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Background: Infusion set function remains the limiting factor of insulin pump therapy due to nonmetabolic complications. Here, we tested an investigational extended-wear infusion set prototype with a soft, angled, wire-reinforced cannula with three additional side holes, and compared failure mechanisms and tissue response with a commercial Teflon control. Methods: A total of 48 Teflon and 48 prototype infusion sets were inserted subcutaneously every other day for 14 days in 12 swine and infused with dilute insulin. After two weeks, tissue around cannulas was excised, and occlusions, leaks, and kinks were determined. Tissue was processed and stained to assess the total area of inflammation (TAI) and the inflammatory layer thickness (ILT) around the cannulas. Data were analyzed using Fisher’s exact, analysis of variance-general linear model, Kruskal-Wallis, and post hoc tests. Results: On average, the TAI surrounding the investigational cannula was 52.6% smaller than around the commercial control. The ILT was 66.3% smaller around investigational cannulas. Kinks occurred in 2.1% (investigational) vs 32.4% (commercial) cannulas ( P Conclusions: The data suggest that the infusion set prototype elicits less inflammation over an extended wear time and is resistant to kinking, compared with a commercial Teflon device. This is consistent with previously published data on the impact of cannula material/angle on the inflammatory tissue response. We highlight the following important aspects of infusion set design: (1) secure skin adhesion, (2) reliable cannula insertion, (3) automatic removal of the stylet, (4) cannula material/design that resists kinking, and (5) minimization of local tissue inflammation.

The article published by Kevin Cowart in this issue of the Journal of Diabetes Science and Technology (JDST) is a detailed overview of the clinical trial data and analysis used to demonstrate the safety and effectiveness of the Eversense continuous glucose monitoring (CGM) System for regulatory approval and clinical acceptance. The article describes the published study results for safety, accuracy, reliability, ease of insertion/removal, adverse events, and ease of diabetes patient-use for controlling their glucose levels short and long term. The author nicely compares Eversense CGM System safety and performance with the short-term subcutaneous tissue CGM systems being commercialized by Dexcom, Medtronic Diabetes, and Abbott Diabetes. This comparison may help the clinician define which type of patient with diabetes might benefit the most from the long-term implantable CGM system. The majority of studied patients describe a positive experience managing their diabetes with the Eversense CGM System and request implantation of a new sensor 90 or 180 days later.

Hyperglycemia, hypoglycemia, and glycemic variability have been associated with increased morbidity, mortality, length of stay, and cost in a variety of critical care and non–critical care patient populations in the hospital. The results from prospective randomized clinical trials designed to determine the risks and benefits of intensive insulin therapy and tight glycemic control have been confusing; and at times conflicting. The limitations of point-of-care blood glucose (BG) monitoring in the hospital highlight the great clinical need for an automated real-time continuous glucose monitoring system (CGMS) that can accurately measure the concentration of glucose every few minutes. Automation and standardization of the glucose measurement process have the potential to significantly improve BG control, clinical outcome, safety and cost.

Background: Hyperglycemia and hypoglycemia are associated with adverse clinical outcomes in intensive care patients. In product development studies at 4 ICUs, the safety and performance of an intravascular continuous glucose monitoring (IV-CGM) system was evaluated in 70 postsurgical patients. Methods: The GluCath System (GluMetrics, Inc) used a quenched chemical fluorescence mechanism to optically measure blood glucose when deployed via a radial artery catheter or directly into a peripheral vein. Periodic ultrasound assessed blood flow and thrombus formation. Patient glucose levels were managed according to the standard of care and existing protocols at each site. Reference blood samples were acquired hourly and compared against prospectively calibrated sensor results. Results: In all, 63 arterial sensors and 9 venous sensors were deployed in 70 patients. Arterial sensors did not interfere with invasive blood pressure monitoring, sampling or other aspects of patient care. A majority of venous sensors (66%) exhibited thrombus on ultrasound. In all, 89.4% (1383/1547) of arterial and 72.2% (182/252) of venous measurements met ISO15197:2003 criteria (within 20%), and 72.7% (1124/1547) of arterial and 56.3% (142/252) of venous measurements met CLSI POCT 12-A3 criteria (within 12.5%). The aggregate mean absolute relative difference (MARD) between the sensors and the reference was 9.6% for arterial and 14.2% for venous sensors. Conclusions: The GluCath System exhibited acceptable accuracy when deployed in a radial artery for up to 48 hours in ICU patients after elective cardiac surgery. Accuracy of venous deployment was substantially lower with significant rates of intravascular thrombus observed using ultrasound.

