bluuebunny/crossref_metadata_2025 huggingface dataset:
Feasibility and Usability of a Text Message-Based Program for Diabetes Self-Management in an Urban African-American Population
Authors: Dick Jonathan J. , Nundy Shantanu , Solomon Marla C. , Bishop Keisha N. , Chin Marshall H. , Peek Monica E.
Published: January 2014

Purpose:

We pilot-tested a text message-based diabetes care program in an urban African-American population in which automated text messages were sent to participants with personalized medication, foot care, and appointment reminders and text messages were received from participants on adherence.

Methods:

Eighteen patients participated in a 4-week pilot study. Baseline surveys collected data about demographics, historical cell phone usage, and adherence to core diabetes care measures. Exit interview surveys (using close-coded and open-ended questions) were administered to patients at the end of the program. A 1-month follow-up interview was conducted surveying patients on perceived self-efficacy. Wilcoxon signed-rank tests were used to compare baseline survey responses about self-management activities to those at the pilot's end and at 1-month follow-up.

Results:

Eighteen urban African-American participants completed the pilot study. The average age was 55 and the average number of years with diabetes was 8. Half the participants were initially uncomfortable with text messaging. Example messages include “Did you take your diabetes medications today” and “How many times did you check your feet for wounds this week?” Participants averaged 220 text messages with the system, responded to messages 80% of the time, and on average responded within 6 minutes. Participants strongly agreed that text messaging was easy to perform and helped with diabetes self-care. Missed medication doses decreased from 1.6 per week to 0.6 ( p = .003). Patient confidence in diabetes self-management was significantly increased during and 1 month after the pilot ( p = .002, p = .008).

Conclusions:

Text messaging may be a feasible and useful approach to improve diabetes self-management in urban African Americans.
Efficacy of a Pilot Internet-Based Weight Management Program (H.E.A.L.T.H.) and Longitudinal Physical Fitness Data in Army Reserve Soldiers
Authors: Newton Robert L. , Han Hongmei , Stewart Tiffany M. , Ryan Donna H. , Williamson Donald A.
Published: January 2014

Background:

The primary aims of this article are to describe the utilization of an Internet-based weight management Web site [Healthy Eating, Activity, and Lifestyle Training Headquarters (H.E.A.L.T.H.)] over a 12–27 month period and to describe concurrent weight and fitness changes in Army Reserve soldiers.

Methods:

The H.E.A.L.T.H. Web site was marketed to Army Reserve soldiers via a Web site promotion program for 27 months (phase I) and its continued usage was observed over a subsequent 12-month period (phase II). Web site usage was obtained from the H.E.A.L.T.H. Web site. Weight and fitness data were extracted from the Regional Level Application Software (RLAS).

Results:

A total of 1499 Army Reserve soldiers registered on the H.E.A.L.T.H. Web site. There were 118 soldiers who returned to the H.E.A.L.T.H. Web site more than once. Registration rate reduced significantly following the removal of the Web site promotion program. During phase I, 778 Army Reserve soldiers had longitudinal weight and fitness data in RLAS. Men exceeding the screening table weight gained less weight compared with men below it ( p < .007). Percentage change in body weight was inversely associated with change in fitness scores.

Conclusions:

The Web site promotion program resulted in 52% of available Army Reserve soldiers registering onto the H.E.A.L.T.H. Web site, and 7.9% used the Web site more than once. The H.E.A.L.T.H. Web site may be a viable population-based weight and fitness management tool for soldier use.
A Controlled Study of the Effectiveness of an Adaptive Closed-Loop Algorithm to Minimize Corticosteroid-Induced Stress Hyperglycemia in Type 1 Diabetes
Authors: Youssef Joseph El , Castle Jessica R. , Branigan Deborah L. , Massoud Ryan G. , Breen Matthew E. , Jacobs Peter G. , Bequette B. Wayne , Ward W. Kenneth
Published: January 2014

To be effective in type 1 diabetes, algorithms must be able to limit hyperglycemic excursions resulting from medical and emotional stress. We tested an algorithm that estimates insulin sensitivity at regular intervals and continually adjusts gain factors of a fading memory proportional-derivative (FMPD) algorithm. In order to assess whether the algorithm could appropriately adapt and limit the degree of hyperglycemia, we administered oral hydrocortisone repeatedly to create insulin resistance. We compared this indirect adaptive proportional-derivative (APD) algorithm to the FMPD algorithm, which used fixed gain parameters. Each subject with type 1 diabetes ( n = 14) was studied on two occasions, each for 33 h.

The APD algorithm consistently identified a fall in insulin sensitivity after hydrocortisone. The gain factors and insulin infusion rates were appropriately increased, leading to satisfactory glycemic control after adaptation (premeal glucose on day 2, 148 ± 6 mg/dl). After sufficient time was allowed for adaptation, the late postprandial glucose increment was significantly lower than when measured shortly after the onset of the steroid effect. In addition, during the controlled comparison, glycemia was significantly lower with the APD algorithm than with the FMPD algorithm. No increase in hypoglycemic frequency was found in the APD-only arm.

