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(®) insulin delivery system (Tandem Diabetes Care(®) Inc., San Diego, CA) is also discussed. Following the development of the t:slim pump, a product evaluation study was conducted to assess users' perceptions of the t:slim pump under actual use conditions versus their current pump system. SUBJECTS AND METHODS:A 30-day, within-subjects study with a total of 74 participants was conducted at four different investigator sites across the United States. Study participants used the t:slim insulin pump in their normal environment for 30 days. Participants were given the Insulin Delivery System Rating Questionnaire during their first visit to assess their current insulin pump and then at the end of the study to measure their perceptions of the t:slim pump. A paired-samples t test was completed to analyze the data. RESULTS:The results indicated that 16 of the questionnaire variables showed statistically significant differences in scores. CONCLUSIONS:It was found that the utilization of a systematic human factors process resulted in an insulin pump that was proved to be safe and effective for human use and was cleared by the Food and Drug Administration for use in the United States. In addition, the results of the product evaluation study showed that, after use of the t:slim pump for 30 days, participants' perceptions of several variables improved.
journal_name
Diabetes Technol Therjournal_title
Diabetes technology & therapeuticsauthors
Schaeffer NEdoi
10.1089/dia.2013.0098subject
Has Abstractpub_date
2013-10-01 00:00:00pages
845-54issue
10eissn
1520-9156issn
1557-8593journal_volume
15pub_type
杂志文章,多中心研究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
abstract:: Background: Continuous subcutaneous insulin infusion (CSII) is associated with improved glycemic control, a reduced incidence of hypoglycemia, and improved quality of life (QOL). To date, however, there has been no QOL scale specific to CSII. The objective of this study wa...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2019.0216
更新日期:2020-03-01 00:00:00
abstract::Self-monitoring of blood glucose (SMBG) is universally considered to be an integral part of type 1 diabetes management and crucial for optimizing the safety and efficacy of complex insulin regimens. This extends to type 2 diabetes patients on intensive insulin therapy, and there is also a growing body of evidence sugg...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,评审
doi:10.1089/dia.2013.0302
更新日期:2014-07-01 00:00:00
abstract:BACKGROUND:Glucose variability has been identified as a predictor of hypoglycemia and has been associated with mortality in critically ill patients without diabetes. A popular metric to quantify glucose variability is the mean amplitude of glycemic excursions (MAGE). The "ruler and pencil" approach to calculate MAGE is...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2013.0138
更新日期:2014-02-01 00:00:00
abstract::This paper presents a critical review of continuous glucose monitoring studies that address accuracy, utility in assessing glucose variability, detection of hypoglycemia for improved metabolic control or reduced glucose variability, impact on quality of life, reduced fear of hypoglycemia, and applicability in helping ...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,评审
doi:10.1089/dia.2007.0261
更新日期:2008-04-01 00:00:00
abstract:BACKGROUND:The Optimizing Control in Diabetes (OPTIMIZE) survey was conducted to understand the patients' perspective to achieving good glycemic control and to determine how patients' perceptions of insulin may affect their decisions to initiate or intensify their insulin therapy. METHODS:A total of 1,444 subjects wit...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,多中心研究
doi:10.1089/dia.2008.0249
更新日期:2008-02-01 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: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::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: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::Continuous glucose monitoring (CGM) systems have been available for more than 15 years by now. However, market uptake is relatively low in most countries; in other words, relatively few patients with diabetes use CGM systems regularly. One major reason for the reluctance of patients to use CGM systems is the costs ass...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2015.0296
更新日期:2016-02-01 00:00:00
abstract:BACKGROUND:Diabetes in elderly adults is associated with an increased risk of fall. The aim of study was to determine whether a virtual reality exercise (VRE) program would improve balance, strength, gait, and falls efficacy in elderly adults with diabetes. SUBJECTS AND METHODS:Fifty-five subjects with diabetes mellit...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1089/dia.2013.0050
更新日期:2013-06-01 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:OBJECTIVE:To evaluate the safety of in-home use of the MiniMed™ 670G system with SmartGuard™ technology in children with type 1 diabetes (T1D). METHODS:Participants (N = 105, ages 7-13 years, mean age 10.8 ± 1.8 years) were enrolled at nine centers (eight in the United States and one in Israel) and completed a 2-week ...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2018.0264
更新日期:2019-01-01 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::There are three main issues in non-invasive (NI) glucose measurements: namely, specificity, compartmentalization of glucose values, and calibration. There has been progress in the use of near-infrared and mid-infrared spectroscopy. Recently new glucose measurement methods have been developed, exploiting the effect of ...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,评审
doi:10.1089/dia.2004.6.660
更新日期:2004-10-01 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: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:Obesity surgery elicits complex changes in glucose metabolism that are difficult to observe with discontinuous glucose measurements. We aimed to evaluate glucose variability after gastric bypass by continuous glucose monitoring (CGM) in a real-life setting. METHODS:CGM was performed for 4.2 ± 1.3 days in th...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2010.0203
更新日期:2011-06-01 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:BACKGROUND:Balance is sensed through peripheral and central receptors and mediated by central control through the brain and spinal cord. Although some evidence exists as to the areas of the brain involved and how processing of data occurs in young individuals, nothing has been published on people with diabetes. The pur...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/dia.2012.0152
更新日期:2012-11-01 00:00:00
abstract::Current clinical guidelines for diabetes care encourage self-monitoring of blood glucose (SMBG) to improve glycemic control. Specific protocols remain variable, however, particularly among non-insulin-using patients. This is due in part to efficacy studies that neglect to consider (1) the performance of monitoring equ...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,评审
doi:10.1089/dia.2008.0104
更新日期:2008-12-01 00:00:00
abstract::Recent years have brought about an explosion in the number of companies offering connected diabetes care products, defined as digital diabetes management systems based around (1) smartphone apps, (2) devices with built-in connectivity, and (3) remote human and automated coaching and support. These nascent models aim t...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,评审
doi:10.1089/dia.2019.0273
更新日期:2020-01-01 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
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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:BACKGROUND:Drugs with unspecific stimulating effects on beta-cell secretion increase the homeostasis model assessment (HOMA)-B score, indicating improved beta-cell "function." We investigated whether the beta-cell protection provided by adding pioglitazone (PIO) to glimepiride (GLIM) in comparison to up-titrating the G...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1089/dia.2010.0019
更新日期:2010-08-01 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: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::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:BACKGROUND:Glucose monitoring based on sampling skin interstitial fluid (ISF) is being developed as an alternative to fingerstick blood glucose monitoring. Time delays between rapidly changing levels of glucose in blood and interstitial fluid have been reported in the literature to be between 5 and 20 minutes. This stu...
journal_title:Diabetes technology & therapeutics
pub_type: 杂志文章
doi:10.1089/152091599317530
更新日期:1999-04-01 00:00:00