bluuebunny/crossref_metadata_2025 huggingface dataset:
“One More Thing to Think about…” Cognitive Burden Experienced by Intensive Care Unit Nurses When Implementing a Tight Glucose Control Protocol
Authors: Ng Lit Soo , Curley Martha A.Q.
Published: January 2014

Critically ill patients require intensive nursing care. Intensive care unit (ICU) nurses, who care for these physiologically unstable patients, are continuously occupied with the integration of assessments, monitoring, and interventions that are responsive to a patient's evolving state. Since 2005, numerous evidenced-based clinical protocols have been implemented in the critical care unit. Individually, each may not appear to be burdensome but, collectively, these clinical protocols add to the cognitive work of ICU nurses. While nurses are central to the successful implementation of these protocols, little is written about the cognitive burden imposed on them by the addition of these clinical protocols. This article explores the impact of clinical protocols on the cognitive burden of ICU nurses, using a tight glucose control (TGC) protocol as an exemplar case. Research from management, ergonomics, systems engineering, and nursing is used to build the concept of cognitive burden. Future research can build upon this understanding to facilitate successful implementation of clinical protocols.
Effect of Disinfectants on Glucose Monitors
Authors: Mahoney John J. , Lim Christine G.
Published: January 2014

Background:

Monitoring blood glucose levels is an integral part of routine diabetes management. To minimize the risk of transmission of bloodborne pathogens during monitoring, the Centers for Disease Control and Prevention (CDC) recommends that glucose meters be disinfected after each use whenever they are used to test multiple patients. The objective of this study is to assess the compatibility of some common disinfectants with certain blood glucose meter systems.

Methods:

We tested six disinfectants for adverse impact on meter performance or the exterior meter surfaces. The disinfectants tested were 0.525% sodium hypochlorite, 20% 2-propanol and 10% ethanol, 17.2% isopropanol, 55% isopropanol, 70% isopropanol, and hydrogen peroxide. To assess meter performance, we tested OneTouch® Ultra® blood glucose monitoring systems with control solution before and after application of either water or disinfectant. To assess the effect on exterior meter surfaces, we performed a soaking test to simulate long-term exposure to disinfectant.

Results:

Paired t-test results showed that the control solution data associated with disinfectant and with water application were not significantly different for each meter type. However, most of the meter types were adversely affected by hydrogen peroxide and/or by the higher concentrations of alcohol-based disinfectants.

Conclusions:

Although none of the six disinfectants affected meter performance, hydrogen peroxide and isopropanol >20% adversely affected the exterior surfaces of the tested meters. When complying with CDC instructions for meter disinfection, users should use caution and choose disinfectants that have been validated by the meter manufacturer.
Noninvasive Measurement of Plasma Triglycerides and Free Fatty Acids from Exhaled Breath
Authors: Minh Timothy Do Chau , Oliver Stacy R. , Flores Rebecca L. , Ngo Jerry , Meinardi Simone , Carlson Matthew K. , Midyett Jason , Rowland F. Sherwood , Blake Donald R. , Galassetti Pietro Renato
Published: January 2014

Background:

Although altered metabolism has long been known to affect human breath, generating clinically usable metabolic tests from exhaled compounds has proven challenging. If developed, a breath-based lipid test would greatly simplify management of diabetes and serious pathological conditions (e.g., obesity, familial hyperlipidemia, and coronary artery disease), in which systemic lipid levels are a critical risk factor for onset and development of future cardiovascular events.

Methods:

We, therefore, induced controlled fluctuations of plasma lipids (insulin-induced lipid suppression or intravenous infusion of Intralipid) during 4-h in vivo experiments on 23 healthy volunteers (12 males/11 females, 28.0 ± 0.3 years) to find correlations between exhaled volatile organic compounds and plasma lipids. In each subject, plasma triglycerides (TG) and free fatty acids (FFA) concentrations were both directly measured and calculated via individualized prediction equations based on the multiple linear regression analysis of a cluster of 4 gases. In the lipid infusion protocol, we also generated common prediction equations using a maximum of 10 gases.

Results:

This analysis yielded strong correlations between measured and predicted values during both lipid suppression ( r = 0.97 for TG; r = 0.90 for FFA) and lipid infusion ( r = 0.97 for TG; r = 0.94 for FFA) studies. In our most accurate common prediction model, measured and predicted TG and FFA values also displayed very strong statistical agreement ( r = 0.86 and r = 0.81, respectively).

