bluuebunny/crossref_metadata_2025_split huggingface dataset:
Obesity Reduction and Awareness and Screening of Noncommunicable Diseases through Group Education in Children and Adolescents (ORANGE): Methodology Paper (ORANGE-1)
Authors: Sonya Jagadesan , Ranjani Harish , Pradeepa Rajendra , Mohan Viswanathan 
Published: January 2014

Aim: Our goal is to estimate the prevalence of obesity, glucose intolerance, hypertension, dyslipidemia, and metabolic syndrome among urban children and adolescents aged 6–19 years and to raise awareness about noncommunicable diseases (NCDs) among school children in Chennai, South India. Methods: The Obesity Reduction and Awareness and Screening of Noncommunicable Diseases through Group Education project plans to reach out to children and adolescents using two approaches: The school and the community approach. The school approach aims to reach out to a representative sample of approximately 20,000 urban school children and adolescents, aged 6–19 years, covering 50 schools from all parts of Chennai. Anthropometric measures will include height, weight, waist, body fat, and blood pressure. Data on demographics, family Profile, behavioral aspects, physical activity, and food pattern will be obtained by using a validated questionnaire. Awareness about metabolic NCDs like obesity and diabetes will be increased by educating the children and adolescents about healthy lifestyles. Through the community approach, 2000 children and adolescents from randomly selected residential colonies in Chennai will be screened for obesity, glucose intolerance, hypertension, dyslipidemia, and metabolic syndrome. Expected Outcomes: Awareness about NCDs will be increased among children and their parents in Chennai. This study will also provide valuable epidemiological data on obesity, glucose intolerance, dyslipidemia, hypertension and metabolic syndrome in children and adolescents in urban India.
Fetal Risk Assessment in Pregnancies Complicated by Diabetes Mellitus
Authors: Zisser Howard C. , Biersmith Michael A. , Jovanovič Lois B. , Yogev Yariv , Hod Moshe , Kovatchev Boris P. 
Published: January 2014

Background: Hypoglycemia and hyperglycemia can pose a number of serious risks to pregnant mothers with diabetes, but these risks are not always related to glucose concentrations directly. Previous studies have shown the utility of using mathematical transformation functions to create patient risk profiles that can then be used to analyze and predict adverse outcomes in individuals with diabetes. We propose a novel use of these functions to analyze the risks posed to the fetus in pregnancies complicated by diabetes. Methods: We retrospectively analyzed 71 h continuous glucose monitoring system (CGMS Gold, Medtronic Northridge, CA) third trimester tracings obtained during a normal pregnancy and in those complicated by gestational diabetes mellitus (GDM), type 2 diabetes mellitus (T2DM), and type 1 diabetes mellitus (T1DM). We then used a transformation function to calculate fetal and maternal risk in each case. Results: In the normal pregnancy (0.93), the risk was at a minimum. Along with mean glucose values, the risk increased in those cases where gestation was complicated by GDM (3.12), T2DM (7.85), and T1DM (16.94). In contrast, the original patient risk profile yielded a minimal value for the GDM tracings. Conclusions: Total fetal risk increases from normal to GDM to T2DM to T1DM pregnancies. This new risk assignment better distinguishes the stages of fetal risk than the original method and therefore may be useful in future clinical trials and applications to predict risk for adverse outcomes in pregnancies complicated by diabetes.
Multinational Study of Subcutaneous Model-Predictive Closed-Loop Control in Type 1 Diabetes Mellitus: Summary of the Results
Authors: Kovatchev Boris , Cobelli Claudio , Renard Eric , Anderson Stacey , Breton Marc , Patek Stephen , Clarke William , Bruttomesso Daniela , Maran Alberto , Costa Silvana , Avogaro Angelo , Man Chiara Dalla , Facchinetti Andrea , Magni Lalo , De Nicolao Giuseppe , Place Jerome , Farret Anne 
Published: January 2014

