bluuebunny/crossref_metadata_2025_split huggingface dataset:
Primary Care Provider Perceptions of the Effectiveness of Two Self-Management Support Programs for Vulnerable Patients with Diabetes
Authors: Ratanawongsa Neda , Bhandari Vijay K. , Handley Margaret , Rundall Thomas , Hammer Hali , Schillinger Dean 
Published: January 2014

Background: Primary care providers (PCPs) in safety net settings face barriers to optimizing care for patients with diabetes. We conducted this study to assess PCPs' perspectives on the effectiveness of two language-concordant diabetes self-management support programs. Methods: One year postintervention, we surveyed PCPs whose patients with diabetes participated in a three-arm multiclinic randomized controlled trial comparing usual care (UC), weekly automated telephone self-management (ATSM) support with nurse care management, and monthly group medical visits (GMVs). We compared PCP perspectives on patient activation to create and achieve goals, quality of care, and barriers to care using regression models accounting for within-PCP clustering. Results: Of 113 eligible PCPs caring for 330 enrolled patients, 87 PCPs (77%) responded to surveys about 245 (74%) enrolled patients. Intervention patients were more likely to be perceived by PCPs as activated to create and achieve goals for chronic care when compared with UC patients (standardized effect size, ATSM vs UC, +0.41, p = 0.01; GMV vs UC, +0.31, p = 0.05). Primary care providers rated quality of care as higher for patients exposed to ATSM compared to UC (odds ratio 3.6, p < 0.01). Compared with GMV patients, ATSM patients were more likely to be perceived by PCPs as overcoming barriers related to limited English proficiency (82% ATSM vs 44% GMV, p = 0.01) and managing medications (80% ATSM vs 53% GMV, p = 0.01). Conclusions: Primary care providers perceived that patients receiving ATSM support had overcome barriers, participated more actively, and received higher quality diabetes care. These views of clinician stakeholders lend additional evidence for the potential to upscale ATSM more broadly to support PCPs in their care of diverse, multi-linguistic populations.
Data Entry Errors and Design for Model-Based Tight Glycemic Control in Critical Care
Authors: Ward Logan , Steel James , Le Compte Aaron , Evans Alicia , Tan Chia-Siong , Penning Sophie , Shaw Geoffrey M. , Desaive Thomas , Chase J. Geoffrey 
Published: January 2014

Introduction: Tight glycemic control (TGC) has shown benefits but has been difficult to achieve consistently. Model-based methods and computerized protocols offer the opportunity to improve TGC quality but require human data entry, particularly of blood glucose (BG) values, which can be significantly prone to error. This study presents the design and optimization of data entry methods to minimize error for a computerized and model-based TGC method prior to pilot clinical trials. Method: To minimize data entry error, two tests were carried out to optimize a method with errors less than the 5%-plus reported in other studies. Four initial methods were tested on 40 subjects in random order, and the best two were tested more rigorously on 34 subjects. The tests measured entry speed and accuracy. Errors were reported as corrected and uncorrected errors, with the sum comprising a total error rate. The first set of tests used randomly selected values, while the second set used the same values for all subjects to allow comparisons across users and direct assessment of the magnitude of errors. These research tests were approved by the University of Canterbury Ethics Committee. Results: The final data entry method tested reduced errors to less than 1–2%, a 60–80% reduction from reported values. The magnitude of errors was clinically significant and was typically by 10.0 mmol/liter or an order of magnitude but only for extreme values of BG < 2.0 mmol/liter or BG > 15.0–20.0 mmol/liter, both of which could be easily corrected with automated checking of extreme values for safety. Conclusions: The data entry method selected significantly reduced data entry errors in the limited design tests presented, and is in use on a clinical pilot TGC study. The overall approach and testing methods are easily performed and generalizable to other applications and protocols.
Blood Glucose Meters and Accessibility to Blind and Visually Impaired People
Authors: Burton Darren M. , Enigk Matthew G. , Lilly John W. 
Published: January 2014

