bluuebunny/crossref_metadata_2025_split huggingface dataset:
Paper Electrocardiograph Strips May Contain Overlooked Clinical Information in Screen-Detected Type 2 Diabetes Patients
Authors: Fleischer Jesper , Charles Morten , Tarnow Lise , Jensen Klaus Skovbo , Nygaard Hans , Sandbaek Annelli , Ejskjaer Niels 
Published: January 2014

Background: A large number of nondigitized electrocardiograph (ECG) strips are routinely collected in larger cohort studies such as the ADDITION study (Anglo-Danish-Dutch Study of Intensive Treatment in People with Screen-Detected Diabetes in Primary Care). These ECG strips are routinely read manually but may contain overlooked information revealing cardiac autonomic dysfunction. The aim of this study was to investigate whether clinical information may be lost using manual R wave to R wave (RR) interval measurements in the calculation of heart rate variability (HRV) in patients with type 2 diabetes mellitus (T2DM). Method: From the Danish part of the ADDITION study, we randomly selected 120 T2DM patients at baseline of the ADDITION study. Analysis of the ECG strips was performed using two different methods: (1) by experienced technicians using rulers and (2) by experienced technicians using a high-resolution computer-assisted method. Calculation of heart rate and time domain HRV [standard deviation of normal-to-normal RR intervals (SDNN) and root mean square of successive differences (RMSSD)] were performed with the same software. Results: When comparing results from the two methods, the following values of Pearson's r are obtained: 0.98 for heart rate, 0.76 for SDNN, and 0.68 for RMSSD. These results indicate that heart rate and HRV measurements by the computer-assisted and manually based methods correlate. However, Bland-Altman plots and Pitman's test of difference in variance revealed poor agreements ( p < .01) for both HRV measurements (SDNN and RMSSD); only heart rate showed substantiated agreement ( p = .54) between the two methods. Low HRV was statistically significantly associated to high heart rate, systolic blood pressure, and diastolic blood pressure in these screen-detected T2DM patients. Conclusions: Paper ECG strips may contain overlooked clinical information on the status of autonomic function in patients with T2DM. In our study, manual measurements of RR intervals were inferior to the computer-assisted method. Based on this study, we recommend cautiousness in the clinical use and interpretation of HRV based on manual or low resolution measurements of RR intervals from ECG strips. High resolution measurements of RR intervals reveal significant associations between low HRV and high heart rate, systolic blood pressure, and diastolic blood pressure among patients with screen-detected T2DM. It is feasible to use a computer-assisted method to determine RR intervals in patients with T2DM.
Accessibility Attributes of Blood Glucose Meter and Home Blood Pressure Monitor Displays for Visually Impaired Persons
Authors: Blubaugh Morgan V. , Uslan Mark M. 
Published: January 2014

The vast majority of diabetes-related self-management technology utilizes small visual displays (SVDs) that often produce a low level of contrast and suffer from high levels of reflection (glare). This is a major accessibility issue for the 3.5 million Americans with diabetes who have reduced vision. The purpose of this article is to gather comparative data on the key display attributes of the SVDs used in blood glucose meters (BGMs) and home blood pressure monitors (HBPMs) on the market today and determine which displays offer the best prospect for being accessible to people with reduced vision. Nine BGMs and eight HBPMs were identified for this study on the basis of amount of devices sold, full-functionality speech output, and advanced display technologies. An optical instrumentation system obtained contrast, reflection (glare), and font height measurements for all 17 displays. The contrast, reflection, and font-height values for the BGMs and HBPMs varied greatly between models. The Michelson contrast values for the BGMs ranged from 11% to 98% and font heights ranged 0.39–1.00 in. for the measurement results. The HBPMs had Michelson contrast values ranging 55–96% and font height ranging 0.28–0.94 in. for the measurement results. Due largely to the lack of display design standards for the technical requirements of SVDs, there is tremendous variability in the quality and readability of BGM and HBPM displays. There were two BGMs and one HBPM that exhibited high-contrast values and large font heights, but most of the devices exhibited either poor contrast or exceptionally high reflection.
Creating Low Vision and Nonvisual Instructions for Diabetes Technology: An Empirically Validated Process
Authors: Williams Ann S. 
Published: January 2014

