bluuebunny/crossref_metadata_2025 huggingface dataset:
Analysis of GlucoMen®Day: A Novel Microdialysis-Based Continuous Glucose Monitor
Authors: Kubiak Thomas
Published: January 2014

In this issue of Journal of Diabetes Science and Technology, Valgimigli and colleagues present promising data on the clinical accuracy of the new microdialysis-based continuous glucose monitoring device GlucoMen®Day. In this analysis, two issues are addressed: First, the established way data analyses may obscure interindividual variability in terms of a glucose monitoring system's accuracy; and second, to fully appreciate the future merits of the new system, data on accuracy, while a clearly necessary prerequisite, are not sufficient and need to be augmented by patient-reported outcome data as highlighted by recent U.S. Food and Drug Administration guidelines.
Missing Elements Revisited: Information Engineering for Managing Quality of Care for Patients with Diabetes
Authors: Connor Matthew J. , Connor Michael J.
Published: January 2014

Introduction:

Advances in information technology offer new avenues for assembling data about diet and care regimens of diabetes patients “in the field.” This creates a challenge for their doctors and the diabetes care community—how to organize and use new data to produce better long-term outcomes for diabetes patients.

Methods:

iAbetics approaches the challenge as a quality management problem, drawing on total quality concepts, which in turn are grounded in application of the scientific method. We frame the diabetes patient's quality-of-care problem as an ongoing scientific investigation aimed at quantifying and predicting relationships between specific care-management actions and their outcomes for individual patients in their ordinary course of life.

Results:

Framing diabetes quality-of-care management as a scientific investigation leads to a seven-step model termed “adaptive empirical iteration.” Adaptive empirical iteration is a deliberate process to perfect the patient's choices, decisions, and actions in routine situations that make up most day-to-day life and to systematically adapt across differences in individual patients and/or changes in their physiology, diet, or environment. The architecture incorporates care-protocol management and version control, structured formats for data collection using mobile smart phones, statistical analysis on secure Web sites, tools for comparing alternative protocols, choice architecture technology to improve patient decisions, and information sharing for doctor review.

Conclusions:

Adaptive empirical iteration is a foundation for information architecture designed to systematically improve quality-of-care provided to diabetes patients who act as their own day-to-day care provider under supervision and with support from their doctor. The approach defines “must-have” capabilities for systems using new information technology to improve long-term outcomes for diabetes patients.
Models of Glucagon Secretion, Their Application to the Analysis of the Defects in Glucagon Counterregulation and Potential Extension to Approximate Glucagon Action
Authors: Farhy Leon S. , McCall Anthony L.
Published: January 2014

This review analyzes an interdisciplinary approach to the pancreatic endocrine network-like relationships that control glucagon secretion and glucagon counterregulation (GCR). Using in silico studies, we show that a pancreatic feedback network that brings together several explicit interactions between islet peptides and blood glucose reproduces the normal GCR axis and explains its impairment in diabetes. An α-cell auto-feedback loop drives glucagon pulsatility and mediates triggering of GCR by hypoglycemia by a rapid switch-off of β-cell signals. The auto-feedback explains the enhancement of defective GCR in β-cell deficiency by a switch-off of signals in the pancreas that suppress α cells. Our models also predict that reduced β-cell activity decreases and delays the GCR. A key application of our models is the in silico simulation and testing of possible scenarios to repair defective GCR in β-cell deficiency. In particular, we predict that partial suppression of hyperglucagonemia may repair the impaired GCR. We also outline how the models can be extended and tested using human data to become a part of a larger construct including the regulation of the hepatic glucose output by the pancreas, circulating glucose, and incretins. In conclusion, a model of the normal GCR control mechanisms and their dysregulation in insulin-deficient diabetes is proposed and partially validated. The model components are clinically measurable, which permits its application to the study of the abnormalities of the human endocrine pancreas and their role in the progression of many diseases, including diabetes, metabolic syndrome, polycystic ovary syndrome, and others. It may also be used to examine therapeutic responses.
Multicenter User Evaluation of ACCU-CHEK® Combo, an Integrated System for Continuous Subcutaneous Insulin Infusion
Authors: Kerr David , Hoogma Roel P.L.M. , Buhr Andreas , Petersen Bettina , Storms Fred E.M.G. ,   for the study investigators
Published: January 2014

Background:

The aim of this study was to evaluate a newly developed system for insulin delivery incorporating a multifunctional blood glucose meter and a remotely controlled insulin pump (ACCU-CHEK® Combo system) in established pump users with type 1 diabetes. The technology was assessed both from device performance and subject usability perspectives.

Method:

A multicenter, prospective, single group study was carried out in five centers in the Netherlands and four centers in the United Kingdom for more than 6 months. The study was divided into two phases: Phase 1 (4 weeks) for device validation purposes and phase 2 (22 weeks) to observe the impact of the system on metabolic control, patient satisfaction [using the Diabetes Treatment Satisfaction Questionnaire (DTSQ)] and device safety.

Results:

Eighty subjects completed the planned study period. There were no unexpected device errors. Treatment satisfaction was high at baseline and further increased to study end (DTSQ change version: Sum score, 10.6 ± 7.2; scale score range, −18 to +18, p < 0.0001). Hemoglobin A1c improved continuously over time, from 7.9% (±0.9%) to 7.7% (±0.8%) at month 3 ( p < 0.001) and 7.6% (±0.8%) at month 6 ( p < 0.0001). The frequency of severe hypoglycemia was 0.08 per patient years. There was no case of ketoacidosis.

