bluuebunny/crossref_metadata_2025_split huggingface dataset:
Institutional Blood Glucose Monitoring System for Hospitalized Patients: An Integral Component of the Inpatient Glucose Control Program
Authors: Boaz Mona , Landau Zohar , Matas Zipora , Wainstein Julio 
Published: January 2014

Background: The ability to measure patient blood glucose levels at bedside in hospitalized patients and to transmit those values to a central database enables and facilitates glucose control and follow-up and is an integral component in the care of the hospitalized diabetic patient. Objective: The goal of this study was to evaluate the performance of an institutional glucometer employed in the framework of the Program for the Treatment of the Hospitalized Diabetic Patient (PTHDP) at E. Wolfson Medical Center, Holon, Israel. Methods: As part of the program to facilitate glucose control in hospitalized diabetic patients, an institutional glucometer was employed that permits uploading of data from stands located in each inpatient department and downloading of that data to a central hospital-wide database. Blood glucose values from hospitalized diabetic patients were collected from August 2007 to October 2008. The inpatient glucose control program was introduced gradually beginning January 2008. Results: During the follow-up period, more than 150,000 blood glucose measures were taken. Mean glucose was 195.7 ± 99.12 mg/dl during the follow-up period. Blood glucose values declined from 206 ± 105 prior to PTHDP (August 2007–December 2007) to 186 ± 92 after its inception (January 2008–October 2008). The decline was associated significantly with time ( r = 0.11, p < 0.0001). The prevalence of blood glucose values lower than 60 mg/dl was 1.48% [95% confidence interval (CI) 0.36%] prior to vs 1.55% (95% CI 0.37%) following implementation of the PTHDP. Concomitantly, a significant increase in the proportion of blood glucose values between 80 and 200 mg/dl was observed, from 55.5% prior to program initiation vs 61.6% after program initiation ( p < 0.0001). Conclusions: The present study was designed to observe changes in institution-wide glucose values following implementation of the PTHDP. Information was extracted from the glucometer system itself. Because the aforementioned study was not a clinical trial, we cannot rule out that factors other than introduction of the program could explain some of the variability observed. With these limitations in mind, it nevertheless appears that the PTHDP, of which the institutional glucometer is an integral, essential component, was associated with improved blood glucose values in the hospitalized diabetic patient.
Usability, Participant Acceptance, and Safety of a Prefilled Insulin Injection Device in a 3-Month Observational Survey in Everyday Clinical Practice in Australia
Authors: Carter John , Beilin Jonathan , Morton Adam , De Luise Mario 
Published: January 2014

Background: SoloSTAR® (SOL; sanofi-aventis, Paris, France) is a prefilled insulin pen device for the injection of insulin glargine and insulin glulisine. This is the first Australian survey to determine its usability, participant acceptance, and safety in clinical practice. Methods: A 3-month, nonrandomized, noncomparative, observational survey in Australia was conducted in individuals with diabetes. Participants were given SOL pens containing glargine, the instruction leaflet, and a toll-free helpline number. Training was offered to all participants. Safety data, including product technical complaints (PTCs), were gathered from ongoing feedback given by the participant or health care professional (HCP) and by independent interviews conducted 6–10 weeks after study start. Results: Some 2674 people consented to take part across 93 sites (150 HCPs), and 2029 participated in interviews. Of these, 52.6% had type 1 diabetes, 16.3% had manual dexterity problems, and 15.5% had poor eyesight not corrected by glasses. At the time of interview, 96.8% of participants were still using SOL. None of the eight PTCs reported were due to technical defects; most were related to handling errors. Some 62 participants reported 77 adverse events; none were related to a PTC. The vast majority of participants (95.4%) were “very satisfied” or “satisfied” with using SOL, and 89.7% of the participants had no questions or concerns using SOL on a daily basis. Similar positive findings were reported by participants with manual or dexterity impairments. Conclusions: In this survey of everyday clinical practice, SOL had a good safety profile and was very well accepted by participants.
Mobile Phone Technology for Children with Type 1 and Type 2 Diabetes: A Parent Survey
Authors: Pena Venessa , Watson Alice J. , Kvedar Joseph C. , Grant Richard W. 
Published: January 2014