An afferent system of duplicate amperometric sensors demonstrated a high degree of accuracy; the mean absolute relative difference of the sensor used to control the algorithm was 9.6 ± 0.5%. We conclude that an adaptive algorithm that frequently estimates insulin sensitivity and adjusts gain factors is capable of minimizing corticosteroid-induced stress hyperglycemia.
Closed-Loop Glucose Control: Psychological and Behavioral Considerations
Authors: Gonder-Frederick Linda , Shepard Jaclyn , Peterson Ninoska
Published: January 2014

Since 2000, the diabetes community has witnessed tremendous technological advances that have revolutionized diabetes management. Currently, closed-loop glucose control (CLC) systems, which link continuous subcutaneous insulin infusion and continuous glucose monitoring, are the newest, cutting edge technology aimed at reducing glycemic variability and improving daily management of diabetes. Although advances in knowledge and technology in the treatment of diabetes have improved exponentially, adherence to diabetes regimens remains complex and often difficult to predict. Human factors, such as patient perceptions and behavioral self-regulation, are central to adherence to prescribed regimens, as well as to adoption and utilization of diabetes technology, and they will continue to be crucial as diabetes management evolves. Thus, the aims of this article are three-fold: (1) to review psychological and behavioral factors that have influenced adoption and utilization of past technologies (2) to examine three theoretical frameworks that may help in conceptualizing relevant patient factors in diabetes management, and (3) to propose patient-selection factors that will likely affect future CLC systems.
“Never Events”: Hepatitis B Outbreaks and Patient Notifications Resulting from Unsafe Practices during Assisted Monitoring of Blood Glucose, 2009–2010
Authors: Thompson Nicola D. , Schaefer Melissa K.
Published: January 2014

Introduction:

Despite sustained public health efforts to publicize the risk of hepatitis B virus (HBV) infection outbreaks during assisted monitoring of blood glucose (AMBG), outbreaks continue to occur. Here, we highlight several outbreaks and patient notifications due to AMBG, discuss prevention initiatives, and highlight gaps that remain.

Methods:

We reviewed available data and information from investigations of health care-associated HBV infection outbreaks and patient notification events associated with AMBG in the United States between 2009 and 2010.

Results:

Four HBV infection outbreaks were reported, all in assisted living facilities. Common infection control breaches included use of reusable finger stick devices, which are intended for personal use, on multiple persons; use of BG meters for more than one person without cleaning and disinfection between each use; and comingling of contaminated and clean equipment and supplies. Twenty-nine (88%) of the 33 residents who acquired acute HBV infection as part of these outbreaks received AMBG. Compared with those who did not, residents undergoing AMBG had significantly increased risk of acquiring acute HBV infection (relative risk: 27.7, 95% confidence interval: 10.3 to 74.4). During two patient notifications, approximately 320 persons were recommended to undergo bloodborne pathogen testing after being placed at risk for exposure to another person's blood when personal-use multilancet finger stick devices were selected for use on multiple persons.

Conclusions:

Misperception on the risk for bloodborne pathogen transmission and confusion regarding selection and appropriate use of BG monitoring devices for AMBG remain a problem. In addition to public health outreach and infection control recommendations, clear labeling, packaging, instructions for device use, and appropriate device marketing will assist in infection prevention efforts.
Evaluation of Different Disinfectants on the Performance of an On-Meter Dosed Amperometric Glucose-Oxidase-Based Glucose Meter
Authors: Sarmaga Don , DuBois Jeffrey A. , Lyon Martha E.
Published: January 2014

Background:

Off-meter dosed photometric glucose-oxidase-based glucose meters have been reported to be susceptible to interference by hydrogen-peroxide-based disinfecting agents. The objective of this study was to determine if a single application of hydrogen-peroxide-containing Accel® wipe to disinfect an on-meter dosed amperometric glucose-oxidase-based glucose meter will influence its performance.

Method:

The performance of five on-meter dosed amperometric glucose-oxidase-based glucose meters was determined before and after disinfecting the devices with a single application of either CaviWipes® (14.3% isopropanol and 0.23% diisobutyl-phenoxy-ethoxyethyl dimethyl benzyl ammonium chloride) or Accel (0.5% hydrogen peroxide) wipes. Replicate glucose measurements were conducted before disinfecting the devices, immediately after disinfecting, and then 1 and 2 min postdisinfecting, with measurements in triplicate. Analysis was sequentially completed for five different meters. Results were analyzed by a two-way analysis of variance (Analyze-it software).

Results:

No clinical (<0.3 mmol/liter) or statistical differences ( p > .05) in glucose concentration were detected when the on-meter dosed amperometric glucose-oxidase-based glucose meters were disinfected with either CaviWipes or Accel wipes and measured immediately or 1 or 2 min postdisinfecting. No clinically significant difference in glucose concentration was detected between meters (<0.3 mmol/liter).

Conclusion:

The on-meter dosed glucose oxidase amperometric-based glucose meters are not analytically susceptible to interference by a single application of hydrogen-peroxide-containing Accel disinfectant wipes.
Data-Mining Technologies for Diabetes: A Systematic Review
Authors: Marinov Miroslav , Mosa Abu Saleh Mohammad , Yoo Illhoi , Boren Suzanne Austin
Published: January 2014

Background:

The objective of this study is to conduct a systematic review of applications of data-mining techniques in the field of diabetes research.