Conclusions:

The new system was evaluated by experienced continuous subcutaneous insulin infusion users as safe in daily practice and associated with favorable treatment satisfaction and a modest improvement in glycemic control.
Analysis: High-Tech Diabetes Technology and the Myth of Clinical “Plug and Play”
Authors: Weinzimer Stuart A.
Published: January 2014

In this issue of Journal of Diabetes Science and Technology, Davey and coauthors present encouraging data that even short-term use of a real-time continuous glucose monitor can lead to marked reduction in hypoglycemia exposure. In this analysis, two particular issues will be discussed: The distinction between short- and long-term experiences with sensors and the use of standardized diabetes treatment algorithms for use with continuous glucose monitoring (CGM) devices. An understanding of both of these aspects of CGM devices is necessary for placing clinical diabetes technology products into the context of how they will be used in “real life.”
Estimates of Total Analytical Error in Consumer and Hospital Glucose Meters Contributed by Hematocrit, Maltose, and Ascorbate
Authors: Lyon Martha E. , DuBois Jeffrey A. , Fick Gordon H. , Lyon Andrew W.
Published: January 2014

Background:

Patients and physicians expect accurate whole blood glucose monitoring even when patients are anemic, are undergoing peritoneal dialysis, or have slightly elevated ascorbate levels. The objective of this study was to estimate analytical error in two consumer and two hospital glucose meters contributed by variations in hematocrit, maltose, ascorbate, and imprecision.

Method:

The Influence of hematocrit (20–60%), maltose, and ascorbate were tested alone and in combination with each glucose meter and with a reference plasma glucose method at three concentrations of glucose. Precision was determined by consecutive analysis ( n = 20) at three levels of glucose. Multivariate regression analysis was used to estimate the bias associated with the interferences, alone and in combination. Total analytical error was estimated as |% bias| + 1.96 (% imprecision).

Results:

Three meters demonstrated hematocrit bias that was dependent upon glucose concentration. Maltose had profound concentration-dependent positive bias on the consumer meters, and the extent of maltose bias was dependent on hematocrit. Ascorbate produced small but statistically significant biases on three meters. Coincident low hematocrit, presence of maltose, and presence of ascorbate increased the observed bias and was summarized by estimation of total analytical error. Among the four glucose meter devices assessed, estimates of total analytical error in glucose measurement ranged from 6 to 68% under the conditions tested.

Conclusions:

The susceptibility of glucose meters to clinically significant analytical biases is highly device-dependent, and low hematocrit exacerbated the observed analytical error.
Novel Glucagon-like Peptide-1 Analog Delivered Orally Reduces Postprandial Glucose Excursions in Porcine and Canine Models
Authors: Eldor Roy , Kidron Miriam , Greenberg-Shushlav Yael , Arbit Ehud
Published: January 2014

Background:

Glucagon-like peptide-1 (GLP-1) and its analogs are associated with a gamut of physiological processes, including induction of insulin release, support of normoglycemia, β-cell function preservation, improved lipid profiles, and increased insulin sensitivity. Thus, GLP-1 harbors significant therapeutic potential for regulating type 2 diabetes mellitus, where its physiological impact is markedly impaired. To date, GLP-1 analogs are only available as injectable dosage forms, and its oral delivery is expected to provide physiological portal/peripheral concentration ratios while fostering patient compliance and adherence.

Methods:

Healthy, fasting, enterically cannulated pigs and beagle canines were administered a single dose of the exenatide-based ORMD-0901 formulation 30 min before oral glucose challenges. Blood samples were collected every 15 min for evaluation of ORMD-0901 safety and efficacy in regulating postchallenge glucose excursions.

Results:

Enterically delivered ORMD-0901 was well tolerated by all animals. ORMD-0901 formulations RG3 and AG2 led to reduced glucose excursions in pigs when delivered prior to a 5 g/kg glucose challenge, where area under the curve (AUC)0-120 values were up to 43% lower than in control sessions. All canines challenged with a glucose load with no prior exposure to exenatide, demonstrated higher AUC0-150 values than in their exenatide-treated sessions. Subcutaneous exenatide delivery amounted to a 51% reduction in mean glucose AUC0-150, while formulations AG4 and AG3 prompted 43% and 29% reductions, respectively.

Conclusions:

When delivered enterically, GLP-1 (ORMD-0901) is absorbed from the canine and porcine gastrointestinal tracts and retains its biological activity. Further development of this drug class in an oral dosage form is expected to enhance diabetes control and patient compliance.
Prevalence of Sleep Abnormalities and Their Association with Metabolic Syndrome among Asian Indians: Chennai Urban Rural Epidemiology Study (CURES − 67)
Authors: Roopa Mahadevan , Deepa Mohan , Indulekha Karunakaran , Mohan Viswanathan
Published: January 2014

Objective:

To estimate the prevalence of sleep abnormalities and their association with glucose intolerance and metabolic syndrome (MS) in the normal-weight urban South Indian population.

