bluuebunny/crossref_metadata_2025 huggingface dataset:
Stabilization of Proximal Interphalangeal Joint in Lesser Toe Deformities With an Angulated Intramedullary Implant
Authors: Coillard Jean-Yves , Petri Gianfranco John , van Damme Geert , Deprez Patrick , Laffenêtre Olivier
Published: January 2014

Background:

Hammertoe and claw toe are among the most common foot deformities. Proximal interphalangeal (PIP) joint realignment can be performed using specifically designed intramedullary implants. The aim of this study was to assess the clinical outcome of patients with lesser toes deformities undergoing PIP joint realignment using an intramedullary implant.

Methods:

Patients requiring PIP joint realignment were included in this prospective multicenter observational study and followed for 12 months. A total of 156 toes, in 117 patients were implanted with the implants. Complications and radiological and functional outcome were assessed.

Results:

The proportion of joints fused on X-rays was 83.8% (95% CI: 77.8, 89.7) after 1 year. American Orthopaedic Foot and Ankle Society lesser metatarsophalangeal-interphalangeal scale (AOFAS-LMIS) improved from 40.4 (SD = 18.3) preoperatively to 85.5 (SD = 9.2) after 1 year. The proportion of patients with pain was 15.5% after 6 weeks and decreased to 4.7% after 1 year. Of the patients, 98% were satisfied about the operation. In patients with incomplete fusion of the PIP joint after 1 year, AOFAS-LMIS improved from 36.7 (SD = 18.9) preoperatively to 84.2 (SD = 10.1) 1 year postoperatively, while pain was reported by 2 patients (8.3%) after 1 year. Toe malalignment and lack of toe pulp-contact were reported slightly more frequently than for the whole group of patients, but not for the majority of the cases. Overall, complications were reported intraoperatively in 1.3% of the patients (2 cases) and postoperatively in 3.2% (5 cases). Revision was required in 1 case. Mallet toe deformity was found in 2.0% of the patients after 1 year.

Conclusion:

This study showed that the use of an intramedullary implant for PIP realignment led to a high rate of fusion and a good outcome. No need of reoperation was reported for patients with incomplete joint fusion who had a stable joint with no pain.

Level of Evidence:

Level IV, prospective case series.
Comparison of Simultaneous and Alternate Bilateral Pneumatic Compression in Hemodynamic Effects and Thromboprophylaxis After Total Knee Arthroplasty
Authors: Choi Jae-Sung , Han Hyuk-Soo , Choi Young Ho , Kwon Jae Hyun , Ahn Hong-Yup
Published: January 2014

In this randomized trial, we compared the hemodynamic effects of 2 different methods of bilateral sequential pneumatic compression (Simultaneous compression with Fixed cycling rate [SF] vs Alternate compression with Adjusted cycling rate [AA]) and investigated whether venous flow augmentation influenced deep vein thrombosis (DVT) development in patients undergoing total knee arthroplasty. Pneumatic compression was started on the operation day and applied to discharge. A total of 108 limbs was evaluated by computed tomographic angiography and duplex ultrasound. Augmented peak volume flow ( P = .008), expelled total volume ( P < .001), and expelled peak volume ( P < .001) were significantly larger in group SF. The DVT developed in 35 (32.4%) limbs, and they were neither symptomatic nor ileofemoral in location. The enhanced hemodynamic parameters did not influence the DVT development. In conclusion, group SF showed superior hemodynamic efficacy, but this superiority may not be a surrogate for better thromboprophylaxis.
Alliance Network Position, Embeddedness and Effects on the Carbon Performance of Firms in Emerging Economies
Authors: Ashraf Naeem , Meschi Pierre-Xavier , Spencer Robert
Published: January 2014

This article explores the effect of network structure on the carbon performance of firms in emerging economies at an ego network level. Building on the theoretical framework of social networks, we posit that an ego firm’s network position, structural embeddedness, and structural constraint affect carbon performance. We examine the research hypotheses using a panel data set made up of 44 Indian firms that entered into alliances under the Clean Development Mechanism over the 2005-2009 period. Our main results show that the central position of the focal firm in the network and its degree of network embeddedness exert a positive effect on its carbon performance. This article contributes to the literature on climate strategy by exploring the influence of the structural characteristics of the firm’s ego network in the carbon market on its environmental performance.
Working towards defining an aesthetics of augmented reality
Authors: Papagiannis Helen
Published: January 2014

The present is a critical time in augmented reality's (AR) definition, as a new medium with aesthetics and conventions just beginning to emerge. We are at a moment when we can look both to the future and to the past: still seeing the previous forms that are shaping AR as a medium while paving new paths, contributing to novel styles and tropes. This article will work toward defining an aesthetics of AR as a new medium in transition, discussing my work as both an artist and a researcher in AR.
Use of the h-index to measure the quality of the output of health services researchers
Authors: Birks Yvonne , Fairhurst Caroline , Bloor Karen , Campbell Marion , Baird Wendy , Torgerson David
Published: January 2014

Objective:

To assess the use of the h-index to measure the quality of the output of health services researchers.

Method:

Online survey, with bibliometric analysis of a convenience volunteer sample of researchers mainly in the UK, North America and Australasia. Self-reported from Google Scholar: h-index; number of papers; number of citations; number of papers with ≥10 citations.

