bluuebunny/crossref_metadata_2025_split huggingface dataset:
An Analysis of the Usability of Inpatient Insulin Ordering in Three Computerized Provider Order Entry Systems
Authors: Neinstein Aaron , Cucina Russ 
Published: January 2014

Background: Insulin is a highly scrutinized drug in hospitals since it is both frequently used and high risk. As the insulin ordering process makes a transition from pen and paper to computerized provider order entry (CPOE) systems, the effective design of these systems becomes critical. There are fundamental usability principles in the field of human-computer interaction design, which help make interfaces that are effective, efficient, and satisfying. To our knowledge, there has not been a study that specifically looks at how these principles have been applied in the design of insulin orders in a CPOE system. Method: We analyzed the usability of inpatient insulin ordering in three widely deployed CPOE systems—two commercially marketed systems and the U.S. Department of Veterans Affairs VistA Computerized Patient Record System. We performed a usability analysis using aspects of three different methods. Our first goal was to note each instance where a usability principle was either upheld or not upheld. Our second goal was to discover ways in which CPOE designers could exploit usability principles to make insulin ordering safer and more intuitive in the future. Results: Commonly encountered usability principles included constraints, obviousness/self-evidence, natural mapping, feedback, and affordance. The three systems varied in their adherence to these principles, and each system had varying strengths and weaknesses. Conclusion: Adherence to usability principles is important when building a CPOE system, yet designers observe them to varying degrees. A well-designed CPOE interface allows a clinician to focus more of his or her mental energy on clinical decisions rather than on deciphering the system itself. In the future, intelligent design of CPOE insulin orders can be used to help optimize and modernize management of hyperglycemia in the hospital.
Hypoglycemia in Critically Ill Children
Authors: Faustino E. Vincent S. , Hirshberg Eliotte L. , Bogue Clifford W. 
Published: January 2014

Background: The practice of glycemic control with intravenous insulin in critically ill patients has brought clinical focus on understanding the effects of hypoglycemia, especially in children. Very little is published on the impact of hypoglycemia in this population. We aimed to review the existing literature on hypoglycemia in critically ill neonates and children. Methods: We performed a systematic review of the literature up to August 2011 using PubMed, Ovid MEDLINE and ISI Web of Science using the search terms “hypoglycemia or hypoglyc*” and “critical care or intensive care or critical illness”. Articles were limited to “all child (0–18 years old)” and “English”. Results: A total of 513 articles were identified and 132 were included for review. Hypoglycemia is a significant concern among pediatric and neonatal intensivists. Its Definition is complicated by the use of a biochemical measure (i.e., blood glucose) for a pathophysiologic problem (i.e., neuroglycopenia). Based on associated outcomes, we suggest defining hypoglycemia as <40–45 mg/dl in neonates and <60–65 mg/dl in children. Below the suggested threshold values, hypoglycemia is associated with worse neurological outcomes, increased intensive care unit stay, and increased mortality. Disruptions in carbohydrate metabolism increase the risk of hypoglycemia in critically ill children. Prevention of hypoglycemia, especially in the setting of intravenous insulin use, will be best accomplished by the combination of accurate measuring techniques, frequent or continuous glucose monitoring, and computerized insulin titration protocols. Conclusion: Studies on hypoglycemia in critically ill children have focused on spontaneous hypoglycemia. With the current practice of maintaining blood glucose within a narrow range with intravenous insulin, the risk factors and outcomes associated with insulin-induced hypoglycemia should be rigorously studied to prevent hypoglycemia and potentially improve outcomes of critically ill children.
Population-Based Study of Severe Hypoglycemia Requiring Emergency Medical Service Assistance Reveals Unique Findings
Authors: Parsaik Ajay K. , Carter Rickey E. , Pattan Vishwanath , Myers Lucas A. , Kumar Hamit , Smith Steven A. , Russi Christopher S. , Levine James A. , Basu Ananda , Kudva Yogish C. 
Published: January 2014

