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 effective as the conventional products is essential. It is important for the clinician to consider what information is therefore necessary for such assurances. Biopharmaceuticals, produced from living organisms and manufactured by complex processes, differ in many respects from chemically derived drugs. The biological source materials and manufacturing processes for non-innovator biologics may differ considerably from those used for producing the innovator substance. Differences between innovator and non-innovator products can be identified analytically (e.g., batch-to-batch consistency, product stability along side clinical safety). This provides a strong argument for caution before automatic substitution of conventional products (e.g., insulin by biosimilars). Several non-innovator insulins, including insulin analogs (while still patent-protected), are already available in many countries. Many of these lack rigorous regulations for biosimilar approval and pharmacovigilance. Recently an application for a biosimilar recombinant human insulin was withdrawn by the European Medicines Agency because of safety and efficacy concerns. Therefore, every biosimilar insulin and insulin analog should be assessed by well-defined globally harmonized preclinical and clinical studies followed by post-marketing pharmacovigilance programs, in the interest of people with diabetes worldwide.
journal_name
Diabetes Technol Therjournal_title
Diabetes technology & therapeuticsauthors
Owens DR,Landgraf W,Schmidt A,Bretzel RG,Kuhlmann MKdoi
10.1089/dia.2012.0105subject
Has Abstractpub_date
2012-11-01 00:00:00pages
989-96issue
11eissn
1520-9156issn
1557-8593journal_volume
14pub_type
杂志文章,评审abstract:BACKGROUND:Lipoprotein-associated phospholipase A₂ (Lp-PLA₂) is a lipoprotein-associated enzyme that cleaves oxidized phosphatidylcholines, generating pro-atherosclerotic lysophosphatidylcholine and oxidized free fatty acids. Lp-PLA₂ is independently associated with cardiovascular disease (CVD) in a variety of populati...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2010.0175
更新日期:2011-03-01 00:00:00
abstract:BACKGROUND:Stress-induced hyperglycemia is prevalent in critical care, even in patients with no history of diabetes. Increased counter-regulatory hormone response increases gluconeogenesis and effective insulin resistance, which can be exacerbated by drug therapy. Control of blood glucose levels to the 4.0-6.1 mmol/L r...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2006.8.449
更新日期:2006-08-01 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:AIM:This study explored the role of glycemic control on cardiac autonomic function, measured by heart rate variability (HRV), in youth with type 1 diabetes. PATIENTS AND METHODS:A retrospective cohort of 345 youth with type 1 diabetes (mean age, 18.5 years; duration, 10 years) participating in the SEARCH for Diabetes ...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,多中心研究
doi:10.1089/dia.2013.0147
更新日期:2013-12-01 00:00:00
abstract::Glucagon-like peptide 1 receptor agonists (GLP-1 RAs) are highly effective at lowering hemoglobin A1c (HbA1c) and facilitating weight loss. Four agents in the GLP-1 RA class, albiglutide, liraglutide, dulaglutide, and semaglutide, also have cardioprotective effects. However, subcutaneous administration of these agents...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,评审
doi:10.1089/dia.2019.0185
更新日期:2020-01-01 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:BACKGROUND:We aimed to assess the effect of continuous subcutaneous insulin infusion (CSII) therapy in patients with "recalcitrant diabetes" whose glycemia had not been controlled adequately with multiple daily injections of insulin or insulin plus oral hypoglycemic agents. PATIENTS AND METHODS:We retrospectively anal...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2009.0066
更新日期:2009-11-01 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: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: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:OBJECTIVE:This study assessed the accuracy and reliability of three continuous glucose monitoring (CGM) systems. RESEARCH DESIGN AND METHODS:We studied the Animas® (West Chester, PA) Vibe™ with Dexcom® (San Diego, CA) G4™ version A sensor (G4A), the Abbott Diabetes Care (Alameda, CA) Freestyle® Navigator I (NAV), and ...