Introduction: Nearly 20% of the adults with diagnosed diabetes in the United States also have visual impairment. Many individuals in this group perform routine diabetes self-management tasks independently often using technology that was not specifically designed for use by people with visual impairment (e.g., insulin pumps and pens). Equitable care for persons with disabilities requires providing instructions in formats accessible for nonreaders. However, instructions in accessible formats, such as recordings, braille, or digital documents that are legible to screen readers, are seldom available. Method: This article includes a summary of existing guidelines for creating accessible documents. The guidelines are followed by a description of the production of accessible nonvisual instructions for use of insulin pens used in a study of dosing accuracy. The study results indicate that the instructions were used successfully by 40 persons with visual impairment. Discussion and Conclusions: Instructions in accessible formats can increase access to the benefits of diabetes technology for persons with visual impairment. Recorded instructions may also be useful to sighted persons who do not read well, such as those with dyslexia, low literacy, or who use English as a second language. Finally, they may have important benefits for fully sighted people who find it easier to learn to use technology by handling the equipment while listening to instructions. Manufacturers may also benefit from marketing to an increased pool of potential users.
Glucose Measurement of Intensive Care Unit Patient Plasma Samples Using a Fixed-Wavelength Mid-Infrared Spectroscopy System
Authors: Krinsley James , Bochicchio Kelly , Calentine Christopher , Bochicchio Grant 
Published: January 2014

Objective: Glycemic control is a rapidly developing field in intensive care medicine with the aim of reducing mortality, morbidity, and cost. Current intensive care unit (ICU) glucose measurement technologies are susceptible to interference from medications, volume expanders, and other substances present in critically ill patients. We hypothesized that a fixed-wavelength mid-infrared (mid-IR) spectroscopy system would be accurate for measuring glucose levels of ICU patients. Research Design and Methods: This is a prospective investigation of plasma samples from two different institutions treating a heterogeneous population of ICU patients. The first 292 samples were collected from 86 patients admitted to Stamford Hospital, and the next 352 samples were collected from 75 patients from three ICUs at the University of Maryland. Plasma samples were measured on a Fourier-transform infrared or a proprietary spectrometer, with a glucose prediction algorithm to correct for spectral interference, which were compared with reference measurements taken using a YSI 2300 glucose analyzer. Results: Glucose values ranged from 24 to 343 mg/dl. Numerous medications and injury/disease states were observed in the patient populations, with metoprolol, fentanyl, and multiple organ failure the most prevalent. Despite these interferents, there was a high correlation ( r ≥ 0.94) and low standard error (≤12.8 mg/dl) between the predicted glucose values and those of the YSI 2300 STAT Plus reference instrument in the three studies. A total of 95.1% of the 644 values in the three studies met International Organization for Standardization 15197 criteria. Conclusion: These results suggest that a fixed-wavelength mid-IR spectrometer can measure glucose accurately in the plasma of ICU patients.
Clinical Performance of a Device That Applies Local Heat to the Insulin Infusion Site: A Crossover Study
Authors: Freckmann Guido , Pleus Stefan , Westhoff Antje , Krinelke Lars G. , Buhr Andreas , Jendrike Nina , Haug Cornelia 
Published: January 2014

Background: Fast-acting insulin analogs have been available since 1996. The absorption rate of these insulins is still too slow to mimic the physiological insulin action in healthy subjects. This study investigates the clinical performance of InsuPatch™, a local skin-heating device, on postprandial glucose excursion. Methods: Twenty-four type 1 diabetes mellitus subjects on continuous subcutaneous insulin infusion were included in this crossover study [10 male, 14 female, age: 43.5 ± 11.3 years, diabetes duration: 18.3 ± 10.5 years, glycosylated hemoglobin: 7.4 ± 0.8%, body mass index: 25.0 ± 3.0 kg/m2 (mean ± standard deviation)]. The impact of local skin heating was measured by dividing the two-hour area under the curve by integration time (AUC/t120) for blood glucose (BG) above baseline after two standardized breakfast and dinner meal pairs (with and without heating) per subject. For the first breakfast pair, venous insulin concentration was also measured. Results: A significant reduction was found for the AUC/t120 after breakfast and after dinner meals (42 breakfast meal pairs, AUC/t120 not heated 66.4 ± 32.8 mg/dl vs heated 56.8 ± 34.0 mg/dl, p = .017; 38 dinner meal pairs, AUC/t120 not heated 30.8 ± 31.0 mg/dl vs heated 18.4 ± 23.9 mg/dl, p = .0028). The maximum venous insulin concentration with heating was 27% higher than without heating ( n = 23). The number of hypoglycemic events on days with heating ( n = 9) was similar to the number of days without heating ( n = 13). Conclusions: Local heating of the skin around the infusion site significantly reduced postprandial BG by enhancing insulin absorption. The heating device was well tolerated, and it could facilitate development of closed-loop systems.
Comparison of Insulin Diluent Leakage Postinjection Using Two Different Needle Lengths and Injection Volumes in Obese Patients with Type 1 or Type 2 Diabetes Mellitus
Authors: Ignaut Debra A. , Fu Haoda 
Published: January 2014

