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 and powder packaging. These components were designed together to assure repeatable dosing when used by a wide range of patients under real-world life-style and handling conditions. The device design is purely mechanical, using patient-generated compressed air as the energy source. Upon actuation, a sonic discharge of air through the novel release unit reproducibly extracts, de-agglomerates, and disperses the inhalation powder into a respirable aerosol. A clear holding chamber allows for patient feedback via dose visualization and separates aerosol cloud generation from the inspiratory effort. The Exubera product was tested under a wide range of typical use conditions and potential misuse scenarios and following long-term usage in clinical trials. These comprehensive characterization programs demonstrated robust aerosol and mechanical performance, confirming the design intent of the inhaler. These studies provide assurance of consistent and reliable dose delivery in a real-world use of the product.
journal_name
Diabetes Technol Therjournal_title
Diabetes technology & therapeuticsauthors
Harper NJ,Gray S,De Groot J,Parker JM,Sadrzadeh N,Schuler C,Schumacher JD,Seshadri S,Smith AE,Steeno GS,Stevenson CL,Taniere R,Wang M,Bennett DBdoi
10.1089/dia.2007.0222subject
Has Abstractpub_date
2007-06-01 00:00:00pages
S16-27eissn
1520-9156issn
1557-8593journal_volume
9 Suppl 1pub_type
杂志文章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: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:The hyperinsulinemic euglycemic clamp is the gold standard for assessment of insulin resistance and requires frequent, accurate measurements of blood glucose concentrations, typically utilizing the YSI 2300 STAT Plus™ glucose analyzer (YSI, Inc., Yellow Springs, OH). Despite its accuracy, the YSI has several...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2013.0288
更新日期:2014-05-01 00:00:00
abstract::We report the first case of the use of continuous subcutaneous insulin infusion (CSII) in a patient with Shwachman-Bodian-Diamond syndrome (SBDS) and diabetes. An Italian boy received diagnosis of SBDS at the age of 7 months (SBDS gene mutation: c.183-184TA → CT and c.258 + 2 T → C in compound heterozygous). The patie...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2014.0184
更新日期:2015-01-01 00:00:00
abstract:BACKGROUND:The recent availability of a continuous glucose monitor offers the opportunity to match the demands of intensive diabetes management with a period of equally intensive blood glucose monitoring. The present study evaluates the performance of the MiniMed continuous glucose monitoring system (CGMS) in patients ...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/152091500316737
更新日期:2000-04-01 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: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: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: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:OBJECTIVE:This study assessed the association of serum adiponectin with carotid intimal medial thickness (IMT) in Asian Indians with different grades of glucose intolerance. METHODS:Subjects with normal glucose tolerance (NGT) (n = 520), impaired glucose tolerance (IGT) (n = 115), and type 2 diabetes mellitus (T2DM) (...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2009.0100
更新日期:2010-02-01 00:00:00
abstract:BACKGROUND:This study explored the relationships between exogenous insulin requirements and endogenous variables in elderly patients with type 2 diabetes (T2D). SUBJECTS AND METHODS:Patients with T2D 65 years of age or older were enrolled for a short hospitalization period in order to start or change their basal-bolus...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2015.0044
更新日期:2016-05-01 00:00:00
abstract:BACKGROUND:There are currently few data available on the long-term use of continuous subcutaneous insulin infusion (CSII) (insulin pump) therapy in children. METHODS:Charts from 291 youth with type 1 diabetes (T1D) who were treated with CSII therapy for at least 1 year were reviewed. Data analysis included hemoglobin ...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2007.0214
更新日期:2007-10-01 00:00:00
abstract:BACKGROUND:Accurate and economic detection of nerve damage in diabetes is key to more widespread diagnosis of patients with diabetic peripheral neuropathy (DPN) and painful diabetic neuropathy. This study examined the diagnostic performance of NerveCheck, an inexpensive ($500) quantitative sensory testing (QST) device....