Methods:

This population-based, cross-sectional study was carried out in 358 subjects aged 20–76 years randomly selected from the Chennai Urban Rural Epidemiology Study in South India. A validated questionnaire assessing various sleep abnormalities (snoring, daytime sleepiness, lack of refreshing sleep, and number of hours of sleep) was administered. All subjects underwent an oral glucose tolerance test, and anthropometric biochemical measurements were obtained to assess cardiometabolic risk factors including glucose intolerance. Diabetes risk was assessed using a previously validated Indian Diabetes Risk Score (IDRS).

Results:

The overall prevalence of snoring and daytime sleepiness was 40% and 59%, respectively. Snorers were more male, older, smokers, and had higher levels of cardiometabolic risk factors. Subjects with daytime sleepiness had higher body mass index (BMI) and abdominal obesity. Both snoring (50.9% vs 30.2%, p < 0.001) and daytime sleepiness (68% vs 49.7%, p < 0.001) were more prevalent among subjects with impaired glucose metabolism compared to those with normal glucose metabolism. Both sleep measures were associated with higher diabetes risk scores, as assessed by the IDRS (snoring: Trend χ2, 11.14, p = 0.001; daytime sleepiness: Trend χ2, 5.12, p = 0.024). Metabolic syndrome was significantly associated with snoring even after adjusting for age, sex, family history of diabetes, physical activity, smoking, and alcohol.

Conclusion:

The prevalence of snoring and daytime sleepiness is high among urban South Indians and these two sleep measures are associated with glucose intolerance, MS, and higher diabetes risk scores.
Technologies for Continuous Glucose Monitoring: Current Problems and Future Promises
Authors: Vaddiraju Santhisagar , Burgess Diane J. , Tomazos Ioannis , Jain Faquir C. , Papadimitrakopoulos Fotios
Published: January 2014

Devices for continuous glucose monitoring (CGM) are currently a major focus of research in the area of diabetes management. It is envisioned that such devices will have the ability to alert a diabetes patient (or the parent or medical care giver of a diabetes patient) of impending hypoglycemic/hyperglycemic events and thereby enable the patient to avoid extreme hypoglycemic/hyperglycemic excursions as well as minimize deviations outside the normal glucose range, thus preventing both life-threatening events and the debilitating complications associated with diabetes. It is anticipated that CGM devices will utilize constant feedback of analytical information from a glucose sensor to activate an insulin delivery pump, thereby ultimately realizing the concept of an artificial pancreas. Depending on whether the CGM device penetrates/breaks the skin and/or the sample is measured extracorporeally, these devices can be categorized as totally invasive, minimally invasive, and noninvasive. In addition, CGM devices are further classified according to the transduction mechanisms used for glucose sensing (i.e., electrochemical, optical, and piezoelectric). However, at present, most of these technologies are plagued by a variety of issues that affect their accuracy and long-term performance. This article presents a critical comparison of existing CGM technologies, highlighting critical issues of device accuracy, foreign body response, calibration, and miniaturization. An outlook on future developments with an emphasis on long-term reliability and performance is also presented.
Implementing a Web-Based Home Monitoring System within an Academic Health Care Network: Barriers and Facilitators to Innovation Diffusion
Authors: Pelletier Alexandra C. , Jethwani Kamal , Bello Heather , Kvedar Joseph , Grant Richard W.
Published: January 2014

The practice of outpatient type 2 diabetes management is gradually moving from the traditional visit-based, fee-for-service model to a new, health information communication technology (ICT)-supported model that can enable non-visit-based diabetes care. To date, adoption of innovative health ICT tools for diabetes management has been slowed by numerous barriers, such as capital investment costs, lack of reliable reimbursement mechanisms, design defects that have made some systems time-consuming and inefficient to use, and the need to integrate new ICT tools into a system not primarily designed for their use. Effective implementation of innovative diabetes health ICT interventions must address local practice heterogeneity and the interaction of this heterogeneity with clinical care delivery. The Center for Connected Health at Partners Healthcare has implemented a new ICT intervention, Diabetes Connect (DC), a Web-based glucose home monitoring and clinical messaging system. Using the framework of the diffusion of innovation theory, we review the implementation and examine lessons learned as we continue to deploy DC across the health care network.
Noninvasive Diagnostic Devices for Diabetes through Measuring Tear Glucose
Authors: Zhang Jin , Hodge William , Hutnick Cindy , Wang Xianbin
Published: January 2014

This article reviews the development of a noninvasive diagnostic for diabetes by detecting ocular glucose. Early diagnosis and daily management are very important to diabetes patients to ensure a healthy life. Commercial blood glucose sensors have been used since the 1970s. Millions of diabetes patients have to prick their finger for a drop of blood 4–5 times a day to check blood glucose levels—almost 1800 times annually. There is a strong need to have a noninvasive device to help patients to manage the disease easily and painlessly. Instead of detecting the glucose in blood, monitoring the glucose level in other body fluids may provide a feasible approach for noninvasive diagnosis and diabetes control. Tear glucose has been studied for several decades. This article reviews studies on ocular glucose and its monitoring methods. Attempts to continuously monitor the concentration of tear glucose by using contact lens-based sensors are discussed as well as our current development of a nanostructured lens-based sensor for diabetes. This disposable biosensor for the detection of tear glucose may provide an alternative method to help patients manage the disease conveniently.
An Overview of Management Issues in Adult Patients with Type 2 Diabetes Mellitus
Authors: Vigersky Robert A.
Published: January 2014

