bluuebunny/crossref_metadata_2025_split huggingface dataset:
Self-Monitoring Technologies for Type 2 Diabetes and the Prevention of Cardiovascular Complications: Perspectives from End Users
Authors: Chudyk Anna , Shapiro Sheree , Russell-Minda Elizabeth , Petrella Robert 
Published: January 2014

Background: The objective of this study was to explore facilitators and barriers to the adoption of self-monitoring devices in individuals with type 2 diabetes mellitus (T2DM). Methods: Individuals with T2DM who were currently using one or more devices to monitor their disease participated in focus groups. Transcripts of focus group meetings were coded into themes by two reviewers using NVivo qualitative software. Results: Twenty-eight adults with T2DM reported using a blood glucose meter, and almost half reported monitoring their blood pressure. Few individuals consistently monitored other aspects of their cardiovascular health. Four major themes impacting device use/disuse were identified: Knowledge gaps, relationships with health care providers, environment, and personal experience. Knowledge barriers included lack of information regarding diabetes and the associated risk of complications. Perceptions of inconvenience, pain, and financial restrictions were important factors influencing the adoption, use, and abandonment of self-monitoring devices. Community-run programs, as well as dieticians and pharmacists, were identified as important resources for accessing information related to T2DM. Conclusions: We identified the need for development of accessible and relevant education material; improved communication of disease-specific information between patients and providers, as well as providers and community resources; and strategies to improve the convenience and cost of monitoring devices.
Prevalence and Clinical Profile of Metabolic Obesity and Phenotypic Obesity in Asian Indians
Authors: Geetha Loganathan , Deepa Mohan , Anjana Ranjit Mohan , Mohan Viswanathan 
Published: January 2014

Background: We estimated the prevalence of metabolically obese nonobese (MONO), metabolically obese obese (MOO), and metabolically healthy obese (MHO) individuals and correlated this with the prevalence of coronary artery disease (CAD) compared to metabolically healthy nonobese (MHNO) in urban South Indians. Method: Study subjects ( n = 2350) were recruited from the Chennai Urban Rural Epidemiology Study. Generalized obesity was defined as a body mass index (BMI) ≥25 kg/m2, based on the World Health Organization Asia Pacific guidelines. Metabolic syndrome (MS) was diagnosed based on the South Asian Modified-National Cholesterol Education Programme criteria. Coronary artery disease was defined by known myocardial infarction or Q waves on resting electrocardiogram. Results: Metabolically obese nonobese was defined as nonobese subjects (BMI < 25 kg/m2) with MS, MOO as obesity (BMI = 25 kg/m2) with MS, MHO as obese subjects (BMI = 25 kg/m2) with no MS, and MHNO as no obesity or MS. Metabolically obese nonobese was identified in 355 (15.1%), MOO in 348 (14.8%), MHO in 312 (13.3%), and MHNO in 1335 (56.8%) subjects. The prevalence of CAD among the MONO, MOO, MHO, and MHNO was 5.5%, 4.2%, 1.4%, and 2.6%. However, when age standardization was done, there was no statistically significant increase in the risk of CAD among MONO [odds ratio (OR) = 1.300, 95% confidence interval (CI) 0.706–2.394, p = .339], MOO (OR = 1.651, 95% CI 0.852–3.199, p = .137), and MHO (OR = 0.524, 95% CI 0.250–2.130, p = .564) groups compared to MHNO, perhaps due to small numbers. Conclusion: Metabolic obesity may have different clinical implications than phenotypic obesity.
Data Processing for Noninvasive Continuous Glucose Monitoring with a Multisensor Device
Authors: Mueller Martin , Talary Mark S. , Falco Lisa , De Feo Oscar , Stahel Werner A. , Caduff Andreas 
Published: January 2014