Results:

There were complete responses from 532 health services researchers of whom 371 (70%) were from the UK. Of the bibliometric measures, the h-index appeared to be the best discriminator between other measures of quality (e.g. seniority; entry into the last UK Research Assessment Exercise). The median h-index was 12, with 90th and 95th quantiles of 40 and 52, respectively. Statisticians had the highest h-index with qualitative researchers the lowest (median 16 and 7, respectively). The h-index was predicted to increase by approximately 1 point annually with the biggest increase in statisticians and smallest in qualitative researchers when estimated by quantile regression.

Conclusions:

The h-index is a useful summary measure of output and quality of health services researchers. However, any accurate interpretation of bibliometric measures needs to take into account a person’s research discipline.
Procedural models of European Union politics: Contributions and suggestions for improvement
Authors: Crombez Christophe , Vangerven Pieterjan
Published: January 2014

This article analyzes the literature on procedural models of European Union politics. We present an overview of the main models of the legislative procedures, with a focus on their relevance to European Union politics and the literature today. We discuss early controversies in the literature and examine the empirical research that tested the models. Furthermore, we consider models of other aspects of policy-making in the European Union. Finally, we discuss the literature’s main contributions and principal shortcomings and formulate suggestions for improvement. We argue that the models contribute greatly to our understanding of European Union politics, offer clear predictions regarding policies, institutions’ powers, and the extent of gridlock and have sparked extensive empirical research. The models of consultation and codecision can serve as standard models of unicameral legislatures with an agenda setter and bicameral legislatures with bargaining between the two chambers, respectively. Moreover, they contribute to the study of the implications of institutional reform.
Combustion diagnosis via block vibration signal in common rail diesel engine
Authors: Chiatti Giancarlo , Chiavola Ornella , Recco Erasmo
Published: January 2014

This article presents a diagnostic technique in which nonintrusive measurements are used with the aim of indirect characterization of the combustion process of an internal combustion diesel engine. The developed technique is based on the vibration signal coming from a mono-axial accelerometer placed in a selected location of the engine block. Such a location is able to guarantee high sensitivity to vibration caused by forces directly linked to the combustion process and low sensitivity to all the other excitation sources. The technique is applied to the signals acquired during two series of experimental tests, carried out on the same kind of engine (multi-cylinder diesel engine, equipped with common rail injection system), in two separate engine test facilities in order to test the engine stand-alone and the engine dressed up with the integrated automatic transmission, aimed at reproducing its real operation condition (it is mainly employed in mini-car sector application). The obtained results suggest the potential applicability of the technique both in the laboratory, during the tuning between the injection parameter settings and the engine, and in the regular running condition of the engine for combustion process diagnosis.
Affect Balance and Relationship With Well-Being in Nursing Home Residents With Dementia
Authors: Kolanowski Ann M. , Van Haitsma Kimberly , Meeks Suzanne , Litaker Mark
Published: January 2014

The purpose of this exploratory study was to determine whether the balance of positive to negative affect can discriminate states of well-being in nursing home residents with dementia and whether affect balance is associated with activity engagement. Baseline data from a randomized clinical trial were used in this secondary analysis. Participants were 128 residents recruited from 9 nursing homes located in Pennsylvania. Participants were primarily female, Caucasian, and had a mean age of 86 years. Measures of agitation and affect were taken from video recordings of 10 observational sessions. Measures of engagement and self-reported mood were taken in real time. Ten percent of participants were categorized as having high well-being. These participants had a mean ratio of positive–negative affect of 2.21 (±0.50), a ratio significantly different than that of participants with moderate or low well-being. Affect balance was related to greater engagement in activity ( r = .23; P = .008).
Balance and Gait Training With Augmented Feedback Improves Balance Confidence in People With Parkinson’s Disease
Authors: Shen Xia , Mak Margaret K. Y.
Published: January 2014

Background. Fear of falling has been identified as an important and independent fall-risk predictor in patients with Parkinson’s disease (PD). However, there are inconsistent findings on the effects of balance and gait training on balance confidence. Objective. To explore whether balance and gait training with augmented feedback can enhance balance confidence in PD patients immediately after treatment and at 3- and 12-month follow-ups. Methods. A total of 51 PD patients were randomly assigned to a balance and gait training (BAL) group or to an active control (CON) group. The BAL group received balance and gait training with augmented feedback, whereas CON participants received lower-limb strength training for 12 weeks. Outcome measures included Activities-Specific Balance Confidence (ABC) Scale, limits-of-stability test, single-leg-stance test, and spatiotemporal gait characteristics. All tests were administered before intervention (Pre), immediately after training (Post), and at 3 months (Post3m) and 12 months (Post12m) after treatment completion. Results. The ABC score improved marginally at Post and significantly at Post3m and Post12m only in the BAL group ( P < .017). Both participant groups increased their end point excursion at Post, but only the BAL group maintained the improvement at Post3m. The BAL group maintained significantly longer time-to-loss-of-balance during the single-leg stance test than the CON group at Post3m and Post12m ( P < .05). For gait characteristics, both participant groups increased gait velocity, but only the BAL group increased stride length at Post, Post3m, and Post12m ( P < .017). Conclusions. Positive findings from this study provide evidence that BAL with augmented feedback could enhance balance confidence and balance and gait performance in patients with PD.
A Novel Method for Assessing Insulin Dose Adjustments by Patients with Diabetes
Authors: Choleau Carine , Albisser A Michael , Bar-Hen Avner , Bihan Hélène , Campinos Catherine , Gherbi Zohra , Jomaa Rached , Aich Mammoud , Cohen Régis , Reach Gérard
Published: January 2014

Background:

Insulin treated diabetic patients often do not adjust their insulin doses. We developed a method to provide a quantitative and qualitative assessment of this behavior.