In the present era of near-continuous glucose monitoring (CGM) and automated therapeutic closed-loop systems, measures of accuracy and of quality of glucose control need to be standardized for licensing authorities and to enable comparisons across studies and devices. Adequately powered, good quality, randomized, controlled studies are needed to assess the impact of different CGM devices on the quality of glucose control, workload, and costs. The additional effects of continuing glucose control on the general floor after the ICU stay also need to be investigated. Current algorithms need to be adapted and validated for CGM, including effects on glucose variability and workload. Improved collaboration within the industry needs to be encouraged because no single company produces all the necessary components for an automated closed-loop system. Combining glucose measurement with measurement of other variables in 1 sensor may help make this approach more financially viable.

Introduction: Recently there has been an evolving paradigm shift toward the treatment of facial volume loss either alone or in conjunction with more traditional modalities. Although volume augmentation is commonly used in rejuvenation of the upper orbital sulcus and brow, the effect on the upper eyelid has not yet been documented. This article describes one clinician's experience (A.N.K.) with autologous fat grafting to the upper orbital sulcus and the effect on upper eyelid position. Materials and Methods: After a detailed clinical evaluation of the periorbital region including overall facial aging, brow position, and eyelid laxity, 7 patients underwent autologous fat transfer to the periorbital region. Comparison of photos taken before and after the procedure showed a clear increase in the upper eyelid height. Results: All 7 patients described in this study demonstrated objective increase in upper lid height after periorbital autologous fat transfer, ranging from 0.41 mm to 2.08 mm, with a mean of 1.00 mm. Discussion: Periocular volume augmentation and its effect on lower eyelid position have been described previously. An attempt to alter upper eyelid height with volume augmentation directly to the upper eyelid has also been described recently. However, to the authors' knowledge, this is the first report of volume augmentation to the periorbital region affecting upper eyelid position in this manner. The clinical application of this observational data is not yet clear. However, the potential exists for extension of this modality to upper eyelid malposition such as ptosis.

Shaken baby syndrome (SBS) is routinely diagnosed on the basis of a classic triad of autopsy findings, namely retinal hemorrhage, subdural hemorrhage, and anoxic encephalopathy. However, ongoing controversy exists regarding the specificity and potential causes of these signs, and hence their reliability as de facto markers of SBS, or of non-accidental head injury, where no external signs of trauma are evident.We investigated the deaths of 35 infants and young children, which fell into two broad groups: those with suspected hyperflexion/extension neck injuries, and those without. At autopsy, the entire cervical spinal column (spinal cord, vertebrae, intervertebral discs, neurovascular structures and adjacent soft tissues) was removed, formalin-fixed, decalcified, dissected, and microscopically evaluated.Of the 12 cases in which hyperflexion/extension was either suspected or confirmed, all had evidence of either bilateral or unilateral hemorrhages within or surrounding the C3, C4, and/or C5 cervical spinal nerve roots.We provide evidence that hyperflexion/extension forces as experienced by shaken and impacted infants and young children lead to injury of the cervical spinal nerve roots that innervate the diaphragm, with resulting asphyxia and hypoxic brain injury. Therefore, we propose that trauma to the third through fifth cervical spinal nerve roots induced by hyperflexion/extension of the neck is the cause of the anoxic encephalopathy of the classic SBS triad, and is therefore not only a more specific indicator of hyperflexion/extension injury than subdural hemorrhage alone, but is the mechanism of injury in these cases.

Automation and standardization of the glucose measurement process have the potential to greatly improve glycemic control, clinical outcome, and safety while reducing cost. The resources required to monitor glycemia in hospitalized patients have thus far limited the implementation of intensive glucose management to patients in critical care units. Numerous available and up-and-coming technologies are targeted for the hospital patient population. Advantages and limitations of these devices are discussed herewith in.