Background: In 2008–2009, the first multinational study was completed comparing closed-loop control (artificial pancreas) to state-of-the-art open-loop therapy in adults with type 1 diabetes mellitus (T1DM). Methods: The design of the control algorithm was done entirely in silico, i.e., using computer simulation experiments with N = 300 synthetic “subjects” with T1DM instead of traditional animal trials. The clinical experiments recruited 20 adults with T1DM at the Universities of Virginia (11); Padova, Italy (6); and Montpellier, France (3). Open-loop and closed-loop admission was scheduled 3–4 weeks apart, continued for 22 h (14.5 h of which were in closed loop), and used a continuous glucose monitor and an insulin pump. The only difference between the two sessions was that insulin dosing was performed by the patient under a physician's supervision during open loop, whereas insulin dosing was performed by a control algorithm during closed loop. Results: In silico design resulted in rapid (less than 6 months compared to years of animal trials) and cost-effective system development, testing, and regulatory approvals in the United States, Italy, and France. In the clinic, compared to open-loop, closed-loop control reduced nocturnal hypoglycemia (blood glucose below 3.9 mmol/liter) from 23 to 5 episodes (p < .01) and increased the amount of time spent overnight within the target range (3.9 to 7.8 mmol/liter) from 64% to 78% (p = .03). Conclusions: In silico experiments can be used as viable alternatives to animal trials for the preclinical testing of insulin treatment strategies. Compared to open-loop treatment under identical conditions, closed-loop control improves the overnight regulation of diabetes.
Design and Clinical Pilot Testing of the Model-Based Dynamic Insulin Sensitivity and Secretion Test (DISST)
Authors: Lotz Thomas F. , Chase J. Geoffrey , McAuley Kirsten A. , Shaw Geoffrey M. , Docherty Paul D. , Berkeley Juliet E. , Williams Sheila M. , Hann Christopher E. , Mann Jim I. 
Published: January 2014

Background: Insulin resistance is a significant risk factor in the pathogenesis of type 2 diabetes. This article presents pilot study results of the dynamic insulin sensitivity and secretion test (DISST), a high-resolution, low-intensity test to diagnose insulin sensitivity (IS) and characterize pancreatic insulin secretion in response to a (small) glucose challenge. This pilot study examines the effect of glucose and insulin dose on the DISST, and tests its repeatability. Methods: DISST tests were performed on 16 subjects randomly allocated to low (5 g glucose, 0.5 U insulin), medium (10 g glucose, 1 U insulin) and high dose (20 g glucose, 2 U insulin) protocols. Two or three tests were performed on each subject a few days apart. Results: Average variability in IS between low and medium dose was 10.3% ( p = .50) and between medium and high dose 6.0% ( p = .87). Geometric mean variability between tests was 6.0% (multiplicative standard deviation (MSD) 4.9%). Geometric mean variability in first phase endogenous insulin response was 6.8% (MSD 2.2%). Results were most consistent in subjects with low IS. Conclusions: These findings suggest that DISST may be an easily performed dynamic test to quantify IS with high resolution, especially among those with reduced IS.
β-Cell Dysfunction under Hyperglycemic Stress: A Molecular Model
Authors: Despa Florin , Berry R. Stephen 
Published: January 2014

Background: Pancreatic β cells respond to chronic hyperglycemia by increasing the synthesis of proinsulin (the precursor molecule of insulin). Prolonged stimulations lead to accumulation of misfolded proinsulin in the secretory track, delayed insulin secretion, and release of unprocessed proinsulin in the blood. The molecular mechanisms connecting the state of endoplasmic reticulum overloading with the efficiency of proinsulin to insulin conversion remain largely unknown. Method: Computer simulations can help us to understand mechanistic features of the β-cell secretory defect and to design experiments that may reveal the molecular basis of this dysfunction. We used molecular crowding concepts and statistical thermodynamics to dissect possible biophysical mechanisms underlying the alteration of the secretory track of β cells and to elucidate the chemistry aspects of the secretory dysfunction. We then used numerical algorithms to relate the degree of biophysical alteration of these secretory compartments with the change of proinsulin to insulin conversion rate. Results: Our computer simulations suggest that overloading the endoplasmic reticulum initiates downstream molecular crowding effects that affect protein translational mechanisms, including proinsulin misfolding, delayed packing of proinsulin in secretory vesicles, and low kinetic coefficient of proinsulin to insulin conversion. Conclusions: Together with previous experimental data, the present study can help us to better understand chemistry aspects related to the secondary translational mechanisms in β cells and how hyperglycemic stress can alter secretory function. This can give a further impetus to the development of novel software to be used in a clinical setup for prediction and assessment of diabetic states in susceptible patients.
Evaluation of an Over-the-Counter Glycated Hemoglobin (A1C) Test Kit
Authors: Chang Anna , Frank Joy , Knaebel Jennifer , Fullam Jeanellen , Pardo Scott , Simmons David A. 
Published: January 2014