Conclusions:

Our results demonstrate the feasibility of measuring plasma lipids through breath analysis. Optimization of this technology may ultimately lead to the development of portable breath analyzers for plasma lipids, replacing blood-based bioassays.
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.
Bioelectrical Impedance Assessment of Wound Healing
Authors: Lukaski Henry C. , Moore Micheal
Published: January 2014

Objective assessment of wound healing is fundamental to evaluate therapeutic and nutritional interventions and to identify complications. Despite availability of many techniques to monitor wounds, there is a need for a safe, practical, accurate, and effective method. A new method is localized bioelectrical impedance analysis (BIA) that noninvasively provides information describing cellular changes that occur during healing and signal complications to wound healing. This article describes the theory and application of localized BIA and provides examples of its use among patients with lower leg wounds. This promising method may afford clinicians a novel technique for routine monitoring of interventions and surveillance of wounds.
Implications of the New Food and Drug Administration Draft Guidance on Human Factors Engineering for Diabetes Device Manufacturers
Authors: Wilcox Stephen B. , Drucker Daniel
Published: January 2014

This article discusses the implications of the new Food and Drug Administration's draft guidance on human factors and usability engineering for the development of diabetes-related devices. Important considerations include the challenge of identifying users, when the user population is so dramatically broad, and the challenge of identifying use environments when the same can be said for use environments. Another important consideration is that diabetes-related devices, unlike many other medical devices, are used constantly as part of the user's lifestyle—adding complexity to the focus on human factors and ease of use emphasized by the draft guidance.
Scientific Reasons for Including Persons with Disabilities in Clinical and Translational Diabetes Research
Authors: Moore Shirley M.
Published: January 2014

Despite disparities in health problems and outcomes, people with disabilities are underrepresented in diabetes research. This results in a lack of evidence-based knowledge regarding best approaches in caring for this population. This article addresses the need for research that includes people with disabilities and describes the common reasons persons with disabilities are not included in research, including scientists' concerns regarding threats to a study's internal validity and cost. Arguments are provided as to how involving people with disabilities in research will improve our science and reduce disparities in this population. In addition to the ethical reasons for including persons with disabilities in research, the ability to generalize study findings to this population and thus speed our development and translation of this knowledge for use by clinicians is discussed. The bias in study conclusions that arise from study samples that do not include persons with disabilities and its possible effect on care delivery are presented. Two strategies that researchers can use to increase the inclusion of persons with disabilities in research are described: (1) Universal Design of Research and (2) intervention optimization study designs. Universal Design of Research includes research design processes such as the use of multisensory formats for recruiting participants, approaches to designing and presenting research instruments and interventions, and methods of data collection to promote the inclusion of participants with a wide range of abilities in research studies. Intervention optimization study designs offer an efficient way for scientists to rapidly build the most potent interventions for a wide range of people, including those with disabilities participating in mainstream research.
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.
Improving Patient Acceptance of Insulin Therapy by Improving Needle Design
Authors: Norman James J. , Prausnitz Mark R.
Published: January 2014

Improved needle designs could increase patient compliance with insulin therapy. In this issue of Journal of Diabetes Science and Technology, Hirsch and colleagues assessed patient pain and preference for a 5-bevel needle design among diabetes patients. A blinded comparison with traditional 3-bevel needles yielded no significant difference, but patients preferred the 5-bevel needle in unblinded home injection and clinical insertion studies. This suggests that important subjective/contextual factors contribute to preference in conjunction with the fundamental needle design change. While 5-bevel needles may increase patient acceptance, more dramatic changes of needle design, such as microneedles, could enable still greater patient acceptance through reduced pain as well as improved insulin pharmacokinetics.
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.
Commentary on “Performance of a Glucose Meter with a Built-in Automated Bolus Calculator versus Manual Bolus Calculation in Insulin-Using Subjects”
Authors: Rossetti Paolo , Vehí Josep , Revert Ana , Calm Remei , Bondia Jorge
Published: January 2014

Since the early 2000s, there has been an exponentially increasing development of new diabetes-applied technology such as continuous glucose monitoring, bolus calculators, and “smart” pumps, with the expectation of partially overcoming clinical inertia and low patient compliance. However, its long-term efficacy in glucose control has not been unequivocally proven. In this issue of Journal of Diabetes Science and Technology, Sussman and colleagues evaluated a tool for the calculation of the prandial insulin dose. A total of 205 insulin-treated patients were asked to compute a bolus dose in two simulated conditions either manually or with the bolus calculator built into the FreeStyle InsuLinx meter, revealing the high frequency of wrong calculations when performed manually. Although the clinical impact of this study is limited, it highlights the potential implications of low diabetes-related numeracy in poor glycemic control. Educational programs aiming to increase patients' empowerment and caregivers' knowledge are needed in order to get full benefit of the technology.
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.
Analysis of the Accuracy and Precision of the Axis-Shield Afinion Hemoglobin A1c Measurement Device
Authors: Little Randie R.
Published: January 2014