Objective: The objective is to report a contemporary population-based estimate of hypoglycemia requiring emergency medical services (EMS), its burden on medical resources, and its associated mortality in patients with or without diabetes mellitus (DM, non-DM), which will enable development of prospective strategies that will capture hypoglycemia promptly and provide an integrated approach for prevention of such episodes. Methods: We retrieved all ambulance calls activated for hypoglycemia in Olmsted County, Minnesota, between January 1, 2003 and December 31, 2009. Results: A total of 1473 calls were made by 914 people (DM 8%, non-DM 16%, unknown DM status 3%). Mean age was 60 ± 16 years with 49% being female. A higher percentage of calls were made by DM patients (87%) with proportionally fewer calls coming from non-DM patients (11%) (chi-square test, p < .001), and the remaining 2% calls by people with unknown DM status. Emergency room transportation and hospitalization were significantly higher in non-DM patients compared to DM patients ( p < .001) and type 2 diabetes mellitus compared to type 1 diabetes mellitus ( p < .001). Sulphonylureas alone or in combination with insulin varied during the study period ( p = .01). The change in incidence of EMS for hypoglycemia was tracked during this period. However, causality has not been established. Death occurred in 240 people, 1.2 (interquartile range 0.2–2.7) years after their first event. After adjusting for age, mortality was higher in non-DM patients compared with DM patients ( p < .001) but was not different between the two types of DM. Conclusions: The population burden of EMS requiring hypoglycemia is high in both DM and non-DM patients, and imposes significant burden on medical resources. It is associated with long-term mortality.
Pilot Study for the Evaluation of Morphological and Functional Changes in Retinal Blood Flow in Patients with Insulin Resistance and/or Type 2 Diabetes Mellitus
Authors: Forst Thomas , Weber Matthias M. , Mitry Michael , Schöndorf Thomas , Forst Senait , Tanis Mukadar , Pfützner Andreas , Michelson Georg 
Published: January 2014

Background: The aim of this study was to investigate early morphological and functional pathology in the retinal micro-circulation in patients with insulin resistance and/or type 2 diabetes mellitus (T2DM). Methods: Fifty-four subjects, without features of retinopathy under ophthalmological investigation, were recruited for study participation and were classifed into three study groups according to their metabolic staging: (1) Group C comprised nondiabetic, insulin-sensitive subjects with a BMI <28kg/m2; (2) Group IR comprised nondiabetic, insulin-resistant, obese subjects with a BMI ≥28 kg/m2; and (3) Group DM comprised patients with manifested T2DM. Retinal microvascular blood flow was assessed using scanning laser doppler flowmetry (Heidelberg Retina Flowmeter) before and after flicker light stimulation (10 Hz; Photo Stimulater 750). Results: No significant difference was observed in retinal blood flow (RBF) among the three groups, neither at baseline nor after stimulating the retina with flicker light. The arterial wall-to-lumen ratio (WLR) tended to be smaller in Group DM compared with Group C, and was significantly lower when comparing Group IR with Group C. When the subjects were grouped according to their insulin resistance, a steady decline in RBF and WLR could be observed with increasing insulin resistance. Conclusions: In conclusion, laser scanner flowmetry of the retina was found to detect very early changes in microvascular blood flow. Development of insulin resistance seems to be an important component in the deterioration of RBF.
Prediction and Prevention of Treatment-Related Inpatient Hypoglycemia
Authors: Elliott Michael B. , Schafers Stephen J. , McGill Janet B. , Tobin Garry S. 
Published: January 2014