Purpose: The novel application of information technology has the potential to improve care for children with diabetes. We surveyed parents of children with type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) to (1) identify their concerns related to their children's diabetes and (2) assess the relationship between these concerns and parental attitudes toward a glucometer integrated into a mobile phone that could provide parents and health care providers with a child's real-time glucose readings via text message and a secure Web site. Methods: We conducted a cross-sectional Web-based survey of parents with children ages 10–19 years (125 with T1DM and 77 with T2DM). Parental concerns were grouped by (1) access to their child's provider, (2) parenting challenges, and (3) knowledge about managing their child's diabetes. Results: Parental concerns focused mostly on access to their child's health care provider. Over half of respondents expressed interest in subscribing to a mobile-phone-based service. In multivariate logistic regression models, the odds of being willing to use the service increased if parents had concerns about provider access, a child with T2DM, a college education, or currently subscribed to text messaging. Enthusiasm decreased with increasing annual service cost. Conclusions: Study participants—particularly parents with provider access concerns or a child with T2DM—were receptive to adopting novel health technology to help manage their children's diabetes. Adoption of such tools is most likely driven by the unmet needs of parents.
Clinical Evaluation of a Noninvasive Alarm System for Nocturnal Hypoglycemia
Authors: Skladnev Victor N. , Ghevondian Nejhdeh , Tarnavskii Stanislav , Paramalingam Nirubasini , Jones Timothy W. 
Published: January 2014

Background: The aim of this study was to evaluate the performance of a prototype noninvasive alarm system (HypoMon®) for the detection of nocturnal hypoglycemia. A prospective cohort study evaluated an alarm system that included a sensor belt, a radio frequency transmitter for chest belt signals, and a receiver. The receiver incorporated integrated “real-time” algorithms designed to recognize hypoglycemia “signatures” in the physiological parameters monitored by the sensor belt. Methods: Fifty-two children and young adults with type 1 diabetes mellitus (T1DM) participated in this blinded, prospective, in-clinic, overnight study. Participants had a mean age of 16 years (standard deviation 2.1, range 12–20 years) and were asked to follow their normal meal and insulin routines for the day of the study. Participants had physiological parameters monitored overnight by a single HypoMon system. Their BG levels were also monitored overnight at regular intervals via an intravenous cannula and read on two independent Yellow Springs Instruments analyzers. Hypoglycemia was not induced by any manipulations of diabetes management, rather the subjects were monitored overnight for “natural” occurrences of hypoglycemia. Performance analyses included comparing HypoMon system alarm times with allowed time windows associated with each hypoglycemic event. Results: The primary recognition algorithm in the prototype alarm system performed at a level consistent with expectations based on prior user surveys. The HypoMon system correctly recognized 8 out of the 11 naturally occurring overnight hypoglycemic events and falsely alarmed on 13 out of the remaining 41 normal nights [sensitivity 73% (8/11), specificity 68% (28/41), positive predictive value 38%, negative predictive value 90%]. Conclusion: The prototype HypoMon shows potential as an adjunct method for noninvasive overnight monitoring for hypoglycemia events in young people with T1DM.
Compatibility of Insulin Lispro, Aspart, and Glulisine with the Solo™ MicroPump, a Novel Miniature Insulin Pump
Authors: Senesh Gil , Bushi Doron , Neta Avraham , Yodfat Ofer 
Published: January 2014

Background: This study compared the stability of commercially available, rapid-acting insulin in the novel tubeless, skin-adhering Solo™ insulin pump over 6 days at extreme environmental conditions. Methods: Forty-eight pumps for each tested analog were loaded with three different insulin lots and operated at 30 U/day (three sets of 12 pumps) and 15 U/day (one set of 12 pumps) with basal/bolus delivery patterns for 6 days under extreme climatic (37°C, 40% relative humidity) and mechanical (35 strokes/min) stresses. The insulin solutions dispensed were sampled periodically and analyzed for potency, related substances, high molecular weight proteins (HMWP), and preservative content by high-performance liquid chromatography techniques. Biological activity (bioidentity) was demonstrated by an abrupt decrease in blood glucose in rabbits. Solutions were inspected for visual appearance and measured for pH levels. Results: During the 6-day sampling period, the potency of all insulin samples was maintained at 95.0–105.0% of the bulk solution concentration of the insulin vials. The levels of HMWP and related substances remained well below labeling limits. The preservative concentration decreased with time but remained bacteriostatic effective. Solutions maintained pH and clarity and were particulate free. The biological activity was verified. Conclusions: Insulin analogs lispro, aspart, and glulisine maintained physical, chemical, and biological properties for 6 days when used in the Solo MicroPump device.
Continuous Glucose Monitoring during Exercise in Patients with Type 1 Diabetes on Continuous Subcutaneous Insulin Infusion
Authors: Kapitza Christoph , Hovelmann Ulrike , Nosek Leszek , Kurth Heinz-Joerg , Essenpreis Matthias , Heinemann Lutz 
Published: January 2014

