bluuebunny/crossref_metadata_2025_split huggingface dataset:
Veterans Affairs Research on Health Information Technologies for Diabetes Self-Management Support
Authors: Piette John D. , Kerr Eve , Richardson Caroline , Heisler Michele 
Published: January 2014

Background: Like many patients with diabetes, Department of Veterans Affairs (VA) patients frequently fall short of self-management goals and experience multiple barriers to self-care. Health information technologies (HITs) may provide the tools that patients need to manage their illness under the direction of their primary care team. Methods: We describe several ongoing projects focused on HIT resources for self-management in VA. VA researchers are developing HITs that seek to bolster a variety of potential avenues for self-management support, including patients' relationships with other patients, connections with their informal care networks, and communication with their health care teams. Results: Veterans Affairs HIT research projects are developing services that can address the needs of patients with multiple challenges to disease self-care, including multimorbidity, health literacy deficits, and limited treatment access. These services include patient-to-patient interactive voice response (IVR) calling systems, IVR assessments with feedback to informal caregivers, novel information supports for clinical pharmacists based on medication refill data, and enhanced pedometers. Conclusion: Large health care systems such as the VA can play a critical role in developing HITs for diabetes self-care. To be truly effective, these efforts should include a continuum of studies: observational research to identify barriers to self-management, developmental studies (e.g., usability testing), efficacy trials, and implementation studies to evaluate utility in real-world settings. VA HIT researchers partner with operations to promote the dissemination of efficacious services, and such relationships will be critical to move HIT innovations into practice.
Longitudinal Approaches to Evaluate Health Care Quality and Outcomes: The Veterans Health Administration Diabetes Epidemiology Cohorts
Authors: Miller Donald R. , Pogach Leonard 
Published: January 2014

Objective: The Institute of Medicine proposed recently that, while current pay for performance measures should target multiple dimensions of care, including measures of technical quality, they should transition toward longitudinal and health-outcome measures across systems of care. This article describes the development of the Diabetes Epidemiology Cohorts (DEpiC), which facilitates evaluation of intermediate “quality of care” outcomes and surveillance of adverse outcomes for veterans with diabetes served by the Veterans Health Administration (VHA) over multiple years. Methods: The Diabetes Epidemiology Cohorts is a longitudinal research database containing records for all diabetes patients in the VHA since 1998. It is constructed using data from a variety of national computerized data files in the VHA (including medical encounters, prescriptions, laboratory tests, and mortality files), Medicare claims data for VHA patients, and large patient surveys conducted by the VHA. Rigorous methodology is applied in linking and processing data into longitudinal patient records to assure data quality. Results: Validity is demonstrated in the construction of the DEpiC. Adjusted comparisons of disease prevalence with general population estimates are made. Further analyses of intermediate outcomes of care demonstrate the utility of the database. In the first example, using growth curve models, we demonstrated that hemoglobin A1c trends exhibit marked seasonality and that serial cross-sectional outcomes overestimate the improvement in population A1c levels compared to longitudinal cohort evaluation. In the second example, the use of individual level data enabled the mapping of regional performance in amputation prevention into four quadrants using calculated observed to expected major and minor amputation rates. Simultaneous evaluation of outliers in all categories of amputation may improve the oversight of foot care surveillance programs. Conclusions: The use of linked, patient level longitudinal data resolves confounding case mix issues inherent in the use of serial cross-sectional data. Policy makers should be aware of the limitations of cross-sectional data and should make use of longitudinal patient databases to evaluate clinical outcomes.
Type 2 Diabetes Phenotype and Progression is Significantly Different if Diagnosed before versus after 65 Years of Age
Authors: Kolb Hubert , Schneider Berthold , Heinemann Lutz , Heise Tim , Lodwig Volker , Tshiananga Jacques K. Tshiang , Weber Christian , Scherbaum Werner A. , Martin Stephan 
Published: January 2014