Despite some progress in reducing the rate of diabetic complications, the epidemic rise in incidence of diabetes mellitus ensures that there will be an increasing number of patients in the coming decades with complex health care management issues who will need efficient and effective care. The management of patients with diabetes is an ever-challenging endeavor attributable to several factors. These include, among others, (1) limited provider expertise, (2) decreasing time of a patient visit, (3) increasing complexity of drug management, (4) limited use of self-monitoring of blood glucose by patients and/or providers, (5) clinical inertia, and (6) nonadherence. Technology-driven innovative solutions, including those using virtual reality, are desperately needed to assist both patients and their providers in overcoming the exigencies of this protean disease.
What Virtual Reality Research in Addictions Can Tell Us about the Future of Obesity Assessment and Treatment
Authors: Bordnick Patrick S. , Carter Brian L. , Traylor Amy C.
Published: January 2014

Virtual reality (VR), a system of human-computer interaction that allows researchers and clinicians to immerse people in virtual worlds, is gaining considerable traction as a research, education, and treatment tool. Virtual reality has been used successfully to treat anxiety disorders such as fear of flying and post-traumatic stress disorder, as an aid in stroke rehabilitation, and as a behavior modification aid in the treatment of attention deficit disorder. Virtual reality has also been employed in research on addictive disorders. Given the strong evidence that drug-dependent people are highly prone to use and relapse in the presence of environmental stimuli associated with drug use, VR is an ideal platform from which to study this relationship. Research using VR has shown that drug-dependent people react with strong craving to specific cues (e.g., cigarette packs, liquor bottles) as well as environments or settings (e.g., bar, party) associated with drug use. Virtual reality has also been used to enhance learning and generalization of relapse prevention skills in smokers by reinforcing these skills in lifelike environments. Obesity researchers and treatment professionals, building on the lessons learned from VR research in substance abuse, have the opportunity to adapt these methods for investigating their own research and treatment questions. Virtual reality is ideally suited to investigate the link between food cues and environmental settings with eating behaviors and self-report of hunger. In addition, VR can be used as a treatment tool for enhancing behavior modification goals to support healthy eating habits by reinforcing these goals in life-like situations.
Extending the Reach of Health Care for Obesity and Diabetes Using Virtual Worlds
Authors: Morie Jacquelyn Ford , Chance Eric
Published: January 2014

Today's epidemic of obesity and diabetes poses challenges to health care similar to those facing soldiers who return with postdeployment mental health issues. These include geographic barriers, social stigma, and the need for behavioral change. Researchers at University of Southern California's Institute for Creative Technologies are adapting their extensive experience in technological solutions for training to techniques that can aid veterans in need. These techniques show promise for concerns in the growing crisis of “diabesity.” Virtual reality (VR) has already demonstrated itself as an impactful treatment method for several behavioral and mental health domains. Virtual worlds, the successor technology of original VR, inherited many of its predecessor's strengths but also presents the new affordances of accessibility, social connectivity, and avatar usage, which pave the way toward future treatment options on a broader scale.
The Key to Unlocking the Virtual Body: Virtual Reality in the Treatment of Obesity and Eating Disorders
Authors: Riva Giuseppe
Published: January 2014

Obesity and eating disorders are usually considered unrelated problems with different causes. However, various studies identify unhealthful weight-control behaviors (fasting, vomiting, or laxative abuse), induced by a negative experience of the body, as the common antecedents of both obesity and eating disorders. But how might negative body image—common to most adolescents, not only to medical patients—be behind the development of obesity and eating disorders?

In this paper, I review the “allocentric lock theory” of negative body image as the possible antecedent of both obesity and eating disorders.

Evidence from psychology and neuroscience indicates that our bodily experience involves the integration of different sensory inputs within two different reference frames: egocentric (first-person experience) and allocentric (third-person experience). Even though functional relations between these two frames are usually limited, they influence each other during the interaction between long- and short-term memory processes in spatial cognition. If this process is impaired either through exogenous (e.g., stress) or endogenous causes, the egocentric sensory inputs are unable to update the contents of the stored allocentric representation of the body. In other words, these patients are locked in an allocentric (observer view) negative image of their body, which their sensory inputs are no longer able to update even after a demanding diet and a significant weight loss. This article discusses the possible role of virtual reality in addressing this problem within an integrated treatment approach based on the allocentric lock theory.
Using Virtual Reality to Improve Walking Post-Stroke: Translation to Individuals with Diabetes
Authors: Deutsch Judith E.
Published: January 2014

Use of virtual reality (VR) technology to improve walking for people post-stroke has been studied for its clinical application since 2004. The hardware and software used to create these systems has varied but has predominantly been constituted by projected environments with users walking on treadmills. Transfer of training from the virtual environment to real-world walking has modest but positive research support. Translation of the research findings to clinical practice has been hampered by commercial availability and costs of the VR systems. Suggestions for how the work for individuals post-stroke might be applied and adapted for individuals with diabetes and other impaired ambulatory conditions include involvement of the target user groups (both practitioners and clients) early in the design and integration of activity and education into the systems.
Automated Near-Continuous Glucose Monitoring Measured in Plasma Using Mid-Infrared Spectroscopy
Authors: Jax Thomas , Heise Tim , Nosek Leszek , Gable Jennifer , Lim Gene , Calentine Christopher
Published: January 2014

Objective:

There are increasing calls for a precise, automated system to enable tight glycemic control and to avoid hypoglycemia in an intensive care unit setting. OptiScan Biomedical has developed a glucose monitor based on mid-infrared spectroscopy that withdraws blood samples (120 μl) and measures plasma glucose. The goal of this study was to validate the performance of the OptiScan Model 5000 over a wide range of glycemic levels in patients.