Background: Impedance spectroscopy has been shown to be a candidate for noninvasive continuous glucose monitoring in humans. However, in addition to glucose, other factors also have effects on impedance characteristics of the skin and underlying tissue. Method: Impedance spectra were summarized through a principal component analysis and relevant variables were identified with Akaike's information criterion. In order to model blood glucose, a linear least-squares model was used. A Monte Carlo simulation was applied to examine the effects of personalizing models. Results: The principal component analysis was able to identify two major effects in the impedance spectra: A blood glucose-related process and an equilibration process related to moisturization of the skin and underlying tissue. With a global linear least-squares model, a coefficient of determination ( R2) of 0.60 was achieved, whereas the personalized model reached an R2 of 0.71. The Monte Carlo simulation proved a significant advantage of personalized models over global models. Conclusion: A principal component analysis is useful for extracting glucose-related effects in the impedance spectra of human skin. A linear global model based on Solianis Multisensor data yields a good predictive power for blood glucose estimation. However, a personalized linear model still has greater predictive power.
Glycated Albumin Modulates Endothelial Cell Thrombogenic and Inflammatory Responses
Authors: Rubenstein David A. , Maria Zahra , Yin Wei 
Published: January 2014

Background: It has become established that a diabetic vasculature promotes cardiovascular disease progression via changes to endothelial cells, platelets, and the interactions of these cells. It is believed that the majority of these changes are induced by the presence of advanced glycation end products (AGEs), which permanently alter various functions. Studies have shown that platelets perpetuate endothelial cell responses under these conditions. However, the role of changes in endothelial cell thrombogenicity and inflammatory responses, after subjected to AGEs, has not been characterized. Our objective was to evaluate the effects of AGEs on these functions. Methods: To accomplish this, albumin was chemically modified by exposure to glucose for up to 8 weeks, and endothelial cells were subjected to glycated albumin for up to 5 days in a cell culture system. A time course for changes in endothelial cell viability, density, morphology, and metabolic activity were investigated, along with the surface expression of intercellular adhesion molecule-1, thrombomodulin, tissue factor, connexin-43, and caveolin-1. Results: Endothelial cells exposed to irreversibly glycated albumin were less viable, proliferated slower, and had a lower metabolic activity as compared to cells exposed to nonglycated albumin. Endothelial cells that were exposed to any glycated albumin were procoagulant and proinflammatory as compared with all other conditions. There were no overall trends in the expression of connexin-43 or caveolin-1. Conclusions: Our data suggest that the presence of irreversible glycated albumin is deleterious to endothelial cells, makes endothelial cells more procoagulant, and promotes inflammatory responses. It is therefore possible that endothelial cell activation may precede and promote platelet activation during diabetic conditions.
Effect of Diabetes Mellitus on Outcomes of Hyperglycemia in a Mixed Medical Surgical Intensive Care Unit
Authors: Schlussel Andrew T. , Holt Danielle B. , Crawley Eric A. , Lustik Michael B. , Wade Charles E. , Uyehara Catherine F. T. 
Published: January 2014

Background: Intensive insulin therapy and degree of glycemic control in critically ill patients remains controversial, particularly in patients with diabetes mellitus. We hypothesized that diabetic patients who achieved tight glucose control with continuous insulin therapy would have less morbidity and lower mortality than diabetic patients with uncontrolled blood glucose. Method: A retrospective chart review was performed on 395 intensive care unit (ICU) patients that included 235 diabetic patients. All patients received an intravenous insulin protocol targeted to a blood glucose (BG) level of 80–140mg/dl. Outcomes were compared between (a) nondiabetic and diabetic patients, (b) diabetic patients with controlled BG levels (80–140mg/dl) versus uncontrolled levels (>140 mg/dl), and (c) diabetic survivors and nonsurvivors. Results: Diabetic patients had a shorter ICU stay compared to nondiabetic patients (10 ± 0.7 vs 13 ± 1.1, p = .01). The mean BG of the diabetic patients was 25% higher on average in the uncontrolled group than in the controlled (166 ± 26 vs 130 ± 9.4 mg/dl, p < .01). There was no difference in ICU and hospital length of stay (LOS) between diabetic patients who were well controlled compared to those who were uncontrolled. Diabetic nonsurvivors had a significantly higher incidence of hypoglycemia (BG <60 mg/dl) compared to diabetic survivors. Conclusions: The results showed that a diagnosis of diabetes was not an independent predictor of mortality, and that diabetic patients who were uncontrolled did not have worse outcomes. Diabetic nonsurvivors were associated with a greater amount of hypoglycemic episodes, suggesting these patients may benefit from a more lenient blood glucose protocol.
Nanotechnology in Elevation of the Worldwide Impact of Obesity and Obesity-Related Diseases: Potential Roles in Human Health and Disease
Authors: Eldaw Abdellatif 
Published: January 2014

