bluuebunny/crossref_metadata_2025_split huggingface dataset:
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.
Intra-Individual Variability of the Metabolic Effect of a Novel Rapid-Acting Insulin (VIAject™) in Comparison to Regular Human Insulin
Authors: Hompesch Marcus , McManus Laura , Pohl Roderike , Simms Patrick , Pfützner Andreas , Bülow Elena , Flacke Frank , Heinemann Lutz , Steiner Solomon S. 
Published: January 2014

Background: The variability of the metabolic action of insulin after subcutaneous (sc) injection hampers optimal insulin therapy. Insulin formulations with a reduced tendency to form hexamers might exhibit a reduced variability of absorption from the sc insulin depot into the blood stream. Methods: We investigated the within-subject variability of pharmacodynamic and pharmacokinetic properties of an ultra-fast insulin (UFI) formulation and regular human insulin (RHI) in patients with type 1 diabetes. Fourteen patients participated in six 10-hour euglycemic glucose clamp experiments. In this double-blind, crossover study, subjects were randomly assigned to a sequence of two experimental blocks: Each block consisted of three doses of 0.1 IU/kg UFI or RHI, respectively, administered on separate days by abdominal sc injection. Results: Ultra-fast insulin has an earlier onset of action and shorter time to maximal plasma insulin concentration when compared to RHI (tGIRmax 99 ± 36 min vs. 154 ± 74 min, p = 0.002; tCmax 33 ± 16 min vs. 97 ± 39 min, p = 0.00001). The within-subject variability of plasma insulin tCmax ( p = 0.027) and of tGIRmax ( p = 0.022) was less for UFI than for RHI. Conclusions: In patients with type 1 diabetes, this UFI showed reduced within-subject variability when compared with RHI.
An Electronic Protocol for Translation of Research Results to Clinical Practice: A Preliminary Report
Authors: Morris Alan H. , Orme James , Rocha Beatriz H. , Holmen John , Clemmer Terry , Nelson Nancy , Allen Jode , Jephson Al , Sorenson Dean , Sward Kathy , Warner Homer ,   for the Reengineering Critical Care Clinical Research Investigators6
Published: January 2014

Introduction: We evaluated the feasibility of using an electronic protocol developed for research use (Research-eProtocol-insulin) for blood glucose management in usual intensive care unit clinical practice. Methods: We implemented the rules of Research-eProtocol-insulin in the electronic medical record of the Intermountain Healthcare hospital system (Clinical-eProtocol-insulin) for use in usual clinical practice. We evaluated the performance of Clinical-eProtocol-insulin rules in the intensive care units of seven Intermountain Healthcare hospitals and compared this performance with the performance of Research-eProtocol-insulin at the LDS Hospital Shock/Trauma/Respiratory Intensive Care Unit. Results: Clinician (nurse or physician) compliance with computerized protocol recommendations was 95% (of 21,325 recommendations) with Research-eProtocol-insulin and 92% (of 109,458 recommendations) with Clinical-eProtocol-insulin. The blood glucose distribution in clinical practice (Clinical-eProtocol-insulin) was similar to the research use distribution (Research-eProtocol-insulin); however, the mean values (119 mg/dl vs 113 mg/dl) were statistically different ( P = 0.0001). Hypoglycemia rates in the research and practice settings did not differ: the percentage of measurements ≤40 mg/dl (0.11% vs 0.1%, P = 0.65) and the percentage of patients with at least one blood glucose ≤40 mg/dl (4.2% vs 3%, P = 0.23) were not statistically significantly different. Conclusion: Our electronic blood glucose protocol enabled translation of a research decision-support tool (Research-eProtocol-insulin) to usual clinical practice (Clinical-eProtocol-insulin).
The DURABLE Trial Study Design: Comparing the Safety, Efficacy, and Durability of Insulin Glargine to Insulin Lispro Mix 75/25 Added to Oral Antihyperglycemic Agents in Patients with Type 2 Diabetes
Authors: Fahrbach Jessie , Jacober Scott , Jiang Honghua , Martin Sherry 
Published: January 2014