Background: The incidence of type 2 diabetes is increasing disproportionately in individuals <65 years of age. It is not known whether disease characteristics in these younger patients are similar to “classic” late-onset type 2 diabetes. Methods: In the epidemiological cohort study entitled “Retrolective Study: Self-Monitoring of Blood Glucose and Outcome in Patients with Type 2 Diabetes,” a total of 3268 patients from randomly contacted primary care practices were documented during a mean follow-up period of 6.5 years. All newly diagnosed patients of these practices were included. Results: At diagnosis, 64.2% of the patients were aged ≤65 years. Thereof, 57.2% were male, whereas in the age group >65 years only 35.0% were male ( p < 0.001). The younger group exhibited more severe metabolic deterioration at diagnosis and in the following years than the older group. Conversely, the older group presented at diagnosis with a higher prevalence of cardiovascular risk factors. Self-monitoring of blood glucose (SMBG) was more prominent in the younger group. In both age groups, the use of SMBG was associated with a significantly lower risk ( p = 0.003) of a combined end point (severe diabetic complication or all-cause mortality). Conclusions: There are considerable differences in disease characteristics between people diagnosed with type 2 diabetes during 45–65 years of age versus diagnosis at a later age. Type 2 diabetes diagnosed before the age of 65 years disproportionately affected men and exhibited a more severe disease course, but was characterized by significantly less cardiovascular risk factors in comparison to type 2 diabetes diagnosed at a later age. The use of SMBG was associated with a better clinical outcome in both age groups.
Computerized Learning Technologies for Diabetes: A Systematic Review
Authors: Boren Suzanne Austin , Gunlock Teira L. , Peeples Malinda M. , Krishna Santosh 
Published: January 2014

Background: The objective of this study was to evaluate computerized learning technology interventions that can empower patients in the self-management of diabetes and support diabetes education over a distance. Methods: We searched Medline (1966–2006), CINAHL (1982–2006), and the Cochrane Central Register of Controlled Trials (first quarter 2007) databases. We also reviewed reference lists from included studies to identify additional studies. We included 25 articles representing 21 randomized controlled trials that evaluated a computerized learning technology and measured the outcome of patient care. We extracted patient sample, intervention, educational content topics, outcome measures, and statistical significance. Results: Of 21 eligible trials, 18 trials (85.7%) reported significant positive outcomes. Almost 44% (43.8%) of the outcomes demonstrated significant improvements (49 of 112 outcomes). Conclusions: Patient self-management behaviors are important in chronic disease management, and initial evidence suggests that computerized learning technology interventions can play a significant role in the future.
Measurement of Glucose in Blood with a Phenylboronic Acid Optical Sensor
Authors: Worsley Graham J. , Tourniaire Guilhem A. , Medlock Kathryn E. S. , Sartain Felicity K. , Harmer Hazel E. , Thatcher Michael , Horgan Adrian M. , Pritchard John 
Published: January 2014

Background: Current methods of glucose monitoring rely predominantly on enzymes such as glucose oxidase for detection. Phenylboronic acid receptors have been proposed as alternative glucose binders. A unique property of these molecules is their ability to bind glucose in a fully reversible covalent manner that facilitates direct continuous measurements. We examined (1) the ability of a phenylboronic-based sensor to measure glucose in blood and blood plasma and (2) the effect on measurement accuracy of a range of potential interferents. We also showed that the sensor is able to track glucose fluctuations occurring at rates mimicking those experienced in vivo. Method: In vitro static measurements of glucose in blood and blood plasma were conducted using holographic sensors containing acrylamide, N,N'-methylenebisacrylamide, 3-acrylamidophenylboronic acid, and (3-acrylamidopropyl) trimethylammonium chloride. The same sensors were also used for in vitro measurements performed under flow conditions. Results: The opacity of the liquid had no affect on the ability of the optical sensor to measure glucose in blood or blood plasma. The presence of common antibiotics, diabetic drugs, pain killers, and endogenous substances did not affect the measurement accuracy, as shown by error grid analysis. Ex vivo flow experiments showed that the sensor is able to track changes accurately in concentration occurring in real time without lag or evidence of hysteresis. Conclusions: The ability of phenylboronic acid sensors to measure glucose in whole blood was demonstrated for the first time. Holographic sensors are ideally suited to continuous blood glucose measurements, being physically and chemically robust and potentially calibration free.
Pioglitazone Improves Metabolic Markers in Patients with Type 2 Diabetes Independently from Physical Activities: Results from the IRIS III Study
Authors: Schöndorf Thomas , Pfützner Andreas , Lübben Georg , Karagiannis Efstrathios , Roth Werner , Forst Thomas 
Published: January 2014