Aim: Exercise is associated with an increased risk of hypoglycemic or hyperglycemic events. The aim of this study was to assess glucose changes during and after physical exercise in patients with type 1 diabetes managed by continuous subcutaneous insulin infusion before and after a 14-day moderate or intense exercise program. Methods: Sixteen male patients [hemoglobin A1c 7.3 ± 0.8% (mean ± standard deviation), age 39 ± 11 years, body mass index 26.0 ± 2.7 kg/m2] were enrolled in this single-center, randomized, open-label study. They underwent exercise challenges before and after a 14-day moderate (group A, n = 8) and intense (group B) exercise program. Changes in glucose levels were monitored continuously by means of a microdialysis technique. Results: Patients in group A trained less intensively than the patients in group B. The treadmill exercise led to a comparable level of challenge in both patient groups. Neither heart rate nor energy consumption differed within the groups or between the groups. Patients in both groups had a comparable basal insulin infusion rate. Prandial insulin doses were higher pretraining than posttraining in both groups. Identical amounts of additional carbohydrates were consumed by the patients in both groups during the 21 h after the exercise challenge. Glucose profiles recorded showed a wide variability. No differences in the glucose profiles with respect to the training intensity could be observed within and between the groups. Patients in group A tended to spend a shorter period of time in hypoglycemia after the exercise challenge posttraining compared to pretraining, but not the patients in group B. The number of hypoglycemic episodes was not different between the groups. Conclusions: The patients with type 1 diabetes exhibit the expected wide variability in glucose profiles before, during, and after physical exercise. Use of continuous glucose monitoring allows handling of this situation without running into the risk of acute metabolic deteriorations.
Epidemiology of Cardiovascular Disease in Type 2 Diabetes: The Indian Scenario
Authors: Mohan Viswanathan , Venkatraman Janarthanan Vijay , Pradeepa Rajendra 
Published: January 2014

Noncommunicable diseases, of which coronary artery disease (CAD) and diabetes top the list, have overtaken communicable diseases with respect to overall mortality, even in developing countries like India. High prevalence rates of diabetes and CAD are seen not only in affluent migrant Indians, but also in those living within the subcontinent. Indeed the epidemic of diabetes and CAD is now spreading to the middle- and lower-income groups in India. The risk for CAD is two to four times higher in diabetic subjects, and in Indians, CAD occurs prematurely, i.e., one to two decades earlier than in the West. Thus there is an urgent need for studies on CAD in diabetic and nondiabetic subjects in India. The Chennai Urban Population Study, a population-based study in Chennai, in South India, showed a prevalence of CAD of 11%, which is 10 times more than what it was in 1970. Clustering of risk factors for CAD such as hyperglycemia, central body obesity, dyslipidemia, and hypertension tends to occur, and interplay of these risk factors could explain the enhanced CAD risk in Indians. Additionally, low-grade inflammation and a possible inherent genetic susceptibility are other contributing factors. Preventive measures such as lifestyle modification with healthy diet, adequate physical activity, and decrease in stress could help prevent the twin epidemics of diabetes and CAD.
Predictors of Initiating Rapid-Acting Insulin Analog Using Vial/Syringe, Prefilled Pen, and Reusable Pen Devices in Patients with Type 2 Diabetes
Authors: Lee Lauren J. , Anderson Julie , Foster Shonda A. , Corrigan Sheila M. , Smith David M. , Curkendall Suellen 
Published: January 2014

