) system for clinical trials within the existing regulatory framework to further AP research projects from both academia and industry. We designed, developed, and tested the interoperable artificial pancreas system (iAPS) smartphone app that can int...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2018.0278
更新日期:2019-01-01 00:00:00
abstract:BACKGROUND:This study assessed the feasibility of a portable bihormonal closed-loop system at home. SUBJECTS AND METHODS:Sixteen pump-treated patients with type 1 diabetes received 48 h of closed-loop therapy with a telemonitored insulin- and glucagon-delivering closed-loop system and 48 h of patient-managed open-loop...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2013.0166
更新日期:2014-03-01 00:00:00
abstract:BACKGROUND:Continuous subcutaneous insulin infusion (CSII) is believed to decrease glycemic variability and clinical hypoglycemia compared with the multiple daily insulin (MDI) regimen. To compare the indices of glycemic instability between CSII and MDI, we analyzed the continuous glucose monitoring system (CGMS) (Medt...
journal_title:Diabetes technology & therapeutics
pub_type: 临床试验,杂志文章
doi:10.1089/dia.2005.7.587
更新日期:2005-08-01 00:00:00
abstract:BACKGROUND:Children with positive islet autoantibodies monitored prospectively avoid metabolic decompensation at type 1 diabetes (T1D) diagnosis. However, the effects of early diagnosis and treatment on preservation of insulin secretion and long-term metabolic control are unknown. We compared characteristics of childre...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2015.0029
更新日期:2015-09-01 00:00:00
abstract:BACKGROUND:Implanted insulin pumps using the peritoneal route provide long-term improvement of glucose control compared with subcutaneous insulin therapy in type 1 diabetes (T1D) patients. The stability of insulin preparation is critical for a safe use in implanted pumps. Insuman implantable(®) (400 IU/mL) (Sanofi-Aven...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1089/dia.2013.0369
更新日期:2014-09-01 00:00:00
abstract:OBJECTIVE:This study was designed to measure pressure and shear reduction of a novel insole design. METHODS:We compared three multilayer viscoelastic insoles to a novel insole design (Glide-Soft, Xilas Medical, Inc., San Antonio, TX). The bottom pad of each insole was fabricated from firm-density Plastazote [Apex Foot...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2005.7.638
更新日期:2005-08-01 00:00:00
abstract::Disease registries are a searchable list of all patients with a particular chronic condition that often interface with an electronic medical record. The well-designed registry links all members of the patient's health team and provides key information for patients and physicians. The critical impact of a registry is t...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2008.0057
更新日期:2009-04-01 00:00:00
abstract:BACKGROUND:Internet technology has been proven to be a successful tool for the management of patients with multiple medical conditions. The purpose of this study was to demonstrate the feasibility of monitoring glucose control in indigent women with gestational diabetes mellitus (GDM) over the Internet. METHODS:Women ...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1089/dia.2006.0034
更新日期:2007-06-01 00:00:00