Method:

We searched the MEDLINE database through PubMed. We initially identified 31 articles by the search, and selected 17 articles representing various data-mining methods used for diabetes research. Our main interest was to identify research goals, diabetes types, data sets, data-mining methods, data-mining software and technologies, and outcomes.

Results:

The applications of data-mining techniques in the selected articles were useful for extracting valuable knowledge and generating new hypothesis for further scientific research/experimentation and improving health care for diabetes patients. The results could be used for both scientific research and real-life practice to improve the quality of health care diabetes patients.

Conclusions:

Data mining has played an important role in diabetes research. Data mining would be a valuable asset for diabetes researchers because it can unearth hidden knowledge from a huge amount of diabetes-related data. We believe that data mining can significantly help diabetes research and ultimately improve the quality of health care for diabetes patients.
What Can We Learn from Patient-Reported Outcomes of Insulin Pen Devices?
Authors: Anderson Barbara J. , Redondo Maria J.
Published: January 2014

Although a variety of effective treatment options are available for patients with type 1 or type 2 diabetes, many patients in the United States have difficulty reaching their glycemic goals. Patient adherence to insulin therapy, which often involves self-administered subcutaneous injections of insulin using either a vial and syringe or an insulin pen device, is often poor. Various factors associated with the type of injection device have been shown to influence the rate of patient adherence to insulin therapy. This article reviews patient-reported outcome (PRO) evidence from pediatric and adult studies that compared insulin pen devices with vial and syringe use. In a majority of these cases, patients preferred the pen devices over vial and syringe, stating advantages such as ease of use, convenience, greater confidence in their ability to properly administer the drug, and a greater perceived social acceptance. The pens were considered less painful than syringes and were associated with less needle fear. In addition, PRO evidence has directed pen technology design, leading to development of more advanced insulin pen devices. By appreciating the correlation between adherence to insulin regimens and a patient's device preference, clinicians can make improved treatment recommendations to facilitate achievement and maintenance of glycemic targets.
Actionable Self-Monitoring of Blood Glucose: Redefining the Role for Patients Using Multiple Daily Injection Therapy
Authors: Kerr David , Messing Rebecca , Resch Ansgar
Published: January 2014

Self-monitoring of blood glucose (SMBG) values is an accepted requirement for patients with diabetes using multiple daily injections of insulin. Nevertheless, for many patients, the full value of SMBG has yet to be realized due to a number of factors that contribute to patients not taking appropriate action based on the achieved result. The reasons for this are complex but are related to the burden imposed by performing the tests, the need for complex numerical calculations, and the demand for undertaking this activity multiple times each day.

In the near future, SMBG devices are likely to include technological innovations that are aimed at overcoming these barriers, offering “actionable” SMBG for patients using insulin. These innovations should include technologies that will allow customization and individualization based upon specific therapy regimens.
Intensive Control of Diabetes in the Hospital: Why, How, and What is in the Future?
Authors: Hsia Elisa , Draznin Boris
Published: January 2014

Intensive management of diabetes is identified as a critical component of inpatient care. However, the fundamental question that remains is whether controlling glycemia in noncritically ill diabetes patients at the lower end of the current guidelines improves outcomes of hospitalization, long-term outcomes of the primary condition, and long-term outcomes of diabetes compared with average glycemia greater than 180 mg/dl. A group of clinical investigators—Planning Research in Inpatient Diabetes (PRIDE)—is preparing randomized controlled trials with the hope of defining optimal glycemic targets for hospitalized patients with diabetes. Given the variety of clinical situations that can occur in the inpatient setting, many medical centers have established dedicated inpatient diabetes teams. There is ample evidence, albeit retrospective, that these teams improve inpatient glucose control and reduce lengths of hospital stays. Using hospitalization as an opportunity to educate patients about diabetes and to optimize their treatment regimen may improve long-term outpatient glycemic control.
Analysis of the Performance of the OneTouch SelectSimple Blood Glucose Monitoring System: Why Ease of Use Studies Need to Be Part of Accuracy Studies
Authors: Krouwer Jan S.
Published: January 2014

The article entitled “Precision, Accuracy, and User Acceptance of the OneTouch SelectSimple Blood Glucose Monitoring System” by Philis-Tsimikas and colleagues in this issue of Journal of Diabetes Science and Technology demonstrates that the OneTouch® SelectSimple™ glucose meter meets current regulatory expectations for glucose meter performance. These authors describe three studies: Precision, accuracy, and ease of use. Accuracy study analysis includes the effects of accuracy and precision. The ease-of-use study was analyzed separately, as recommended by the International Organization for Standardization 15197 glucose standard. The ultimate goal of an evaluation is to estimate the distribution of errors (from any source) that will be experienced in routine use. To accomplish this, ease-of-use results need to be part of the accuracy dataset.
Glycemic Control in the Pediatric Intensive Care Unit of Leuven: Two Years of Experience
Authors: Van Herpe Tom , Vanhonsebrouck Koen , Mesotten Dieter , De Moor Bart , Van den Berghe Greet
Published: January 2014