Background: Smaller gauge, shorter needles have been shown to be as safe and effective for insulin delivery as longer needles in many patients. However, in obese patients with diabetes, results have been inconsistent with regard to the impact of needle length on leakage of injectate. Methods: A single-blind, randomized, two-period, crossover study compared injections with 5 mm needles to 8 mm needles regarding leakage, pain, bleeding, and bruising at abdominal injection sites in obese patients with diabetes using 20- and 60-unit (U) volume equivalent injections of sterile insulin diluent. Results: Fifty-six patients (54% male; mean age 56 years; mean body mass index of 36 kg/m2) with type 1 ( n = 13) or type 2 ( n = 43) diabetes participated. Median leakage (U) was similar for both needles [0.04 (5 mm/20 U) vs 0.02 (8 mm/20 U), P = .32; and 0.04 (5 mm/60 U) vs 0.02 (8 mm/60 U), P = 48]. Pain scores (mean) were similar [1.27 (5 mm/20 U) vs 1.14 (8 mm/20 U), P = .75, and 1.68 (5 mm/60 U) vs 0.95 (8 mm/60 U, P = .21)]. The proportion of injections with bleeding [10.8% (5 mm/20 U) vs 5.83% (8 mm/20 U), P = .23, and 4.92% (5 mm/60 U) vs 6.56% (8 mm/60 U), P = .73] and the proportion of patients with bruising [8.11% (5 mm/20 U) vs 10.81% (8 mm/20 U), p = .56, and 21.05% (5 mm/60 U) vs 26.32% (8 mm/60 U), p = .65] at injection sites were similar. Mean bruise size (mm) [0.73 (5 mm/20 U] vs 2.68 (8 mm/20 U), P = .23; and 1.11 (5 mm/60 U) vs 4.21 (8 mm/60 U), P = .08] at injection sites was similar. Conclusions: This study supports the suitability of the 5 mm needle for the injection of insulin in obese patients with diabetes.
New Criteria for Assessing the Accuracy of Blood Glucose Monitors Meeting, October 28, 2011
Authors: Walsh John , Roberts Ruth , Vigersky Robert A. , Schwartz Frank 
Published: January 2014

Glucose meters (GMs) are routinely used for self-monitoring of blood glucose by patients and for point-of-care glucose monitoring by health care providers in outpatient and inpatient settings. Although widely assumed to be accurate, numerous reports of inaccuracies with resulting morbidity and mortality have been noted. Insulin dosing errors based on inaccurate GMs are most critical. On October 28, 2011, the Diabetes Technology Society invited 45 diabetes technology clinicians who were attending the 2011 Diabetes Technology Meeting to participate in a closed-door meeting entitled New Criteria for Assessing the Accuracy of Blood Glucose Monitors. This report reflects the opinions of most of the attendees of that meeting. The Food and Drug Administration (FDA), the public, and several medical societies are currently in dialogue to establish a new standard for GM accuracy. This update to the FDA standard is driven by improved meter accuracy, technological advances (pumps, bolus calculators, continuous glucose monitors, and insulin pens), reports of hospital and outpatient deaths, consumer complaints about inaccuracy, and research studies showing that several approved GMs failed to meet FDA or International Organization for Standardization standards in post-approval testing. These circumstances mandate a set of new GM standards that appropriately match the GMs' analytical accuracy to the clinical accuracy required for their intended use, as well as ensuring their ongoing accuracy following approval. The attendees of the New Criteria for Assessing the Accuracy of Blood Glucose Monitors meeting proposed a graduated standard and other methods to improve GM performance, which are discussed in this meeting report.
New Bundled World: Quality of Care and Readmission in Diabetes Patients
Authors: Chen Judy Y. , Ma Qiufei , Chen Hua , Yermilov Irina 
Published: January 2014