Methods:

Fourteen patients provided logbook pages of their self-monitoring of blood glucose (SMBG) data and insulin doses. We compared the actual decisions of patients in real-life to what they would decide on the same SMBG, as an a posteriori exercise. We also compared these decisions and those proposed by 6 diabetologists on the same sets of data to the recommendations made by HumaLink, an automated insulin dosage system.

Results:

1) Patients in real-life modified their insulin doses least often. However, given a chance to make these decisions a posteriori, they modified their insulin doses more often. HumaLink proposed changes even more often, and diabetologists were the most aggressive in changing insulin doses. 2) The decisions proposed by the patients in real-life or a posteriori and by the diabetologists were compared to the recommendations made by HumaLink, using a decisions analysis grid (DAG). For these three groups, full disagreement with HumaLink (patient or physician increases while HumaLink decreases and the opposite) was observed for less than 5% of the cases. 3) By comparison to HumaLink, patient decisions seemed guided by the desire to avoid hypoglycemia. By contrast, decisions by diabetologists seemed often to be guided by the desire to avoid hyperglycemia.

Conclusion:

These methods provide an objective evaluation of insulin dose adjustments by patients with diabetes and may be useful to assess the effectiveness of educational programs.
The Artificial Pancreas: How Sweet Engineering Will Solve Bitter Problems
Authors: Klonoff David C.
Published: January 2014

An artificial pancreas is a closed-loop system containing only synthetic materials which substitutes for an endocrine pancreas. No artificial pancreas system is currently approved; however, devices that could become components of such a system are now becoming commercially available. An artificial pancreas will consist of functionally integrated components that will continuously sense glucose levels, determine appropriate insulin dosages, and deliver the insulin. Any proposed closed loop system will be closely scrutinized for its safety, efficacy, and economic impact. Closed loop control utilizes models of glucose homeostasis which account for the influences of feeding, stress, insulin, exercise, and other factors on blood glucose levels. Models are necessary for understanding the relationship between blood glucose levels and insulin dosing; developing algorithms to control insulin dosing; and customizing each user's system based on individual responses to factors that influence glycemia. Components of an artificial pancreas are now being developed, including continuous glucose sensors; insulin pumps for parenteral delivery; and control software, all linked through wireless communication systems. Although a closed-loop system providing glucagon has not been reported in 40 years, the use of glucagon to prevent hypoglycemia is physiologically attractive and future devices might utilize this hormone. No demonstration of long-term closed loop control of glucose in a free-living human with diabetes has been reported to date, but many centers around the world are working on closed loop control systems. It is expected that many types of artificial pancreas systems will eventually be available, and they will greatly benefit patients with diabetes.
Increased Arterial Augmentation and Augmentation Index as Surrogate Parameters for Arteriosclerosis in Subjects with Diabetes Mellitus and Nondiabetic Subjects with Cardiovascular Disease
Authors: Wilhelm Birgit , Klein Johannes , Friedrich Christiane , Forst Senait , Pfützner Andreas , Kann Peter H. , Weber Matthias M. , Forst Thomas
Published: January 2014

Background:

Arterial augmentation (AP) and the augmentation index (Aix) are surrogate parameters of arterial stiffness and are commonly used as predictors for cardiovascular risk. The aim of this study is to compare these parameters in diabetic subjects and nondiabetic cardiovascular risk subjects with healthy control subjects.

Methods:

One hundred sixty-six nonsmoking subjects aged between 35 and 70 years were included in the study, which included 100 subjects with cardiovascular disease but not diabetes (mean age 62.73±8.75 years), 33 subjects with type 2 diabetes (66.58±2.69 years), and 33 healthy controls (51.89±8.91 years). In these subjects, arterial stiffness was measured by the difference between the second and the first systolic peak of the central pressure waveform, and the Aix was calculated as the percentage of Aix from pulse pressure.

Results:

Arterial augmentation was increased in subjects with diabetes (DM) with 10.21±6.97 mm Hg and in subjects with cardiovascular disease but not diabetes (CV) with 10.74±5.29 mm Hg in comparison to healthy controls (C) with 6.59±3.97 mm Hg ( p < 0.0005 DM vs C; p < 0.00005 CV vs C). Moreover, Aix was increased with 26.00±9.91% in CV subjects compared to healthy controls with 19.84±9.37% ( p < 0.02 CV vs C). The augmentation index was increased with 21.12±11.21% in subjects with type 2 diabetes mellitus compared to controls, but failed to be statistically significant. There was no statistical significance in arterial augmentation or the augmentation index between CV and diabetic subjects.