Research Design and Methods:

Sixty people with type 1 ( n = 18) or type 2 ( n = 42) diabetes who were otherwise healthy were connected to OptiScanners. Their blood glucose concentrations were kept in a euglycemic, hypoglycemic (<75 mg/dl), and hyperglycemic (>180 mg/dl) range by intravenous administrations of insulin and glucose. OptiScanner venous blood samples were automatically withdrawn every 15 minutes. Reference measurements were done using the YSI 2300 glucose analyzer.

Results:

The aggregate data points (1155 paired readings) were within International Organization for Standardization standards, with 98.6% of the glucose values within ±20% above 75 mg/dl and ±15 mg/dl below this value. A Clarke error grid analysis showed a total of 1139 points (98.6%) in zone A. Points outside of A exceeded the A zone boundary by an average of 4.3%. The r2 was 0.99. The total coefficient for variance was 6.4%.

Conclusions:

These results show that the OptiScanner is highly accurate in healthy patients with diabetes across a wide range of glucose values. Mid-infrared spectroscopy may become the method of choice for highly accurate, high frequency, automated glucose measurements and may thus enable better glycemic control in critically ill patients.
Accuracy Performance of the Medtronic NexSensor® for 6 Days in an Inpatient Setting Using Abdomen and Buttocks Insertion Sites
Authors: Peoples Tim , Bailey Timothy , Brazg Ronald , Zisser Howard C. , Janowski Bob , Huang Suiying , Talbot Cary , Yang Qingqing
Published: January 2014

Background:

Users of continuous glucose monitoring are concerned with product accuracy and choice of insertion site. The Medtronic NexSensor® was evaluated for accuracy during 6 days of wear when inserted in the abdomen and buttocks areas.

Methods:

Adults (ages 18–75) with type 1 diabetes wore two sensors simultaneously for 6 days, one each inserted in the abdomen and buttocks. Subjects underwent a frequent blood sampling study for 12 hours, during which time reference blood glucose values were obtained every 15 minutes and compared to sensor values.

Results:

Sixty-three subjects were enrolled, and 61 subjects completed the study. The mean agreement rate between sensor and blood glucose values was 75.5% [95% confidence interval (CI), 69.5, 81.4] at the abdomen site, 73.8% (95% CI, 68.8, 78.8) at the buttocks site, and 75.6% (95% CI, 70.8, 80.4) when sensor and reference data were combined between sites. Over 90% of paired sensor-reference values on Clarke error grids were within the A and B ranges. The mean absolute relative differences were 17.1% at the abdomen site, 16.5% at the buttocks site, and 16.8% when sites were combined.

Conclusion:

The NexSensor was accurate for inpatient, frequent-sample testing for 6 days when inserted into the abdomen and buttocks. The results of this study also provide evidence that both the abdomen and buttocks are suitable as sensor insertion sites.
Indian Diabetes Risk Score Helps to Distinguish Type 2 from Non-Type 2 Diabetes Mellitus (GDRC-3)
Authors: Sharma Kunal M. , Ranjani Harish , Nguyen Ha , Shetty Shuba , Datta Manjula , Narayan K. M. Venkat , Mohan Viswanathan
Published: January 2014

Aim:

The aim of this study was to investigate whether the Indian Diabetes Risk Score (IDRS) could assist in classifying type 2 diabetes mellitus (T2DM) and non-T2DM among patients attending clinics in India.

Methods:

Patient records from 2006 through 2009 were taken from the clinical database of a tertiary care diabetes hospital in Chennai, Southern India. A total of 8747 patients with diabetes, diagnosed by a physician either as type 1 diabetes mellitus (T1DM), T2DM, or other types were included for analysis. The IDRS, based on age, abdominal obesity, family history of diabetes, and physical activity, was calculated for each patient at first visit to our clinic. Receiver operating characteristic (ROC) curves were generated to obtain optimal IDRS cut points for predicting T2DM and non-T2DM.

Results:

Of the 8747 patient records analyzed, 204 (2.3%) were classified as non-T2DM and 8543 (97.7%) as T2DM. In ROC analysis, an IDRS ≥60 [area under the curve (AUC), 0.894; sensitivity, 83.8%; specificity, 81.0%] was predictive of T2DM, while an IDRS <60 (AUC, 0.882; sensitivity, 79.9%; specificity, 83.8%) was predictive of non-T2DM.

Conclusions:

The IDRS, a simple, cost-effective risk score, can assist in classifying T2DM versus non-T2DM among clinic patients in India.
Using Web Technology to Support Population-Based Diabetes Care
Authors: Cunningham Scott , McAlpine Ritchie , Leese Graham , Brennan Geraldine , Sullivan Frank , Connacher Alan , Waller Annalu , Boyle Douglas I. R. , Greene Stephen , Wilson Elaine , Emslie-Smith Alistair , Morris Andrew D.
Published: January 2014

Background:

Managed clinical networks have been used to coordinate chronic disease management across geographical regions in the United Kingdom. Our objective was to review how clinical networks and multidisciplinary team-working can be supported by Web-based information technology while clinical requirements continually change.