Stress hyperglycemia and hypoglycemia are associated with increased mortality and morbidity in critically ill patients. Three randomized controlled trials, in the surgical, medical, and pediatric intensive care unit (PICU) of the Leuven University in Belgium, demonstrated the beneficial response of tightly controlling blood glucose levels within age-adjusted narrow limits by applying intensive insulin therapy. Follow-up studies could not confirm the results obtained in the Leuven studies but revealed the complexity associated with tight glycemic control (TGC). This article gives an overview of the methodological aspects typical of the Leuven TGC concept, with the focus on the PICU. Differences between the adult and the PICU are described. This overview article might help other ICUs by addressing potential differences in clinical practice when implementing TGC.
Paper Electrocardiograph Strips May Contain Overlooked Clinical Information in Screen-Detected Type 2 Diabetes Patients
Authors: Fleischer Jesper , Charles Morten , Tarnow Lise , Jensen Klaus Skovbo , Nygaard Hans , Sandbaek Annelli , Ejskjaer Niels
Published: January 2014

Background:

A large number of nondigitized electrocardiograph (ECG) strips are routinely collected in larger cohort studies such as the ADDITION study (Anglo-Danish-Dutch Study of Intensive Treatment in People with Screen-Detected Diabetes in Primary Care). These ECG strips are routinely read manually but may contain overlooked information revealing cardiac autonomic dysfunction. The aim of this study was to investigate whether clinical information may be lost using manual R wave to R wave (RR) interval measurements in the calculation of heart rate variability (HRV) in patients with type 2 diabetes mellitus (T2DM).

Method:

From the Danish part of the ADDITION study, we randomly selected 120 T2DM patients at baseline of the ADDITION study. Analysis of the ECG strips was performed using two different methods: (1) by experienced technicians using rulers and (2) by experienced technicians using a high-resolution computer-assisted method. Calculation of heart rate and time domain HRV [standard deviation of normal-to-normal RR intervals (SDNN) and root mean square of successive differences (RMSSD)] were performed with the same software.

Results:

When comparing results from the two methods, the following values of Pearson's r are obtained: 0.98 for heart rate, 0.76 for SDNN, and 0.68 for RMSSD. These results indicate that heart rate and HRV measurements by the computer-assisted and manually based methods correlate. However, Bland-Altman plots and Pitman's test of difference in variance revealed poor agreements ( p < .01) for both HRV measurements (SDNN and RMSSD); only heart rate showed substantiated agreement ( p = .54) between the two methods. Low HRV was statistically significantly associated to high heart rate, systolic blood pressure, and diastolic blood pressure in these screen-detected T2DM patients.

Conclusions:

Paper ECG strips may contain overlooked clinical information on the status of autonomic function in patients with T2DM. In our study, manual measurements of RR intervals were inferior to the computer-assisted method. Based on this study, we recommend cautiousness in the clinical use and interpretation of HRV based on manual or low resolution measurements of RR intervals from ECG strips. High resolution measurements of RR intervals reveal significant associations between low HRV and high heart rate, systolic blood pressure, and diastolic blood pressure among patients with screen-detected T2DM. It is feasible to use a computer-assisted method to determine RR intervals in patients with T2DM.
Introduction to Human Factors
Authors: Bergman Eric
Published: January 2014

This paper provides an introduction to “human factors engineering”, an applied science that seeks to optimize usability and safety of systems. Human factors engineering pursues this goal by aligning system design with the perceptual, cognitive, and physical capabilities of users. Human factors issues loom large in the diabetes management domain because patients and health care professionals interact with a complex variety of systems, including medical device hardware and software, which are themselves embedded within larger systems of institutions, people, and processes. Usability considerations must be addressed in these systems and devices to ensure safe and effective diabetes management.
Accessibility Attributes of Blood Glucose Meter and Home Blood Pressure Monitor Displays for Visually Impaired Persons
Authors: Blubaugh Morgan V. , Uslan Mark M.
Published: January 2014

The vast majority of diabetes-related self-management technology utilizes small visual displays (SVDs) that often produce a low level of contrast and suffer from high levels of reflection (glare). This is a major accessibility issue for the 3.5 million Americans with diabetes who have reduced vision. The purpose of this article is to gather comparative data on the key display attributes of the SVDs used in blood glucose meters (BGMs) and home blood pressure monitors (HBPMs) on the market today and determine which displays offer the best prospect for being accessible to people with reduced vision.

Nine BGMs and eight HBPMs were identified for this study on the basis of amount of devices sold, full-functionality speech output, and advanced display technologies. An optical instrumentation system obtained contrast, reflection (glare), and font height measurements for all 17 displays.

The contrast, reflection, and font-height values for the BGMs and HBPMs varied greatly between models. The Michelson contrast values for the BGMs ranged from 11% to 98% and font heights ranged 0.39–1.00 in. for the measurement results. The HBPMs had Michelson contrast values ranging 55–96% and font height ranging 0.28–0.94 in. for the measurement results.