Conclusion:

The results of our study revealed a comparable increased augmentation index as a surrogate measure of arterial stiffness and arteriosclerosis in subjects with diabetes mellitus and in nondiabetic subjects with cardiovascular disease.
Glycemia Prediction in Critically Ill Patients Using an Adaptive Modeling Approach
Authors: Herpe Tom Van , Espinoza Marcelo , Haverbeke Niels , De Moor Bart , Van den Berghe Greet
Published: January 2014

Background:

Strict blood glucose control by applying nurse-driven protocols is common nowadays in intensive care units (ICUs). Implementation of a predictive control system can potentially reduce the workload for medical staff but requires a model for accurately predicting the glycemia signal within a certain time horizon.

Methods:

GlucoDay (A. Menarini Diagnostics, Italy) data coming from 19 critically ill patients (from a surgical ICU) are used to estimate the initial ICU “minimal” model (based on data of the first 24 hours) and to reestimate the model as new measurements are obtained. The reestimation is performed every hour or every 4 hours. For both approaches the optimal size of the data set for each reestimation is determined.

Results:

The prediction error that is obtained when applying the 1-hour reestimation strategy is significantly smaller than when the model is reestimated only every 4 hours (p < 0.001). The optimal size of the data set to be considered in each reestimation process of the ICU minimal model is found to be 4 hours. The obtained average “mean percentage error” is 7.6% (SD 3.1%) and 14.6% (SD 7.0%) when the model is reestimated every hour and 4 hours, respectively.

Conclusions:

Implementation of the ICU minimal model in the appropriate reestimation process results in clinically acceptable prediction errors. Therefore, the model is able to predict glycemia trends of patients admitted to the surgical ICU and can potentially be used in a predictive control system.
Public Policy Implications for Using Remote Monitoring Technology to Treat Diabetes
Authors: Ubl Stephen J.
Published: January 2014

Daily medical practice in the United States is at the threshold of a significant and permanent change. The driving force is technologies that permit remote physiological monitoring of patients who have diabetes and other chronic diseases, along with widespread access to the Internet and the adoption of email as a primary means of communicating in our society. Utilization of these technologies not only improves the quality of patient care, it also reduces the need for frequent physician office appointments, costly emergency room visits, and unnecessary hospitalizations. The Remote Monitoring Access Act of 2007 will eliminate disincentives in current Medicare rules that only provide payment for face-to-face meetings between patients and their doctors.
Inflammation and Glucose Sensors: Use of Dexamethasone to Extend Glucose Sensor Function and Life Span in Vivo
Authors: Klueh Ulrike , Kaur Manjot , Montrose David C. , Kreutzer Donald L.
Published: January 2014

Background:

It has been generally accepted that the acute loss of sensor function is the consequence of sensor biofouling as a result of inflammation induced at sites of sensor implantation, as well as tissue trauma induced by the sensor and its implantation. Because anti-inflammatory therapies are used routinely to control inflammation in a wide variety of diseases, we hypothesized that anti-inflammatory therapy would likely extend glucose sensor function in vivo. To test this hypothesis, we utilized our recently developed mouse model of implantable glucose sensors and the potent anti-inflammatory steroid dexamethasone (DEX).

Method:

For this study, glucose sensors were implanted subcutaneously into the head and neck area of mice and sensor function was determined up to 14 days postimplantation. These mice received a daily intraperitoneal injection of DEX at a dose of 1, 6, or 10 mg/kg body weight.

Results:

Mice not treated with DEX lost sensor functionality very rapidly, usually within the first 24 hours postimplantation. Mice treated with DEX at the various doses had an increased sensor life span of up to 2 weeks postimplantation. Additionally, sensitivity was maintained in DEX-treated mice as compared to control mice (non-DEX treated). Histologic evaluation of tissue surrounding the site of sensor implantation had almost no inflammatory cells in DEX-treated mice, whereas control mice had an intense band of inflammation surrounding the site of sensor implantation.

Conclusion:

To our knowledge this is the first study directly demonstrating that anti-inflammatory therapy can extend glucose sensor function in vivo and supports the key role of inflammation in loss of sensor function in vivo, as well as the uses of anti-inflammatory therapy as a potential key adjuvant in enhancing glucose sensor function and life span in vivo.
Blood Lactate Measurements and Analysis during Exercise: A Guide for Clinicians
Authors: Goodwin Matthew L. , Harris James E. , Hernández Andrés , Gladden L. Bruce
Published: January 2014