Background: Hospital readmissions among patients with diabetes are substantial and costly. Although prior studies have shown that receipt of outpatient quality of care significantly reduces the risk of hospitalization among patients with diabetes, little is known about its impact on hospital readmission. The objective of this study is to assess the impact of outpatient quality of care on 30-day readmission among patients with diabetes. Methods: We used deidentified administrative claims data from the IMS LifeLink and included commercially insured diabetes patients ≥ 19 years old discharged from hospitals in the United States in 2009 and 2010 ( n = 30,139). The outcome was readmission within 2–30 days of discharge. The main independent variables were receipt of outpatient quality-of-care measures (i.e., two hemoglobin A1c tests, low-density lipoprotein (LDL) test, 90-day supply of statin, and 90-day supply of angiotensin-converting enzyme inhibitors/angiotensin receptor blockers). Multivariate logistic regression was used to examine the impact of outpatient quality of care on hospital readmission while controlling for demographics, clinical characteristics, health care utilization, and insurance type in the year prior to admission. Results: Overall 30-day readmission rates among patients with diabetes were 18.9%. Patients who received at least one LDL test [odds ratio (OR) = 0.918, 95% confidence interval (CI; 0.852 0.989), p < .025] and ≥90-day supply of statins (OR = 0.91, 95% CI [0.85 0.97], p < .01) were less likely to be readmitted to the hospital. Conclusions: Receipt of LDL testing and adherence to statin medications were effective in decreasing the likelihood of 30-day hospital readmission and may be considered as elements of a quality focused incentive-based health care delivery package for diabetes patients.
Prediction of the Risk to Develop Diabetes-Related Late Complications by Means of the Glucose Pentagon Model: Analysis of Data from the Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study
Authors: Thomas Andreas , Heinemann Lutz 
Published: January 2014

Background: By taking parameters into account that describe the variability of continuously monitored glucose and long-term metabolic control [hemoglobin A1c (HbA1c)], the glucose pentagon model (GPM) allows characterization of the glucose profile of individual patients with diabetes in a graphical format. A glycemic risk parameter (GRP) derived from this model might allow a better prognosis of the risk to develop diabetes-related complications than the HbA1c. Methods: To evaluate this hypothesis, we analyzed a subset of data from the Juvenile Diabetes Research Foundation continuous glucose monitoring (CGM) study. The values of the different parameters that are integrated in the GPM were extracted automatically from CGM profiles registered before and after 6 months by means of the Medtronic CGM system in 108 patients. Results: In these patients, the significant reduction in HbA1c from 7.4% to 7.0% was accompanied by a reduction in glycemia from 164 to 156 mg/dl, standard deviation from 61 to 57 mg/dl, area under the curve >160 mg/dl 29.2 to 23.1, and time per day >160 mg/dl 634 to 576 min. This led to a subsequent reduction in GRP from 3.3 to 2.7; this decrease by 18.2% was significantly larger than that in HbA1c by 8.6% ( p < .001). Changes in individual GPMs/GRPs support this observation. They also show the impact of high glycemic variability on GPM/GRP. Conclusions: Our analysis of data of a study with a considerable sample size and study duration showed that the GPM is not only helpful for rapid assessment of individual glycemic profiles and how therapeutic interventions influence these, but also appears to provide a better prognosis of the risk to develop late complications than the HbA1c per se. However, it is also clear that a true validation of such a model requires performance of a long-term study in a large number of patients with diabetes.
A Bio-Inspired Glucose Controller Based on Pancreatic β-Cell Physiology
Authors: Herrero Pau , Georgiou Pantelis , Oliver Nick , Johnston Desmond G , Toumazou Christofer 
Published: January 2014

