bluuebunny/crossref_metadata_2025 huggingface dataset:
Celebratory Health Technology
Authors: Parker Andrea Grimes , Harper Richard , Grinter Rebecca E.
Published: January 2014

There are numerous everyday health technologies (applications designed for people to use in their daily lives) that promote healthy eating habits. From educational games to monitoring applications, these systems often take a corrective approach in that they are designed to fix the problematic aspects of people's interactions with, and thoughts about, food. We propose a complementary approach, termed celebratory health technology design, in which systems promote healthy eating by highlighting positive food interactions, meanings, and values. We present a case study from our research to show the benefit and feasibility of designing celebratory health applications. Our goal is to encourage a more comprehensive approach to everyday health technology design, one that encompasses not only corrective systems, but celebratory applications as well.
Application of Virtual Reality Methods to Obesity Prevention and Management Research
Authors: Persky Susan
Published: January 2014

There is a great need for empirical evidence to inform clinical prevention and management of overweight and obesity. Application of virtual reality (VR) methods to this research agenda could present considerable advantages. Use of VR methods in basic and applied obesity prevention and treatment research is currently extremely limited. However, VR has been employed for social and behavioral research in many other domains where it has demonstrated validity and utility. Advantages of VR technologies as research tools include the ability to situate hypothetical research scenarios in realistic settings, tight experimental control inherent in virtual environments, the ability to manipulate and control any and all scenario elements, and enhanced behavioral measurement opportunities. The means by which each of these features could enhance obesity prevention and management research is discussed and illustrated in the context of an example research study. Challenges associated with the application of VR methods, such as technological limitations and cost, are also considered. By employing experimental VR methods to interrogate clinical encounters and other health-related situations, researchers may be able to elucidate causal relationships, strengthen theoretical models, and identify potential targets for intervention. In so doing, researchers stand to make important contributions to evidence-based practice innovation in weight management and obesity prevention.
The Fixed Combination of Pioglitazone and Metformin Improves Biomarkers of Platelet Function and Chronic Inflammation in Type 2 Diabetes Patients: Results from the PIOfix Study
Authors: Schöndorf Thomas , Musholt Petra B. , Hohberg Cloth , Forst Thomas , Lehmann Ute , Fuchs Winfried , Löbig Mirjam , Müller Jürgen , Pfützner Andreas
Published: January 2014

Background:

Type 2 diabetes mellitus (T2DM) is characterized by a proinflammatory and procoagulant condition. This study investigates the impact of a pioglitazone plus metformin therapy on biomarkers of inflammation and platelet activation in comparison to a treatment with glimepiride plus metformin.

Methods:

The study was designed as a multicenter, randomized, double-blinded two-arm trial. Patients with T2DM and dyslipidemia under metformin monotherapy with hemoglobin A1c value between 6.5% and 9.0% were eligible for trial participation. Blood was drawn at baseline and after 24 weeks of treatment from patients of five centers. Markers of inflammation and thrombocyte function (soluble CD40 ligand, thromboxane, vWillebrand factor, adhesion molecules, clotting reaction) were evaluated subsequently in a central laboratory.

Results:

A total of 46 patients were included in the final analyses. Mean (± standard deviation) age was 58.5 ± 9.0 years (13 women, 33 men; disease duration 6.3 ± 5.0 years; body mass index 32.0 ± 4.8 kg/m2). A total of 25 patients were treated with pioglitazone plus metformin, and 21 patients were in the glimepiride arm. There was a significant decline of E-selectin (-3.7 ± 4.8 ng/ml, p < .001 versus baseline), vWillebrand factor (−19.5 ± 32.0%, p < .05), and high-sensitivity C-reactive protein concentrations (−1.08 ± 0.91 mg/liter, p < .05) in the metformin + pioglitazone arm only (metformin + glimepiride, −0.5 ± 3.4 ng/ml, +1.4 ± 33.2%, + 0.08 ± 0.72 mg/liter, respectively, all not significant). Also, all other surrogate markers for platelet function and inflammation showed slight improvements in the metformin + pioglitazone arm but not in the metformin + glimepiride arm.

Conclusions:

The fixed metformin + pioglitazone combination treatment showed an overall improvement of laboratory surrogate markers, indicating improvement of platelet function and of chronic systemic inflammation, which was not seen with metformin + glimepiride.
GlyCulator: A Glycemic Variability Calculation Tool for Continuous Glucose Monitoring Data
Authors: Czerwoniuk Dorota , Fendler Wojciech , Walenciak Lukasz , Mlynarski Wojciech
Published: January 2014

Glycemic variability has become a major concern over the years as growing evidence is gathered on its detrimental impact on the risk of diabetes complications. Glycated hemoglobin, although ubiquitous in clinical practice, does not adequately summarize short-term glycemic variability. This gap may be addressed through the use of continuous glucose monitoring, which continuously estimates glycemia based on interstitial fluid glucose concentration. As the amount of collected data is substantial, variability of the glycemic pattern can be analyzed in context of its direction, periodicity, and amplitude. As freely available variability calculation tools are limited in number and complexity, the authors have devised a simple-to-use Web-based application, “GlyCulator,” allowing for rapid computation of glucose variability parameters from continuous glucose monitoring data.
Data Standards in Diabetes Patient Registries
Authors: Richesson Rachel L.
Published: January 2014