Blood lactate concentration ([La−]b) is one of the most often measured parameters during clinical exercise testing as well as during performance testing of athletes. While an elevated [Lai may be indicative of ischemia or hypoxemia, it may also be a “normal” physiological response to exertion. In response to “all-out” maximal exertion lasting 30–120 seconds, peak [La−]b values of =15–25 mM may be observed 3–8 minutes postexercise. In response to progressive, incremental exercise, [La−]b increases gradually at first and then more rapidly as the exercise becomes more intense. The work rate beyond which [La−]b increases exponentially [the lactate threshold (LT)] is a better predictor of performance than VO2max and is a better indicator of exercise intensity than heart rate; thus LT (and other valid methods of describing this curvilinear [La−]b response with a single point) is useful in prescribing exercise intensities for most diseased and nondiseased patients alike. H+-monocarboxylate cotransporters provide the primary of three routes by which La− transport proceeds across the sarcolemma and red blood cell membrane. At rest and during most exercise conditions, whole blood [La−] values are on average 70% of the corresponding plasma [La−] values; thus when analyzing [La−]b, care should be taken to both (1) validate the [LaT-measuring instrument with the criterion/reference enzymatic method and (2) interpret the results correctly based on what is being measured (plasma or whole blood). Overall, it is advantageous for clinicians to have a thorough understanding of [La−] responses, blood La− transport and distribution, and [La−] analysis.
Effect of Duration of Disease on Ventilatory Function in an Ethnic Saudi Group of Diabetic Patients
Authors: Meo Sultan A. , Al Drees Abdul Majeed , Ahmed Jehangeer , Shah Sayed Fayaz Ahmed , Al-Regaiey Khalid , Husain Ashraf , Al-Rubean Khalid
Published: January 2014

Background:

Diabetes mellitus is a leading cause of illness and death across the world and is responsible for a growing proportion of global health care expenditures. The present study was designed to observe the effect of diabetes mellitus on lung function in patients with diabetes belonging to a specific ethnic group, namely Saudis.

Method:

In this study, a group of 47 apparently healthy volunteer male Saudi patients with diabetes was randomly selected. Their ages ranged from 20 to 70 years. The patients were matched with another group of 50 healthy male control subjects in terms of age, height, weight, ethnicity, and socioeconomic status. Both groups met exclusion criteria as per standard. Spirometry was performed with an electronic spirometer (Schiller AT-2 Plus, Switzerland), and results were compared by a Student's t test.

Results:

Subjects with diabetes showed a significant reduction in forced vital capacity (FVC) and forced expiratory volume in the first second (FEV1) relative to their matched controls. However, there were no significant differences in the forced expiratory ratio (FE1/FVC%) and the middle half of the FVC (FEF25–75%) between the groups. We observed a significantly negative correlation between duration of disease and pulmonary function, as measured by FEV1 ( r = 0.258, p = 0.04), FVC ( r = 0.282, p = 0.28), and the middle half of the FVC (FEF25–75%) ( r = 0.321, p = 0.014).

Conclusions:

Pulmonary function in a specific ethnic group of patients with diabetes was impaired as evidenced by a decrease in FVC and FEV1 compared to pulmonary function in matched controls. Stratification of results by years of disease revealed a significant correlation between duration of disease and a decline in pulmonary function.
Recent Advances in Free-Living Physical Activity Monitoring: A Review
Authors: Andre David , Wolf Donna L.
Published: January 2014

It has become clear recently that the epidemic of type 2 diabetes sweeping the globe is associated with decreased levels of physical activity and an increase in obesity. Incorporating appropriate and sufficient physical activity into one's life is an essential component of achieving and maintaining a healthy weight and overall health, especially for those with type II diabetes mellitus. Regular physical activity can have a positive impact by lowering blood glucose, helping the body to be more efficient at using insulin. There are other substantial benefits for patients with diabetes, including prevention of cardiovascular disease, hyperlipidemia, hypertension, and obesity. Several complications of utilizing a self-care treatment methodology involving exercise include (1) patients may not know how much activity that they engage in and (2) health-care providers do not have objective measurements of how much activity their patients perform. However, several technological advances have brought a variety of activity monitoring devices to the market that can address these concerns. Ranging from simple pedometers to multisensor devices, the different technologies offer varying levels of accuracy, comfort, and reliability. The key notion is that by providing feedback to the patient, motivation can be increased and targets can be set and aimed toward. Although these devices are not specific to the treatment of diabetes, the importance of physical activity in treating the disease makes an understanding of these devices important. This article reviews these physical activity monitors and describes the advantages and disadvantages of each.
Incorporating a Generic Model of Subcutaneous Insulin Absorption into the AIDA v4 Diabetes Simulator 2. Preliminary Bench Testing
Authors: Lehmann Eldon D. , Tarín Cristina , Bondia Jorge , Teufel Edgar , Deutsch Tibor
Published: January 2014

Background:

The AIDA interactive educational diabetes simulator has been available without charge for over a decade via the Internet (see www.2aida.org ). Part 1 of this report [J Diabetes Sci Technol. 2007;1(3):423–35] described the model components to be integrated to enhance the utility of the software, with the aim being to provide enhanced functionality and educational simulations of regimens utilizing insulin analogues, as well as insulin doses greater than 40 units. This report provides some preliminary subcutaneous insulin absorption bench testing results for the updated modeling prototype.

Methods:

An analysis has been done of the spatial distribution of insulin in the region of the injection site for different classes of insulin preparations and times after the administration of a set insulin injection. Demonstrations of the proportion of residual insulin in depot versus time after a subcutaneous bolus have also been simulated for different insulin injection volumes and concentrations, as well as to show the proportions of hexameric, dimeric, and bound insulin over time after an injection.