Due largely to the lack of display design standards for the technical requirements of SVDs, there is tremendous variability in the quality and readability of BGM and HBPM displays. There were two BGMs and one HBPM that exhibited high-contrast values and large font heights, but most of the devices exhibited either poor contrast or exceptionally high reflection.
Creating Low Vision and Nonvisual Instructions for Diabetes Technology: An Empirically Validated Process
Authors: Williams Ann S.
Published: January 2014

Introduction:

Nearly 20% of the adults with diagnosed diabetes in the United States also have visual impairment. Many individuals in this group perform routine diabetes self-management tasks independently often using technology that was not specifically designed for use by people with visual impairment (e.g., insulin pumps and pens). Equitable care for persons with disabilities requires providing instructions in formats accessible for nonreaders. However, instructions in accessible formats, such as recordings, braille, or digital documents that are legible to screen readers, are seldom available.

Method:

This article includes a summary of existing guidelines for creating accessible documents. The guidelines are followed by a description of the production of accessible nonvisual instructions for use of insulin pens used in a study of dosing accuracy. The study results indicate that the instructions were used successfully by 40 persons with visual impairment.

Discussion and Conclusions:

Instructions in accessible formats can increase access to the benefits of diabetes technology for persons with visual impairment. Recorded instructions may also be useful to sighted persons who do not read well, such as those with dyslexia, low literacy, or who use English as a second language. Finally, they may have important benefits for fully sighted people who find it easier to learn to use technology by handling the equipment while listening to instructions. Manufacturers may also benefit from marketing to an increased pool of potential users.
The Role of Human Factors in the Design and Development of an Insulin Pump
Authors: Schaeffer Noel E.
Published: January 2014

This article discusses human factors (HF) processes and how they are applied during the development of a medical device to minimize the risk that the user interface design could lead to patient errors, adverse events, and product recalls. This process is best defined as “prevention through design.” The HF design process is exemplified by three distinct phases: (1) preliminary analysis, (2) formative design evaluation and modification, and (3) design validation. Additional benefits of employing HF principles during medical device development are briefly reviewed, including reduced patient risk by eliminating design flaws, increased patient adherence through the reduction in the complexity of therapeutic regimes, and reduced likelihood for product recalls.
Glucose Measurement of Intensive Care Unit Patient Plasma Samples Using a Fixed-Wavelength Mid-Infrared Spectroscopy System
Authors: Krinsley James , Bochicchio Kelly , Calentine Christopher , Bochicchio Grant
Published: January 2014

Objective:

Glycemic control is a rapidly developing field in intensive care medicine with the aim of reducing mortality, morbidity, and cost. Current intensive care unit (ICU) glucose measurement technologies are susceptible to interference from medications, volume expanders, and other substances present in critically ill patients. We hypothesized that a fixed-wavelength mid-infrared (mid-IR) spectroscopy system would be accurate for measuring glucose levels of ICU patients.

Research Design and Methods:

This is a prospective investigation of plasma samples from two different institutions treating a heterogeneous population of ICU patients. The first 292 samples were collected from 86 patients admitted to Stamford Hospital, and the next 352 samples were collected from 75 patients from three ICUs at the University of Maryland. Plasma samples were measured on a Fourier-transform infrared or a proprietary spectrometer, with a glucose prediction algorithm to correct for spectral interference, which were compared with reference measurements taken using a YSI 2300 glucose analyzer.

Results:

Glucose values ranged from 24 to 343 mg/dl. Numerous medications and injury/disease states were observed in the patient populations, with metoprolol, fentanyl, and multiple organ failure the most prevalent. Despite these interferents, there was a high correlation ( r ≥ 0.94) and low standard error (≤12.8 mg/dl) between the predicted glucose values and those of the YSI 2300 STAT Plus reference instrument in the three studies. A total of 95.1% of the 644 values in the three studies met International Organization for Standardization 15197 criteria.

Conclusion:

These results suggest that a fixed-wavelength mid-IR spectrometer can measure glucose accurately in the plasma of ICU patients.
Clinical Performance of a Device That Applies Local Heat to the Insulin Infusion Site: A Crossover Study
Authors: Freckmann Guido , Pleus Stefan , Westhoff Antje , Krinelke Lars G. , Buhr Andreas , Jendrike Nina , Haug Cornelia
Published: January 2014

Background:

Fast-acting insulin analogs have been available since 1996. The absorption rate of these insulins is still too slow to mimic the physiological insulin action in healthy subjects. This study investigates the clinical performance of InsuPatch™, a local skin-heating device, on postprandial glucose excursion.

Methods:

Twenty-four type 1 diabetes mellitus subjects on continuous subcutaneous insulin infusion were included in this crossover study [10 male, 14 female, age: 43.5 ± 11.3 years, diabetes duration: 18.3 ± 10.5 years, glycosylated hemoglobin: 7.4 ± 0.8%, body mass index: 25.0 ± 3.0 kg/m2 (mean ± standard deviation)]. The impact of local skin heating was measured by dividing the two-hour area under the curve by integration time (AUC/t120) for blood glucose (BG) above baseline after two standardized breakfast and dinner meal pairs (with and without heating) per subject. For the first breakfast pair, venous insulin concentration was also measured.