Background: Limited data are available on the predictors of insulin delivery device choice. This study assessed the patient- and health-care-system-related factors that predict the initiation of one rapid-acting insulin analog (RAIA) delivery system over another. Methods: A retrospective analysis using a claims database (January 1, 2007, through March 31, 2009) was conducted. Patients were required to be diagnosed with type 2 diabetes mellitus, and have ≥12 months of continuous eligibility prior to their first prescription of a RAIA on or after January 1, 2008. The three cohorts in the study were vial/syringe ( n = 6820), prefilled pen ( n = 5840), and reusable pen ( n = 2052). Multiple factors were examined using stepwise logistic regression. Results: Factors that increased the likelihood of initiating RAIA using prefilled pen versus vial/syringe included endocrinologist visit [odds ratio (OR) = 3.13, 95% confidence interval (CI) = 2.56, 3.82], prior basal insulin use with pen (OR = 4.85, 95% CI = 4.21, 5.59), and use of ≥1 oral antihyperglycemic agents (OR = 1.32, 95% CI = 1.20, 1.45). Factors that decreased the likelihood included inpatient admission (OR = 0.76, 95% CI = 0.70, 0.83), nursing home visit (OR = 0.22, 95% CI = 0.18, 0.27), and obesity (OR = 0.67, 95% CI = 0.53, 0.83). There were fewer differences between prefilled and reusable pen initiators. Factors that increased the likelihood of initiating with prefilled versus reusable pen included endocrinologist visit (OR = 1.87, CI = 1.50, 2.34) and inpatient admission (OR = 1.46, 95% CI = 1.30, 1.64). Conclusion: Significant differences in predictors were observed between prefilled pen and vial/syringe initiators. The differences were fewer between prefilled and reusable pen initiators. These differences should be taken into consideration when evaluating outcomes associated with specific insulin delivery systems.
Impact of Blood Glucose Self-Monitoring Errors on Glucose Variability, Risk for Hypoglycemia, and Average Glucose Control in Type 1 Diabetes: An In Silico Study
Authors: Breton Marc D. , Kovatchev Boris P. 
Published: January 2014

Background: Clinical trials assessing the impact of errors in self-monitoring of blood glucose (SMBG) on the quality of glycemic control in diabetes are inherently difficult to execute. Consequently, the objectives of this study were to employ realistic computer simulation based on a validated model of the human metabolic system and to provide potentially valuable information about the relationships among SMBG errors, risk for hypoglycemia, glucose variability, and long-term glycemic control. Methods: Sixteen thousand computer simulation trials were conducted using 100 simulated adults with type 1 diabetes. Each simulated subject was used in four simulation experiments aiming to assess the impact of SMBG errors on detection of hypoglycemia (experiment 1), risk for hypoglycemia (experiment 2), glucose variability (experiment 3), and long-term average glucose control, i.e., estimated hemoglobin A1c (HbA1c)(experiment 4). Each experiment was repeated 10 times at each of four increasing levels of SMBG errors: 5, 10, 15, and 20% deviation from the true blood glucose value. Results: When the permitted SMBG error increased from 0 to 5–10% to 15–20%—the current level allowed by International Organization for Standardization 15197—(1) the probability for missing blood glucose readings of 60 mg/dl increased from 0 to 0–1% to 3.5–10%; (2) the incidence of hypoglycemia, defined as reference blood glucose ≤70 mg/dl, changed from 0 to 0–0% to 0.1–5.5%; (3) glucose variability increased as well, as indicated by control variability grid analysis; and (4) the incidence of hypoglycemia increased from 15.0 to 15.2–18.8% to 22–25.6%. When compensating for this increase, glycemic control deteriorated with HbA1c increasing gradually from 7.00 to 7.01–7.12% to 7.26–7.40%. Conclusions: A number of parameters of glycemic control deteriorated substantially with the increase of permitted SMBG errors, as revealed by a series of computer simulations (e.g., in silico) experiments. A threshold effect apparent between 10 and 15% permitted SMBG error for most parameters, except for HbA1c, which appeared to be increasing relatively linearly with increasing SMBG error above 10%.
Frequently Repeated Glucose Measurements Overestimate the Incidence of Inpatient Hypoglycemia and Severe Hyperglycemia
Authors: Weinberg Melissa E. , Bacchetti Peter , Rushakoff Robert J. 
Published: January 2014