Background: While studies have compared the safety and efficacy of starter insulin regimens in type 2 diabetes, none have evaluated regimen durability (length of time a patient can maintain glycemic control) or the safety and efficacy of subsequent intensification regimens in a large, multinational cohort. Methods: The DURABLE (Assessing the DURAbility of Basal vs Lispro Mix 75/25 Insulin Efficacy) trial will compare the ability of glargine once daily vs lispro mix 75/25 (75% insulin lispro protamine suspension, 25% lispro) twice daily added to oral antihyperglycemic agents to achieve and maintain hemoglobin A1c (HbA1c) goals. This randomized, open label, parallel study will enroll over 2000 insulin-naïve patients with type 2 diabetes from 11 countries, ages 30 to 80, with HbA1c >7.0% on at least two oral antihyperglycemic agents. At the completion of the 6-month initiation phase, safety and efficacy of the two regimens will be compared. Patients who achieve an HbA1c ≤7.0% at 6 months will continue into the 24-month maintenance phase to evaluate durability. In a substudy, patients not achieving HbA1c ≤7.0% at 6 months may be randomized to one of two intensification comparisons: patients previously on glargine will receive lispro mix 75/25 twice daily or basal/bolus therapy (glargine + thrice-daily mealtime lispro) and patients previously on lispro mix 75/25 will receive lispro mix 50/50 (50% insulin lispro protamine suspension, 50% lispro) thrice daily or basal/bolus therapy. Results: Upon completion, this trial will provide new information about starter insulin durability, defined as the length of time patients can maintain HbA1c control (HbA1c ≤7.0%, or >7.0% but with an increase of <0.4% from the most recent HbA1c ≤7.0%). Additionally, the study will provide comparative data on HbA1c, blood glucose profiles, 1,5-anhydroglucitol, hypoglycemic episodes, weight change, and insulin dose for starter insulin regimens following 6 and 24 months of treatment, as well as intensified insulin via the 6-month substudy. Conclusion: This trial aims to broaden clinicians' understanding of the ability of starter insulin and insulin intensification regimens to achieve and maintain glycemic control in patients with type 2 diabetes.
A Review of Glycated Albumin as an Intermediate Glycation Index for Controlling Diabetes
Authors: Roohk H. Vernon , Zaidi Asad R. 
Published: January 2014

Introduction: This article reviews glycated albumin (GA) as a potential intermediate-term glycation index to fill the gap between self-monitoring of blood glucose (SMBG) and hemoglobin A1c testing in diabetes management. The introduction gives an assessment of available short-, medium-, and long-term glycemic indicators. Methodologies and Utility: Methods of GA measurement are summarized, and the variance of normal and diabetic GA values are discussed. Greatest uniformity in GA measurement is generally associated with immunoassay and the newer affinity chromatography methodologies utilized by reference laboratories. Utility of GA measurement includes its value as a marker for glycation, its substantial relationship to diabetes complications such as nephropathy and coronary artery disease, and as an unambiguous indicator of glycemic control in diabetes patients undergoing hemodialysis. Studies support the utility of GA in detecting short-term changes in glycemic control, and GA testing has been strongly recommended for gestational diabetes. Results and Discussion: The results of a survey with mailings to over 3500 diabetes care professionals primarily in the United States are outlined and analyzed (margin of error: +/-6.5%, 95% confidence). Respondents strongly supported the need for a test for intermediate glycemic control as well as the utility of a rapid GA test as a monthly glycemic indicator. Conclusions: Such a test, as yet unavailable, could increase compliance and enhance empowerment among diabetes patients. It also has the potential to reduce the number of recommended SMBG tests, which may result in significant health care cost savings.
Temporal and Geographic Patterns of Hypoglycemia among Hospitalized Patients with Diabetes Mellitus
Authors: Bailon Rachel M. , Cook Curtiss B. , Hovan Michael J. , Hull Bryan P. , Seifert Karen M. , Miller-Cage Victoria , Beer Karen A. , Boyle Mary E. , Littman Stephanie D. , Magallanez Janice M. , Fischenich Joanne M. , Harris Jana K. , Scoggins Susie S. , Uy Josephine 
Published: January 2014

Background: Hypoglycemia is often cited as a barrier to achieving inpatient glycemic targets. We sought to characterize hypoglycemic events in our institution by work-shift cycle and by specific treatment area. Methods: Capillary (bedside) and blood (laboratory) glucose values of <70 mg/dl for patients with either a known diagnosis of diabetes or with evidence of hyperglycemia were abstracted from our laboratory database for hospitalizations between October 1, 2007, and February 3, 2008. Hypoglycemic events were analyzed by 12 h nursing work-shift cycles (day shift, 07:00 to 18:59; night shift, 19:00 to 06:59) and by the six medical, surgical, and intensive care areas in the hospital (designated areas 1 to 6). Results: We identified 206 individual patients with either diabetes or hyperglycemia (mean age, 67 years; 56% men; 83% white) who had 423 hypoglycemic events. There were 78% more hypoglycemic events during the night shift ( n = 271 events in 128 individual patients) than during the day shift ( n = 152 events in 96 individual patients). Most of the night-shift hypoglycemic measurements were detected between 04:00 and 04:59 or 06:00 and 06:59. The mean hypoglycemic level was comparable between shifts ( p = .79) and across the six inpatient areas. The number of hypoglycemic events per person increased with lengths of hospital stay >5 days. The prevalence of hypoglycemia varied across patient care areas within the hospital, with most (28%) detected in one area of the hospital. Conclusion: There are temporal and geographic patterns in the occurrence of hypoglycemia among patients with diabetes or hyperglycemia in our hospital. Further study should focus on the reasons underlying these variations so that specific interventions can address the risk of hypoglycemia during peak times and places.
Fabrication of Polymer Microneedles Using a Two-Photon Polymerization and Micromolding Process
Authors: Gittard Shaun D. , Ovsianikov Aleksandr , Monteiro-Riviere Nancy A. , Lusk Jason , Morel Pierre , Minghetti Paola , Lenardi Cristina , Chichkov Boris N. , Narayan Roger J. 
Published: January 2014