Results:

A significant reduction was found for the AUC/t120 after breakfast and after dinner meals (42 breakfast meal pairs, AUC/t120 not heated 66.4 ± 32.8 mg/dl vs heated 56.8 ± 34.0 mg/dl, p = .017; 38 dinner meal pairs, AUC/t120 not heated 30.8 ± 31.0 mg/dl vs heated 18.4 ± 23.9 mg/dl, p = .0028). The maximum venous insulin concentration with heating was 27% higher than without heating ( n = 23). The number of hypoglycemic events on days with heating ( n = 9) was similar to the number of days without heating ( n = 13).

Conclusions:

Local heating of the skin around the infusion site significantly reduced postprandial BG by enhancing insulin absorption. The heating device was well tolerated, and it could facilitate development of closed-loop systems.
Comparison of Insulin Diluent Leakage Postinjection Using Two Different Needle Lengths and Injection Volumes in Obese Patients with Type 1 or Type 2 Diabetes Mellitus
Authors: Ignaut Debra A. , Fu Haoda
Published: January 2014

Background:

Smaller gauge, shorter needles have been shown to be as safe and effective for insulin delivery as longer needles in many patients. However, in obese patients with diabetes, results have been inconsistent with regard to the impact of needle length on leakage of injectate.

Methods:

A single-blind, randomized, two-period, crossover study compared injections with 5 mm needles to 8 mm needles regarding leakage, pain, bleeding, and bruising at abdominal injection sites in obese patients with diabetes using 20- and 60-unit (U) volume equivalent injections of sterile insulin diluent.

Results:

Fifty-six patients (54% male; mean age 56 years; mean body mass index of 36 kg/m2) with type 1 ( n = 13) or type 2 ( n = 43) diabetes participated. Median leakage (U) was similar for both needles [0.04 (5 mm/20 U) vs 0.02 (8 mm/20 U), P = .32; and 0.04 (5 mm/60 U) vs 0.02 (8 mm/60 U), P = 48]. Pain scores (mean) were similar [1.27 (5 mm/20 U) vs 1.14 (8 mm/20 U), P = .75, and 1.68 (5 mm/60 U) vs 0.95 (8 mm/60 U, P = .21)]. The proportion of injections with bleeding [10.8% (5 mm/20 U) vs 5.83% (8 mm/20 U), P = .23, and 4.92% (5 mm/60 U) vs 6.56% (8 mm/60 U), P = .73] and the proportion of patients with bruising [8.11% (5 mm/20 U) vs 10.81% (8 mm/20 U), p = .56, and 21.05% (5 mm/60 U) vs 26.32% (8 mm/60 U), p = .65] at injection sites were similar. Mean bruise size (mm) [0.73 (5 mm/20 U] vs 2.68 (8 mm/20 U), P = .23; and 1.11 (5 mm/60 U) vs 4.21 (8 mm/60 U), P = .08] at injection sites was similar.

Conclusions:

This study supports the suitability of the 5 mm needle for the injection of insulin in obese patients with diabetes.
Accuracy in Blood Glucose Measurement: What Will a Tightening of Requirements Yield?
Authors: Heinemann Lutz , Lodwig Volker , Freckmann Guido
Published: January 2014

Nowadays, almost all persons with diabetes—at least those using antidiabetic drug therapy—use one of a plethora of meters commercially available for self-monitoring of blood glucose. The accuracy of blood glucose (BG) measurement using these meters has been presumed to be adequate; that is, the accuracy of these devices was not usually questioned until recently. Health authorities in the United States (Food and Drug Administration) and in other countries are currently endeavoring to tighten the requirements for the accuracy of these meters above the level that is currently stated in the standard ISO 15197. At first glance, this does not appear to be a problem and is hardly worth further consideration, but a closer look reveals a considerable range of critical aspects that will be discussed in this commentary. In summary, one could say that as a result of modern production methods and ongoing technical advances, the demands placed on the quality of measurement results obtained with BG meters can be increased to a certain degree. One should also take into consideration that the system accuracy (which covers many more aspects as the analytical accuracy) required to make correct therapeutical decisions certainly varies for different types of therapy. At the end, in addition to analytical accuracy, thorough and systematic training of patients and regular refresher training is important to minimize errors. Only under such circumstances will patients make appropriate therapeutic interventions to optimize and maintain metabolic control.
New Criteria for Assessing the Accuracy of Blood Glucose Monitors Meeting, October 28, 2011
Authors: Walsh John , Roberts Ruth , Vigersky Robert A. , Schwartz Frank
Published: January 2014

Glucose meters (GMs) are routinely used for self-monitoring of blood glucose by patients and for point-of-care glucose monitoring by health care providers in outpatient and inpatient settings. Although widely assumed to be accurate, numerous reports of inaccuracies with resulting morbidity and mortality have been noted. Insulin dosing errors based on inaccurate GMs are most critical. On October 28, 2011, the Diabetes Technology Society invited 45 diabetes technology clinicians who were attending the 2011 Diabetes Technology Meeting to participate in a closed-door meeting entitled New Criteria for Assessing the Accuracy of Blood Glucose Monitors. This report reflects the opinions of most of the attendees of that meeting.

