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-Aventis Deutschland GmbH, Frankfurt am Main, Germany), a recombinant human insulin, has been developed as a replacement for Insuplant(®) (Aventis Pharma, Frankfurt am Main, Germany), a semisynthetic insulin, the only one used so far. The aim of the study was to demonstrate the noninferiority of Insuman versus Insuplant, in terms of safety and effectiveness when used in implanted pumps. SUBJECTS AND METHODS:The patients enrolled, currently treated for T1D by the Medtronic MiniMed (Northridge, CA) implantable pump model 2007 with Insuplant, were randomized into two study arms and received either Insuman or Insuplant for four pump refill cycles. Each pump refill cycle was 40±5 days. The co-primary end points included glycated hemoglobin (HbA1c) change from baseline and pump infusion accuracy. RESULTS:In total, 169 patients were randomized. Noninferiority of Insuman versus Insuplant was demonstrated both for the HbA1c change from baseline (as a percentage) with intergroup difference of 95% confidence interval (-0.36;+0.11) and for the infusion accuracy assessed by the measured percentage of error at pump refill, as shown by intergroup difference of 95% confidence interval (-5.81; -0.50), in per-protocol populations, although the insulin daily dose was similar. Severe hypoglycemia occurred at least once in 12 versus 11 patients, respectively, and metabolic or technical adverse events were comparable. CONCLUSIONS:Findings suggest that Insuman can safely and effectively replace Insuplant in implanted pumps.
journal_name
Diabetes Technol Therjournal_title
Diabetes technology & therapeuticsauthors
Schaepelynck P,Riveline JP,Renard E,Hanaire H,Guerci B,Baillot-Rudoni S,Sola-Gazagnes A,Catargi B,Fontaine P,Millot L,Martin JF,Tachouaft H,Jeandidier N,EVADIAC Group.doi
10.1089/dia.2013.0369subject
Has Abstractpub_date
2014-09-01 00:00:00pages
582-9issue
9eissn
1520-9156issn
1557-8593journal_volume
16pub_type
杂志文章,多中心研究,随机对照试验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::Treatments for type 1 diabetes have advanced significantly over recent years. There are now multiple hybrid closed-loop systems commercially available and additional systems are in development. Challenges remain, however. This review outlines the recent advances in closed-loop systems and outlines the remaining challe...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2019.0469
更新日期:2020-07-01 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: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: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: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::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::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::This study was designed to determine plasma glucose and insulin levels after administration of three escalating doses of the oral insulin product hexyl-insulin monoconjugate 2 (HIM2) in fasting, insulin-deprived adult patients with type 1 diabetes. The study was also designed to assess the safety of the product. Sixte...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/152091502760306544
更新日期:2002-01-01 00:00:00
abstract:BACKGROUND:The aim of this study was to elucidate the characteristics of accuracy of subcutaneous continuous glucose monitoring (SCGM) in the perioperative period for neurosurgical and cardiac surgery patients. METHODS:Forty-five subjects, including healthy volunteers (n = 15), neurosurgical patients (n = 15), and car...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2018.0140
更新日期:2018-10-01 00:00:00
abstract:BACKGROUND:Type 2 diabetes is an individual health challenge requiring ongoing self-management. Remote patient reporting of relevant health parameters and linked automated feedback via mobile telephone have potential to strengthen self-management and improve outcomes. This research involved development and evaluation o...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1089/dia.2013.0056
更新日期:2013-08-01 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:BACKGROUND:Improved insulin infusion set survival and faster insulin action are important issues for pump users and for the development of an artificial pancreas. The current recommendation is to change infusion sets every 3 days. Our objectives were to determine the effect of lipohypertrophy (LH) on infusion set survi...
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.2015.0432
更新日期:2016-07-01 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: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: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: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: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
abstract:BACKGROUND:Computer decision support systems are potentially effective methods for adjusting insulin, but current models do not take into account simultaneous changes of more than one agent. We describe the development of the Multiagent Intelligent Dosing System (MAIDS, Dimensional Dosing Systems, Wexford, PA) for pred...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2005.7.937
更新日期:2005-12-01 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:BACKGROUND:Narcolepsy is a severe sleep disorder that in most patients is characterized by the deficiency of central orexin. Clinically, narcolepsy is associated with obesity. Currently, there is a literature controversy about the potential alteration of leptin levels in narcoleptic patients. Theoretically, diminished ...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2006.0037
更新日期:2007-08-01 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: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:The management of hyperglycemia in the intensive care unit has been a controversial topic for more than a decade, with target ranges varying from 80-110 mg/dL to <200 mg/dL. Multiple insulin infusion protocols exist, including several computerized protocols, which have attempted to achieve these targets. Imp...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2016.0101
更新日期:2016-08-01 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:Computer simulation environments have been used in the development of many artificial pancreas systems. A glucose sensor model is an essential part of these environments, and different models have been proposed. However, not one of these models accounts for drop-outs of sensor readings, a well-known phenomen...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2014.0309
更新日期:2015-06-01 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::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::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: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