Background: Glycated hemoglobin (A1C) monitoring is an integral component of diabetes management. This study was conducted to evaluate the performance of the A1CNow® SELFCHECK device when used by lay users and health care professionals (HCPs) to measure A1C. Methods: Subjects performed two A1CNow SELFCHECK finger-stick self-tests followed by a finger-stick test of the subject's blood by a HCP. The primary endpoint assessed accuracy of the subject and HCP A1CNow SELFCHECK readings. Secondary endpoints included precision, comprehension of instructional material (written material ± DVD), and product satisfaction. For accuracy comparison, a venous blood sample was drawn from each subject and tested by laboratory (TOSOH) analysis. Subject comprehension of product instructional material was evaluated via first-time failure (FTF) rate as recorded by the HCP, and subject satisfaction was assessed through written survey. Results: A total of 110 subjects with ( n = 93) and without ( n = 17) diabetes participated. Of 177 subject A1C values, 165 (93.2%) were within the acceptable range of ±13.5% of the laboratory reference value and considered accurate. Regression analysis showed good correlation of subject values to laboratory and HCP results ( R2 = 0.93 for both). The average within-subject coefficient of variation was 4.57% ( n = 74). The FTF rates with and without instructional DVD were 11.3% ( n = 56) and 39.6% ( n = 54), respectively. Subjects with diabetes/prediabetes overwhelmingly indicated that they were “very” to “extremely” likely (93.5%) to discuss their home A1C results with their HCP. Conclusions: Lay users found the A1CNow SELFCHECK easy to use, and both lay users and HCPs were able to measure A1C accurately.
How Continuous Monitoring Changes the Interaction of Patients with a Mobile Telemedicine System
Authors: Martínez-Sarriegui Iñaki , García-Sáez Gema , Rigla Mercedes , Brugués Eulalia , de Leiva Alberto , Gómez Enrique J. , Hernando M. Elena 
Published: January 2014

Background: The combination of telemedicine systems integrating mobile technologies with the use of continuous glucose monitors improves patients' glycemic control but demands a higher interaction with information technology tools that must be assessed. In this article, we analyze patients' behavior from the use-of-the-system point of view, identifying how continuous monitoring may change the interaction of patients with the mobile telemedicine system. Methods: Patients' behavior were evaluated in a clinical experiment consisting of a 2-month crossover randomized study with 10 type 1 diabetes patients. During the entire experiment, patients used the DIABTel telemedicine system, and during the intervention phase, they wore a continuous glucose monitor. Throughout the experiment, all user actions were automatically registered. This article analyzes the occurrence of events and the behavior patterns in blood glucose (BG) self-monitoring and insulin adjustments. A subjective evaluation was also performed based on the answers of the patients to a questionnaire delivered at the end of the study. Results: The number of sessions established with the mobile Smart Assistant was considerably higher during the intervention period than in the control period (29.0 versus 18.8, p < .05), and it was also higher than the number of Web sessions (29.0 versus 22.2, p < .01). The number of daily boluses was higher during the intervention period than in the control period (5.27 versus 4.40, p < .01). The number of daily BG measurements was also higher during the intervention period (4.68 versus 4.05, p < .05) and, in percentage, patients increased the BG measurements not associated to meals while decreasing the percentage of preprandial measurements. The subjective evaluation shows that patients would recommend the use of DIABTel in routine care. Conclusions: The use of a continuous glucose monitor changes the way patients manage their diabetes, as observed in the increased number of daily insulin bolus, the increased number of daily BG measurements, and the differences in the distribution of BG measurements throughout the day. Continuous monitoring also increases the interaction of patients with the information system and modifies their patterns of use. We can conclude that mobile technologies are especially useful in scenarios of tight monitoring in diabetes, and they are well accepted by patients.
DrishtiCare: A Telescreening Platform for Diabetic Retinopathy Powered with Fundus Image Analysis
Authors: Joshi Gopal Datt , Sivaswamy Jayanthi 
Published: January 2014