Results:

Some early bench testing results are highlighted following subcutaneous injections of a rapidly acting insulin analogue (such as lispro/Humalog or aspart/NovoLog), a short-acting (regular) insulin preparation (e.g., Actrapid), intermediate-acting insulins (both Semilente and neutral protamine Hagedorn types), and a very long-acting insulin analogue (such as glargine/Lantus). The transformation, dissociation/association, and absorption processes by which insulin moves from the subcutaneous injection site to the plasma are also illustrated.

Discussion:

This report demonstrates how enhanced capabilities may be added to AIDA once a new model of subcutaneous insulin absorption is incorporated. The revised approach, once fully implemented, should permit the simulation of plasma insulin profiles for rapidly acting and very long-acting insulin analogues, as well as insulin injections greater than 40 units.
Automated Computation of Glycemic Index for Foodstuffs Using Continuous Glucose Monitoring
Authors: Chlup Rudolf , Sečkař Pavel , Zapletalová Jana , Langová Kateřina , Kudlová Pavla , Chlupová Karolina , Bartek Josef , Jelenová Daniela
Published: January 2014

Background:

The glycemic index (GI) is a measure of the ability of a food to raise glucose levels after it is eaten. Continuous glucose monitoring (CGM) has been shown to give identical values of GI when compared to traditional methods. However, there has been no standardized protocol for measuring GI that takes into account interindividual variability and chronophysiological glycemic response to food. Our aim was (1) to create and describe software based on a Microsoft Excel 2000 spreadsheet to facilitate rapid, automated, accurate, and standardized processing of data obtained using recent CGM methodology to measure GI and its variability and (2) to assess the benefits of this new approach.

Method:

Twenty healthy subjects consumed 50 grams of glucose or four alternative foodstuffs (chocolate, apple baby food, rice squares, or yogurt) at breakfast and dinner during 1 week, resulting in 300 CGMS glucose profiles; 92% of meal tests were satisfactory for evaluation. Application and functions of the software DegifXL are described.

Results:

Using the new spreadsheet software DegifXL, time required for data processing for the 15 data sets for each subject was reduced from 2000 to 160 minutes relative to previously used manual methods. We characterized the GI for four foodstuffs with three replicate measurements in each of 20 subjects and evaluated between person, between time period, and between replicate GI variabilities.

Conclusion:

DegifXL, combined with CGM, was an efficient and effective tool for routine measurement of group- and subject-related GI.
Establishing a Continuous Glucose Monitoring Program
Authors: Wolpert Howard
Published: January 2014

Real-time continuous glucose monitoring (RT-CGM) devices provide detailed information on glucose patterns and trends, and alarms that alert the patient to both hyper- and hypoglycemia. This technology can dramatically improve the day-to-day management of patients with diabetes and promises to be a major advance in diabetes care. The safe and effective use of RT-CGM in diabetes management rests on an understanding of several physiological as well as technological issues. This article outlines the key issues that should be addressed in the training curriculum for patients starting on RT-CGM: (1) physiologic lag between interstitial and blood glucose levels and the implications for device calibration, and interpretation and use of data in diabetes management; (2) practical considerations with the use of sensor alarms and caveats in the setting of alarm thresholds; and (3) potential risk for hypoglycemia related to excessive postprandial bolusing by RT-CGM users, and the practical implications for patient training.
Indication-Based Ordering: A New Paradigm for Glycemic Control in Hospitalized Inpatients
Authors: Lee Joshua , Clay Brian , Zelazny Ziband , Maynard Gregory
Published: January 2014

Background:

Inpatient glycemic control is a constant challenge. Institutional insulin management protocols and structured order sets are commonly advocated but poorly studied. Effective and validated methods to integrate algorithmic protocol guidance into the insulin ordering process are needed.

Methods:

We introduced a basic structured set of computerized insulin orders (Version 1), and later introduced a paper insulin management protocol, to assist users with the order set. Metrics were devised to assess the impact of the protocol on insulin use, glycemic control, and hypoglycemia using pharmacy data and point of care glucose tests. When incremental improvement was seen (as described in the results), Version 2 of the insulin orders was created to further streamline the process.

Results:

The percentage of regimens containing basal insulin improved with Version 1. The percentage of patient days with hypoglycemia improved from 3.68% at baseline to 2.59% with Version 1 plus the paper insulin management protocol, representing a relative risk for hypoglycemic day of 0.70 [confidence interval (CI) 0.62, 0.80]. The relative risk of an uncontrolled (mean glucose over 180 mg/dl) patient stay was reduced to 0.84 (CI 0.77, 0.91) with Version 1 and was reduced further to 0.73 (CI 0.66, 0.81) with the paper protocol. Version 2 used clinician-entered patient parameters to guide protocol-based insulin ordering and simultaneously improved the flexibility and ease of ordering over Version 1.