The Food and Drug Administration (FDA), the public, and several medical societies are currently in dialogue to establish a new standard for GM accuracy. This update to the FDA standard is driven by improved meter accuracy, technological advances (pumps, bolus calculators, continuous glucose monitors, and insulin pens), reports of hospital and outpatient deaths, consumer complaints about inaccuracy, and research studies showing that several approved GMs failed to meet FDA or International Organization for Standardization standards in post-approval testing. These circumstances mandate a set of new GM standards that appropriately match the GMs' analytical accuracy to the clinical accuracy required for their intended use, as well as ensuring their ongoing accuracy following approval. The attendees of the New Criteria for Assessing the Accuracy of Blood Glucose Monitors meeting proposed a graduated standard and other methods to improve GM performance, which are discussed in this meeting report.
The Use of Peptide-Major-Histocompatibility-Complex Multimers in Type 1 Diabetes Mellitus
Authors: Gojanovich Greg S. , Murray Sabrina L. , Buntzman Adam S. , Young Ellen F. , Vincent Benjamin G. , Hess Paul R.
Published: January 2014

Major histocompatibility complex (MHC) class I and MHC class II molecules present short peptides that are derived from endogenous and exogenous proteins, respectively, to cognate T-cell receptors (TCRs) on the surface of T cells. The exquisite specificity with which T cells recognize particular peptide-major-histocompatibility-complex (pMHC) combinations has permitted development of soluble pMHC multimers that bind exclusively to selected T-cell populations. Because the pathogenesis of type 1 diabetes mellitus (T1DM) is driven largely by islet-reactive T-cell activity that causes β-cell death, these reagents are useful tools for studying and, potentially, for treating this disease. When coupled to fluorophores or paramagnetic nanoparticles, pMHC multimers have been used to visualize the expansion and islet invasion of T-cell effectors during diabetogenesis. Administration of pMHC multimers to mice has been shown to modulate T-cell responses by signaling through the TCR or by delivering a toxic moiety that deletes the targeted T cell. In the nonobese diabetic mouse model of T1DM, a pMHC-I tetramer coupled to a potent ribosome-inactivating toxin caused long-term elimination of a specific diabetogenic cluster of differentiation 8+ T-cell population from the pancreatic islets and delayed the onset of diabetes. This review will provide an overview of the development and use of pMHC multimers, particularly in T1DM, and describe the therapeutic promise these reagents have as an antigen-specific means of ameliorating deleterious T-cell responses in this autoimmune disease.
New Bundled World: Quality of Care and Readmission in Diabetes Patients
Authors: Chen Judy Y. , Ma Qiufei , Chen Hua , Yermilov Irina
Published: January 2014

Background:

Hospital readmissions among patients with diabetes are substantial and costly. Although prior studies have shown that receipt of outpatient quality of care significantly reduces the risk of hospitalization among patients with diabetes, little is known about its impact on hospital readmission. The objective of this study is to assess the impact of outpatient quality of care on 30-day readmission among patients with diabetes.

Methods:

We used deidentified administrative claims data from the IMS LifeLink and included commercially insured diabetes patients ≥ 19 years old discharged from hospitals in the United States in 2009 and 2010 ( n = 30,139). The outcome was readmission within 2–30 days of discharge. The main independent variables were receipt of outpatient quality-of-care measures (i.e., two hemoglobin A1c tests, low-density lipoprotein (LDL) test, 90-day supply of statin, and 90-day supply of angiotensin-converting enzyme inhibitors/angiotensin receptor blockers). Multivariate logistic regression was used to examine the impact of outpatient quality of care on hospital readmission while controlling for demographics, clinical characteristics, health care utilization, and insurance type in the year prior to admission.

Results:

Overall 30-day readmission rates among patients with diabetes were 18.9%. Patients who received at least one LDL test [odds ratio (OR) = 0.918, 95% confidence interval (CI; 0.852 0.989), p < .025] and ≥90-day supply of statins (OR = 0.91, 95% CI [0.85 0.97], p < .01) were less likely to be readmitted to the hospital.

Conclusions:

Receipt of LDL testing and adherence to statin medications were effective in decreasing the likelihood of 30-day hospital readmission and may be considered as elements of a quality focused incentive-based health care delivery package for diabetes patients.
Prediction of the Risk to Develop Diabetes-Related Late Complications by Means of the Glucose Pentagon Model: Analysis of Data from the Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study
Authors: Thomas Andreas , Heinemann Lutz
Published: January 2014

Background:

By taking parameters into account that describe the variability of continuously monitored glucose and long-term metabolic control [hemoglobin A1c (HbA1c)], the glucose pentagon model (GPM) allows characterization of the glucose profile of individual patients with diabetes in a graphical format. A glycemic risk parameter (GRP) derived from this model might allow a better prognosis of the risk to develop diabetes-related complications than the HbA1c.

Methods:

To evaluate this hypothesis, we analyzed a subset of data from the Juvenile Diabetes Research Foundation continuous glucose monitoring (CGM) study. The values of the different parameters that are integrated in the GPM were extracted automatically from CGM profiles registered before and after 6 months by means of the Medtronic CGM system in 108 patients.

Results:

In these patients, the significant reduction in HbA1c from 7.4% to 7.0% was accompanied by a reduction in glycemia from 164 to 156 mg/dl, standard deviation from 61 to 57 mg/dl, area under the curve >160 mg/dl 29.2 to 23.1, and time per day >160 mg/dl 634 to 576 min. This led to a subsequent reduction in GRP from 3.3 to 2.7; this decrease by 18.2% was significantly larger than that in HbA1c by 8.6% ( p < .001). Changes in individual GPMs/GRPs support this observation. They also show the impact of high glycemic variability on GPM/GRP.