Widespread adoption of electronic health records (EHRs) and expansion of patient registries present opportunities to improve patient care and population health and advance translational research. However, optimal integration of patient registries with EHR functions and aggregation of regional registries to support national or global analyses will require the use of standards. Currently, there are no standards for patient registries and no content standards for health care data collection or clinical research, including diabetes research. Data standards can facilitate new registry development by supporting reuse of well-defined data elements and data collection systems, and they can enable data aggregation for future research and discovery. This article introduces standardization topics relevant to diabetes patient registries, addresses issues related to the quality and use of registries and their integration with primary EHR data collection systems, and proposes strategies for implementation of data standards in diabetes research and management.
Identifying Type 1 and Type 2 Diabetic Cases Using Administrative Data: A Tree-Structured Model
Authors: Lo-Ciganic Weihsuan , Zgibor Janice C. , Ruppert Kristine , Arena Vincent C. , Stone Roslyn A.
Published: January 2014

Background:

To date, few administrative diabetes mellitus (DM) registries have distinguished type 1 diabetes mellitus (T1DM) from type 2 diabetes mellitus (T2DM).

Objective:

Using a classification tree model, a prediction rule was developed to distinguish T1DM from T2DM in a large administrative database.

Methods:

The Medical Archival Retrieval System at the University of Pittsburgh Medical Center included administrative and clinical data from January 1, 2000, through September 30, 2009, for 209,647 DM patients aged ≥18 years. Probable cases (8,173 T1DM and 125,111 T2DM) were identified by applying clinical criteria to administrative data. Nonparametric classification tree models were fit using TIBCO Spotfire S+ 8.1 (TIBCO Software), with model size based on 10-fold cross validation. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of T1DM were estimated.

Results:

The main predictors that distinguished T1DM from T2DM are age <40 years; International classification of Disease, 9th revision, codes of T1DM or T2DM diagnosis; inpatient oral hypoglycemic agent use; inpatient insulin use; and episode(s) of diabetic ketoacidosis diagnosis. Compared with a complex clinical algorithm, the tree-structured model to predict T1DM had 92.8% sensitivity, 99.3% specificity, 89.5% PPV, and 99.5% NPV.

Conclusion:

The preliminary predictive rule appears to be promising. Being able to distinguish between DM subtypes in administrative databases will allow large-scale subtype-specific analyses of medical care costs, morbidity, and mortality.
Building a Diabetes Screening Population Data Repository Using Electronic Medical Records
Authors: Tuan Wen-Jan , Sheehy Ann M. , Smith Maureen A.
Published: January 2014

There has been a rapid advancement of information technology in the area of clinical and population health data management since 2000. However, with the fast growth of electronic medical records (EMRs) and the increasing complexity of information systems, it has become challenging for researchers to effectively access, locate, extract, and analyze information critical to their research. This article introduces an outpatient encounter data framework designed to construct an EMR-based population data repository for diabetes screening research. The outpatient encounter data framework is developed on a hybrid data structure of entity-attribute-value models, dimensional models, and relational models. This design preserves a small number of subject-specific tables essential to key clinical constructs in the data repository. It enables atomic information to be maintained in a transparent and meaningful way to researchers and health care practitioners who need to access data and still achieve the same performance level as conventional data warehouse models. A six-layer information processing strategy is developed to extract and transform EMRs to the research data repository. The data structure also complies with both Health Insurance Portability and Accountability Act regulations and the institutional review board's requirements. Although developed for diabetes screening research, the design of the outpatient encounter data framework is suitable for other types of health service research. It may also provide organizations a tool to improve health care quality and efficiency, consistent with the “meaningful use” objectives of the Health Information Technology for Economic and Clinical Health Act.
Pediatric Diabetes Registries: When Baby Steps are Not Enough
Authors: Malone Chad , Kennedy Gary D.
Published: January 2014

Effective diabetes research relies on pattern recognition. Although information technology (IT) has been used to aid researchers in recognizing patterns, there are still barriers to effective data collection, analysis, and collaboration inherent in using outdated methods and technology designed to fulfill clinical, not research, purposes. This article discusses seven problems with current research and outlines a solution in which innovative IT can be harnessed to overcome each problem, resulting in better research outcomes.