Conclusion:

Patient parameter and protocol-based clinical decision support, added to computerized provider order entry, has a track record of improving glycemic control indices. This justifies the incorporation of these algorithms into online order management.
Multicenter Validation of a Computer-Based Clinical Decision Support Tool for Glucose Control in Adult and Pediatric Intensive Care Units
Authors: Thompson B. Taylor , Orme James F. , Zheng Hui , Luckett Peter M. , Truwit Jonathon D. , Willson Douglas F. , Hite R. Duncan , Brower Roy G. , Bernard Gordon R. , Curley Martha A. Q. , Steingrub Jay S. , Sorenson Dean K. , Sward Kathy , Hirshberg Ellie , Morris Alan H. ,   for the Reengineering Critical Care Clinical Research Investigators
Published: January 2014

Introduction:

Hyperglycemia during critical illness is common, and intravenous insulin therapy (IIT) to normalize blood glucose improves outcomes in selected populations. Methods differ widely in complexity, insulin dosing approaches, efficacy, and rates of hypoglycemia. We developed a simple bedside-computerized decision support protocol (eProtocol-insulin) that yields promising results in the development center. We examined the effectiveness and safety of this tool in six adult and five pediatric intensive care units (ICUs) in other centers.

Methods:

We required attending physicians of eligible patients to independently intend to use intravenous insulin to normalize blood glucose. We used eProtocol-insulin for glucose control for a duration determined by the clinical caregivers. Adults had an anticipated length of stay of 3 or more days. In pediatric ICUs, we also required support or intended support with mechanical ventilation for greater than 24 hours or with a vasoactive infusion. We recorded all instances in which eProtocol-insulin instructions were not accepted and all blood glucose values. An independent data safety and monitoring board monitored study results and subject safety. Bedside nurses were selected randomly to complete a paper survey describing their perceptions of quality of care and workload related to eProtocol-insulin use.

Results:

Clinicians accepted 93% of eProtocol-insulin instructions (11,773/12,645) in 100 adult and 48 pediatric subjects. Forty-eight percent of glucose values were in the target range. Both of these results met a priori-defined efficacy thresholds. Only 0.18% of glucose values were ≤40 mg/dl. This is lower than values reported in prior IIT studies. Although nurses reported eProtocol-insulin required as much work as managing a mechanical ventilator, most nurses felt eProtocol-insulin had a low impact on their ability to complete non-IIT nursing activities.

Conclusions:

A multicenter validation demonstrated that eProtocol-insulin is a valid, exportable tool that can assist clinicians in achieving control of glucose in critically ill adults and children.
Safety and Effectiveness of a Computerized Subcutaneous Insulin Program to Treat Inpatient Hyperglycemia
Authors: Juneja Rattan , Golas Adam A. , Carroll Joni , Nelson Deborah , Abad Victor J. , Roudebush Corbin P. , Flanders Samuel J.
Published: January 2014

Background:

This proof of concept study was designed to evaluate the safety and effectiveness of a computerized insulin program, the Clarian GlucoStabilizer™ Subcutaneous Insulin Program (CGS-SQ). This paper discusses the CGS-SQ's impact on the glycemic control of hospitalized patients with hyperglycemia.

Methods:

Patients at Methodist and Indiana University Hospitals requiring subcutaneous insulin were treated using the CGS-SQ. This program calculates subcutaneous bolus insulin doses based on the current blood glucose (BG), using an insulin sensitivity factor, the number of grams of carbohydrates eaten, and an insulin-to-carbohydrate ratio, with a goal of maintaining the patient's BG in a prespecified target range. The target range, insulin sensitivity factor, and insulin-to-carbohydrate ratio are established by the physician.

Results:

From April 2006 to September 2007, the CGS-SQ treated 1772 patients at Methodist and Indiana University Hospitals, with 46,575 BGs in its database. For these patients, the average BG was 158.3 mg/dl, 40.5% percent of BGs were in the default target range of 100–150 mg/dl, and 69.8% were in the wider range of 70–180 mg/dl. The hypoglycemia (BG <40 mg/dl) rate was 0.18%.

Conclusions:

The CGS-SQ provided a means to deliver insulin in a standardized manner, resulting in satisfactory BG control with a low hypoglycemia rate, thus serving as a tool for safe and effective insulin therapy for hospitalized patients.
Impact of Human Factors on Clinical Protocol Performance: A Proposed Assessment Framework and Case Examples
Authors: Chase J. Geoffrey , Andreassen Steen , Jensen Karsten , Shaw Geoffrey M.
Published: January 2014

Background:

Hyperglycemia is prevalent in critical care and tight control can save lives. Current ad-hoc clinical protocols require significant clinical effort and can often produce highly variable results. Thus, tight control remains elusive as there is not enough understanding of the relationship between control performance and protocol design, particularly with regard to how a given protocol is implemented.

Methods:

This article examines the role of human factors and how individuals relate to technological protocols in clinical settings. The study consists of an overall brief review that is used to create a first graphical representation of the impact of human factors in clinical medical protocol implementations. This initial framework is examined in the context of two similar, but different, case studies—the specialized relative insulin and nutrition tables glycemic control protocol and the TREAT system for antibiotic selection.

Results:

A graphical framework relating the human factors impact on medical protocol implementation is created. This framework describes the primary impacts on performance as resulting from clinical burden and protocol transparency. Their primary effect is on compliance with the protocol, which directly affects performance and outcome, particularly in long-term studies versus short pilot studies.