Point-of-care (POC) hemoglobin A1c measurement is now used by many physicians to make more timely decisions on therapy changes. A few studies have highlighted the drawbacks of some POC methods, e.g., poor precision and lot-to-lot variability. Evaluating performance in the clinical setting is difficult because there is minimal proficiency testing data on POC methods. In this issue of Journal of Diabetes Science and Technology, Wood and colleagues describe their experience with the Afinion method in a pediatric clinic network, comparing these results to another POC method as well as to a laboratory high-performance liquid chromatography method. Although they conclude that the Afinion exhibits adequate performance, they do not evaluate lot-to-lot variability. As with laboratory methods, potential assay interferences must also be considered.
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.
Nonhuman Primates and other Animal Models in Diabetes Research
Authors: Harwood H. James , Listrani Paul , Wagner Janice D.
Published: January 2014

Animal models are important for determining the pathogenesis of and potential treatments for obesity and diabetes. Nonhuman primates (NHPs) are particularly useful for studying these disorders. As in humans, type 2 diabetes mellitus is the most common form of diabetes in NHPs and occurs more often in older obese animals, with a metabolic progression from insulin resistance (IR) and impaired glucose tolerance to overt diabetes. Histopathologic changes in pancreatic islets are also similar to those seen in humans with diabetes. Initially, there is islet hyperplasia with abundant insulin production to compensate for IR, followed by insufficient insulin production with replacement of islets with islet-associated amyloid. Diabetic NHPs also have adverse changes in plasma lipid and lipoprotein concentrations, biomarkers of obesity, inflammation, and oxidative stress, and protein glycation that contribute to the numerous complications of the disease. Furthermore, sex hormones, pregnancy, and environmental factors (e.g., diet and stress) affect IR and can also contribute to diabetes progression in NHPs. Additionally, due to their similar clinical and pathologic characteristics, NHPs have been used in many pharmacological studies to assess new therapeutic agents. For these reasons, NHPs are particularly valuable animal models of obesity and diabetes for studying disease pathogenesis, risk factors, comorbidities, and therapeutic interventions.
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%.
Analysis of an Electrochemical Blood Glucose Monitoring System with Hematocrit Compensation: Improved Accuracy by Design
Authors: Lyon Martha E. , Lyon Andrew W.
Published: January 2014

The article entitled “Hematocrit Compensation in Electrochemical Blood Glucose Monitoring Systems” by Teodorczyk and colleagues in this issue of Journal of Diabetes Science and Technology demonstrates that the OneTouch® Verio™ glucose meter meets current regulatory expectations for glucose meter performance and is relatively free from interference by hematocrit. The lack of influence of hematocrit on whole blood glucose results is a valuable attribute for hospital applications, where greater variation of hematocrit among patients is anticipated. The choice of reference method for evaluation of glucose meters is an important consideration, and it is not clear to what extent reference methods used to evaluate glucose meters are also free from hematocrit interferences.
Noninvasive Monitoring of Glucose Levels: Is Exhaled Breath the Answer?
Authors: Roberts Kiera , Jaffe Adam , Verge Charles , Thomas Paul S.
Published: January 2014

Monitoring of blood glucose levels is clinically important in the management of diseases affecting insulin secretion and resistance, most notably diabetes mellitus and cystic fibrosis. Typically, blood glucose monitoring is an invasive technique that may cause distress and discomfort, particularly in the pediatric population. Development of noninvasive methods of monitoring blood glucose is therefore indicated, particularly for use in children. Using respiratory fluids (the liquid present in the lumen of the airways and alveoli) to estimate blood glucose levels indirectly is one potential method. Glucose concentrations in respiratory fluids are typically low, maintained by the equilibrium between paracellular leakage of glucose from the lung interstitium and active cotransport of glucose by epithelial cells. Measurement of glucose in respiratory fluid by collection of exhaled breath condensate is therefore a potentially clinically useful method of estimating blood glucose levels if it can be shown that there is good agreement between these values. This article reviews the research in this area.
An Analysis of the “Effect of Olibra: A 12-Week Randomized Control Trial and a Review of Earlier Studies”
Authors: Heer Martina
Published: January 2014

Nutrients affect hunger and satiety. However, food structure, in particular that of emulsions, may also affect the body's satiety mechanisms. Olibra™ is a fat emulsion, a mixture of fractionated palm oil and fractionated oat oil manufactured by Lipid Technologies Provider AB, Sweden, which affects hunger sensation. However, up to now, no data have shown convincingly that reduced appetite or hunger sensations induced by Olibra lead, in the long run, to a significant and clinically relevant reduction in body mass. To clearly demonstrate a cause-and-effect relationship of Olibra to weight loss, it seems that longer studies with strict control of energy intake and nutrient composition, as well as control of energy expenditure by exercise, are needed.
Designing Serious Video Games for Health Behavior Change: Current Status and Future Directions
Authors: Thompson Debbe
Published: January 2014