Methods:

A Web-based population information system was developed and implemented in November 2000. The system incorporates local guidelines and shared clinical information based upon a national dataset for multispecialty use. Automated data linkages were developed to link to the master index database, biochemistry, eye screening, and general practice systems and hospital diabetes clinics. Web-based data collection forms were developed where computer systems did not exist. The experience over the first 10 years (to October 2010) was reviewed.

Results:

The number of people with diabetes in Tayside increased from 9694 (2.5% prevalence) in 2001 to 18,355 (4.6%) in 2010. The user base remained stable (~400 users), showing a high level of clinical utility was maintained. Automated processes support a single point of data entry with 10,350 clinical messages containing 40,463 data items sent to external systems during year 10. The system supported quality improvement of diabetes care; for example, foot risk recording increased from 36% in 2007 to 73.3% in 2010.

Conclusions:

Shared-care datasets can improve communication between health care service providers. Web-based technology can support clinical networks in providing comprehensive, seamless care across a geographical region for people with diabetes. While health care requirements evolve, technology can adapt, remain usable, and contribute significantly to quality improvement and working practice.
Quality of Life and Objective Measures of Diabetic Neuropathy in a Prospective Placebo-Controlled Trial of Ruboxistaurin and Topiramate
Authors: Boyd Amanda , Casselini Carolina , Vinik Etta , Vinik Aaron
Published: January 2014

Background:

The Norfolk Quality of Life Questionnaire-Diabetic Neuropathy (Norfolk QOL-DN) is a validated comprehensive questionnaire designed to capture the entire spectrum of DN related to large fiber, small fiber, and autonomic neuropathy not captured in existing instruments. We aimed to determine if the Norfolk QOL-DN could be used to capture changes in QOL that correlate with nerve fiber-specific objective measures in a placebo-controlled trial of two agents that affect different nerve fibers.

Methods:

Sixty patients with DN were allocated to treatment on ruboxistaurin (RBX) ( n = 18), topiramate (TPX) ( n = 18), or placebo ( n = 18). QOL-DN was administered and objective measures of nerve function were performed at entry and end of the study period.

Results:

Total QOL scores improved significantly in the active treatment groups (RBX −9.56 ± 4.13; TPX −12.22 ± 2.76) but not in placebo (−5.56 ± 3.49). There were differences in nerve function improvement between treatments. Neurological symptom scores (NSS) improved with TPX from 5.5 (2.3) to 4.3 (0.65) ( p = .007), sensory scores improved with TPX from 15.5 (1.79) to 8.3 (1.19) ( p < .001), motor scores did not change, and sensory and motor impairment scores improved with TPX from 18.8 (2.15) to 12.1 (1.71) ( p = .003). Total neuropathy scores (TNS) improved with TPX from 24.35 (2.61) to 16.35 (2.02) ( p = .001). Neuropathy total symptom score−6 (NTSS−6) changes were significant for both treatments: RBX 4.38 (0.75) to 1.49 (0.38) ( p < .001) and TPX 7.57 (1.3) to 4.26 (0.95) ( p = .036). Changes in QOL-DN large fiber subscores correlated (Spearman's rank) significantly with changes in NTSS-6 ( r = 0.55; p < .0001), NSS ( r = 0.31; p < .04), neuropathy impairment score (NIS) ( r = 0.35; p < .02), and TNS ( r = 0.48; p < .0006). Changes in QOL-DN small fiber subscores correlated significantly with changes in NTSS-6 total scores ( r = 0.40; p < .005) and intraepidermal nerve fiber density (IENFD) ( r = −0.29; p < .05).

Conclusion:

Ruboxistaurin produced significant improvement in large fiber measures while TPX produced significant changes in small fiber measures. The Norfolk QOL-DN tool differentiated between these changes captured in the fiber-specific domains. Correlations were found between objective measures of neuropathy and total QOL, but those with nerve fiber domain scores were modest and reinforce the need to quantify QOL as an endpoint in neuropathy independent of other measures.
Elevated Intact Proinsulin Levels are Indicative of Beta-Cell Dysfunction, Insulin Resistance, and Cardiovascular Risk: Impact of the Antidiabetic Agent Pioglitazone
Authors: Pfützner Andreas , Forst Thomas
Published: January 2014

Background:

Insulin resistance (IR) and deterioration of beta-cell secretion are main features in the development of type 2 diabetes, which is reflected in increasing serum intact proinsulin levels in later disease stage. Introduction of stable assays that are able to distinguish between intact proinsulin and its specific and unspecific cleavage products has resulted in the finding that serum intact proinsulin values can serve as a direct marker for beta-cell dysfunction, are a highly specific indicator of IR, and can predict cardiovascular risk.

Method:

Determination of fasting intact proinsulin may be used to monitor and optimize antidiabetic therapeutic approaches. Our study group has been involved in a variety of clinical studies investigating drug effects on beta-cell secretory capacity, IR, and intact proinsulin levels. One focus was on the impact of insulin-sensitizing therapy with pioglitazone on the pancreatic beta-cell load.

Results:

Treatment with pioglitazone resulted in significant decreases in elevated proinsulin levels in type 2 diabetes patients. This effect was independent from glycemic control.