Conclusions:

Our analysis of data of a study with a considerable sample size and study duration showed that the GPM is not only helpful for rapid assessment of individual glycemic profiles and how therapeutic interventions influence these, but also appears to provide a better prognosis of the risk to develop late complications than the HbA1c per se. However, it is also clear that a true validation of such a model requires performance of a long-term study in a large number of patients with diabetes.
A Bio-Inspired Glucose Controller Based on Pancreatic β-Cell Physiology
Authors: Herrero Pau , Georgiou Pantelis , Oliver Nick , Johnston Desmond G , Toumazou Christofer
Published: January 2014

Introduction:

Control algorithms for closed-loop insulin delivery in type 1 diabetes have been mainly based on control engineering or artificial intelligence techniques. These, however, are not based on the physiology of the pancreas but seek to implement engineering solutions to biology. Developments in mathematical models of the β-cell physiology of the pancreas have described the glucose-induced insulin release from pancreatic β cells at a molecular level. This has facilitated development of a new class of bio-inspired glucose control algorithms that replicate the functionality of the biological pancreas. However, technologies for sensing glucose levels and delivering insulin use the subcutaneous route, which is nonphysiological and introduces some challenges. In this article, a novel glucose controller is presented as part of a bio-inspired artificial pancreas.

Methods:

A mathematical model of β-cell physiology was used as the core of the proposed controller. In order to deal with delays and lack of accuracy introduced by the subcutaneous route, insulin feedback and a gain scheduling strategy were employed. A United States Food and Drug Administration-accepted type 1 diabetes mellitus virtual population was used to validate the presented controller.

Results:

Premeal and postmeal mean ± standard deviation blood glucose levels for the adult and adolescent populations were well within the target range set for the controller [(70, 180) mg/dl], with a percent time in range of 92.8 ± 7.3% for the adults and 83.5 ± 14% for the adolescents.

Conclusions:

This article shows for the first time very good glucose control in a virtual population with type 1 diabetes mellitus using a controller based on a subcellular β-cell model.
Predicting Subcutaneous Glucose Concentration Using a Latent-Variable-Based Statistical Method for Type 1 Diabetes Mellitus
Authors: Zhao Chunhui , Dassau Eyal , Jovanovič Lois , Zisser Howard C. , Doyle Francis J. , Seborg Dale E.
Published: January 2014

Background:

Accurate prediction of future glucose concentration for type 1 diabetes mellitus (T1DM) is needed to improve glycemic control and to facilitate proactive management before glucose concentrations reach undesirable concentrations. The availability of frequent glucose measurements, insulin infusion rates, and meal carbohydrate estimates can be used to good advantage to capture important information concerning glucose dynamics.

Methods:

This article evaluates the feasibility of using a latent variable (LV)-based statistical method to model glucose dynamics and to forecast future glucose concentrations for T1DM applications. The prediction models are developed using a proposed LV-based approach and are evaluated for retrospective clinical data from seven individuals with T1DM and for In silico simulations using the Food and Drug Administration-accepted University of Virginia/University of Padova metabolic simulator. This article provides comparisons of the prediction accuracy of the LV-based method with that of a standard modeling alternative. The influence of key design parameters on the performance of the LV-based method is also illustrated.

Results:

In general, the LV-based method provided improved prediction accuracy in comparison with conventional autoregressive (AR) models and autoregressive with exogenous input (ARX) models. For larger prediction horizons (=30 min), the LV-based model with exogenous inputs achieved the best prediction performance based on a paired t-test (α = 0.05).

Conclusions:

The LV-based method resulted in models whose glucose prediction accuracy was as least as good as the accuracies of standard AR/ARX models and a simple model-free approach. Furthermore, the new approach is less sensitive to changing conditions and the effect of key design parameters.
Resting Blood Flow in the Skin: Does it Exist, and What is the Influence of Temperature, Aging, and Diabetes?
Authors: Petrofsky Jerrold Scott
Published: January 2014

Measurement of resting blood flow to the skin and other organs is an important indicator of health and disease and a way to assess the reaction to various stimuli and pharmaceutical interventions. However, unlike plasma ions such as sodium or potassium, it is difficult to determine what the proper value for resting blood flow really is. Part of the problem is in the measurement of blood flow; various techniques yield very different measures of skin blood flow even in the same area. Even if there were common techniques, resting blood flow to tissue, such as the skin, is determined by the interaction of a plurality of factors, including the sympathetic nervous system, temperature, pressure, shear forces on blood vessels, tissue osmolality, and a variety of other stimuli. Compounding this variability, the blood flow response to any stressor is reduced by free radicals in the blood and diminished by aging and diabetes. Race also has an effect on resting blood flow to the skin. All these factors interact to make the exact resting blood flow difficult to determine in any one individual and at any one time. This review examines the main techniques to assess blood flow, the factors that alter blood flow in the skin, and how aging and diabetes affect blood flow. Recommendations for the measurement of resting blood flow are presented.