Aim: Pioglitazone is an established peroxisome proliferator-activated receptor γ agonist for the treatment of insulin resistance in patients with type 2 diabetes mellitus. This analysis of the observational IRIS III study was performed to evaluate the effects of pioglitazone treatment in relation to the degree of physical exercise activities in a large patient population under daily life conditions. Methods: A total of 1298 patients out of 2092 enrolled into the IRIS III study who had provided information about their exercise level could be included in the final analysis (622 female, 676 male; age: 63.1 ± 10.4 years, diabetes duration: 6.6 ± 5.0 years, mean ± SD). All patients were glitazone naïve prior to study entry. They received pioglitazone in addition to their previous oral antidiabetic treatment. The patients were stratified according to their physical activity level (never, sometimes, and regularly). Data were evaluated at baseline and after 20 ± 2 weeks of treatment. Observation parameters were fasting blood glucose, lipids, and blood pressure. Hemoglobin A1c (HbA1c) was determined in a central laboratory, and insulin sensitivity was assessed by the IRIS II score. Results: Glycemic control, blood pressure, and the lipid profile improved independently from the degree of physical activity (e.g., no exercise vs frequent exercise: ΔHbA1c: −0.89 ± 1.2% vs −0.72 ± 1.1%, not significant). A positive impact of exercise on insulin resistance could be observed at baseline, which, however, was further decreased by pioglitazone treatment [IRIS II score (baseline/end point): no exercise vs frequent exercise: 74.0 ± 15.9/62.5 ± 20.2 vs 66.7 ± 19.0/58.0 ± 21.8, p < 0.001/not significant]. Conclusions: These observational results, obtained from a nonselected patient population under daily routine conditions, confirm that the benefits of pioglitazone treatment on glycemic control, lipid metabolism, and blood pressure are independent from physical activity. Exercise has a positive influence on insulin sensitivity, but pioglitazone shows additional favorable effects and is, therefore, recommended for use independently from the activity level of the patients.
Diabetes: An Investor's Perspective
Authors: Harris Bernard 
Published: January 2014

Total health care expenditure in 2006 was $2.1 trillion. This figure is estimated to double within the next few years as the cost of treating diabetes and other chronic conditions continues to rise. Moreover, the baby boomer demographic is anticipated to place an enormous burden on the health care system and employer-based health insurance premiums were increased at rates as high as 10% per year in 2006. The quest to address these challenges has also created opportunities for investment, particularly in the fields of telemedicine, health care information technology, and medical technology. The author shares his business perspective, informed by years of experience as a physician and astronaut at NASA, and describes new applications of exciting technologies that deliver effective and efficient health care to diabetes patients, no matter where they may be.
DUROS® Technology Delivers Peptides and Proteins at Consistent Rate Continuously for 3 to 12 Months
Authors: Rohloff Catherine M. , Alessi Thomas R. , Yang Bing , Dahms Janice , Carr John P. , Lautenbach Scott D. 
Published: January 2014