Background: Prolonged severe hypoglycemia (SH) in hospitalized patients is associated with increased morbidity and mortality. This study was undertaken to identify risk factors for SH, to apply that knowledge to the development of a prediction algorithm, and to institute a prevention program at a tertiary medical center. Methods: We analyzed SH events for 172 patients and developed computer algorithms to predict SH that were tested on a population of 3028 inpatients who were found to have blood glucose (BG) <90 mg/dl during their hospital stay. Variables with significant bivariate associations were entered into partition analyses to identify interactions. Logistic regression was performed by calculating parameters related to the odds of hypoglycemia below each cut point. Sensitivity and specificity were determined at various cut points. The cut points resulting in 50% sensitivity for each hypoglycemia level were determined. These algorithms were tested against the initial 172 adjudicated patients. Results: Variables related to the BG <40 mg/dl cut off point were basal and adjustment scale insulin doses, weight, and creatinine clearance, while variables related to the 60 mg/dl and 70 mg/dl cut points were basal, prandial, and adjustment scale insulin doses, weight, creatinine clearance, and sulfonylurea use. The 50% sensitivity cut point developed using the <70 mg/dl algorithm correctly identified 71% of the adjudicated cases, while the <60 mg/dl and <40 mg/dl algorithms identified 70% and 55% respectively. Conclusions: A validated prediction algorithm for SH can aid in the identification of patients at risk for SH and may be useful in the development of prevention strategies.
A Human Pilot Study of the Fluorescence Affinity Sensor for Continuous Glucose Monitoring in Diabetes
Authors: Dutt-Ballerstadt Ralph , Evans Colton , Pillai Arun P. , Orzeck Eric , Drabek Rafal , Gowda Ashok , McNichols Roger 
Published: January 2014

Objective: We report results of a pilot clinical study of a subcutaneous fluorescence affinity sensor (FAS) for continuous glucose monitoring conducted in people with type 1 and type 2 diabetes. The device was assessed based on performance, safety, and comfort level under acute conditions (4 h). Research Design and Methods: A second-generation FAS (BioTex Inc., Houston, TX) was subcutaneously implanted in the abdomens of 12 people with diabetes, and its acute performance to excursions in blood glucose was monitored over 4 h. After 30–60 min the subjects, who all had fasting blood glucose levels of less than 200 mg/dl, received a glucose bolus of 75 g/liter dextrose by oral administration. Capillary blood glucose samples were obtained from the finger tip. The FAS data were retrospectively evaluated by linear least squares regression analysis and by the Clarke error grid method. Comfort levels during insertion, operation, and sensor removal were scored by the subjects using an analog pain scale. Results: After retrospective calibration of 17 sensors implanted in 12 subjects, error grid analysis showed 97% of the paired values in zones A and B and 1.5% in zones C and D, respectively. The mean absolute relative error between sensor signal and capillary blood glucose was 13% [±15% standard deviation (SD), 100–350 mg/dl] with an average correlation coefficient of 0.84 (±0.24 SD). The actual average “warm-up” time for the FAS readings, at which highest correlation with glucose readings was determined, was 65 (±32 SD) min. Mean time lag was 4 (±5 SD) min during the initial operational hours. Pain levels during insertion and operation were modest. Conclusions: The in vivo performance of the FAS demonstrates feasibility of the fluorescence affinity technology to determine blood glucose excursions accurately and safely under acute dynamic conditions in humans with type 1 and type 2 diabetes. Specific engineering challenges to sensor and instrumentation robustness remain. Further studies will be required to validate its promising performance over longer implantation duration (5–7 days) in people with diabetes.
Accuracy and Precision of the Axis-Shield Afinion Hemoglobin A1c Measurement Device
Authors: Wood Jamie R. , Kaminski Brett M. , Kollman Craig , Beck Roy W. , Hall Callyn A. , Yun Jason P. , Cengiz Eda , Haller Michael J. , Hassan Krishna , Klingensmith Georgeanna J. , Tamborlane William V. 
Published: January 2014