Introduction: Control algorithms for closed-loop insulin delivery in type 1 diabetes have been mainly based on control engineering or artificial intelligence techniques. These, however, are not based on the physiology of the pancreas but seek to implement engineering solutions to biology. Developments in mathematical models of the β-cell physiology of the pancreas have described the glucose-induced insulin release from pancreatic β cells at a molecular level. This has facilitated development of a new class of bio-inspired glucose control algorithms that replicate the functionality of the biological pancreas. However, technologies for sensing glucose levels and delivering insulin use the subcutaneous route, which is nonphysiological and introduces some challenges. In this article, a novel glucose controller is presented as part of a bio-inspired artificial pancreas. Methods: A mathematical model of β-cell physiology was used as the core of the proposed controller. In order to deal with delays and lack of accuracy introduced by the subcutaneous route, insulin feedback and a gain scheduling strategy were employed. A United States Food and Drug Administration-accepted type 1 diabetes mellitus virtual population was used to validate the presented controller. Results: Premeal and postmeal mean ± standard deviation blood glucose levels for the adult and adolescent populations were well within the target range set for the controller [(70, 180) mg/dl], with a percent time in range of 92.8 ± 7.3% for the adults and 83.5 ± 14% for the adolescents. Conclusions: This article shows for the first time very good glucose control in a virtual population with type 1 diabetes mellitus using a controller based on a subcellular β-cell model.
Predicting Subcutaneous Glucose Concentration Using a Latent-Variable-Based Statistical Method for Type 1 Diabetes Mellitus
Authors: Zhao Chunhui , Dassau Eyal , Jovanovič Lois , Zisser Howard C. , Doyle Francis J. , Seborg Dale E. 
Published: January 2014

Background: Accurate prediction of future glucose concentration for type 1 diabetes mellitus (T1DM) is needed to improve glycemic control and to facilitate proactive management before glucose concentrations reach undesirable concentrations. The availability of frequent glucose measurements, insulin infusion rates, and meal carbohydrate estimates can be used to good advantage to capture important information concerning glucose dynamics. Methods: This article evaluates the feasibility of using a latent variable (LV)-based statistical method to model glucose dynamics and to forecast future glucose concentrations for T1DM applications. The prediction models are developed using a proposed LV-based approach and are evaluated for retrospective clinical data from seven individuals with T1DM and for In silico simulations using the Food and Drug Administration-accepted University of Virginia/University of Padova metabolic simulator. This article provides comparisons of the prediction accuracy of the LV-based method with that of a standard modeling alternative. The influence of key design parameters on the performance of the LV-based method is also illustrated. Results: In general, the LV-based method provided improved prediction accuracy in comparison with conventional autoregressive (AR) models and autoregressive with exogenous input (ARX) models. For larger prediction horizons (=30 min), the LV-based model with exogenous inputs achieved the best prediction performance based on a paired t-test (α = 0.05). Conclusions: The LV-based method resulted in models whose glucose prediction accuracy was as least as good as the accuracies of standard AR/ARX models and a simple model-free approach. Furthermore, the new approach is less sensitive to changing conditions and the effect of key design parameters.
Efficacy of Olibra: A 12-Week Randomized Controlled Trial and a Review of Earlier Studies
Authors: Rebello Candida J. , Martin Corby K. , Johnson William D. , O'Neil Carol E. , Greenway Frank L. 
Published: January 2014

Background: Intervention strategies that harness the body's appetite and satiety regulating signals provide a means of countering excessive energy intake. Methods: Eighty-two subjects were enrolled (18–60 years, body mass index: 25–40 kg/m2) in a randomized, placebo-controlled, double-blind, parallel trial. During a 12-week period, the effects of Olibra™ fat emulsion (2.1 g twice daily) on food intake, appetite, satiety, weight, and body composition were compared with those of a twice daily administered placebo (1.95 g milk fat). On days −7, 0, and 28, Olibra or the placebo added to 200 g of yogurt was served at breakfast and lunch. Food intake, appetite, and satiety were assessed after lunch and dinner. Body weight was measured on days −7, 0, 14, 28, 56, and 84. Body fat, waist circumference, and waist-hip ratio were determined on days 0 and 84. The Eating Inventory was administered at screening and on day 28. Data relating to 71 subjects were analyzed using analysis of covariance. Results: At 12 weeks, body weight was reduced in the test group (2.17 ± 0.46 kg standard error of the mean, p < .0001) and the control group (1.68 ± 0.42 kg, p < .0001). Waist circumference decreased by 2.93 ± 0.85 cm in the test group ( p = .001) and by 1.78 ± 0.74 cm in the control group ( p = .02). differential weight and waist circumference reductions were not significant. Hunger scores (Eating Inventory) decreased more in the test group ( p = .0082). differential group effects were not significant for body fat, waist-hip ratio, food intake, appetite, and satiety. Conclusions: At this dose, Olibra did not exert a consistent effect on food intake, appetite regulation, body weight, or body composition.