Objective: Diabetic retinopathy is the leading cause of blindness in urban populations. Early diagnosis through regular screening and timely treatment has been shown to prevent visual loss and blindness. It is very difficult to cater to this vast set of diabetes patients, primarily because of high costs in reaching out to patients and a scarcity of skilled personnel. Telescreening offers a cost-effective solution to reach out to patients but is still inadequate due to an insufficient number of experts who serve the diabetes population. Developments toward fundus image analysis have shown promise in addressing the scarcity of skilled personnel for large-scale screening. This article aims at addressing the underlying issues in traditional telescreening to develop a solution that leverages the developments carried out in fundus image analysis. Method: We propose a novel Web-based telescreening solution (called DrishtiCare) integrating various value-added fundus image analysis components. A Web-based platform on the software as a service (SaaS) delivery model is chosen to make the service cost-effective, easy to use, and scalable. A server-based prescreening system is employed to scrutinize the fundus images of patients and to refer them to the experts. An automatic quality assessment module ensures transfer of fundus images that meet grading standards. An easy-to-use interface, enabled with new visualization features, is designed for case examination by experts. Results: Three local primary eye hospitals have participated and used DrishtiCare's telescreening service. A preliminary evaluation of the proposed platform is performed on a set of 119 patients, of which 23% are identified with the sight-threatening retinopathy. Currently, evaluation at a larger scale is under process, and a total of 450 patients have been enrolled. Conclusion: The proposed approach provides an innovative way of integrating automated fundus image analysis in the telescreening framework to address well-known challenges in large-scale disease screening. It offers a low-cost, effective, and easily adoptable screening solution to primary care providers.
Utilizing Information Technologies for Lifelong Monitoring in Diabetes Patients
Authors: Capozzi Davide , Lanzola Giordano 
Published: January 2014

Background: Information and communication technologies have long been acknowledged to support information sharing along the whole chain of care, from the clinic to the homes of patients and their relatives. Thus they are increasingly being considered for improving the delivery of health care services also in light of clinical and technological achievements that propose new treatments requiring a tighter interaction among patients and physicians. Methods: The multiagent paradigm has been utilized within an architecture for delivering telemedicine services to chronic outpatients at their domiciles and enforcing cooperation among patients, caregivers, and different members of the health care staff. The architecture sees each communication device such as a palmtop, smart phone, or personal digital assistant as a separate agent upon which different services are deployed, including telemetry, reminders, notifications, and alarms. Decoupling services from agents account for a highly configurable environment applicable to almost any context that can be customized as needed. Results: The architecture has been used for designing and implementing a prototypical software infrastructure, called LifePhone, that runs on several communication devices. A basic set of services has been devised with which we were able to configure two different applications that address long-term and short-term monitoring scenarios for diabetes patients. The long-term scenario encompasses telemetry and reminder services for patients undergoing peritoneal dialysis, which is a treatment for chronic renal failure, a diabetes complication. The short-term scenario incorporates telemetry and remote alarms and is applicable for training patients to use an artificial pancreas. Conclusions: Our experiments proved that an infrastructure such as LifePhone can be used successfully for bridging the interaction gap that exists among all the components of a health care delivery process, improving the quality of service and possibly reducing the overall costs of health care. Furthermore, the modularity of services allows for more complex scenarios encompassing data analysis or even involving actors at multiple institutions in order to better support the overall health care organization.
Self-Monitoring of Cardiac Autonomic Function at Home is Feasible
Authors: Fleischer Jesper , Nielsen Roni , Laugesen Esben , Nygaard Hans , Poulsen Per Logstrup , Ejskjaer Niels 
Published: January 2014