Background: Microneedle-mediated drug delivery is a promising method for transdermal delivery of insulin, incretin mimetics, and other protein-based pharmacologic agents for treatment of diabetes mellitus. One factor that has limited clinical application of conventional microneedle technology is the poor fracture behavior of microneedles that are created using conventional materials and methods. In this study polymer microneedles for transdermal delivery were created using a two-photon polymerization (2PP) microfabrication and subsequent polydimethylsiloxane (PDMS) micromolding process. Methods: Solid microneedle arrays, fabricated by means of 2PP, were used to create negative molds from PDMS. Using these molds microneedle arrays were subsequently prepared by molding eShell 200, a photo-reactive acrylate-based polymer that exhibits water and perspiration resistance. Results: The eShell 200 microneedle array demonstrated suitable compressive strength for use in transdermal drug delivery applications. Human epidermal keratinocyte viability on the eShell 200 polymer surfaces was similar to that on polystyrene control surfaces. In vitro studies demonstrated that eShell 200 microneedle arrays fabricated using the 2PP microfabrication and PDMS micromolding process technique successfully penetrated human stratum corneum and epidermis. Conclusions: Our results suggest that a 2PP microfabrication and subsequent PDMS micromolding process may be used to create microneedle structures with appropriate structural, mechanical, and biological properties for transdermal drug delivery of insulin and other protein-based pharmacologic agents for treatment of diabetes mellitus.
Diabetes Connected Health: A Pilot Study of a Patient- and Provider-Shared Glucose Monitoring Web Application
Authors: Watson Alice J. , Kvedar Joseph C. , Rahman Basmah , Pelletier Alexandra C. , Salber Gregory , Grant Richard W. 
Published: January 2014

Background: Real-time sharing of blood glucose results with providers could improve communication and lead to more timely medication titration. New technology platforms are available to support the delivery of innovative models of care delivery. Methods: In the Diabetes Connected Health (DCH) pilot study, patients with diabetes received access to an online application that stored and graphed glucose readings uploaded from a standard glucometer. Both patients and providers had access to this Web site, where data could be viewed, analyzed, and discussed. To examine the impact of the DCH program, we assessed adoption of the program, patient and provider satisfaction, frequency of use, and changes in glucose levels over a period of 3 months. Results: The mean age of the 7 pilot participants was 51 (range 35–65). Participants sent in an average of 50 readings in Month 1 and 38 readings in Month 3 and made, on average, 6 comments in Months 1 and 12 comments in Month 3. The mean blood glucose range decreased in Month 3 versus Month 1 (141.1 and 146.5, respectively). Self-reported HbA1c fell from 6.8% at the start of the study to 5.8% at the end. Five/seven participants described the site as excellent or good. Qualitative data analysis highlighted key benefits of the program as well as areas for improvement. Conclusions: This pilot study of a shared glucose monitoring Web application was well received by patients. Programs like this may lead to improvements in the quality of clinical care delivered to people with type 2 diabetes.
Use of Serial Patient Hemoglobin A1c Differences to Determine Long-Term Imprecision of Immunoassay and High-Performance Liquid Chromatography Analyzers
Authors: Tran David V. , Lyon Andrew W. , Higgins Trefor N. , Wesenberg James C. , Vandergouwe Lisa , Wiley Carmen L. , Cembrowski George S. 
Published: January 2014

