Abstract:
:On May 26, 1976, the Food and Drug Administration (FDA) began implementing the Medical Device Amendments to the Federal Food Drug and Cosmetic Act. These amendments give FDA specific authority to regulate "medical devices." Additional authority was provided in the Safe Medical Devices Act of 1990. The pathways to get in vitro diagnostic products to market for commercial distribution include: premarket notification [or 510(k)] and premarket approval (PMA). Reviews of these applications are performed in the Division of Clinical Laboratory Devices, Office of Device Evaluation within the Center for Devices and Radiological Health. Most submissions for invasive glucose devices are 510(k) applications. Through this process the manufacturer demonstrates that its device is substantially equivalent to another device that is already legally marketed, referred to as the predicate device. To date, noninvasive and minimally invasive glucose testings have been approved through the PMA process and will be discussed in a separate article.
journal_name
Diabetes Technol Therjournal_title
Diabetes technology & therapeuticsauthors
Gutman S,Bernhardt P,Pinkos A,Moxey-Mims M,Knott T,Cooper Jdoi
10.1089/152091502321118784keywords:
subject
Has Abstractpub_date
2002-01-01 00:00:00pages
775-7issue
6eissn
1520-9156issn
1557-8593journal_volume
4pub_type
杂志文章abstract:: Background: Current manual diabetic retinopathy (DR) screening using eye care experts cannot scale to screen the growing population of diabetes patients who are at risk for vision loss. EyeArt system is an automated, cloud-based artificial intelligence (AI) eye screening t...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2019.0164
更新日期:2019-11-01 00:00:00
abstract::Self-monitoring of blood glucose was described as one of the most important advancements in diabetes management since the invention of insulin in 1920. Recent advances in glucose sensor technology for measuring interstitial glucose concentrations have challenged the dominance of glucose meters in diabetes management, ...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,评审
doi:10.1089/dia.2009.0002
更新日期:2009-06-01 00:00:00
abstract:BACKGROUND:Recent evidence emphasizes the importance of maintaining normoglycemia in critically ill patients to reduce morbidity and mortality. Different analytical methods of varying accuracy exist for obtaining and measuring blood glucose in critically ill patients. The purpose of this study was to determine if there...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2008.0263
更新日期:2008-06-01 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::Glucose oxidase has had a central role in previous glucose sensing methods and is key to the development of certain new glucose sensors. The immobilized enzyme is specific for glucose and sufficiently long-lived for many sensor applications, but new glucose sensing applications may place increased demands on the enzym...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/15209150050194242
更新日期:2000-10-01 00:00:00
abstract:BACKGROUND:Weight gain often occurs when insulin therapy is initiated. The long-acting insulin analog insulin detemir has been shown to be effective and well tolerated when used in basal-bolus regimens or as an add-on to oral antidiabetic drugs (OADs) and causes less weight gain than other insulins. The aim of this exp...
