Abstract:
:With the expiration of patent protection for several originator insulin analog molecules, the availability of insulin analog copies is set to increase. Many regulatory authorities have developed, and continue to refine, guidelines for the approval of biosimilar insulin analogs. Aspects such as the structure, pharmacokinetics and pharmacodynamics, efficacy, safety, and immunogenicity of biosimilar insulin analogs are extensively addressed in these guidelines, but how the biosimilar insulin analog is administered to people with diabetes is not usually a topic. The aim of this article is to highlight that the delivery device-drug combination is of particular importance. Regulatory, legal, and practical aspects of the delivery device, be it a syringe, pen, or pump, have to be considered in the context of biosimilar insulin analogs. Although the safety and efficacy of biosimilar insulin analogs per se are of primary importance for physicians and people with diabetes, functions and features of the devices used for administration also require attention from a practical point of view. Unfortunately, although there are several clinical studies investigating the technical aspects of and patient preference for the originator insulin analog pens, there are currently very little published data for nonoriginator or biosimilar insulin analog pens. In addition, it is not known if it is safe to assume that a biosimilar insulin analog cartridge is compatible with an existing originator insulin analog pen. We believe that there is a need for more discussion on the role of devices for administration of biosimilar insulin analogs.
journal_name
Diabetes Technol Therjournal_title
Diabetes technology & therapeuticsauthors
Heinemann L,Fritz I,Khatami H,Edelman SVdoi
10.1089/dia.2016.0263subject
Has Abstractpub_date
2017-02-01 00:00:00pages
79-84issue
2eissn
1520-9156issn
1557-8593journal_volume
19pub_type
杂志文章,评审abstract::Use of the Medtronic MiniMed Continuous Glucose Monitoring System (CGMS) in non-diabetic children has revealed many low and high sensor glucose (SG) values, suggesting that the original analytical algorithm (Solutions 2.0) might be overreading glycemic excursions. A revised algorithm (Solutions 3.0) was introduced in ...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/152091503765691866
更新日期:2003-01-01 00:00:00
abstract::Type 2 diabetes is characterized by insulin resistance and progressive β-cell deterioration. As β-cell function declines, most patients with type 2 diabetes treated with oral agents, in monotherapy or combination, will require insulin therapy. Addition of basal insulin (glargine, detemir, or NPH/neutral protamine lisp...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,评审
doi:10.1089/dia.2011.0001
更新日期:2011-06-01 00:00:00
abstract::The Exubera system (Pfizer, New York, NY/Nektar Therapeutics, San Carlos, CA) is an integration of five major new technologies: protein formulation, powder processing, powder filling, drug packaging, and delivery device. The product provides a simple interface, where the patient interacts only with the delivery device...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2007.0222
更新日期:2007-06-01 00:00:00
abstract:BACKGROUND:Persistent use of real-time continuous glucose monitoring (CGM) improves diabetes control in individuals with type 1 diabetes (T1D) and type 2 diabetes (T2D). METHODS:PRECISE II was a nonrandomized, blinded, prospective, single-arm, multicenter study that evaluated the accuracy and safety of the implantable...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,多中心研究
doi:10.1089/dia.2017.0142
更新日期:2018-03-01 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:Preventing the complications of diabetes requires tight control and minimizing blood glucose fluctuation. Pursuing these goals increases the risk of severe hypoglycemia. The authors hoped to identify if using continuous glucose monitoring (CGM) decreased the incidence of severe hypoglycemia, resulted in less...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2009.0121
更新日期:2010-03-01 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::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:OBJECTIVE:We sought to cross validate several metrics for quality of glycemic control, hypoglycemia, and hyperglycemia. RESEARCH DESIGN AND METHODS:We analyzed the mathematical properties of several metrics for overall glycemic control, and for hypo- and hyperglycemia, to evaluate their similarities, differences, and ...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2017.0416
更新日期:2018-05-01 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::Subcutaneous (s.c.) injections of identical insulin doses may lead to considerable intra- and inter-individual differences in the current metabolic control of patients with diabetes mellitus. This well-known variability of the metabolic effect of insulin hampers practical insulin therapy considerably. The aim of this ...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,评审
doi:10.1089/152091502320798312
更新日期:2002-01-01 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:AIMS:Skin autofluorescence (AF) has been associated with complications of diabetes. We evaluated the influence of skin color and ethnicity on the association between skin AF and the presence of diabetes-related complications. MATERIALS AND METHODS:In a multiethnic type 2 diabetes cohort we investigated all patients wi...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2013.0374
更新日期:2015-02-01 00:00:00
abstract:BACKGROUND:Pregnancy and early motherhood are extraordinarily demanding periods for women with type 1 diabetes, who therefore need optimal support. This article describes the process of developing person-centered Web-based support for women with type 1 diabetes during the period of pregnancy through early motherhood. I...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2012.0217
更新日期:2013-01-01 00:00:00
abstract::Existing standards of the management of the diabetic patients are not efficient enough, and further improvement is needed. The major objective of this paper is to present and discuss the therapeutic effectiveness of an intensive care telematic system designed and applied for intensive treatment of pregnant type 1 diab...