New IT solutions on the market, such as meta-registries, are designed specifically to handle the complex data collection and analysis problems associated with diabetes research. A meta-registry with an ontology automatically harmonizes data from disparate sources, allowing researchers to devote their time to pattern recognition. With all essential data centralized and harmonized, researchers are also provided with a more complete view of each patient or research subject. When researchers can view and report across all data types at the same time, they are able to discover patterns and associations that are indistinguishable using traditional methodologies. This capability proves extremely beneficial, particularly for multifactorial disease research such as diabetes research.
Interstitial Fluid Physiology as it Relates to Glucose Monitoring Technologies: Symposium Introduction
Authors: Wisniewski Natalie A. , Klueh Ulrike , Stenken Julie
Published: January 2014

Nearly all commercially available glucose sensors share the subcutaneous interstitial fluid (ISF) compartment as their preferred implantation site. However, ISF physiology as it relates to glucose sensors is not well understood. This special symposium titled “Interstitial Fluid Physiology as It Relates to Glucose Monitoring Technologies” is intended to help to bridge the gap in our understanding. This symposium is intended to foster a greater understanding of biological factors that impact the success of implantable glucose monitors and to inspire additional research in the area of ISF physiology as it relates to glucose sensing. Recognition that sensor designers need to have an intimate understanding of the biological environment in which their sensor will reside is emphasized. The symposium is published in two parts, with part I published in September 2010 and part II published in May 2011. All articles published in this symposium are summarized herein.
Monitoring of Glucose in Brain, Adipose Tissue, and Peripheral Blood in Patients with Traumatic Brain Injury: A Microdialysis Study
Authors: Rostami Elham , Bellander Bo-Michael
Published: January 2014

Background:

Episodes of hyperglycemia are considered to be a secondary insult in traumatically brain-injured patients and have been shown to be associated with impaired outcome. Intensive insulin therapy to maintain a strict glucose level has been suggested to decrease morbidity and mortality in critically ill patients but this aggressive insulin treatment has been challenged. One aspect of strict glucose control is the risk of developing hypoglycemia. Extracellular intracerebral hypoglycemia monitored by intracerebral microdialysis has been shown to correlate with poor outcome. Monitoring of blood glucose during neurointensive care is important because adequate glucose supply from the systemic circulation is crucial to maintain the brain's glucose demand after brain injury. This study investigates the correlation of glucose levels in peripheral blood, subcutaneous (SC) fat, and extracellular intracerebral tissue in patients with severe traumatic brain injury during neurointensive care.

Methods:

In this study, we included 12 patients with severe traumatic brain injury. All patients received one microdialysis catheter each, with a membrane length of 10 mm (CMA 70, CMA Microdialysis AB) in the injured hemisphere of the brain and in the noninjured hemisphere of the brain. An additional microdialysis catheter with a membrane length of 30 mm (CMA 60, CMA Microdialysis AB) was placed in the periumbilical subcutaneous adipose tissue. We studied the correlation among levels of glucose measured in peripheral blood, adipose tissue, and the noninjured hemisphere of the brain during the first 12 hours and during 3 consecutive days in neurointensive care.

Results:

We found a significant positive correlation between levels of glucose in peripheral blood, SC fat, and the noninjured brain during the initial 12 hours but not in injured brain. However, the result varied between the patients during the 3-day measurements. In 7 patients, there was a significant positive correlation between glucose in blood and noninjured brain, while in 4 patients this correlation was poor. In 4 patients, there was a significant positive correlation in injured brain and blood. Furthermore, there was a significant correlation between brain and adipose tissue glucose during the 3-day measurements in 11 out of 12 patients.

Conclusion:

This study indicates that there is a good correlation between blood glucose and adipose tissue during initial and later time points in the neurointensive care unit whereas the correlation between blood and brain seems to be more individualized among patients. This emphasizes the importance of using intracerebral microdialysis to ensure adequate intracerebral levels of glucose in patients suffering from severe traumatic brain injury and to detect hypoglycemia in the brain despite normal levels of blood glucose.
Modulation of the Foreign Body Reaction for Implants in the Subcutaneous Space: Microdialysis Probes as Localized Drug Delivery/Sampling Devices
Authors: Mou Xiaodun , Lennartz Michelle R. , Loegering Daniel J. , Stenken Julie A.
Published: January 2014

Modulation of the foreign body reaction is considered to be an important step toward creation of implanted sensors with reliable long-term performance. In this work, microdialysis probes were implanted into the subcutaneous space of Sprague-Dawley rats. The probe performance was evaluated by comparing collected endogenous glucose concentrations with internal standard calibration (2-deoxyglucose, antipyrine, and vitamin B12). Probes were tested until failure, which for this work was defined as loss of fluid flow. In order to determine the effect of fbrous capsule formation on probe function, monocyte chemoattractant protein-1/CC chemokine ligand 2 (MCP-1/CCL2) was delivered locally via the probe to increase capsule thickness and dexamethasone 21-phosphate was delivered to reduce capsule thickness. Probes delivering MCP-1 had a capsule that was twice the thickness (500–600 μm) of control probes (200–225 μm) and typically failed 2 days earlier than control probes. Probes delivering dexamethasone 21-phosphate had more fragile capsules and the probes typically failed 2 days later than controls. Unexpectedly, extraction efficiency and collected glucose concentrations exhibited minor differences between groups. This is an interesting result in that the foreign body capsule formation was related to the duration of probe function but did not consistently relate to probe calibration.
Biomechanics of the Sensor-Tissue Interface—Effects of Motion, Pressure, and Design on Sensor Performance and the Foreign Body Response—Part I: Theoretical Framework
Authors: Helton Kristen L. , Ratner Buddy D. , Wisniewski Natalie A.
Published: January 2014