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.2008.0282
更新日期:2008-08-01 00:00:00
abstract:BACKGROUND:Lipohypertrophy (LH) is a complication of insulin therapy. We assessed LH prevalence, risk factors, insulin usage, and clinical and health economic effects in China. METHODS:In four cities, 401 adult patients injecting insulin ≥1 year were surveyed for diabetes/insulin injection history and practices, pen n...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2016.0334
更新日期:2017-01-01 00:00:00
abstract:BACKGROUND:The Ascensia CONTOUR System (Bayer HealthCare LLC, Elkhart, IN) is a new blood glucose (BG) monitoring system (BGMS) that uses glucose dehydrogenase chemistry and that combines low sample volume, fast response time, an auto-control marking feature, and an auto-calibration function in a small package. METHOD...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,多中心研究
doi:10.1089/dia.2005.7.283
更新日期:2005-04-01 00:00:00
abstract:BACKGROUND:Continuous glucose monitoring (CGM) has been shown to be a valuable tool to improve glycemic control in patients with diabetes. The objective of this pilot study was to develop and implement CGM in an existing diabetes clinic for low-income patients on multiple daily injections. SUBJECTS AND METHODS:This wa...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1089/dia.2013.0072
更新日期:2013-10-01 00:00:00
abstract::AIDA is a diabetes-computing program freely available from www.2aida.org on the Web. The software is intended to serve as an educational support tool, and can be used by anyone who has an interest in diabetes, whether they be patients, relatives, health-care professionals, or students. In previous "Diabetes Informatio...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/152091503763816490
更新日期:2003-01-01 00:00:00
abstract:BACKGROUND:Understanding the effect size, variability, and underlying physiology of the dawn phenomenon is important for next-generation closed-loop control algorithms for type 1 diabetes (T1D). SUBJECTS AND METHODS:We used an iterative protocol design to study 16 subjects with T1D on individualized insulin pump thera...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2015.0011
更新日期:2015-08-01 00:00:00
abstract::The Editor of Diabetes Technology & Therapeutics is officially retracting the article entitled, "No Deleterious Effect of Lockdown Due to COVID-19 Pandemic on Glycaemic Control, Measured by Glucose Monitoring, in Adults with Type 1 Diabetes," by Beato-Vibora PI. Diabetes Technol Ther 2020; epub DOI: 10.1089/dia.2020.0...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,收录出版
doi:10.1089/dia.2020.0184
更新日期:2020-05-12 00:00:00
abstract:AIM:Insulin therapy induces remission in subjects with newly diagnosed type 2 diabetes mellitus (T2DM). This study assessed the insulin and C-peptide levels in newly diagnosed T2DM subjects during low-dose insulin therapy. SUBJECTS AND METHODS:Twenty newly diagnosed, drug-naive, T2DM patients without acute or chronic ...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2010.0187
更新日期:2011-04-01 00:00:00
abstract:BACKGROUND:This study was designed to validate the use of SoloSTAR (sanofi-aventis Deutschland GmbH, Frankfurt, Germany), a new disposable pen developed for use with insulin glargine by patients with type 1 or type 2 diabetes. METHODS:This single-center, open-label, single-arm, sequential trial enrolled subjects with ...
journal_title:Diabetes technology & therapeutics
pub_type: 临床试验,杂志文章
doi:10.1089/dia.2008.0079
更新日期:2008-10-01 00:00:00
abstract:OBJECTIVE:Hemoglobin A1c (A1C) has recently been recommended for diagnosing diabetes mellitus and diabetes risk (prediabetes). Its performance compared with fasting plasma glucose (FPG) and 2-h post-glucose load (2HPG) is not well delineated. We compared the performance of A1C with that of FPG and 2HPG in preoperative ...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2011.0074
更新日期:2011-12-01 00:00:00
abstract::Thanks to significant improvements in the precision, accuracy, and usability of continuous glucose monitoring (CGM), its relevance in both ambulatory diabetes care and clinical research is increasing. In this study, we address the latter perspective and derive provisional reporting recommendations. CGM systems have be...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,评审
doi:10.1089/dia.2017.0054
更新日期:2017-07-01 00:00:00
abstract:: Background: Continuous glucose monitoring (CGM) systems are widely and increasingly used in diabetes self-management and in the context of clinic visits. However, access to CGM data during visits can be challenging. Clinic inefficiencies can restrict the time available for...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2019.0377
更新日期:2020-08-01 00:00:00