In 2007, five blood glucose meters (BGMs) were introduced with integrated speech output necessary for use by persons with vision loss. One of those five meters had fully integrated speech output, allowing a person with vision loss independence in accessing all features and functions of the meter. In comparison, 13 BGMs with integrated speech output were available in 2011. Accessibility attributes of these 11 meters were tabulated and product design features examined. All 13 meters were found to be usable by persons with vision loss to obtain a blood glucose measurement. However, only 4 of them featured the fully integrated speech output necessary for a person with vision loss to access all features and functions independently.
Intrinsic Fibrillation of Fast-Acting Insulin Analogs
Authors: Woods R. Jeremy , Alarcón Javier , McVey Elaine , Pettis Ronald J. 
Published: January 2014

Background: Aggregation of insulin into insoluble fibrils (fibrillation) may lead to complications for diabetes patients such as reduced insulin potency, occlusion of insulin delivery devices, or potentially increased immunological potential. Even after extensive investigation of fibril formation in regular human insulin, there are little published data about the intrinsic fibrillation of fast-acting analogs. This article investigates and compares the intrinsic fibrillation of three fast-acting insulin analogs—lispro, aspart, and glulisine—as a function of their primary protein structure and exclusive of the stabilizing excipients that are added to their respective commercial formulations. Methods: The insulin analogs underwent a buffer exchange into phosphate-buffered saline to remove formulation excipients and then were heated and agitated to characterize intrinsic fibrillation potentials devoid of excipient stabilizing effects. Different analytical methods were used to determine the amount of intrinsic fibrillation for the analogs. After initial lag times, intrinsic fibrillation was detected by an amyloid-specific stain. Precipitation of insulin was confirmed by ultraviolet analysis of soluble insulin and gravimetric measurement of insoluble insulin. Electron microscopy showed dense fibrous material, with individual fibrils that are shorter than typical insulin fibrils. Higher resolution kinetic analyses were carried out in 96-well plates to provide more accurate measures of lag times and fibril growth rates. Results: All three analogs exhibited longer lag times and slower intrinsic fibrillation rates than human insulin, with glulisine and lispro rates slower than aspart. This is the first study comparing the intrinsic fibrillation of fast-acting insulin analogs without the stabilizing excipients found in their commercial formulations. Conclusions: Data show different intrinsic fibrillation potentials based on primary molecular structures when the formulation excipients that are critical for stability are absent. Understanding intrinsic fibrillation potential is critical for evaluating insulin analog stability and device compatibility.
Postprandial Glucose Monitoring Further Improved Glycemia, Lipids, and Weight in Persons with Type 2 Diabetes Mellitus Who Had Already Reached Hemoglobin A1c Goal
Authors: Zhang David A. , Katznelson Laurence , Li Ming 
Published: January 2014

Background: Postprandial hyperglycemia contributes to poor glucose control and is associated with increased cardiovascular risk in type 2 diabetes mellitus (T2DM). The objective of the study was to determine the effect of postprandial self-monitoring of blood glucose (pp-SMBG) on glucose control, lipids, body weight, and cardiovascular events. Method: Subjects with T2DM hemoglobin A1c (A1C) between 6.5 to 7.0% were randomized into the study group (at least two pp-SMBG a day and dietary modification based on glucose readings) and control group (dietary modification based on glucose readings but no mandatory pp-SMBG) for a 6-month, observational study. Oral antidiabetic drugs or insulin regimen was unchanged in either group if A1C remained less than 7.0% during the study. End points included A1C, lipids, body weight, and cardiovascular events. Results: One hundred sixty-nine subjects, mean age 63 years, and body weight 88 kg were recruited. Hemoglobin A1c, weight, low-density lipoprotein (LDL), and triglycerides (TGs) were similar in the groups at baseline. By the end of 6 months, A1C (6.7 ± 0.1 to 6.4 ± 0.1%, p < .05), body weight (88.5 ± 7.3 to 85.2 ± 6.3 kg, p < .05), LDL (92.3 ± 2 8.4 to 81.1 ± 22.6 mg/dl, p < .05), and TGs (141 ± 21 to 96 ± 17 mg/dl, p < .05) decreased in the study group, but did not change in the control group. No cardiovascular events were observed in either group during the 6-month study period. Conclusions: In T2DM subjects who had already reached their A1C goal, pp-SMBG at least twice a day was associated with further improvement in glycemia, lipids, and weight, as well as exercise and dietary habit. We assume that lifestyle modification promoted by postprandial hyperglycemia awareness may underlie these findings. These results substantiate the importance of implementing pp-SMBG into lifestyle modification, and emphasize that pp-SMBG is critical in the control of T2DM.
Mobile Phone-Based Video Messages for Diabetes Self-Care Support
Authors: Bell Amanda M. , Fonda Stephanie J. , Walker M. Susan , Schmidt Virginia , Vigersky Robert A. 
Published: January 2014