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2016.0279
更新日期:2016-12-01 00:00:00
abstract:BACKGROUND:SAR342434 is a biosimilar follow-on of insulin lispro-Humalog®. This study aimed to show similar efficacy, safety, and immunogenicity of SAR342434 (SAR-Lis) versus insulin lispro-Humalog (Ly-Lis) in adult patients with type 1 diabetes (T1DM) treated with multiple daily injections while using basal insulin gl...
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.2017.0117
更新日期:2017-09-01 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:Insulin pumps (for continuous subcutaneous insulin infusion [CSII]) are used widely in type 1 diabetes mellitus. Although there has been considerable study of outcomes, there are few recent data on CSII-associated adverse events and no data on family perceptions of adverse events and their confidence in deal...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2013.0315
更新日期:2014-04-01 00:00:00
abstract:OBJECTIVE:Over the past 35 years considerable research has been performed toward the investigation of noninvasive and minimally invasive glucose monitoring techniques. Optical polarimetry is one noninvasive technique that has shown promise as a means to ascertain blood glucose levels through measuring the glucose conce...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2012.0070
更新日期:2012-09-01 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:: 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::Basal insulin analogs are recognized as an effective method of achieving and maintaining glycemic control for patients with type 2 diabetes. However, the progressive nature of the disease means that some individuals may require additional ways to maintain their glycemic goals. Intensification in these circumstances ha...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,评审
doi:10.1089/dia.2010.0250
更新日期:2011-09-01 00:00:00
abstract::Continuous glucose monitoring (CGM) is a new tool that has recently become available to people with diabetes. Properly designing and conducting trials in order to answer important questions regarding the clinical usefulness of CGM is very difficult and fraught with many confounding variables and unique challenges. Ini...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2009.0012
更新日期:2009-06-01 00:00:00
abstract:BACKGROUND:We evaluated the impact of a 2-year chat line involving adolescents with type 1 diabetes regarding quality of life and metabolic control. METHODS:We enrolled 193 children, 10-18 years of age (mean ± SD, 13.6 ± 2.7 years), with type 1 diabetes for 1.2-6 years (3.6 ± 2.4 years), body mass index of 23.2 ± 4.1 ...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2010.0188
更新日期:2011-05-01 00:00:00
abstract::Innovo (Novo Nordisk A/S, Hillerød, Denmark) is a new insulin injection system that offers built-in memory and a large, clear display to provide patients with more control during insulin injections. The aim of this trial was to compare the efficacy and safety of Innovo and NovoPen 3 (Novo Nordisk A/S) in patients expe...
journal_title:Diabetes technology & therapeutics
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.1089/152091504322783413
更新日期:2004-02-01 00:00:00
abstract:BACKGROUND:Visual disabilities due to diabetes are on the rise, especially in urban areas of developing countries. Proper health planning will need evidence-based information. STUDY DESIGN AND METHODS:We estimated the prevalence and identified the determinants of eye complications among persons with diabetes screened ...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2009.0033
更新日期:2009-09-01 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::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 use of real-time continuous glucose monitoring (rtCGM) systems has proved to positively impact the management of type 1 diabetes with the potential to lower HbA1c, reduce frequency and time spent in hypoglycemia, and lower glycemic variability. Nevertheless...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2018.0397
更新日期:2019-05-01 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::Since the late 1970s, self-monitoring of blood glucose has been the standard for assessing daily glycemic control. The first continuous glucose monitor became available in 1999. Numerous clinical trials have documented the benefits of continuous glucose monitoring (CGM) in patients with type 1 diabetes mellitus (DM). ...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,评审
doi:10.1089/dia.2011.0086
更新日期:2012-02-01 00:00:00
abstract:BACKGROUND:The purpose of this study is to test the agreement between energy expenditure estimate of the SenseWear(®) Armband Pro3 (SWA) (BodyMedia, Pittsburgh, PA) and the Omron HJ-720 (Omron Healthcare, Kyoto, Japan) step counter with indirect calorimetry (IC) as a gold standard in older individuals with type 1 and t...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2012.0235
更新日期:2013-05-01 00:00:00