The importance of biomechanics in glucose sensor function has been largely overlooked. This article is the first part of a two-part review in which we look beyond commonly recognized chemical biocompatibility to explore the biomechanics of the sensor-tissue interface as an important aspect of continuous glucose sensor biocompatibility. Part I provides a theoretical framework to describe how biomechanical factors such as motion and pressure (typically micromotion and micropressure) give rise to interfacial stresses, which affect tissue physiology around a sensor and, in turn, impact sensor performance. Three main contributors to sensor motion and pressure are explored: Applied forces, sensor design, and subject/patient considerations. We describe how acute forces can temporarily impact sensor signal and how chronic forces can alter the foreign body response and Inflammation around an implanted sensor, and thus impact sensor performance. The importance of sensor design (e.g., size, shape, modulus, texture) and specific implant location on the tissue response are also explored. In Part II: Examples and Application (a sister publication), examples from the literature are reviewed, and the application of biomechanical concepts to sensor design are described. We believe that adding biomechanical strategies to the arsenal of material compositions, surface modifications, drug elution, and other chemical strategies will lead to improvements in sensor biocompatibility and performance.
Benefits of Blinded Continuous Glucose Monitoring during a Randomized Clinical Trial
Authors: Muchmore Douglas , Sharp Melissa , Vaughn Daniel
Published: January 2014

Background:

Real-time, personal continuous glucose monitoring (CGM) is a validated technology that can help patients improve glycemic control. Blinded CGM is a promising technology for obtaining retrospective data in clinical research where the quantity and quality of blood glucose information is important. This study was designed to investigate the use of novel procedures to enhance data capture from blinded CGM.

Methods:

Following a 4-week run-in, 46 patients with type 1 diabetes were randomized to one of two prandial insulins for a 12-week treatment period, after which they were crossed over to the alternate treatment for 12 weeks. Continuous glucose monitoring was implemented at the end of run-in (practice only) and during the last 2 weeks of each treatment period. Eighty percent of 288 possible daily glucose values were required for at least three days. Continuous glucose monitoring was extended for an additional week if these criteria were not met, and patients were allowed to insert sensors at home when necessary. Continuous glucose monitoring results were compared to reference eight-point self-monitoring of blood glucose (SMBG).

Results:

Higher than expected sensor failure rate was approximately 25%. During run-in, 12 of 45 attempted profiles failed adequacy criteria. However, treatment periods had only 1 of 82 attempted profiles considered inadequate (6 cases required an additional week of CGM). Using SMBG as reference, 93.7% of 777 CGM values were in Clarke error grid zones A+B.

Conclusions:

With appropriate training, adequate practice, and opportunity to repeat blinded CGM as needed, nearly 100% of attempted profiles can be obtained successfully.
Reduction of Postprandial Glycemic Excursions in Patients with Type 1 Diabetes: A Novel Human Insulin Formulation versus a Rapid-Acting Insulin Analog and Regular Human Insulin
Authors: Heinemann Lutz , Hompesch Marcus , Flacke Frank , Simms Patrick , Pohl Rody , Albus Kerstin , Pfützner Andreas , Steiner Solomon
Published: January 2014

Background:

Evaluation of postprandial glycemic excursions in patients with type 1 diabetes with three prandial insulins: VIAject™ (Linjeta™), an ultra-fast insulin (UFI); insulin lispro (LIS); and regular human insulin (RHI).

Methods:

After stabilization of preprandial glycemia, 18 patients received a subcutaneous injection with an individualized insulin dose prior to a meal.

Results:

Injection of UFI resulted in a more rapid insulin absorption than with either LIS or RHI (time to half-maximal insulin levels: 13.1 ± 5.2 vs 25.4 ± 7.6 and 38.4 ± 19.5 min; p = .001 vs LIS and p < .001 vs RHI, LIS vs. RHI p < .001). Maximal postprandial glycemia was lower with UFI (0–180 min; 157 ± 30 mg/dl; p = .002 vs RHI) and LIS (170 ± 42 mg/dl; p = .668 vs RHI) than after RHI (191 ± 46 mg/dl; RHI vs LIS p = .008). The difference between maximum and minimum glycemia was smaller with UFI (70 ± 17 mg/dl) than with either RHI (91 ± 33 mg/dl; p = .007 vs UFI) or LIS (89 ± 18 mg/dl; p = .011 vs UFI). Also, the area under the blood glucose profile was lower with UFI than with RHI (0–180 min; 21.8 ± 5.8 vs 28.4 ± 7.6 g·min/dl; p < .001).