abstract::Hyperspectral imaging (HSI) has been useful in monitoring several medical conditions, which to date have generally involved local changes in skin oxygenation of isolated regions of interest such as skin flaps or small burns. Here, by contrast, we present a study in which HSI was used to assess the local cutaneous mani...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/152091503322527058
更新日期:2003-01-01 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:To protect against ischemia, pressure-induced vasodilation (PIV) causes an increase in skin blood flow. Endothelial dysfunction, which is commonly found in older patients and those with diabetes, and global temperatures can affect the resting blood flow in skin, which may reduce the blood flow during and aft...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2009.0097
更新日期:2009-12-01 00:00:00
abstract::Self-monitoring of blood glucose (SMBG) is universally considered to be an integral part of type 1 diabetes management and crucial for optimizing the safety and efficacy of complex insulin regimens. This extends to type 2 diabetes patients on intensive insulin therapy, and there is also a growing body of evidence sugg...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,评审
doi:10.1089/dia.2013.0302
更新日期:2014-07-01 00:00:00
abstract:BACKGROUND:Diabetes mellitus is rare in young infants and neonates. Continuous subcutaneous insulin infusion (CSII) is used most frequently for insulin treatment in this age group. However, the individual doctor's experience is scarce because of the low prevalence of diabetes in this age. For this study patients treate...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,多中心研究
doi:10.1089/dia.2015.0030
更新日期:2015-12-01 00:00:00
abstract:BACKGROUND:Glucose variability (GV) has been increasingly (or more extensively) studied in patients with type 1 diabetes (T1D) in the ambulatory setting; limited data exist on GV in hospitalized patients with T1D. MATERIALS AND METHODS:Retrospective single center cohort study, we analyzed in-hospital glucose measureme...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2017.0107
更新日期:2017-10-01 00:00:00
abstract:AIMS:The aim was to investigate the prevalence of diabetic sensorimotor polyneuropathy (DSPN) and cardiovascular autonomic neuropathy (CAN) in a Danish population of young adults with type 1 diabetes (T1D) using both established and novel measuring modalities. Furthermore, to investigate the association between continu...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2018.0249
更新日期:2018-11-21 00:00:00
abstract:BACKGROUND:Insulin initiation and optimization is a challenge for patients with type 2 diabetes. Our objective was to determine whether safety and efficacy of AIR inhaled insulin (Eli Lilly and Co., Indianapolis, IN) (AIR is a registered trademark of Alkermes, Inc., Cambridge, MA) using a simplified regimen was noninfe...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1089/dia.2009.0036
更新日期:2009-09-01 00:00:00
abstract:: Objective: 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. Research Design and Methods: ...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2020.0490
更新日期:2020-12-30 00:00:00
abstract::Skin integrity and diabetes device placement are ongoing concerns for people with diabetes who utilize continuous glucose monitors (CGMs) and continuous subcutaneous insulin infusion pumps. This is especially significant for individuals with skin sensitivities, pediatric patients, and those who use devices chronically...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2018.0080
更新日期:2018-06-01 00:00:00
abstract::Diabetic nephropathy is one of the major causes of end-stage renal disease and is often associated with other macrovascular complications such as ischemic heart disease and peripheral vascular disease. Angiotensin converting enzyme inhibitors (ACE-I) and angiotensin II receptor blockers (AIIR) have both been shown to ...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,评审
doi:10.1089/152091502760098456
更新日期:2002-01-01 00:00:00
abstract:INTRODUCTION:The ProAct study has shown that a pump switch to the Accu-Chek(®) Combo system (Roche Diagnostics Deutschland GmbH, Mannheim, Germany) in type 1 diabetes patients results in stable glycemic control with significant improvements in glycated hemoglobin (HbA1c) in patients with unsatisfactory baseline HbA1c a...
journal_title:Diabetes technology & therapeutics
pub_type: 临床试验,杂志文章,多中心研究
doi:10.1089/dia.2014.0278
更新日期:2015-06-01 00:00:00
abstract:BACKGROUND:The aim of this investigation was to assess clinical predictors of the glycosylated hemoglobin (HbA1C) response after the addition of a thiazolidinedione (TZD) to a biguanide, a sulfonylurea, or both in subjects with type 2 diabetes. METHODS:Chart review (n = 68 physicians) was used to identify consecutive ...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2007.0248
更新日期:2007-12-01 00:00:00