Conclusions:

Measurement of fasting intact proinsulin values allows a staging of beta-cell dysfunction and evaluation of IR, thus providing an interesting diagnostic tool for both selection of appropriate therapy and monitoring of treatment success.
Geoenvironmental Diabetology
Authors: Cook Curtiss B. , Wellik Kay E. , Fowke Margaret
Published: January 2014

Many reports have documented the negative health consequences that environmental stressors can have on patients with diabetes. Studies examining the interaction between the environment and a patient with diabetes can be unified under a single discipline termed “geoenvironmental diabetology.” Geoenvironmental diabetology is defined more specifically as the study of how geophysical phenomena impact a patient with diabetes, to include effects on metabolic control, ancillary equipment (e.g., glucometers and insulin pumps), medications, supplies, access to care, and influences on the adaptive strategies employed by patients to care for their diabetes under extreme circumstances. Geological events such as natural disasters (e.g., earthquakes) or extreme weather (e.g., heat waves) are examples of stressors that can affect patients with diabetes and that can be included under the heading of geoenvironmental diabetology. As proposed here, geoenvironmental diabetology refers to how events in the physical world affect those with diagnosed diabetes, rather than how environmental factors might trigger development of disease. As the global prevalence of diabetes continues to increase, including in parts of the world that are especially vulnerable to disasters and climate change, further discussion is warranted on how to best prepare for management of diabetes under conditions of extreme geological and weather events and a changing climate. An overview is presented of various studies that have detailed how geoenvironmental phenomena can adversely affect patients with diabetes and concludes with a discussion of requirements for developing strategies for geoenvironmental diabetes management.
Efficacy of Continuous Glucose Monitoring in Improving Glycemic Control and Reducing Hypoglycemia: A Systematic Review and Meta-Analysis of Randomized Trials
Authors: Gandhi Gunjan Y. , Kovalaske Michelle , Kudva Yogish , Walsh Kristin , Elamin Mohamed B. , Beers Melody , Coyle Cathy , Goalen Melissa , Murad Mohammad Safwan , Erwin Patricia J. , Corpus Joshua , Montori Victor M. , Murad M. Hassan
Published: January 2014

Objective:

We conducted a systematic review and meta-analysis to assess the efficacy of continuous glucose monitoring (CGM) in improving glycemic control and reducing hypoglycemia compared to self-monitored blood glucose (SMBG).

Methods:

We searched MEDLINE, EMBASE, Cochrane Central, Web of Science, and Scopus for randomized trials of adults and children with type 1 or type 2 diabetes mellitus (T1DM or T2DM). Pairs of reviewers independently selected studies, assessed methodological quality, and extracted data. Meta-analytic estimates of treatment effects were generated using a random-effects model.

Results:

Nineteen trials were eligible and provided data for meta-analysis. Overall, CGM was associated with a significant reduction in mean hemoglobin A1c [HbA1c; weighted mean difference (WMD) of −0.27% (95% confidence interval [CI] −0.44 to −0.10)]. This was true for adults with T1DM as well as T2DM [WMD −0.50% (95% CI −0.69 to −0.30) and −0.70 (95% CI, −1.14 to −0.27), respectively]. No significant effect was noted in children and adolescents. There was no significant difference in HbA1c reduction between studies of real-time versus non-real-time devices (WMD −0.22%, 95% CI, −0.59 to 0.15 versus −0.30%, 95% CI, −0.49 to −0.10; p for interaction 0.71). The quality of evidence was moderate due to imprecision, suggesting increased risk for bias. Data for the incidence of severe or nocturnal hypoglycemia were sparse and imprecise. In studies that reported patient satisfaction, users felt confident about the device and gave positive reviews.

Conclusion:

Continuous glucose monitoring seems to help improve glycemic control in adults with T1DM and T2DM. The effect on hypoglycemia incidence is imprecise and unclear. Larger trials with longer follow-up are needed to assess the efficacy of CGM in reducing patient-important complications without significantly increasing the burden of care for patients with diabetes.
High Sensitivity C-Reactive Protein, Tumor Necrosis Factor-α, Interleukin-6, and Vascular Cell Adhesion Molecule-1 Levels in Asian Indians with Metabolic Syndrome and Insulin Resistance (CURES-105)
Authors: Indulekha Karunakaran , Surendar Jayagopi , Mohan Viswanathan
Published: January 2014

Aim:

The aim of this study was to assess levels of high-sensitivity C-reactive protein (hs-CRP), tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6), and vascular cell adhesion molecule-1 (VCAM-1) in South Indian subjects with and without MS and among MS subjects with and without insulin resistance (IR).

Methodology:

From the population-based Chennai Urban Rural Epidemiology Study, 334 subjects with MS and 342 subjects without MS were selected. Metabolic syndrome was diagnosed based on modified National Cholesterol Education Program criteria. High-sensitivity C-reactive protein, TNF-α, IL-6, and VCAM-1 were measured by enzyme-linked immunosorbent assay. Insulin resistance was calculated using the homeostasis model assessment (HOMA-IR) using the following formula: fasting insulin (μIU/ml) x fasting glucose (mmol/liter)/22.5.