Conclusions:

The rapid absorption of UFI results in a reduction of postprandial glycemic excursions.
Biosimilar Insulins: How Similar is Similar?
Authors: Heinemann Lutz , Hompesch Marcus
Published: January 2014

Biosimilar insulins (BIs) are viewed as commercially attractive products by a number of companies. In order to obtain approval in the European Union or the United States, where there is not a single BI currently on the market, a manufacturer needs to demonstrate that a given BI has a safety and efficacy profile that is similar to that of the “original” insulin formulation that is already on the market. As trivial as this may appear at first glance, it is not trivial at all for a good number of reasons that will be discussed in this commentary. As with protein manufacturing, modifications in the structure of the insulin molecule can take place (which can have serious consequences for the biological effects induced), so a rigid and careful assessment is absolutely necessary. The example of Marvel's failed application with the European Medicines Agency provides insights into the regulatory and clinical challenges surrounding the matter of BI. Although a challenging BI approval process might be regarded as a hurdle to keep companies out of certain markets, it is fair to say that the potential safety and efficacy issues surrounding BI are substantial and relevant and do warrant a careful and evidence-driven approval process.
Self-Management Support Interventions That are Clinically Linked and Technology Enabled: Can They Successfully Prevent and Treat Diabetes?
Authors: Kaufman Neal D. , Woodley Paula D. Patnoe
Published: January 2014

Patients with diabetes need a complex set of services and supports. The challenge of integrating these services into the diabetes regimen can be successfully overcome through self-management support interventions that are clinically linked and technology enabled: Self-management support because patients need help mastering the knowledge, attitudes, skills, and behaviors so necessary for good outcomes; interventions because comprehensive theory-based, evidence-proven, long-term, longitudinal interventions work better than direct-to-consumer or nonplanned health promotion approaches; clinically linked because patients are more likely to adopt new behaviors when the approach is in the context of a trusted therapeutic relationship and within an effective medical care system; and technology enabled because capitalizing on the amazing power of information technology leads to the delivery of cost-effective, scalable, engaging solutions that prevent and manage diabetes.
Analysis: The Impact of Needle, Syringe, and Lancet Disposal on the Community
Authors: Gold Kathleen
Published: January 2014

There are over 7.5 billion needles and syringes used outside of the health care system each year by individuals with diabetes, migraines, allergies, infertility, arthritis, HIV, hepatitis, multiple sclerosis, osteoporosis, psoriasis, or other conditions. Disposal of needles, syringes, lancets, and other medical products are not regulated in the home, while these same products used in health care facilities are strictly regulated. Home-generated medical waste is routinely placed into curbside trash, placing sanitation workers and custodial personnel at personal risk of a needle-stick injury. The Coalition for Safe Community Needle Disposal is working to establish a solution that is satisfactory to all stakeholders, sharing the burden of these programs with the pharmaceutical industry, medical device industry, waste management industry, recycling companies, and local and state governments.
Waste Disposal in the 21st Century and Diabetes Technology: A Little Coffee (Cup) or Beer (Can) with that Insulin Infusion (Set)
Authors: Krisiunas Ed
Published: January 2014

The advent of single-use disposable syringes along with myriad similar products for the health care industry has raised interest in the impact of these devices on the environment. Interest does not stop at impact of the device, but also includes associated pharmaceutical agents. Across the spectrum of health care, providers as well as end users of products are assessing the impact of product design and contents upon land, air, and water. In this issue of Journal of Diabetes Science and Technology, Pfützner and colleagues tackle the issue by focusing on a product for the diabetes patient. As environmental sustainability has become part of the evaluation process of many products, their assessment sheds some interesting light on the impact of a group of devices when compared and contrasted against the ever-popular disposable coffee cup or beer/soda aluminum can. Regional variations in waste disposal practices need to be understood when conducting these types of assessments.
Creation of the Web-Based University of Chicago Monogenic Diabetes Registry: Using Technology to Facilitate Longitudinal Study of Rare Subtypes of Diabetes
Authors: Greeley Atma W. , Naylor Rochelle N. , Cook Lindsay S. , Tucker Susan E. , Lipton Rebecca B. , Philipson Louis H.
Published: January 2014

Background:

Monogenic diabetes is a group of disorders caused by mutations in any one of a number of genes. Although a monogenic diagnosis—estimated to represent as much as 2% of all diabetes patients—can have a transformational impact on treatment, the majority of monogenic cases remain unidentified and little is known about their natural history. We thus created the first United States Monogenic Diabetes Registry ( http://www.kovlerdiabetescenter.org/registry/ ) for individuals with either neonatal diabetes diagnosed before 1 year of age or with a phenotype suggestive of maturity-onset diabetes of the young.

Methods:

Inclusion criteria and consent documents are viewable on our Web site, which allows secure collection of contact information to facilitate telephone consent and enrollment. Relevant medical, family, and historical data are collected longitudinally from a variety of sources and stored in our Web-accessible secure database.

Results:

We have enrolled well over 700 subjects in the registry so far, with steady recruitment of those diagnosed under 1 year of age and increasing enrollment of those diagnosed later in life. Initially, participants were mostly self-referred but are increasingly being referred by their physicians. Comprehensive survey and medical records data are collected at enrollment, with ongoing collection of longitudinal data. Associated private Facebook and email discussion groups that we established have already fostered active participation.