Background: Cardiovascular autonomic neuropathy (CAN) is associated with diabetes and may be related to the development of hypertension, ischemic stroke, and a number of other late complications. The earliest sign of CAN is a reduction of heart rate variability (HRV). Standard HRV tests for CAN include expiration-to-inspiration ratio, response to active standing (30:15), and the Valsalva maneuver. Because of the technical requirements for these tests, they are limited to the point-of-care Office or a clinical laboratory setting. It is unknown if a “white-coat” phenomenon exists in autonomic neuropathy testing and if home testing is feasible. The aims of this study were (1) to evaluate the reproducibility of CAN testing in a clinical setting, (2) to evaluate the feasibility of self-monitoring of cardiovascular autonomic function at home, and (3) report possible differences in measurements taken at the hospital versus those taken at home. Method: Ten healthy subjects were included. Participants underwent in-hospital testing for CAN before and after home monitoring. For 6 consecutive days, participants measured autonomic function once a day at home. The intra- and interindividual reproducibility was determined by coefficient of variation (CV) and the reproducibility coefficient (RC). Agreement between hospital and home testing was analyzed using Pearson r, mean difference, and Bland-Altman analysis with Pitman's test of difference in variance. Results: Pitman's test showed no Significant difference in variance between hospital and home measurements, indicating suitable agreement between the two measurements. Reproducibility was moderate to high in all measures, with RC ranging from 66–94% and CV ranging from 5–10%. Conclusions: Home testing of CAN is feasible. The evaluations showed no Significant systematic error of in-hospital testing compared with self-monitoring at home. In this study, we were not able to demonstrate the presses of “white coat” effect in standard cardiovascular reflex tests.
Guidelines for Optimal Bolus Calculator Settings in Adults
Authors: Walsh John , Roberts Ruth , Bailey Timothy 
Published: January 2014

Bolus insulin calculators (BCs) became available in insulin pumps in 2002 and are being integrated into glucose meters and portable device applets for use with multiple daily injections. A retrospective analysis of continuous subcutaneous insulin infusion data from the Actual Pump Practices (APP) study is used in this article to generate formulas for more precise BC settings. A well-designed BC determines accurate bolus doses for carbohydrate intake and for correcting elevated glucose levels. It should also provide the logic necessary to track residual bolus insulin and reduce bolus recommendations to minimize insulin stacking. To provide appropriate bolus doses, a BC requires accurate settings for the carbohydrate factor or insulin:carbohydrate ratio, glucose correction factor, duration of insulin action, and correction target. We provide guidelines to select BC settings from the user's current total daily dose (TDD) of insulin and to determine more appropriate BC settings from an improved TDD based on the mean glucose level.
Performance of the CONTOUR® TS Blood Glucose Monitoring System
Authors: Frank Joy , Wallace Jane F. , Pardo Scott , Parkes Joan Lee 
Published: January 2014

Background: Self-monitoring of blood glucose (SMBG) remains an important component of diabetes management, engendering a need for affordable blood glucose (BG) meters that are accurate, precise, and convenient. The CONTOUR® TS is a BG meter that endeavors to meet this need. It uses glucose dehydrogenase/flavin dinucleotide chemistry, automatic test strip calibration, and autocompensation for hematocrit along with the ease of use that has come to be expected of a modern meter. The objective of this clinical trial was to determine whether the CONTOUR TS system met these criteria. Methods: The system was evaluated at a single clinical site with 106 subjects with type 1 or type 2 diabetes. Blood glucose values ranged from 60 to 333 mg/dl over all subjects. Both lay users and health care professionals (HCPs) tested the meters, with test strips from three different lots. Results were compared to a reference analyzer of verified precision and accuracy. Forty-nine of the subjects also participated in a home study of the meter. Lay users learned to use the system without assistance and were surveyed on its use at the end of the study. Results: When used with capillary blood, both subjects and HCPs obtained results that exceeded the International Organization for Standardization 15197:2003 criteria, (i.e., ≥95% of values fell within 20% or 15 mg/dl of the laboratory value for BG levels greater than or less than 75 mg/dl, respectively). Specifically, lay users achieved 97.9% and HCPs 98.6%. When used with venous blood, 99.8% of measurements were within the criteria. All measurements for both capillary and venous blood fell into zones A or B of the Parkes error grid, deemed clinically accurate. Hematocrit was found to have no influence on BG measurements. A large majority of the subjects found the system easy to learn and to use. Conclusions: The CONTOUR TS BG meter system gave accurate and reproducible results with both capillary and venous blood; subjects learned to use the meter system by following the user guide and quick reference guide.