Background: This study examined whether mobile phone-based, one-way video messages about diabetes self-care improve hemoglobin A1c (A1C) and self-monitoring of blood glucose (SMBG). Methods: This was a 1-year prospective randomized trial with two groups. The active intervention lasted 6 months. The study enrolled 65 people with A1C >8.0% who were established (>6 months) patients in the endocrinology clinics of the Walter Reed Health Care System. Participants were randomized to receive “usual care” or self-care video messages from their diabetes nurse practitioner. Video messages were sent daily to cell phones of study participants. Hemoglobin A1c and SMBG data were collected at 0, 3, 6, 9, and 12 months. Results: Participants who received the messages had a larger rate of decline in A1C than people who received usual care (0.2% difference over 12 months, adjusting for covariates; p = .002 and p = .004 for the interaction between time and group and for the quadratic effect of time by group, respectively). Hemoglobin A1c decline was greatest among participants who received video messages and viewed >10 a month (0.6% difference over 12 months, adjusting for covariates; p < .001 for the interaction between time and group and the quadratic effect). Self-monitoring of blood glucose metrics were not related to the intervention. Conclusions: A one-way intervention using mobile phone-based video messages about diabetes self-care can improve A1C. Engagement with the technology is an important predictor of its success. This intervention is simple to implement and sustain.
Impact of a Modified Needle Tip Geometry on Penetration Force as Well as Acceptability, Preference, and Perceived Pain in Subjects with Diabetes
Authors: Hirsch Laurence , Gibney Michael , Berube Julie , Manocchio John 
Published: January 2014

Background: Multiple factors impact subcutaneous insulin injection pain. Injection devices [e.g., syringe or pen needle (PN)] affect pain due to needle length, diameter, needle polishing and lubrication, and needle tip geometry. Methods: We evaluated a modified 5-bevel PN tip in 32 G × 4 mm 31 G × 5 mm and 8 mm PNs vs the equivalent marketed 3-bevel PNs in laboratory penetration force testing, as well as in insulin-taking subjects for overall acceptability, comparative pain, and preference. The clinical tests were done in three ways: Paired insertions with the subjects blinded to PN tip geometry, after brief at-home use of 5-bevel PNs, and again with subjects informed about each needle's tip geometry in paired insertions. Results: Average penetration force in a skin substitute was 23% lower with the 5-bevel PNs vs similar 3-bevel PNs ( p ≤ 0.01). In blinded testing and after at-home use, patients rated the 5-bevel needle as acceptable. After short-term home use, patients rated the 5-bevel PN less painful and preferable to their usual PN (both p < 0.01). In paired, informed testing, the 5-bevel PN was less painful and preferred to subjects' currently used needles ( p ≤ 0.01) and to other marketed PNs ( p < 0.01). Conclusions: Needle tip geometry affects penetration force. When blinded, patients did not distinguish differences in PN tip geometry with fine-gauge PN insertions. A 5-bevel needle tip is perceived as less painful and is preferred by subjects following home use for usual injections. Similar results occurred when patients were informed that they were using a needle with a modified tip.
Performance of a Glucose Meter with a Built-in Automated Bolus Calculator versus Manual Bolus Calculation in Insulin-Using Subjects
Authors: Sussman Allen , Taylor Elizabeth J. , Patel Mona , Ward Jeanne , Alva Shridhara , Lawrence Andrew , Ng Ronald 
Published: January 2014