Current worldwide data show epidemics of obesity and type 2 diabetes with no real solutions apart from continuous calls to changing lifestyle and food habits. Despite health messages that are communicated by health authorities, the epidemic is growing. More people are affected with health consequences that are usually frightening as more resources are wasted, especially in areas where health care and resources are lacking. Nanotechnology applications in food industry present practical approaches that help produce more tasty food with little calories, functional foods, and nutritional supplements and alter the fats and sugar contents of our foods with potential for many more applications. Consequently, this opens more windows to better control of many nutritional deficiencies as well as obesity and type 2 diabetes, especially among children and young adults who are addicted to fast food. With such potential, food producers, policy makers, health authorities, food scientists, and governments need to collaborate and make all possible efforts to fund and support research in different areas of food produced using nanotechnology. So far, consumers are not prepared to accept food produced using nanotechnology, mainly because information on the safety of such products are not enough. This issue needs to be addressed and researched well using suitable risk assessment methodologies. Consumers need to be assured, and involved as well, to avoid the “refusal state” that still exists against many safe products such as genetically modified organisms and irradiated food. There is the possibility that consumers could perceive that they will bear the potential risks posed by nanotechnology applications while the benefits will accrue mainly to others, such as food processors or farmers.
Accuracy of the CONTOUR® Blood Glucose Monitoring System
Authors: Harrison Bern , Leazenby Cheryl , Halldorsdottir Solveig 
Published: January 2014

Objective: The aim of the study was to assess the accuracy of the CONTOUR® blood glucose monitoring system (BGMS) according to the International Organization for Standardization's International Standard 15197 (ISO 15197:2003) guidelines and to more stringent criteria. Method: Finger stick blood samples from 105 subjects with diabetes (25 with type 1, 77 with type 2, and 3 with type unknown) were tested using the CONTOUR BGMS and YSI glucose analyzer. Results: 99.3% of results were within ISO 15197:2003 criteria (±15 mg/dl of YSI results at glucose concentrations <75 mg/dl and ±20% at glucose concentrations ≥75 mg/dl). Additionally, 96.7% of results were accurate according to more stringent criteria (±15 mg/dl of YSI results for glucose concentrations <100 mg/dl and ±15% for glucose concentrations ≥100 mg/dl). Error grid analysis showed that 99.3% and 0.7% of results were within zones A and B, respectively. Conclusion: The CONTOUR BGMS exceeded both the minimum acceptable accuracy based on ISO 15197:2003 and the more stringent accuracy criteria.
Design and Fabrication of a High-Performance Electrochemical Glucose Sensor
Authors: Vaddiraju Santhisagar , Legassey Allen , Wang Yan , Qiang Liangliang , Burgess Diane J. , Jain Faquir , Papadimitrakopoulos Fotios 
Published: January 2014

Objective: Development of electrochemical sensors for continuous glucose monitoring is currently hindered by a variety of problems associated with low selectivity, low sensitivity, narrow linearities, delayed response times, hysteresis, biofouling, and tissue inflammation. We present an optimized sensor architecture based on layer stratification, which provides solutions that help address the aforementioned issues. Method: The working electrode of the electrochemical glucose sensors is sequentially coated with five layers containing: (1) electropolymerized polyphenol (PPh), (2) glutaraldehyde-immobilized glucose oxidase (GOx) enzyme, (3) dip-coated polyurethane (PU), (4) glutaraldehyde-immobilized catalase enzyme, and (5) a physically cross linked polyvinyl alcohol (PVA) hydrogel membrane. The response of these sensors to glucose and electroactive interference agents (i.e., acetaminophen) was investigated following application of the various layers. Sensor hysteresis (i.e., the difference in current for a particular glucose concentration during ascending and descending cycles after 200 s) was also investigated. Results: The inner PPh membrane improved sensor selectivity via elimination of electrochemical interferences, while the third PU layer afforded high linearity by decreasing the glucose-to-O2 ratio. The fourth catalase layer improved sensor response time and eliminated hysteresis through active withdrawal of GOx-generated H2O2 from the inner sensory compartments. The outer PVA hydrogel provided mechanical support and a continuous pathway for diffusion of various participating species while acting as a host matrix for drug-eluting microspheres. Conclusions: Optimal sensor performance has been achieved through a five-layer stratification, where each coating layer works complementarily with the others. The versatility of the sensor design together with the ease of fabrication renders it a powerful tool for continuous glucose monitoring.
Average Daily Risk Range as a Measure of Glycemic Risk is Associated with Mortality in the Intensive Care Unit: A Retrospective Study in a Burn Intensive Care Unit
Authors: Farhy Leon S. , Ortiz Edward A. , Kovatchev Boris P. , Mora Alejandra G. , Wolf Steven E. , Wade Charles E. 
Published: January 2014