Compliance is a key element in obtaining the best clinical outcome that a given protocol can provide. The issues that most affect compliance are quite often unrelated to the patient or treatment, but are a function of the protocol design and its ability to integrate (by its design) into a given clinical setting. A framework for examining these issues in design and in post-hoc assessment is therefore proposed and examined in two brief case studies.
Development of a Clinical Type 1 Diabetes Metabolic System Model and in Silico Simulation Tool
Authors: Wong Xing-Wei , Chase J. Geoffrey , Hann Christopher E. , Lotz Thomas F. , Lin Jessica , Le Compte Aaron J. , Shaw Geoffrey M.
Published: January 2014

Objectives:

The goal of this study was to develop a system model of type 1 diabetes for the purpose of in silico simulation for the prediction of long-term glycemic control outcomes.

Methods:

The system model was created and identified on a physiological cohort of virtual type 1 diabetes patients ( n = 40). Integral-based identification was used to develop ( n = 40) insulin sensitivity profiles.

Results:

The n = 40 insulin sensitivity profiles provide a driving input for virtual patient trials using the models developed. The identified models have a median (90% range) absolute percentage error of 1.33% (0.08–7.20%). The median (90% range) absolute error was 0.12 mmol/liter (0.01–0.56 mmol/liter). The model and integral-based identification of S I captured all patient dynamics with low error, which would lead to more physiological behavior simulation.

Conclusions:

A simulation tool incorporating n = 40 virtual patient data sets to predict long-term glycemic control outcomes from clinical interventions was developed based on a physiological type 1 diabetes metabolic system model. The overall goal is to utilize this model and insulin sensitivity profiles to develop and optimize self-monitoring blood glucose and multiple daily injection therapy.
Concealed Maternal Blood Glucose Excursions Correlate with Birth Weight Centile
Authors: Taslimi Masoud Mark , Navabi Kasra , Acosta Reinaldo , Helmer Amy , El-Sayed Yasser Y.
Published: January 2014

Background:

The objective of this study was to test the hypothesis that maternal blood glucose excursions correlate with deviation from optimized birth weight.

Methods:

Patients were recruited for 3-day continuous glucose monitoring (CGM) plus self-blood glucose monitoring followed by routine diabetes screening at 26–28 weeks gestation. Patients and caregivers were blinded to CGM results. The magnitude and duration of blood glucose (BG) excursions were measured as a “glycemia index.” A customized birth weight centile was calculated.

Results:

Twenty-three patients consented, 21 completed the study: 5 diabetic and 16 nondiabetic individuals. The duration of CGM was 72 (±7.2) hours, and each patient performed self-BG monitoring ≥3 times per day. All diabetic and 10 nondiabetic patients had several measured BG excursions above 130 mg/dl. A positive correlation was observed between birth weight centile and glycemia index above 130 ( p < 0.03); the trend persisted for nondiabetic patients alone ( p < 0.05). No significant correlation was noted between birth weight centile and average 3-day CGM values, 3-day fasting BG, average 3-day self-BG monitoring values, or diabetes screening BG value.

Conclusions:

The glycemia index has a better correlation with birth weight centile than BG measured by conventional methods in a mixed diabetic and nondiabetic population. Fetal exposure to maternal blood glucose excursions correlates positively with fetal growth, even in nondiabetic patients with apparently normal glucose tolerance.
FreeStyle Lite—A Blood Glucose Meter That Requires No Coding
Authors: Alva Shridhara
Published: January 2014

Background:

Abbott Diabetes Care introduced the FreeStyle® Lite blood glucose monitoring system, which simplifies the management of diabetes. The FreeStyle Lite system relies on FreeStyle technology but eliminates the need for coding the meter for individual strip lots. The meter is precoded for the FreeStyle Lite strips. FreeStyle systems use coulometry technology where the glucose signal is calculated from the total charge generated as a result of the glucose reaction in the sample. FreeStyle strip calibration parameters can be controlled by controlling the sample volume. Coulometry technology is less sensitive to measurement conditions such as temperature and hematocrit. FreeStyle chemistry is less sensitive to interference from electroactive compounds. The ability to control calibration parameters coupled to a robust measurement technology enabled the development of a blood glucose monitoring system that does not require coding by the user.

Methods:

Laboratory studies were performed to determine analytical performance, such as linearity, precision, and sensitivity to operating temperature. Clinical accuracy for finger tip capillary blood testing was assessed with five lots of FreeStyle Lite test strips. FreeStyle Lite results in these studies were compared to the plasma equivalent glucose values of finger tip blood samples measured by the Yellow Springs Instrument glucose analyzer.

Results:

In the analytical performance evaluation, repeatability (within-run precision) of the FreeStyle Lite system showed an average standard deviation of 3.4 mg/dl (0.19 mmol/liter) at glucose concentrations <100 mg/dl (<5.56 mmol/liter) and an average coefficient of variation of 4.3% at glucose concentrations ≥100 mg/dl (≥5.56 mmol/liter). Linearity demonstrated across the measuring range of the FreeStyle Lite system was 20–500 mg/dl (1.1–27.8 mmol/liter) with r2 > 0.99. The FreeStyle Lite system was also shown to maintain accuracy across the operating temperature range of 4 to 40°C.

Conclusions:

The FreeStyle Lite system has good analytical performance and clinical accuracy. While simplifying the process of blood glucose monitoring, the FreeStyle Lite system continues to provide the performance that users have come to expect from FreeStyle products.