journal_title:Diabetes technology & therapeutics
pub_type: 临床试验,杂志文章
doi:10.1089/15209150152811207
更新日期:2001-01-01 00:00:00
abstract:OBJECTIVE:This study was designed to develop predictive formulas for precise insulin dosing in young children with type 1 diabetes (T1DM). RESEARCH DESIGN AND METHODS:Consecutive 1-year data from a group of 14 young patients (eight girls, six boys) 3.9 ± 0.8 years old with diabetes duration of 2.0 ± 0.8 years, transit...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2011.0184
更新日期:2012-05-01 00:00:00
abstract::Although hypodermic needles rapidly deliver large doses of drugs such as insulin across the skin for systemic administration, the pain, local trauma, and difficulty to achieve sustained or complex delivery profiles has motivated development of novel alternative technologies. Microneedles, jet injectors, and thermal po...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,评审
doi:10.1089/152091501300209606
更新日期:2001-07-01 00:00:00
abstract:AIMS:Recent advances in analytical technology allow the detection of several hundred volatile organic compounds (VOCs) in human exhaled air, many of which reflect unidentified endogenous pathways. This study was performed to determine whether a breath gas analysis using proton transfer reaction-mass spectrometry (PTR-M...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2009.0181
更新日期:2010-06-01 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:BACKGROUND:The optimal treatment of diabetes in pregnancy requires accurate measurement of blood glucose levels, in order to minimize adverse outcomes for both mother and neonate. Self-monitoring of blood glucose is routinely used to measure glycemic control and to assess whether treatment targets are being met; howeve...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,收录出版
doi:10.1089/dia.2015.0104
更新日期:2016-02-01 00:00:00
abstract:OBJECTIVE:Exercise is a cornerstone of diabetes therapy in type 1 diabetes mellitus (DMT1) patients. The type of exercise is important in determining the propensity to hypoglycemia. We assessed, by continuous glucose monitoring (CGM), the glucose profiles during and in the following 20h after a session of two different...
journal_title:Diabetes technology & therapeutics
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1089/dia.2010.0038
更新日期:2010-10-01 00:00:00
abstract:BACKGROUND:The junction of telemedicine home monitoring with multifaceted disease management programs seems nowadays a promising direction to combine the need for an intensive approach to deal with diabetes and the pressure to contain the costs of the interventions. Several projects in the European Union and the United...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2004.6.567
更新日期:2004-10-01 00:00:00
abstract::Several biopharmaceuticals, including insulin and insulin analogs, are, or shortly will be, off-patent, thereby providing an opportunity for companies to attempt to manufacture "copies" commonly referred to as biosimilars and also known as follow-on biologics. Reassurance that such copy biologics are equally safe and ...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,评审
doi:10.1089/dia.2012.0105
更新日期:2012-11-01 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::The foreign body capsule that forms around implanted devices such as glucose sensors is hypovascular and has limited permeability to glucose. Such a capsule may function better if well vascularized. We hypothesized that capsular vascularization achieved by local release of vascular endothelial growth factor (VEGF) wou...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/152091504773731320
更新日期:2004-04-01 00:00:00
abstract:OBJECTIVE:To assess whether snacking could be used with closed-loop (CL) insulin delivery to avoid exercise-induced reductions in plasma glucose (PG), as well as elevations in PG at the end of exercise. RESEARCH DESIGN AND METHODS:Twelve type 1 diabetes (T1D) subjects (age 13-36 years, duration 10.7 ± 8.4 years, A1c 7...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1089/dia.2016.0311
更新日期:2016-12-01 00:00:00
abstract:BACKGROUND:Multicenter long-term studies of predictors for the effectiveness of continuous subcutaneous insulin infusion (CSII) in clinical practice are lacking. We hypothesized that there are substantially greater reductions in hemoglobin A1c (HbA1c) in patients with poor glycemic control and that other predictors may...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2014.0139
更新日期:2015-01-01 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:Different reference methods are used for the accuracy assessment of continuous glucose monitoring (CGM) systems. The effect of using venous, arterialized-venous, or capillary reference measurements on CGM accuracy is unclear. METHODS:We evaluated 21 individuals with type 1 diabetes using a capillary calibra...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1089/dia.2017.0189
更新日期:2017-11-01 00:00:00
abstract:BACKGROUND:The value of self-monitoring of blood glucose (SMBG) for persons with type 2 diabetes who do not use insulin remains controversial. This observational study compares the likelihood of medication adherence and change in glycated hemoglobin (A1C) for non-insulin-using patients using SMBG versus those not using...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2012.0047
更新日期:2012-09-01 00:00:00