Background: DUROS® delivery technology consists of sterile, nonbiodegradable, single-use devices for continuous, subcutaneous administration of therapeutic molecules at steady rates. DUROS delivery technology is capable of delivering a wide range of therapeutic molecules for durations ranging from 3 to 12 months. Administration of therapy via DUROS devices may facilitate patient compliance with treatment since the DUROS device does not require self-injections. Consistent delivery of drug levels within a targeted therapeutic window achievable with DUROS delivery technology avoids exposure to high initial drug concentrations that can result from bolus injections and that may be associated with certain adverse drug effects. Methods: Several approaches have been taken to assess the suitability of DUROS devices for delivery of the therapeutic molecules leuprolide acetate, glucagon-like peptide-1 (GLP-1), and omega interferon (omega IFN). Testing includes determining protein stability and measuring in vitro protein release rates. Results: Three peptides or proteins were formulated into either a solution (leuprolide) or Intarcia's proprietary DUROS suspension formulation (GLP-1, omega IFN) and filled into DUROS devices. The devices demonstrated reliable start-up and continuous steady drug delivery in in vitro studies. Stability of the molecules was maintained for 3 years at 37°C (leuprolide), 2 years at 30°C (omega IFN), or 6 months at 37°C (GLP-1). Patients in clinical studies of a 1-year DUROS device found the device to be comfortable and convenient. Conclusions: Multiple studies demonstrated that peptides or proteins remain stable in DUROS devices and that delivery at a steady rate can be achieved over a wide range of delivery rates.
Differences in the Dose Accuracy of Insulin Pens
Authors: Hänel Heike , Weise Alexander , Sun Wei , Pfützner Johannes W. , Thomé Nicole , Pfützner Andreas 
Published: January 2014

Background: Modern insulin injection pens provide a convenient and accurate way for diabetes patients to inject insulin. They have widespread use among children and adults with type 1 and type 2 diabetes in the U.S. and Europe. This study compared the dosing accuracy of four commonly available insulin pens (OptiClik® and SoloSTAR® from sanofi-aventis, FlexPen® from Novo Nordisk, and HumaPen® LUXURA™ from Eli Lilly). Methods: The dosing accuracy was tested for all pens with 24 × 10 IU and 9 × 30 IU injection volumes to investigate whether the pens complied with the acceptable International Organization for Standardization (ISO) limits of 10% (± 1 IU) for 10 IU and 5% (± 1.5 IU) for 30 IU. The doses were each applied with a new needle strictly according to the instructions for use by the pen manufacturers. A pharmaceutical balance was used for the assessment of the applied volumes, and the results were corrected for the specific density of the insulin formulations. Four insulin pens (two each from different production lots) were used for each of the two volumes, resulting in a total of 192 doses per pen with 10 IU, and 72 doses per pen with 30 IU. Results: FlexPen (mean absolute percent deviation for 10 IU and 30 IU: 1.64 ± 0.84% and 0.83 ± 0.26%, respectively) and HumaPen LUXURA (1.10 ± 0.20% and 0.62 ± 0.19%; not significant versus FlexPen for both doses) were more accurate than the OptiClik (4.78 ± 3.31% and 2.97 ± 2.48%, p <.01) and the SoloSTAR (2.61 ± 0.92% and 1.70 ± 0.84%, p <.05). While 6.8% of doses were outside the ISO limit at 10 IU with OptiClik (13.9% at 30 IU), the corresponding figures were 0.5% and 4.1%, respectively, for SoloSTAR. No doses outside the ISO limits were seen with FlexPen or HumaPen LUXURA at 10 IU and only one 30 IU dose (1.4%) was outside the limit for FlexPen. Conclusions: A direct head-to-head comparison of four insulin pens with a standardized protocol resulted in a more stable dosing accuracy of the FlexPen and the HumaPen LUXURA in comparison to the OptiClik and SoloSTAR. Even though all insulin delivery systems undergo rigorous testing before being approved for sale, there may be reasons to be attentive to the performance of the devices in practical use.
“No Coding” of Glucose Test Strips: A Roche Perspective
Authors: Essenpreis Matthias , Scherff Dirk 
Published: January 2014