Results:

Subjects with MS had significantly higher levels of all four inflammatory markers compared to those without MS: hs-CRP (2.57 vs 2.19 mg/liter) ( p < .05), TNF-α (4.47 vs 3.89 pg/ml) ( p < .05), IL-6 (16.22 vs 10.96 pg/ml) ( p < .05), and VCAM-1 (13.8 vs 7.94 pg/ml) ( p < .05). In the total study subjects, hs-CRP ( r = 0.089, p = .047), TNF-α ( r = 0.113, p = .040), IL-6 ( r = 0.176, p = .042), and VCAM-1 ( r = 0.230, p = .06) were significantly correlated with MS. With increasing quartiles of IR, mean levels of hs-CRP ( p for trend <.001) and TNF-α ( p for trend <.05) increased linearly. MS subjects with IR had higher levels of hs-CRP ( p < .001) and TNF-α ( p < .05) compared to MS subjects without IR.

Conclusion:

In Asian Indians, inflammatory cytokines hs-CRP, TNF-α, IL-6, and VCAM-1 are elevated in subjects with MS while hs-CRP and TNF-α are further elevated in those with MS and IR.
Outcome Measures for Outpatient Hypoglycemia Prevention Studies
Authors: Beck Roy W. , Kollman Craig , Xing Dongyuan , Buckingham Bruce A. , Chase H. Peter
Published: January 2014

Systems are being developed that utilize algorithms to predict impending hypoglycemia using commercially available continuous glucose monitoring (CGM) devices and to discontinue insulin delivery if hypoglycemia is predicted. In outpatient studies designed to test such systems, CGM-measured glycemic indices will not only be important outcome measures of efficacy but, in certain cases, will be the only good outcome. This is especially true in short-term studies designed to reduce hypoglycemia since the event rate for severe hypoglycemic events is too low for it to be a good outcome, and milder hypoglycemia often will be variably detected. Continuous glucose monitoring inaccuracy can be accounted for in the study design by increasing sample size and/or study duration.
Comparison of Clinically Relevant Technical Attributes of Five Insulin Injection Pens
Authors: Asakura Toshinari
Published: January 2014

Background:

Insulin injection pens are the predominant devices for insulin delivery in Europe and Japan because of their ease of use and convenience. This study compared clinically relevant technical attributes of durable insulin pens that are important to people with diabetes, specifically functions relating to cartridge-fitting, dose-setting, and dose-delivery on NovoPen® 4, ClikStar®, HumaPen Luxura®, Itango®, and Biosulin® Pen.

Methods:

Frequency components and duration of audible clicks on dose setting and injection were measured using audio equipment when setting and delivering 20 IU of insulin. To assess cartridge-fitting torque, each pen was attached to a torque gauge via the attached needle, and torque was measured with each 180° turn as the cartridge was screwed into the body of the pen. Rotary torque of the dose-setting dial was measured when setting the dose to the maximum dose unit of the pen. Injection force was measured when delivering 20 IU at 5 mm/s in a vertical position and at a tilt of 14.7° from vertical.

Results:

Audible clicks on dose-setting and dose-delivery were most distinguishable on NovoPen 4, while NovoPen 4 and ClikStar had generally lower cartridge-fitting torque and injection (both vertical and angled) force values.

Conclusion:

Overall, the results showed that durable insulin pens such as NovoPen 4 have useful features related to assembly, dose-setting, and injection, which may facilitate ease of use for diabetes patients, particularly elderly patients and those with visual and/or manual dexterity impairments.
Analysis and Perspective: A Randomized, Open-Label, Comparative Crossover Handling Trial between Two Durable Pens in Patients with Type 1 or 2 Diabetes Mellitus
Authors: Bailey Timothy S.
Published: January 2014

Insulin pen therapy is superior to vial and syringe with regard to more accurate insulin delivery, patient preference, adherence, and favorable health economics. In this issue of Journal of Diabetes Science and Technology, Sommavilla and Pietranera compare two generations of NovoPen, showing significant improvements in selecting and injecting the insulin dose as well as superior overall satisfaction with the newer versus older generation insulin pen among both experienced pen users and insulin-naïve patients.

There are other potentially useful features that might be implemented and better-studied in future pen devices. These include insulin dose tracking, insulin error mitigation, and insulin dosing advice. Caring more effectively for the multitude of people impacted by the diabetes epidemic requires a new approach that will require “smarter,” more “connected” devices.
Mechanisms Responsible for Excess Weight Loss after Bariatric Surgery
Authors: Ionut Viorica , Bergman Richard N.
Published: January 2014

Obesity has increased alarmingly in the United States and is increasing in many countries of the world. Because obesity is an important risk factor for type 2 diabetes and other chronic diseases, it is important to develop approaches to counter the rapid increase in adiposity. One approach is bariatric surgery, the most successful clinical intervention known for treating obesity. Surgery can result in impressive weight loss and improvement of obesity-related comorbidities. Yet the mechanisms responsible for this remarkable effect of surgery remain controversial. It is now clear that caloric restriction, per se, does not explain all the reduction in stored fat mass after surgery. A number of gastrointestinal hormones, including glucagon-like peptide (GLP)-1, peptide YY, oxyntomodulin, GLP-2, glucose-dependent insulinotropic polypeptide, ghrelin, and others, can play roles in energy homeostasis and could be involved in bariatric-surgery-related weight loss and weight loss maintenance. Vagal innervation may play a role. In addition, there may be other yet-uncharacterized factors that could participate. This review discusses the possible roles of these hormonal mechanisms in various types of bariatric surgery to help elucidate some of the potential mechanisms at play in short-term and long-term post-bariatric surgery weight loss. Understanding such mechanisms could lead to new and efficacious means to control or even reduce the epidemic of obesity.