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 type 1 or type 2 diabetes, 21-78 years old. After face-to-face training (Part 1) or self-training (Part 2), subjects performed three dose-delivery repetitions into an injection pad using separate pens; pens were weighed before and after each dose delivery. The primary outcome was the proportion of subjects delivering successful doses (target dose, 40 units) with all three repetitions. Secondary outcomes included pen accuracy and precision. RESULTS:Validation population included 50 (Part 1) and 54 (Part 2) subjects. In Part 1, 100% of the subjects delivered a successful dose on all three repetitions. In Part 2, 98% of subjects delivered a successful dose on all three repetitions, with five cases of dose-delivery failures reported in the study population. The mean dose delivered was 40.2 units (95% confidence interval [CI], 40.1-40.3 units) in Part 1 and 38.0 units (95% CI, 36.7-39.3 units) in Part 2; 99% and 88% of dose repetitions in Parts 1 and 2, respectively, were within 38-42 units. The safety test was successfully performed by 80% (95% CI, 70.2-88.0%) of subjects in Part 1 and 68% (95% CI, 58.1-77.6%) in Part 2. CONCLUSIONS:This study successfully validated the SoloSTAR pen for use by subjects with or without face-to-face training. SoloSTAR was shown to be easy to use, accurate, and precise.
journal_name
Diabetes Technol Therjournal_title
Diabetes technology & therapeuticsauthors
Schwartz S,Vlajnic Adoi
10.1089/dia.2008.0079subject
Has Abstractpub_date
2008-10-01 00:00:00pages
351-7issue
5eissn
1520-9156issn
1557-8593journal_volume
10pub_type
临床试验,杂志文章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:A brief history of the field of human factors research is covered, along with how this discipline is leveraged within medical device companies, to eliminate design flaws in products, in order to make them safe and effective for human use. The way in which human factors research was used to develop the t:slim...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,多中心研究
doi:10.1089/dia.2013.0098
更新日期:2013-10-01 00:00:00
abstract:: Background: This observational study investigated whether the connected NovoPen® 6 could influence insulin regimen management and glycemic control in people with type 1 diabetes (T1D) using a basal-bolus insulin regimen and continuous glucose monitoring in a real-world set...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2019.0411
更新日期:2020-10-01 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:Faster aspart is insulin aspart (IAsp) in a new formulation, which in continuous subcutaneous insulin infusion (CSII) in subjects with type 1 diabetes has shown a faster onset and offset of glucose-lowering effect than IAsp. METHODS:This double-blind, randomized, crossover active-controlled trial compared 2...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1089/dia.2016.0350
更新日期:2017-01-01 00:00:00
abstract::It is becoming increasingly acknowledged that people with Type 2 Diabetes represent what can be termed "an enriched population": a group that has the greatest risk of morbidity and mortality from cardiovascular diseases such as myocardial infarcts and strokes. Due to the tremendous toll, both human and financial, that...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,评审
doi:10.1089/15209150050025258
更新日期:2000-07-01 00:00:00
abstract::Insulin infusion pump therapy has dramatically improved over the past 20 years and can now address some of the specific challenges related to toddlers with diabetes. We discuss both the non-randomized and randomized controlled trials comparing continuous subcutaneous insulin infusion (CSII) and multiple daily injectio...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2009.0182
更新日期:2010-06-01 00:00:00
abstract:BACKGROUND:Patients undergoing intensive insulin therapy may have blood glucose (BG) samples drawn from arterial, capillary, or venous sources. This study compared capillary and venous BG across a range of glucose concentrations and under conditions of rapid change in BG. METHODS:Following a 10-h fast, 40 adult patien...
journal_title:Diabetes technology & therapeutics
pub_type: 临床试验,杂志文章
doi:10.1089/dia.2009.0023
更新日期:2009-10-01 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: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: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 Glycated hemoglobin A1c (HbA1c) is a key biomarker in the glycemic management of individuals with diabetes but the relationship with glucose levels can be variable. A recent kinetic model has described a calculated HbA1c (cHbA1c) that is individual-specific. Our aim was to validate the routine clinical use ...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2020.0553
更新日期:2021-01-04 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:Various insulin delivery systems have been considered for systemic absorption other than injections. Although the ocular route has been suggested, its use is limited by the amount of insulin absorbed systemically via eyes. In order to improve the absorption rate of insulin into systemic circulations, the eff...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2005.7.695
更新日期:2005-10-01 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
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: The prevalence of diabetes in youth is increasing worldwide in parallel with the obesity epidemic. This study aimed to determine the incidence rates of dysglycemia (diabetes or prediabetes) and evaluate the predictors of its progression or regression to normal ...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2020.0109
更新日期:2020-12-01 00:00:00
abstract::Patients with diabetes play with a double-edged sword when it comes to deciding glucose and A1c target levels. On the one side, tight control has been shown to be crucial in avoiding long-term complications; on the other, tighter control leads to an increased risk of iatrogenic hypoglycemia, which is compounded when h...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2005.7.3
更新日期:2005-02-01 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:OBJECTIVE:The purpose of the present study was to determine the effectiveness of a fluorescent contact lens glucose sensor in monitoring glucose in patients with diabetes. METHODS:Under an institutional review board-approved protocol, five fasting patients with type II diabetes were given a challenge consisting of 75 ...
journal_title:Diabetes technology & therapeutics
pub_type: 临床试验,杂志文章
doi:10.1089/dia.2004.6.782
更新日期:2004-12-01 00:00:00
abstract:OBJECTIVES:We evaluated patterns of meal intake, insulin bolus delivery, and fingerstick glucose measurements during hybrid closed-loop and sensor-augmented pump (SAP) therapy, including associations with glucose control. METHODS:Data were retrospectively analyzed from pump-treated adults with type 1 diabetes who unde...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1089/dia.2016.0307
更新日期:2017-07-01 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: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: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::Rates of diabetes are increasing worldwide and there is not a sufficient clinical workforce to care for these patients. Diabetes-related apps are a feasible way to provide diabetes education to large numbers of people with diabetes but attrition rates are high. Apps enhanced by virtual coaching may be a way to circumn...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,评审
doi:10.1089/dia.2019.0016
更新日期:2019-06-01 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::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: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: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::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