Conclusions:

Our early success with the Monogenic Diabetes Registry demonstrates the effectiveness of low-cost Web-based tools, including surveys, the Research Electronic Data Capture database program, and discussion groups, for efficient enrollment and support of rare patients, and collection and maintenance of their data.
Hypoglycemia Impairs Quality of Blood Glucose Simulation in a Clinical Decision Support System
Authors: Johansen Mette Dencker , Hejlesen Ole K. , Cavan David A.
Published: January 2014

Background:

Clinical decision support systems allow for decisions based on blood glucose simulations. The DiasNet simulation tool is based on accepted principles of physiology and simulates blood glucose concentrations accurately in type 1 diabetes mellitus (T1DM) patients during periods without hypoglycemia, but deviations appear after hypoglycemia, possibly because of the long-term glucose counter-regulation to hypoglycemia. The purpose of this study was to evaluate the impact of hypoglycemia on blood glucose simulations.

Method:

Continuous glucose monitoring (CGM) data and diary data (meals, insulin, self-monitored blood glucose) were collected for 2 to 5 days from 17 T1DM patients with poor glycemic control. Hypoglycemic episodes [CGM glucose <63 mg/dl (3.5 mmol/liter) for ≥20 min] were identified in valid (well-calibrated) CGM data. For 24 hours after each hypoglycemic episode, a simulated (DiasNet) glucose profile was compared to the CGM glucose.

Results:

A total of 52 episodes of hypoglycemia were identified in valid data. All subjects had at least one hypoglycemic episode. Ten episodes of hypoglycemia from nine subjects were eligible for analysis. The CGM glucose was significantly ( p < .05) higher than simulated blood glucose for a period of 13 h, beginning 8 h after hypoglycemia onset.

Conclusions:

The present data show that hypoglycemia introduces substantial and systematic simulation errors for up to 24 h after hypoglycemia. This underlines the need for further evaluation of mechanisms behind this putative long-term glucose counter-regulation to hypoglycemia. When using blood glucose simulations in decision support systems, the results indicate that simulations for several hours following a hypoglycemic event may underestimate glucose levels by 100 mg/dl (5.6 mmol/liter) or more.
Analysis of the Indian Council of Medical Research—India Diabetes (ICMR-INDIAB) Study
Authors: Narayan K. M. Venkat , Echouffo-Tcheugui Justin B.
Published: January 2014

The Indian Council of Medical Research-India Diabetes (ICMR-INDIAB) study is the first nationally representative survey of diabetes in India. It aims to provide national and regional counts of diabetes and prediabetes and also of cardiovascular risk factors. This ambitious and complex survey uses robust sampling techniques, standardized methods, appropriate quality assurance, and a three-phase data collection. However, the survey should be completed within a reasonable time span to avoid a differential effect of secular trends on regional estimates. A high response rate and low missing values must also be ensured.

Reliance on capillary whole blood glucose (CBG) for the diagnosis of hyperglycemic states is a limitation of the survey. However, this is a reasonable compromise given the practical challenges of such a large study. Despite a good correlation between CBG and venous plasma glucose (VPG), the use of CBG may misclassify glycemic status. A better characterization of the CBG-VPG relationship, and the performance of CBG for detecting hyperglycemia, using a much larger sample, seems therefore advisable. This should be possible given that venous blood has been collected on a sizeable subset of participants.

The Indian Council of Medical Research and the Madras Diabetes Research Foundation deserve praise for this massive undertaking, which will highlight areas for policy action and establish a national framework for noncommunicable disease (NCD) surveillance. The ICMR-INDIAB survey lays the foundation for effective NCD prevention and control and for applied public health research.
The Use of Optical Coherence Tomography to Determine the Effect of Thiazolidinediones on Retinal Thickness in Patients with Type 2 Diabetes
Authors: Tarbett Aaron K. , VanRoekel Ronald C. , Howard Robin S. , Vigersky Robert A.
Published: January 2014

Objective:

Thiazolidinediones (TZDs) are insulin-sensitizing agents that are associated with peripheral edema and have been reported to be associated with diabetic macular edema (DME). We hypothesized that TZDs produce subclinical increases in retinal thickness that may be detected by optical coherence tomography (OCT) but are not seen on routine dilated funduscopic examination.

Research Design and Methods:

We used OCT to screen for subclinical DME in a cross-sectional study of patients with type 2 diabetes; 29 patients were taking TZDs and 58 were not taking TZDs. We analyzed data using multiple linear regression analysis to investigate associations of retinal thickness with clinical characteristics.

Results:

There was no significant difference between the central subfield retinal thickness in the non-TZD group (206.4 ± 28.0 microns; n = 59) and TZD group (204.1 ± 26.1 microns; n = 29) ( p = .72) nor were there significant differences in any other retinal subfield. There was no significant correlation of retinal thickness with laboratory results studies—peripheral edema, gender, age, duration of diabetes, individual, or combinations of medications. Retinal thickness differences between regions displayed normal anatomical variation. However, ethnic differences were found in which African-Americans had thinner retinas in all regions than Caucasians regardless of whether or not they used TZDs.