Serious video games for health are designed to entertain while changing a specific health behavior. This article identifies behavioral principles that can guide the development of serious video games focused on changing a variety of health behaviors, including those attempting to decrease risk of obesity and type 2 diabetes. Guidelines discussed include how to develop video games that provide a solid foundation for behavior change by enhancing a player's knowledge and skill, ways in which personal mastery experiences can be incorporated into a video game environment, using game characters and avatars to promote observational learning, creating personalized experiences through tailoring, and the importance of achieving a balance between “fun-ness” and “seriousness.” The article concludes with suggestions for future research needed to inform this rapidly growing field.
Motivating Effects of Cooperative Exergame Play for Overweight and Obese Adolescents
Authors: Staiano Amanda E. , Abraham Anisha A. , Calvert Sandra L.
Published: January 2014

Background:

Exergames (i.e., video games that require gross motor activity) may provide intrinsically motivating experiences that engage youth in sustained physical activity.

Method:

Thirty-one low-income 15– to 19-year-old overweight and obese African American adolescents were randomly assigned to a competitive exergame ( n = 17) or a cooperative exergame ( n = 14) condition. Participants played a preassigned Wii Active exergame routine that took between 30 and 60 min each school day, and sessions occurred during lunch time or an after-school program over a 6 month period. Participation was voluntary, so students decided whether to come or not on a given day. Cooperative exergame players worked together with a peer to expend calories and earn points, while competitive exergame players competed individually against a peer to expend calories and earn points. Motivation was measured through surveys and interviews at the end of the intervention, and energy expenditure was measured by accelerometry during game play.

Results:

Compared with the competitive group, the cooperative players were significantly more intrinsically motivated to play ( p = .034, partial eta-squared = 0.366) and more psychologically attracted to the design of the exergame ( p = .034, partial eta-squared = 0.320). Intrinsic motivation was significantly positively correlated with energy expenditure during game play: Individuals who were motivated by control/choice had higher energy expenditure ( p = .026), and those who were more goal motivated ( p = .004) and more immersed in game play ( p = .024) had lower energy expenditure during game play.

Conclusions:

Cooperative exergame play produced higher intrinsic motivation to play the exergame than competitive exergame play did. Intrinsic motivation that came from a desire for control/choice was related to higher energy expenditure during game play. Cooperative exergame play holds promise as a method for engaging overweight and obese youth in physical activity.
Neuropsychological Benefits of Stationary Bike Exercise and a Cybercycle Exergame for Older Adults with Diabetes: An Exploratory Analysis
Authors: Anderson-Hanley Cay , Arciero Paul J. , Westen Sarah C. , Nimon Joseph , Zimmerman Earl
Published: January 2014

Objective:

This quasi-experimental exploratory study investigated neuropsychological effects of exercise among older adults with diabetes mellitus (DM) compared with adults without diabetes (non-DM), and it examined the feasibility of using a stationary bike exergame as a form of exercise for older adults with and without diabetes. It is a secondary analysis that uses a small dataset from a larger randomized clinical trial (RCT) called the Cybercycle Study, which compared cognitive and physiological effects of traditional stationary cycling versus cybercycling.

Methods:

In the RCT and the secondary analysis, older adults living in eight independent living retirement facilities in the state of New York were enrolled in the study and assigned to exercise five times per week for 45 min per session (two times per week was considered acceptable for retention in the study) by using a stationary bicycle over the course of 3 months. They were randomly assigned to use either a standard stationary bicycle or a “cybercycle” with a video screen that displayed virtual terrains, virtual tours, and racing games with virtual competitors. For this secondary analysis, participants in the RCT who had type 2 DM ( n = 10) were compared with age-matched non-DM exercisers ( n = 10). The relationship between exercise and executive function (i.e., Color Trials 2, Digit Span Backwards, and Stroop C tests) was examined for DM and non-DM patients.

Results:

Older adults with and without diabetes were able to use cybercycles successfully and complete the study, so the feasibility of this form of exercise for this population was supported. However, in contrast with the larger RCT, this small subset did not demonstrate statistically significant differences in executive function between the participants who used cybercycles and those who used stationary bikes with no games or virtual content on a video screen. Therefore, the study combined the two groups and called them “exercisers” and compared cognitive outcomes for DM versus non-DM patients. As predicted, exercisers with DM exhibited significant gains in executive function as measured by the Color Trails 2 test, controlling for age and education, while non-DM exercisers did not significantly gain in this measure [group x time interaction, F(1,16]) = 9.75; p = .007].

Conclusions:

These preliminary results support the growing literature that finds that exercise may improve cognition among older adult with DM. Additional research is needed to clarify why certain aspects of executive function might be differentially affected. The current findings may encourage physicians to prescribe exercise for diabetes management and may help motivate DM patients' compliance for engaging in physical activity.