Background: The Afinion HbA1c (Axis-Shield) is a newer point-of-care device for measurement of hemoglobin A1c (A1C) using a boronate affinity method unlike the more commonly used DCA immunoassay method (Siemens Medical Solutions Diagnostics). The Afinion's accuracy and precision, when compared with high-performance liquid chromatography (HPLC) and DCA methods, have not been established in pediatric practice settings. Methods: Capillary blood was collected from 700 subjects with diabetes mellitus at seven Pediatric Diabetes Consortium sites. Each subject's A1C was measured locally using Afinion and DCA devices, and by a central laboratory (University of Minnesota) using a Tosoh HPLC method. In addition, repeated measurements on six whole blood samples provided by the National Glycohemoglobin Standardization Program (NGSP) were taken at three clinical centers using the Afinion and DCA methods and centrally using the Tosoh HPLC method to assess the precision of each device. Results: The coefficient of variation for measurements of whole blood samples for precision analysis was 2% for Afinion, 3% for DCA, and 1% for HPLC. In the patient samples measured at the seven clinic sites, the Afinion generated higher A1C results than the HPLC (mean difference = +0.15; p < 0.001), while the DCA produced lower values (mean difference = −0.19; p < 0.001). The absolute differences with HPLC were similar for the Afinion and DCA (median 0.2%) with a slight advantage for the Afinion when compared with DCA ( p < 0.001 by rank test). The DCA tended to read lower than HPLC, particularly at high A1C levels ( p < 0.001), while the Afinion's accuracy did not vary by A1C. Conclusions: When compared to the central laboratory HPLC method, the differences between the results of the Afinion and DCA devices are clinically insignificant, and the Afinion and DCA have similar accuracy and precision when used in pediatric practice settings.
Tighter Accuracy Standards within Point-of-Care Blood Glucose Monitoring: How Six Commonly Used Systems Compare
Authors: Robinson Charlotte S. , Sharp Patrick 
Published: January 2014

Introduction: Blood glucose monitoring systems (BGMS) are used in the hospital environment to manage blood glucose levels in patients at the bedside. The International Organization for Standardization (ISO) 15197:2003 standard is currently used by regulatory bodies as a minimum requirement for the performance of BGMS, specific to self-testing. There are calls for the tightening of accuracy requirements and implementation of a standard specifically for point-of-care (POC) BGMS. Methods: The accuracy of six commonly used BGMS was assessed in a clinical setting, with 108 patients' finger stick capillary samples. Using the accuracy criteria from the existing standard and a range of tightened accuracy criteria, system performance was compared. Other contributors to system performance have been measured, including hematocrit sensitivity and meter error rates encountered in the clinical setting. Results and Discussion: Five of the six BGMS evaluated met current accuracy criteria within the ISO 15197 standard. Only the Optium Xceed system had >95% of all readings within a tightened criteria of ±12.5% from the reference at glucose levels ≥72 mg/dl (4 mmol/liter) and ±9 mg/dl (0.5 mmol/liter) at glucose levels <72 mg/dl (4 mmol/liter). The Nova StatStrip Xpress had the greatest number of error messages observed; Optium Xceed the least. OneTouch Ultra2, Nova StatStrip Xpress, Accu-Chek Performa, and Contour TS products were all significantly influenced by blood hematocrit levels. Conclusions: From evidence obtained during this clinical evaluation, the Optium Xceed system is most likely to meet future anticipated accuracy standards for POC BGMS. In this clinical study, the results demonstrated the Optium Xceed product to have the highest level of accuracy, to have the lowest occurrence of error messages, and to be least influenced by blood hematocrit levels.
Safety and Efficacy of Mild Compression (18–25 mm Hg) Therapy in Patients with Diabetes and Lower Extremity Edema
Authors: Wu Stephanie C. , Crews Ryan T. , Najafi Bijan , Slone-Rivera Nancy , Minder Jessica L. , Andersen Charles A. 
Published: January 2014

Background: Patients with diabetes often present with lower extremity (LE) edema; however, because of concomitant peripheral arterial disease, compression therapy is generally avoided by providers in fear of compromising arterial circulation. This pilot study sought to assess whether diabetic socks with mild compression (18–25 mm Hg) can reduce LE edema in patients with diabetes without negatively impacting vascularity. Methods: Eighteen subjects (9 males, 9 females) aged 61 ± 11 years with diabetes, LE edema, and a mean ankle-brachial index (ABI) of 1.10 ± 0.21 successfully completed this uncontrolled study. At baseline, subjects were fitted and instructed to wear the socks during all waking hours. Follow-up visits occurred weekly for four consecutive weeks. Edema was quantified through midfoot, ankle, and calf circumferences and cutaneous fluid measurements. Vascular status was tracked via ABI. Results: Repeated measures analysis of variance and least significant difference post hoc analyses were used for data analyses. Calf circumferences showed a statistically significant ( p < .05) decrease of 1.3 ± 0.28 cm after just one week and remained significantly smaller than baseline throughout the study. Foot circumferences were significantly reduced at week 2 (-0.98 ± 0.35 cm) and remained significantly below baseline for the remainder of the study. The ankle also demonstrated a trend of circumference reduction but was not statistically significant. Cutaneous edema significantly reduced by week 3 (-3.1 ± 1.3 U) and remained so at week 4. Ankle-brachial index significantly increased (0.14 ± 0.049) at week 2 but was not significantly higher at weeks 3 or 4. No adverse events occurred during the study. Conclusions: Mild compression therapy (18–25 mm Hg) decreased swelling in diabetes patients with LE edema without compromising vascularity.
Usage and Perceptions of Pen Injectors for Diabetes Management: A Survey of Type 2 Diabetes Patients in the United States
Authors: Toscano Deborah , Brice Jennifer , Alfaro Christina 
Published: January 2014