Background: Patients consider multiple parameters in adjusting prandial insulin doses for optimal glycemic control. Difficulties in calculations can lead to incorrect doses or induce patients to administer fixed doses, rely on empirical estimates, or skip boluses. Method: A multicenter study was conducted with 205 diabetes subjects who were on multiple daily injections of rapid/short-acting insulin. Using the formula provided, the subjects manually calculated two prandial insulin doses based on one high and one normal glucose test result, respectively. They also determined the two doses using the FreeStyle InsuLinx Blood Glucose Monitoring System, which has a built-in, automated bolus calculator. After dose determinations, the subjects completed opinion surveys. Results: Of the 409 insulin doses manually calculated by the subjects, 256 (63%) were incorrect. Only 23 (6%) of the same 409 dose determinations were incorrect using the meter, and these errors were due to either confirmed or potential deviations from the study instructions by the subjects when determining dose with meter. In the survey, 83% of the subjects expressed more confidence in the meter-calculated doses than the manually calculated doses. Furthermore, 87% of the subjects preferred to use the meter than manual calculation to determine prandial insulin doses. Conclusions: Insulin-using patients made errors in more than half of the manually calculated insulin doses. Use of the automated bolus calculator in the FreeStyle InsuLinx meter minimized errors in dose determination. The patients also expressed confidence and preference for using the meter. This may increase adherence and help optimize the use of mealtime insulin.
The Identifiable Virtual Patient Model: Comparison of Simulation and Clinical Closed-Loop Study Results
Authors: Kanderian Sami S. , Weinzimer Stuart A. , Steil Garry M. 
Published: January 2014

Background: Optimizing a closed-loop insulin delivery algorithm for individuals with type 1 diabetes can be potentially facilitated by a mathematical model of the patient. However, model simulation studies that evaluate changes to the control algorithm need to produce conclusions similar to those that would be obtained from a clinical study evaluating the same modification. We evaluated the ability of a low-order identifiable virtual patient (IVP) model to achieve this goal. Methods: Ten adult subjects (42.5 ± 11.5 years of age; 18.0 ± 13.5 years diabetes; 6.9 ± 0.8% hemoglobin A1c) previously characterized with the IVP model were studied following the procedures independently reported in a pediatric study assessing proportional-integral-derivative control with and without a 50% meal insulin bolus. Peak postprandial glucose levels with and without the meal bolus and use of supplemental carbohydrate to treat hypoglycemia were compared using two-way analysis of variance and chi-square tests, respectively. Results: The meal bolus decreased the peak postprandial glucose levels in both the adult-simulation and pediatric-clinical study (231 ± 38 standard deviation to 205 ± 33 mg/dl and 226 ± 51 to 194 ± 47 mg/dl, respectively; p = .0472). No differences were observed between the peak postprandial levels obtained in the two studies (clinical and simulation study not different, p = .57; interaction p = .83) or in the use of supplemental carbohydrate (3 occurrences in 17 patient days of closed-loop control in the clinical-pediatric study; 7 occurrences over 20 patient days in the adult-simulation study, p = .29). Conclusions: Closed-loop simulations using an IVP model can predict clinical study outcomes in patients studied independently from those used to develop the model.
Clinical Use of U-500 Regular Insulin: Review and Meta-Analysis
Authors: Reutrakul Sirimon , Wroblewski Kristen , Brown Rebecca L. 
Published: January 2014

The use of U-500 regular insulin (U-500R) to treat diabetic patients with severe insulin resistance has increased. In this review, we performed a meta-analysis of PubMed studies reporting the use of U-500R to evaluate the effects of U-500R on hemoglobin A1c (HbA1c), body weight, and total daily insulin dose (TDD). These studies included 310 patients using U-500R as multiple daily injections (MDI) and 55 patients using U-500R via continuous subcutaneous insulin infusion (CSII). Overall, the use of U-500R as MDI resulted in a significant HbA1c reduction of 1.59%, a significant weight gain of 4.38 kg, and a significant increase in TDD by 51.9 units. The use of U-500R via CSII resulted in a similarly significant HbA1c reduction of 1.64% but a nonsignificant weight gain and a nonsignificant change in TDD. The use of U-500 regular insulin both as MDI and via CSII was not reported to be associated with severe hypoglycemia but was associated with an increase in patient satisfaction as well as in cost savings. Suggestions in initiating U-500R in the outpatient setting using U-500R in hospitalized patients are reviewed. In addition, precautions for avoiding prescription and patient errors are discussed.
Clinical Requirements for Closed-Loop Control Systems
Authors: Clarke William L. , Renard Eric 
Published: January 2014