Conclusions:

These data suggest that TZDs do not cause subclinical DME in a demographically diverse patient population with diabetes. The established normal ranges for macular thickness may require adjustment based on ethnicity.
Lancing: Quo Vadis?
Authors: Heinemann Lutz , Boecker Dirk
Published: January 2014

Today, lancing fingertips or alternative sites for obtaining a blood sample for self-monitoring of blood glucose (SMBG) is a standard procedure for most patients with diabetes. The need for frequent lancing and associated discomfort and pain can be seen as a key hurdle for patients to comply with SMBG regimens. This article provides an overview of the status quo and future of lancing, focusing on key areas for future developments driven by customer and market needs. We also review technical issues and provide a background for possible improvements.

The act of puncturing the skin with a lancet to obtain a blood sample seems to remain the standard procedure for the foreseeable future, because alternate ways of providing a blood sample have not demonstrated overall superiority (e.g., with laser technology). Other methods, which avoid lancing entirely, have also not gained broad market acceptance (e.g., minimally invasive continuous glucose monitoring) or not shown technical viability (e.g., noninvasive glucose monitoring).

In relation to blood glucose (BG) meters and test strips, lancing has been a “stepchild” with regards to commercial attention and development efforts. Nevertheless, significant technological improvements have been made in this field to address key customer needs, including better performance (regarding pain, wound healing, and long-term sensitivity), reduced cost, and higher integration with other components of BG monitoring (e.g., integration of the lancing device with the glucose monitor). From a technical perspective, it is apparent that highly comfortable lancing can be accomplished; however, this still requires fairly advanced and complex devices. New developments are necessary to achieve this level of sophistication and performance with less intricate and costly system designs. Manufacturers' motivation to pursue these developments is compromised by the fact that they might not recoup their development cost on commercial advanced lancing systems through direct profits, but only through its positive influence on adherence and increased more profitable sensor utilization.

We believe that two main driving forces will continue to push the evolution of lancing and sampling technology: (1) the need for maximum lancing comfort and (2) the advent of fully integrated systems, realizing a device in which all steps for SMBG are incorporated, thus providing a “one-step” experience. Rendering lancing a “nonissue” will eliminate a key barrier to adherence with appropriate SMBG regimens. Providing sophisticated lancing devices that allow the highest level of comfort and/or seamless blood sampling is key to improving user acceptance. This may have a greater impact on metabolic control than many of the new and expensive antidiabetic drugs.
Review of Glucose Oxidases and Glucose Dehydrogenases: A Bird's Eye View of Glucose Sensing Enzymes
Authors: Ferri Stefano , Kojima Katsuhiro , Sode Koji
Published: January 2014

The evolution from first-generation through third-generation glucose sensors has witnessed the appearance of a number of very diverse oxidoreductases, which vary tremendously in terms of origin, structure, substrate specificity, cofactor used as primary electron acceptor, and acceptable final electron acceptor. This article summarizes our present knowledge of redox enzymes currently utilized in commercially available glucose monitoring systems to promote a fuller appreciation of enzymatic properties and principles employed in blood glucose monitoring to help avoid potential errors.
Intravascular Microdialysis as a Method for Measuring Glucose and Lactate during and after Cardiac Surgery
Authors: Möller Fanny , Liska Jan , Eidhagen Fredrik , Franco-Cereceda Anders
Published: January 2014

Background:

The aim was to evaluate intravascular microdialysis as a method for measuring blood glucose and lactate in a clinical setting during and after cardiac surgery.

Methods:

Ten patients undergoing cardiac surgery were included. A microdialysis catheter was percutaneously placed in the superior vena cava or right atrium. Glucose and lactate values measured by the microdialysis technique were analyzed and compared with reference methods, i.e., arterial and venous blood gas values, once every hour up to 24 hours postoperatively. Laboratory plasma glucose was additionally analyzed every 4 hours for reference value.

Results:

Mean absolute differences were low between microdialysis and reference methods for both glucose and lactate values. All microdialysis glucose values were in the clinically acceptable zone of error grid analysis when compared with plasma glucose values. Accuracy of glucose values was 92% according to International Organization for Standardization criteria.

Conclusions:

Intravascular microdialysis is a novel and promising technique for real-time and accurate measurement of glucose and lactate during and after open heart surgery. Development of sensor technology may allow for continuous measurement of blood glucose and lactate using intravascular microdialysis.
Health Care Provision for People with Diabetes and Postgraduate Training of Diabetes Specialists in Eastern European Countries
Authors: Doničová Viera , Brož Jan , Sorin Iocara
Published: January 2014

Background:

In many eastern European countries, information is limited regarding (1) prevalence of diabetes and its complications, (2) health care provisions for diabetes, (3) diabetes management, and (4) the structure of postgraduate training in diabetes for doctors and nurses. These have been reviewed here.

Methods:

Source material was derived from publications and through personal communication with diabetes specialists in leading clinical centers in Bulgaria, the Czech Republic, Hungary, Poland, Romania, Russia, Slovakia, and Ukraine.