Objective: The aim was to determine if frequently repeated glucose measurements mandated by an inpatient protocol led to falsely elevated reported rates of both hypo- and hyperglycemia. Methods: In our academic medical center, a mandatory standardized subcutaneous insulin order form and protocol was implemented in May 2006. We analyzed point-of-care blood glucose (BG) measurements collected on all medical/surgical wards during the month of August in both 2005 and 2006 by all BGs measured, by patient admission, and by monitored patient-day. We then repeated all analyses using an algorithm that excluded BG values if another BG was measured less than 5 minutes later or 5–60 minutes earlier. Results: In 2005 versus 2006, there were 7034 versus 8016 glucoses measured in 397 versus 389 patients over 1704 versus 1710 patient days, respectively. Analyses based on patient-day balanced differences in BG measurement frequency and patient length of stay. In both years, failure to exclude repeat values overestimated both the proportion of patient days with hypoglycemia (3.5% versus 1.8% in 2005, p = .003; 2.6% versus 1.3% in 2006, p = .007) and severe hyperglycemia (9.3% versus 7.4% in 2005, p = .09; 7.7% versus 5.9% in 2006, p = .08). Mean, median, and proportion of patient-day means within our target range (80–150 mg/dl) were not significantly different. Conclusions: Glucometric reports should exclude repeated BG measurements from a single clinical episode of hypo- or hyperglycemia in order to accurately reflect inpatient glycemic control.
Laboratory Evaluation of a New Lateral-Flow-Based Point-of-Care Rapid Test for Assessment of Chronic Systemic Inflammation
Authors: Siebenhaar Renate , Mushholt Petra B. , Forst Thomas , Weber Matthias M. , Maurer Robert , Pfützner Andreas 
Published: January 2014

The determination of C-reactive protein (CRP) by means of a highly sensitive laboratory method as an independent biomarker for assessment of chronic systemic vascular inflammation and cardiovascular risk is recommended by therapeutic guidelines for diabetes and cardiovascular disease in the United States and in Europe. The purpose of this investigation was to investigate the specificity and sensitivity of a newly developed lateral-flow-based point-of-care (POC) rapid test with semi-quantitative visual reading in comparison with a laboratory reference standard method. The high-sensitivity CRP concentrations of 66 samples were determined by means of turbidimetry and the POC test (5 μl serum/10 μl capillary whole blood, 10 minutes) was independently performed by three investigators blinded to each other's results. The visual readings were classified, as recommended by the American Heart Association, to represent a low risk (0–1 mg/liter), moderate risk (>1–3 mg/liter), or high risk (>3–10 mg/liter) or to indicate an unspecific inflammation (>10 mg/liter). According to the reference method, there were 17 samples in the low-risk group, 19 samples in the moderate-risk group, and 26 samples in the high-risk group, and 4 samples showed an unspecific inflammation. All three investigators reached very conclusive results. The range of agreement between the visual readings of the investigators and the laboratory method ranged between 94% and 97%. The sensitivity for assessment of moderate-to-high cardiovascular risk was 100% (45/45 were detected), and the specificity ranged between 90% and 95%. The newly developed lateral-flow-based POC rapid test showed an excellent agreement between individual visual reading and the laboratory reference method. It may therefore be suitable for a fast and convenient screening, which, after laboratory test confirmation, may help to identify patients with elevated risk of macrovascular disease.
Consumer Engagement for Diabetes Technology: Easier Said Than Done
Authors: Gruber David 
Published: January 2014

Direct spending on diabetes, already exceeding $118 billion, is forecast to reach $336 billion in 2034, driven by newly diagnosed cases secondary to an aging, increasingly sedentary, obese population and the advent of comorbidities, particularly cardiovascular complications affecting more than one-third of persons with diabetes. Traditional, directive, and fragmented approaches to patient management based on acute intervention and specialty care has been unable to stem the impending tsunami of diabetes-related complications and costs. Health care reform and the growing shortage of primary care physicians will only exacerbate the situation. Consumer-centric health care, enabled by digital media and technology, is integral to engagement, self-management, behavior change, and outcomes. It is time for the health care establishment to consider the “other” 360 days per year when a patient is not being seen by a physician.