Introduction: Glucose test strips vary slightly from batch to batch. These variations are accounted for by a batch-specific “code”: A set of parameters defining the relationship between the signal change induced on the glucose test strip and the blood glucose concentration. Methods: We assessed the impact on accuracy of miscoding the ACCU-CHEK® Aviva system across a wide range of glucose test strip batches and glucose levels, throughout the shelf life of the glucose test strips. Results: The deviations in coding that we investigated had no effect on clinical action. Additionally, we showed, with mathematical modeling of a worst-case scenario, that the probability of an error altering clinical action is low. The batch-specific code of glucose test strips ensures the accuracy and safety of each blood glucose measurement. In addition to the parameters directly related to the blood glucose measurement, the electronic code chip contains the expiration date of the test strips and can deliver firmware updates for upgrades to the glucose meter. Conclusions: We eliminated the handling step of coding and retained all the advantages of coding. In Roche's newest all-in-one glucose meter, the ACCU-CHEK Compact Plus system, the batch-specific code is integrated into the drum that contains the glucose test strips. As a result, changing the drum containing the glucose test strips automatically changes the glucose test strip code. Patients with diabetes who use the ACCU-CHEK Compact Plus glucose meter do not have to be concerned with coding.
Miscoding and other User Errors: Importance of Ongoing Education for Proper Blood Glucose Monitoring Procedures
Authors: Schrock Linda E. 
Published: January 2014

Background: This article reviews the literature to date and reports on a new study that documented the frequency of manual code-requiring blood glucose (BG) meters that were miscoded at the time of the patient's initial appointment in a hospital-based outpatient diabetes education program. Method: Between January 1 and May 31, 2007, the type of BG meter and the accuracy of the patient's meter code (if required) and procedure for checking BG were checked during the initial appointment with the outpatient diabetes educator. If indicated, reeducation regarding the procedure for the BG meter code entry and/or BG test was provided. Results: Of the 65 patients who brought their meter requiring manual entry of a code number or code chip to the initial appointment, 16 (25%) were miscoded at the time of the appointment. Two additional problems, one of dead batteries and one of improperly stored test strips, were identified and corrected at the first appointment. Conclusions: These findings underscore the importance of checking the patient's BG meter code (if required) and procedure for testing BG at each encounter with a health care professional or providing the patient with a meter that does not require manual entry of a code number or chip to match the container of test strips (i.e., an autocode meter).
Use of Case-Based Reasoning to Enhance Intensive Management of Patients on Insulin Pump Therapy
Authors: Schwartz Frank L. , Shubrook Jay H. , Marling Cynthia R. 
Published: January 2014

Background: This study was conducted to develop case-based decision support software to improve glucose control in patients with type 1 diabetes mellitus (T1DM) on insulin pump therapy. While the benefits of good glucose control are well known, achieving and maintaining good glucose control remains a difficult task. Case-based decision support software may assist by recalling past problems in glucose control and their associated therapeutic adjustments. Methods: Twenty patients with T1DM on insulin pumps were enrolled in a 6-week study. Subjects performed self-glucose monitoring and provided daily logs via the Internet, tracking insulin dosages, work, sleep, exercise, meals, stress, illness, menstrual cycles, infusion set changes, pump problems, hypoglycemic episodes, and other events. Subjects wore a continuous glucose monitoring system at weeks 1, 3, and 6. Clinical data were interpreted by physicians, who explained the relationship between life events and observed glucose patterns as well as treatment rationales to knowledge engineers. Knowledge engineers built a prototypical system that contained cases of problems in glucose control together with their associated solutions. Results: Twelve patients completed the study. Fifty cases of clinical problems and solutions were developed and stored in a case base. The prototypical system detected 12 distinct types of clinical problems. It displayed the stored problems that are most similar to the problems detected, and offered learned solutions as decision support to the physician. Conclusions: This software can screen large volumes of clinical data and glucose levels from patients with T1DM, identify clinical problems, and offer solutions. It has potential application in managing all forms of diabetes.