Background: This study was conducted to investigate type 2 diabetes mellitus (T2DM) patient perceptions of their pen injectors and determine which features were deemed most important to overall satisfaction. Methods: Frost & Sullivan conducted a Web-based survey of T2DM patients in the United States in November 2010. Survey participants were initially screened prior to full participation. A total of 1002 adult T2DM patients who were using a pen injector on a regular basis to administer their diabetes medication(s) were surveyed. The survey consisted of 24 questions focused on awareness and current usage of pen injectors by type and brand, specific features of pen injectors, and patients' preferences for and satisfaction with pen injectors. Results: The majority of surveyed patients were using prefilled pen injectors as compared with durable pens. The LANTUS SoloSTAR (sanofi-aventis) was reported to be the most commonly used pen. The LANTUS SoloSTAR was also ranked highly for overall satisfaction and likelihood of continued usage. Regardless of brand, most surveyed patients reported that they were likely to continue using their current pen. In general, the single most important feature for user satisfaction was an easy push-button injection. Conclusions: Ease of self-administration is of highest priority to users of pen injectors. Important features facilitating ease of use, such as an easily depressed push-button injection, are likely to minimize the burden on T2DM patients, thereby improving compliance and clinical outcomes.
Pharmacokinetics and Postprandial Glycemic Excursions following Insulin Lispro Delivered by Intradermal Microneedle or Subcutaneous Infusion
Authors: McVey Elaine , Hirsch Laurence , Sutter Diane E. , Kapitza Christoph , Dellweg Sibylle , Clair Janina , Rebrin Kerstin , Judge Kevin , Pettis Ronald J. 
Published: January 2014

Background: Intradermal (ID) delivery has been shown to accelerate insulin pharmacokinetics (PK). We compared the PK and pharmacodynamic (PD) effects of insulin lispro administered before two daily standardized solid mixed meals (breakfast and lunch), using microneedle-based ID or traditional subcutaneous (SC) delivery. Method: The study included 22 subjects with type 1 diabetes in an eight-arm full crossover block design. One arm established each subject's optimal meal dose. In six additional arms, the optimal, higher, and lower doses (+30%, −30%) were each given ID and SC delivery, in random order. The final arm assessed earlier timing for the ID optimal dose (−12 versus −2 min). The PK/PD data were collected for 6 h following meals. Intravenous basal regular insulin was given throughout, and premeal blood glucose (BG) adjusted to 115 mg/dl. Results: The primary end point, postprandial time in range (70–180 mg/dl), showed no route-based differences with a high level of overall BG control for both SC and ID delivery. Secondary insulin PK end points showed more rapid ID availability versus SC across doses and meals (ΔTmax −16 min, ΔT50rising −7 min, ΔT50falling −30 min, all p < .05). Both intrasubject and intersubject variability for ID Tmax were significantly lower. Intradermal delivery showed modest, statistically significant secondary PD differences across doses and meals, generally within 90–120 min postprandially (Δ12 mg/dl BG at 90 min, Δ7 mg/dl BGmax, Δ7 mg/dl mean BG 0–2 h, all p < .05). Conclusions: This study indicates that ID insulin delivery is superior to SC delivery in speed of systemic availability and PK consistency and may improve postprandial glucose control.