Closed-loop (CL) therapy systems should be safe, efficacious, and easily manageable for type 1 diabetes mellitus patient use. For the first two clinical requirements, noninferiority and superiority criteria must be determined based on current conventional and intensive therapy outcomes. Current frequencies of hypoglycemia and diabetic ketoacidosis are reviewed and safety expectations for CL therapy systems are proposed. Glycosylated hemoglobin levels lower than current American Diabetes Association recommendations for different age groups are proposed as superiority criteria. Measures of glycemic variability are described and the recording of blood glucose levels as percentages within, above, and below a target range are suggested as reasonable alternatives to sophisticated statistical analyses. It is also suggested that Diabetes Quality of Life and Fear of Hypoglycemia surveys should be used to track psychobehavioral outcomes. Manageability requirements for safe and effective clinical management of CL systems are worth being underscored. The weakest part of the infusion system remains the catheter, which is exposed to variable and under-delivery incidents. Detection methods are needed to warn both the system and the patient about altered insulin delivery, including internal pressure and flow alarms. Glucose monitor sensor accuracy is another requirement; it includes the definition of conditions that lead to capillary glucose measurement, eventually followed by sensor recalibration or replacement. The crucial clinical requirement will be a thorough definition of the situations when the patient needs to move from CL to manual management of insulin delivery, or inversely can switch back to CL after a requested interruption. Instructions about these actions will constitute a major part of the education process of the patients before using CL systems and contribute to the manageability of these systems.
Diabetes, Insulin Resistance, and Metabolic Syndrome in Horses
Authors: Johnson Philip J. , Wiedmeyer Charles E. , LaCarrubba Alison , Ganjam V. K. Seshu , Messer Nat T. 
Published: January 2014

Analogous to the situation in human medicine, contemporary practices in horse management, which incorporate lengthy periods of physical inactivity coupled with provision of nutritional rations characterized by inappropriately high sugar and starch, have led to obesity being more commonly recognized by practitioners of equine veterinary practice. In many of these cases, obesity is associated with insulin resistance (IR) and glucose intolerance. An equine metabolic syndrome (MS) has been described that is similar to the human MS in that both IR and aspects of obesity represent cornerstones of its definition. Unlike its human counterpart, Identification of the equine metabolic syndrome (EMS) portends greater risk for development of laminitis, a chronic, crippling affliction of the equine hoof. When severe, laminitis sometimes necessitates euthanasia. Unlike the human condition, the risk of developing type 2 diabetes mellitus and many other chronic conditions, for which the risk is recognized as increased in the face of MS, is less likely in horses. The equine veterinary literature has been replete with reports of scientific investigations regarding the epidemiology, pathophysiology, and treatment of EMS.
Hematocrit Compensation in Electrochemical Blood Glucose Monitoring Systems
Authors: Teodorczyk Maria , Cardosi Marco , Setford Steven 
Published: January 2014

Background: Hematocrit (Hct) is a common interferent in test strips used by diabetes patients to self-monitor blood glucose (BG), resulting in measurement bias. Described is an electrochemical BG monitoring system (OneTouch® Verio™) that uses a cofacial sensor design, soluble enzyme chemistry, and multiphasic waveform to effectively correct for patient Hct, delivering an accurate reading for whole BG. Methods: The test strip comprises thin-film gold and palladium electrodes arranged cofacially and spatially separated with a thin spacer. Soluble glucose-sensing reagents are located on the lower palladium electrode and are hydrated on sample application. Blood glucose is oxidized by flavoprotein glucose dehydrogenase, with electron transfer via (reduced) potassium ferrocyanide mediator at the palladium electrode. Hematocrit levels are estimated by measuring oxidation of mediator diffusion to the upper gold electrode during the first portion of the assay. The Hct-corrected glucose levels are determined by an on-meter algorithm. Results: In performance testing of blood samples at five glucose levels (30–560 mg/dl) and five Hct levels (19–61%), using 12 test meters and 3 test strip lots, 100% of results ( N = 2700) met International Organization for Standardization accuracy criteria (within ± 15 mg/dl and ± 20% of reference results at glucose levels of <75 and ≥75 mg/dl, respectively). Furthermore, 99.9% (2698 of 2700) of results were within ±12 mg/dl and ± 15% of reference values at glucose levels <80 and ≥80 mg/dl, respectively. Conclusions: The technology used in this system provides accurate BG measurements that are insensitive to Hct levels across the range 20–60%.