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.2013.0049
更新日期:2013-08-01 00:00:00
abstract:BACKGROUND:Continuous glucose monitoring (CGM) technologies report measurements of interstitial glucose concentration every 5 min. CGM technologies have the potential to be utilized for prediction of prospective glucose concentrations with subsequent optimization of glycemic control. This article outlines a feed-forwar...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2010.0104
更新日期:2011-02-01 00:00:00
abstract::Most previous attempts at the development of a "smart tattoo" for glucose monitoring in diabetes--implantable fluorescent microspheres that can be implanted intradermally and interrogated transdermally using light--have focused on the encapsulation of a competitive binding assay for glucose within hydrogel microsphere...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2006.8.288
更新日期:2006-06-01 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: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:Relatively little is known about parents' or children's attitudes toward recruitment for, and participation in, studies of new diabetes technologies immediately after diagnosis. This study investigated factors affecting recruitment of participants for studies in newly diagnosed youth with type 1 diabetes. M...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2016.0157
更新日期:2016-09-01 00:00:00
abstract:BACKGROUND:Real-time continuous glucose monitoring (CGM) was studied in 140 adults with diabetes over a 12-week period of home use. Hemoglobin A(1c)(HbA1c) was measured on day 1 (baseline) and at weeks 6 and 12. METHODS:On day 1, participants received the CGM device (STS(R) System, DexCom, Inc., San Diego, CA) and und...
journal_title:Diabetes technology & therapeutics
pub_type: 临床试验,杂志文章,多中心研究
doi:10.1089/dia.2007.0205
更新日期:2007-06-01 00:00:00
abstract:BACKGROUND:As healthy diet and physical activity can improve glucometabolic control in patients with type 2 diabetes, lifestyle changes should be the basis for each therapy. The only tool to visualize immediate effects of food pattern and exercise on blood glucose levels is self-monitoring of blood glucose (SMBG). Ther...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2010.0008
更新日期:2010-07-01 00:00:00
abstract:OBJECTIVES:Hyperglycemia is a prominent feature among patients exposed to major stress such as in cardiac surgery. The implementation of a continuous glucose monitoring system (CGMS) for glucose monitoring during cardiac surgery was assessed. SUBJECTS AND METHODS:Fifty-nine consecutive patients who underwent cardiac s...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2011.0154
更新日期:2012-03-01 00:00:00
abstract:BACKGROUND:Microneedles have previously been used to deliver insulin to animal models, but not in human subjects. This study tested the hypothesis that hollow microneedles can deliver insulin to modulate blood glucose levels in subjects with type 1 diabetes in a minimally invasive manner. METHODS:This study was carrie...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2008.0103
更新日期:2009-06-01 00:00:00
abstract:AIMS:This study evaluated treatment satisfaction, comfort, and function using the wireless OmniPod™ Insulin Management System (Insulet Corp., Bedford, MA) compared with conventional (infusion set) insulin pumps in young adults with type 1 diabetes. RESEARCH DESIGN AND METHODS:Twenty-nine patients (age, 24.0 ± 5.1 year...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1089/dia.2011.0228
更新日期:2012-05-01 00:00:00
abstract:AIM:The aim of this study was to assess the associations of six single nucleotide polymorphisms (SNPs) of three genes (DRD3, COMT, and SCL6A4) with type 2 diabetes mellitus (T2DM) in Southern Chinese. SUBJECTS AND METHODS:Five hundred ninety-five cases with T2DM and 725 healthy controls of Han origin were recruited fr...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2014.0344
更新日期:2015-08-01 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::There is a clear role for inflammation in the development of type 2 diabetes and its associated co-morbidities. Circulating inflammatory markers such as C-reactive protein, sialic acid, and interleukin- 6 are all significant independent predictors of disease. A number of nutritional components are hypothesized to modu...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,评审
doi:10.1089/dia.2006.8.45
更新日期:2006-02-01 00:00:00
abstract:BACKGROUND:The masked continuous glucose monitoring system (Masked-CGMS) differs from standard CGMSs in three ways: (1) there is no feedback to the user so that no immediate regimen changes can be made; (2) it can only be worn for up to 5 days; and (3) there are no alarms to warn of hyperglycemia or hypoglycemia. Since...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2013.0297
更新日期:2014-05-01 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:BACKGROUND AND OBJECTIVE:Hyperglycemia occurs commonly in patients admitted to medical intensive care units (MICUs). Whether real-time (RT) continuous glucose monitoring (CGM) improves glycemic control and variability and reduces hypoglycemia in severely ill MICU patients with an Acute Physiology and Chronic Health Eva...
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.2015.0151
更新日期:2015-12-01 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: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: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