Background: Although tight glycemic control has been associated with improved outcomes in the intensive care unit (ICU), glycemic variability may be the influential factor in mortality. The main goal of the study was to relate blood glucose (BG) variability of burn ICU patients to outcomes using a sensitive measure of glycemic variability, the average daily risk range (ADRR). Method: Data from patients admitted to a burn ICU were used. Patients were matched by total body surface area (TBSA) and injury severity score (ISS) to test whether increased BG variability measured by ADRR was associated with higher mortality risk and whether we could identify ADRR-based classifications associated with the degree of risk. Results: Four ADRR classifications were identified: Low risk, medium-low, medium-high, and high. Mortality progressively increased from 25% in the low-risk group to over 60% in the high-risk group ( p < .001). In a post hoc analysis, age also contributed to outcome. Younger (age < 43 years) survivors and nonsurvivors matched by TBSA and ISS had no significant difference in age, mean BG or standard deviation of BG; however, nonsurvivors had higher ADRR ( p < .01). Conclusions: Independent of injury severity, glycemic variability measured by the ADRR was significantly associated with mortality in the ICU. When age was considered, ADRR was the only measure of glycemia significantly associated with mortality in younger patients with burns.
Dose Accuracy of the ClikSTAR, NovoPen 4, and Luxura Insulin Pens: Results of Laboratory and Field Studies
Authors: Friedrichs Arnd , Basso Nils , Adler Steffen 
Published: January 2014

Background: A high dosing accuracy is needed to maintain normal glycemia in patients with diabetes. This study investigated the dose accuracy of the commonly used reusable insulin pens ClikSTAR®, NovoPen® 4, and Luxura®. Methods: Pens were tested in a laboratory setting by one trained technician who delivered four doses of 30 U from each of 15 pens per pen model (a total of 60 doses from each pen model). Pens were also tested in a simulated clinical setting by 48 people with diabetes. Each participant delivered 27 doses: Three doses of 30 U from each of three pens per pen model. Overall, the technician delivered 180 doses and the participants 1296 doses. Results: All pens met the tolerance limits defined by the German edition of the International Standardization Organization (ISO) 11608-1: 2000 standard [30 ± 1.5 U (28.5–31.5 U)]. All doses were delivered within the limits proposed by the ISO, except for two doses with Luxura in the clinical setting. In laboratory testing, the mean dose delivered by ClikSTAR (29.69 U) or Luxura (29.89 U) was less than the expected 30 U and significantly less than the mean dose delivered by NovoPen 4 (30.04 U; p < .001 for both comparisons). Similar results were observed in the simulated clinical setting. NovoPen 4 had the greatest variance in laboratory testing but the least in the simulated clinical setting. Conclusions: This study demonstrates comparable dose accuracy and variability of the ClikSTAR, Luxura, and NovoPen 4 insulin pens. The slight differences in mean doses between pens are unlikely to be clinically significant.
FlexTouch: A Prefilled Insulin Pen with a Novel Injection Mechanism with Consistent High Accuracy at Low- (1 U), Medium- (40 U), and High- (80 U) Dose Settings
Authors: Wielandt Jakob Oest , Niemeyer Marcus , Hansen Marianne Rye , Bucher Ditlef , Thomsen Niels Bjerrum 
Published: January 2014