Results:

In many countries, information about diabetes prevalence is incomplete or inaccurate with many undiagnosed cases but varies from 7.7–9.6%. Diabetic complications and adverse outcomes (blindness, amputation, and chronic renal failure) are common, with a high mortality resulting from cardiovascular disease. State-funded and private systems often exist side by side. Diabetes care is provided by diabetologists, endocrinologists, internal medicine physicians, and general practitioners, but their involvement varies considerably between countries and some have too few specialists who are located only in large centers. Specialized dietetics and foot care services are, in general, poorly developed. Insulin is freely available although analogs may incur a cost to the patient, while newer drugs (glucagon-like peptide-1 agonists, dipeptidyl peptidase-4 inhibitors) are either expensive or unavailable. Glucose monitoring is often rationed. Postgraduate training in diabetes is now well established in most countries and specialist training for nurses is being developed.

Conclusions:

Continuing disparities with western European countries are related mainly to deficient economic resources and inadequate financial investment. Some countries have introduced national programs to improve diabetes care with better clinical outcomes being obtained following treatment initiatives.
Putting Brakes on Insulin Pump Infusion to Prevent Hypoglycemia
Authors: Cengiz Eda
Published: January 2014

The author provides an analysis of the study published by Agrawal and colleagues, in this issue of Journal of Diabetes Science and Technology, which describes usage and effectiveness of the low glucose suspend feature that is integrated into the Medtronic Paradigm® Veo™ sensor-augmented pump system.
Performance of the DIDGET Blood Glucose Monitoring System in Children, Teens, and Young Adults
Authors: Deeb Larry C. , Parkes Joan L. , Pardo Scott , Schachner Holly C. , Viggiani Maria T. , Wallace Jane , Bailey Timothy
Published: January 2014

Background:

This study evaluated the performance of the DIDGET® blood glucose monitoring system (BGMS) in the hands of its intended users: Children, teens, and young adults with diabetes.

Methods:

Finger stick capillary blood samples were tested in duplicate by subjects (with parent/guardian assistance, if needed) and health care professionals using the DIDGET BGMS, and results were compared with those obtained using a Yellow Springs Instruments (YSI) glucose analyzer. Modified venous blood samples (i.e., glycolyzed or spiked with glucose) were used to analyze meter performance under extreme glucose concentrations. Accuracy was assessed using International Organization for Standardization (ISO) 15197:2003 guidelines (i.e., 95% of meter results within ±15 mg/dl or ±20% of reference values).

Results:

A total of 123 subjects aged 4 to 24 years with type 1 or type 2 diabetes were enrolled. The DIDGET meter achieved accuracy according to ISO 15197:2003 criteria: >97% of meter results were within ±15 mg/dl or ±20% of reference values. Regression analyses showed a high degree of correlation between meter and YSI results: Coefficient of determination ( R2) = 98.2% for all samples combined and 97.2% for capillary samples only. Clinical accuracy for combined samples was demonstrated by Parkes consensus error grid analyses; 100% of meter results were in zone A (98.5%) or zone B (1.5%). There was no difference in performance or accuracy across age subsets. Hematocrit values did not affect meter blood glucose results.

Conclusion:

The DIDGET BGMS provided accurate test results across all age ranges in children, teens, and young adults with diabetes.
Analysis Article: Accuracy of the DIDGET Glucose Meter in Children and Young Adults with Diabetes
Authors: Kim Sarah
Published: January 2014

Diabetes is one of the most common chronic diseases among American children. Although studies show that intensive management, including frequent glucose testing, improves diabetes control, this is difficult to accomplish. Bayer's DIDGET® glucose meter system pairs with a popular handheld video game system and couples good blood glucose testing habits with video-game-based rewards. In this issue, Deeb and colleagues performed a study demonstrating the accuracy of the DIDGET meter, a critical asset to this novel product designed to alleviate some of the challenges of managing pediatric diabetes.
Injection Force of Reusable Insulin Pens: Novopen 4, Lilly Luxura, Berlipen, and ClikSTAR
Authors: Friedrichs Arnd , Korger Volker , Adler Steffen
Published: January 2014

Background:

Insulin pen devices are used by approximately half of insulin users worldwide. The injection force of insulin pens is a key element in their design. This study aimed to demonstrate that the sanofi-aventis reusable ClikSTAR® (CS) pen has an improved injection force over existing insulin pens.

Methods:

The injection force of four reusable insulin pens—Novopen® 4 (NP4; Novo Nordisk), Luxura® (LL; Eli Lilly and Co.), Berlipen® (BP; Haselmeier GmbH), and CS (sanofi-aventis)—was tested in a laboratory setting. Injection force was tested using two methods: Six dispense rates between 6 and 24.66 U/s (constant volume flow rate) and constant button speeds of 4 and 8 mm/s.

Results:

The CS required a lower mean injection force versus NP4, LL, and BP at both doses and all dispense rates. Mean injection force was 45%, 126%, and 60% higher for NP4, LL, and BP versus CS, respectively ( p < .05 for each of the comparisons), for a flow rate of 6 U/s at 60 U dose. Mean injection force in all pens increased with the dispense rate, but the injection force remained significantly lower for CS versus all other pens ( p < .05). The injection force for CS was significantly lower for 60 U at 10 and 17.03 U/s than for 80 U.

Conclusions:

The study demonstrated that CS pens require a lower injection force at a wide range of different injection speeds than other reusable insulin pens. This is an important benefit for patients with diabetes, especially those with limited dexterity.