Background: The quality of the HbA1c assay is inversely proportional to the variation of the assay. Most published measures of HbA1c variation are limited by the data collection period, the statistical treatment of outliers, and even the noncommutability of the products used to generate the variation measurements. We have used an alternate approach to derive HbA1c variation, using serial patient data. Methods: HbA1c measurements of outpatient blood sample pairs drawn within 30 days of each other were made on three different immunoassay systems: the Roche INTEGRA® 700, the Roche INTEGRA® 400, and the Dade Dimension® RxL; and two high-performance liquid chromatography assays: the Tosoh G7 and the Tosoh 2.2+. The standard deviation of duplicates was calculated for the following time intervals: 1 to 3 days, 4 to 6 days, 7 to 9 days, …, 28 to 30 days. These intra-individual variations were then plotted; extrapolation to time zero yields the long term total random error which consists of both analytic and pre-analytic error. Data collection periods were usually 2 years. Results: At the mean HbA1cs of 7.08%, 7.14%, 7.20%, 6.96%, and 7.51% for populations tested on the Roche INTEGRA 700, Roche INTEGRA 400, Dade Dimension RxL, Tosoh 2.2+, and Tosoh G7, respectively, the total analytic imprecisions (coefficient of variation) were 2.56%, 2.29%, 2.25%, 1.66%, and 1.14%, respectively. Conclusion: Assessment of the HbA1c long term total imprecisions shows that while the three immunoassay systems are acceptable, the Tosoh HbA1c analyzers demonstrate superior analytic performance.
Value of Self-Monitoring Blood Glucose Pattern Analysis in Improving Diabetes Outcomes
Authors: Parkin Christopher G. , Davidson Jaime A. 
Published: January 2014

Self-monitoring of blood glucose (SMBG) is an important adjunct to hemoglobin A1c (HbA1c) testing. This action can distinguish between fasting, preprandial, and postprandial hyperglycemia; detect glycemic excursions; identify and monitor resolution of hypoglycemia; and provide immediate feedback to patients about the effect of food choices, activity, and medication on glycemic control. Pattern analysis is a systematic approach to identifying glycemic patterns within SMBG data and then taking appropriate action based upon those results. The use of pattern analysis involves: (1) establishing pre- and postprandial glucose targets; (2) obtaining data on glucose levels, carbohydrate intake, medication administration (type, dosages, timing), activity levels and physical/emotional stress; (3) analyzing data to identify patterns of glycemic excursions, assessing any influential factors, and implementing appropriate action(s); and (4) performing ongoing SMBG to assess the impact of any therapeutic changes made. Computer-based and paper-based data collection and management tools can be developed to perform pattern analysis for identifying patterns in SMBG data. This approach to interpreting SMBG data facilitates rational therapeutic adjustments in response to this information. Pattern analysis of SMBG data can be of equal or greater value than measurement of HbA1c levels.
Validation of a Multimarker Model for Assessing Risk of Type 2 Diabetes from a Five-Year Prospective Study of 6784 Danish People (Inter99)
Authors: Urdea Mickey , Kolberg Janice , Wilber Judith , Gerwien Robert , Moler Edward , Rowe Michael , Jorgensen Paul , Hansen Torben , Pedersen Oluf , Jørgensen Torben , Borch-Johnsen Knut 
Published: January 2014

Background: Improved identification of subjects at high risk for development of type 2 diabetes would allow preventive interventions to be targeted toward individuals most likely to benefit. In previous research, predictive biomarkers were identified and used to develop multivariate models to assess an individual's risk of developing diabetes. Here we describe the training and validation of the PreDx™ Diabetes Risk Score (DRS) model in a clinical laboratory setting using baseline serum samples from subjects in the Inter99 cohort, a population-based primary prevention study of cardiovascular disease. Methods: Among 6784 subjects free of diabetes at baseline, 215 subjects progressed to diabetes (converters) during five years of follow-up. A nested case-control study was performed using serum samples from 202 converters and 597 randomly selected nonconverters. Samples were randomly assigned to equally sized training and validation sets. Seven biomarkers were measured using assays developed for use in a clinical reference laboratory. Results: The PreDx DRS model performed better on the training set (area under the curve [AUC] = 0.837) than fasting plasma glucose alone (AUC = 0.779). When applied to the sequestered validation set, the PreDx DRS showed the same performance (AUC = 0.838), thus validating the model. This model had a better AUC than any other single measure from a fasting sample. Moreover, the model provided further risk stratification among high-risk subpopulations with impaired fasting glucose or metabolic syndrome. Conclusions: The PreDx DRS provides the absolute risk of diabetes conversion in five years for subjects identified to be “at risk” using the clinical factors.
Factors Affecting Blood Glucose Monitoring: Sources of Errors in Measurement
Authors: Ginsberg Barry H. 
Published: January 2014

Glucose monitoring has become an integral part of diabetes care but has some limitations in accuracy. Accuracy may be limited due to strip manufacturing variances, strip storage, and aging. They may also be due to limitations on the environment such as temperature or altitude or to patient factors such as improper coding, incorrect hand washing, altered hematocrit, or naturally occurring interfering substances. Finally, exogenous interfering substances may contribute errors to the system evaluation of blood glucose. In this review, I discuss the measurement of error in blood glucose, the sources of error, and their mechanism and potential solutions to improve accuracy in the hands of the patient. I also discuss the clinical measurement of system accuracy and methods of judging the suitability of clinical trials and finally some methods of overcoming the inaccuracies. I have included comments about additional information or education that could be done today by manufacturers in the appropriate sections. Areas that require additional work are discussed in the final section.