On March 12, 2009, four representatives of Journal of Diabetes Science and Technology interviewed John Oxendine, one of the United States government's leading officials in the field of telemedicine legislation and regulation. Mr. Oxendine has been the Georgia Insurance and Fire Commissioner since 1994. In 2005, Mr. Oxendine spearheaded the Rural Georgia Healthcare Initiative. This initiative launched one of the largest and most comprehensive telemedicine networks in the United States, which is the Georgia Partnership for Telehealth. This program consists of 77 telemedicine and teleradiology sites across Georgia and provides residents of rural regions of Georgia with local access to specialty care that is usually found only in large urban areas. Paula Guy, R.N, who serves as the chief executive officer of the Georgia Partnership for Telehealth and who has 9 years of leadership experience in building telemedicine networks in the state of Georgia, also participated in the interview.

Manual methods of blood glucose monitoring are labor-intensive, costly, prone to error, and expose the caregiver to blood. The VIA(R) blood chemistry monitor for glucose can automatically measure plasma glucose (PG) every 5 minutes for 72 hours using blood sampled from a peripheral vein/artery or a central vein.VIA performance was evaluated in eight normal and five type 1 diabetic (T1DM) subjects in 15 separate experiments. The VIA device was connected to a peripheral vein and reported a PG value every 5 minutes during each 510-minute experiment. Blood samples were collected manually every 10 minutes and assayed using a HemoCue(R) beta-glucose analyzer (HC). Whole blood HC measurements were corrected to PG values. Paired HC/VIA measurements (n = 717) were analyzed.Mean PG was 90 +/- 14 and 96 +/- 12 mg/dl in normal subjects and 194 +/- 64 and 173 +/- 48 mg/dl in T1DM subject as measured by the HC and VIA, respectively. Clark error grid analysis revealed 86% points in zone A, 11% points in zone B, and 2% points in zone D. Linear regression analysis yielded the following equation: VIA = 0.732 x HC + 30.5 (r(2) = 0.954). Residual analysis revealed a glucose-dependent bias between the HC and the VIA. VIA data were transformed using the linear regression equation to correct for bias. After the correction, the mean absolute relative difference between the VIA and the HC was less than 10%, and 99.6% of data were in zones A and B. The VIA was able to sample blood automatically every 5 minutes for more than 8 hours in the laboratory setting. On average, the VIA reported glucose values for 94% of the samples it attempted to obtain.This study demonstrated that the VIA blood chemistry monitor for glucose can reliably sample blood frequently for a prolonged period of time safely and effectively in diabetic and nondiabetic volunteers. Agreement between the two devices was the closest at normal glucose concentrations. After correcting for a glucose-dependent bias between the devices, the MARD was consistently less than 10% for all glucose ranges.

INTRODUCTION The methodology for in vitro testing of insulin delivery systems for long-term infusion of lispro insulin requires insulin flow studies over time, with the measurement of lispro concentrations in wells or other laboratory fluid collection systems. We postulated that the efficiency of the insulin assay could be improved if the insulin collected in the wells could be measured without having to perform dilutions of insulin samples. The manufacturer's method for the identification of Humalog(R) insulin by high-performance liquid chromatography (HPLC) does not provide a detailed method for the quantitation of the clinical formulation. No reports could be found in the literature describing a method to quantitate lispro insulin's entire concentration range, nor could we find detailed information on pH effects. The purpose of this study was to investigate the use of a reversed-phase HPLC method to quantitate Humalog insulin at three levels of pH. METHODS Serial dilutions of Humalog insulin stock solution were prepared at pH levels of 2.6 and 7.4 (concentrations 0.20-100 IU/ml) to construct calibration curves. Samples were also prepared at lower concentrations (0.23-15.0 IU/ml) at pH levels of 4.0 and 7.4. Areas under curve data were plotted against known concentrations, and the limit of quantitation and precision of the assay were determined. RESULTS Calibration curves for the 0.20-100 IU/ml concentration (pH 7.4 and 2.6) revealed no significant differences (p < 0.01) between those curves. pH and concentration did not have an effect on the overall precision of the method. Linearity was not conserved past the 15-IU/ml concentration. Coefficient of variation (CV) values were generally