Background: FlexTouch® is the only prefilled insulin pen that utilizes an easy touch button that does not extend at any dose in place of a push-button extension. Rigorous testing has shown that the new FlexTouch pen accurately and consistently delivers insulin doses. Methods: This study assessed dose accuracy of FlexTouch, KwikPen®, and SoloSTAR®. Dose accuracy for minimum, medium, and maximum doses of each pen type (1, 40, and 80 U for FlexTouch and SoloSTAR and 1, 30, and 60 U for KwikPen) was assessed. Results: FlexTouch delivered all doses consistently, as demonstrated by low standard deviations. FlexTouch showed similar accuracy to KwikPen at 1 U and to SoloSTAR at 40 and 80 U. However, FlexTouch was significantly more accurate at delivering 1 U of insulin than SoloSTAR ( p < .0001). Conclusions: This study demonstrates that FlexTouch, a new prefilled pen, delivers insulin accurately and consistently at low, medium, and high doses. In addition, FlexTouch is currently the only prefilled pen that has a push button that does not extend at any dose, making FlexTouch easier to use than other pens.
A Randomized, Open-Label, Comparative Crossover Handling Trial between Two Durable Pens in Patients with Type 1 or 2 Diabetes Mellitus
Authors: Sommavilla Bärbel , Pietranera Giacomo 
Published: January 2014

Background: This open-label, randomized, comparative crossover usability study investigated preference between durable insulin pens, NovoPen® 4 and NovoPen 3, among patients with types 1 and 2 diabetes. Methods: In a timed test, 82 current NovoPen 3 users (mean age, 48.5 years) assessed intuitiveness of NovoPen 4. After timed training, this group and 34 insulin-naïve patients (mean age, 61.8 years) were randomized to a handling evaluation of NovoPen 4 followed by NovoPen 3, or vice versa, in which participants made three injections into a foam cushion. A device-specific questionnaire was filled out for each pen. A third questionnaire asked participants to compare pens. Results: Current NovoPen 3 users completed the intuitive assessment of NovoPen 4 in an average time of 1.94 min (range, 0.57–4.98 min). The training of insulin-naïve patients occurred in slightly less time with NovoPen 4 than with NovoPen 3 but did not reach significance (9.9 versus 11.5 min; p = .32). Survey responses showed that both groups had less difficulty and were more confident in handling NovoPen 4 than NovoPen 3; 96.3% of the NovoPen 3 users and 100% of the insulin-naïve group preferred to use NovoPen 4 ( p < .0001). Conclusion: Patients currently using NovoPen 3 or who were insulin naïve expressed a preference for NovoPen 4 in this study, reporting it to be simpler to learn and easier to use than NovoPen 3. NovoPen 4 may help facilitate insulin therapy among newly diagnosed patients and potentially improve adherence and treatment satisfaction among current NovoPen 3 users.
A Pan-European and Canadian Prospective Survey to Evaluate Patient Satisfaction with the SoloSTAR Insulin Injection Device in Type 1 and Type 2 Diabetes
Authors: Hancu Nicolae , Czupryniak Leszek , Genestin Elisabeth , Sourij Harald 
Published: January 2014

Objective: This study evaluated patient satisfaction with SoloSTAR® (sanofi-aventis), a prefilled insulin pen device for injection of insulin glargine or insulin glulisine. Methods: This was a 6–8-week multicenter ( n = 652), observational, prospective Pan-European and Canadian registry study in patients with diabetes mellitus ( n = 6542) who recently switched to or started treatment with insulin glargine and/or insulin glulisine using SoloSTAR or were insulin naïve. At the baseline visit, patients were asked to evaluate their satisfaction with their previous device, if applicable. After 6–8 weeks of SoloSTAR use, patients were asked to rate their satisfaction. Results: Overall, 6481 patients (mean age 54 years, 48.7% male, 72% type 2 diabetes) were analyzed in this study. Of these, 4995 (77.1%) patients had used insulin before the study and 1641 (32.9%) and 3395 (68.0%) patients had previously used prefilled and/or reusable pens, respectively. During the study, SoloSTAR was used to administer insulin glargine and/or insulin glulisine by 97.3% and 36.0% of patients, respectively (both: 27.0%). Most patients rated SoloSTAR as “excellent/good” for ease of use (97.9%), learning to use (98.3%), selecting the dose (97.6%), and reading the dose (95.1%). Most patients rated ease of use (88.4%) and injecting a dose (84.5%) with SoloSTAR as “much easier/easier” versus their previous pen. Overall, 98% planned to continue using SoloSTAR. No safety concerns were reported. Conclusion: This European and Canadian survey shows that SoloSTAR was well accepted in this large patient population. Most patients preferred SoloSTAR to their previous pen and planned to continue SoloSTAR use.