Performance and System Validation of a New Cellular-Enabled Blood Glucose Monitoring System Using a New Standard Reference Measurement Procedure of Isotope Dilution UPLC-MRM Mass Spectrometry
Conclusions: To our knowledge this is the first touch screen glucose meter and the first study where accuracy of a new BGMS has been measured against a true primary reference standard, namely IDLC-MS. (Source: Journal of Diabetes Science and Technology)
Source: Journal of Diabetes Science and Technology - September 1, 2015 Category: Endocrinology Authors: Angelides, K., Matsunami, R. K., Engler, D. A. Tags: Original Articles Source Type: research

Development and Validation of a Rapid 13C6-Glucose Isotope Dilution UPLC-MRM Mass Spectrometry Method for Use in Determining System Accuracy and Performance of Blood Glucose Monitoring Devices
Conclusions: The newly developed ID UPLC-MRM assay can serve as a validated reference measurement procedure to which new BGMS can be assessed for glucose measurement performance. (Source: Journal of Diabetes Science and Technology)
Source: Journal of Diabetes Science and Technology - September 1, 2015 Category: Endocrinology Authors: Matsunami, R. K., Angelides, K., Engler, D. A. Tags: Original Articles Source Type: research

System Accuracy Evaluation of Four Systems for Self-Monitoring of Blood Glucose Following ISO 15197 Using a Glucose Oxidase and a Hexokinase-Based Comparison Method
Conclusions: In this study, all 4 systems complied with the evaluated test strip lots with accuracy criteria of ISO 15197:2003. Applying ISO 15197:2013 accuracy limits, differences in the accuracy of the tested systems were observed, also demonstrating that the applied comparison method/system and the lot-to-lot variability can have a decisive influence on accuracy data obtained for a SMBG system. (Source: Journal of Diabetes Science and Technology)
Source: Journal of Diabetes Science and Technology - September 1, 2015 Category: Endocrinology Authors: Link, M., Schmid, C., Pleus, S., Baumstark, A., Rittmeyer, D., Haug, C., Freckmann, G. Tags: Original Articles Source Type: research

Performance Comparison of CGM Systems: MARD Values Are Not Always a Reliable Indicator of CGM System Accuracy
Conclusions: MARD is a reasonable parameter to characterize the performance of CGM systems when keeping its limitations in mind. To support clinicians and patients in selecting which CGM system to use in a clinical setting, care should be taken to make MARD more comparable by employing a standardized evaluation procedure. (Source: Journal of Diabetes Science and Technology)
Source: Journal of Diabetes Science and Technology - September 1, 2015 Category: Endocrinology Authors: Kirchsteiger, H., Heinemann, L., Freckmann, G., Lodwig, V., Schmelzeisen-Redeker, G., Schoemaker, M., del Re, L. Tags: Original Articles Source Type: research

Analysis: The Accuracy and Efficacy of the Dexcom G4 Platinum Continuous Glucose Monitoring System
In this issue of Journal of Diabetes Science and Technology, Nakamura and Balo report on accuracy and efficacy of the Dexcom G4 Platinum Continuous Glucose Monitoring System. The authors demonstrate good overall performance of this real-time continuous glucose monitoring (RT-CGM) system, although accuracy data of the next generation RT-CGM system, the G4AP, is already available. Also, now that MARDs seem to move to single-digit numbers, the question comes up how low we need to go with accuracy. Results of the study also showed a reduction in time spent in hypoglycemia, although the clinical relevance should be questioned. ...
Source: Journal of Diabetes Science and Technology - September 1, 2015 Category: Endocrinology Authors: van Beers, C. A. J., DeVries, J. H. Tags: Original Articles Source Type: research

The Accuracy and Efficacy of the Dexcom G4 Platinum Continuous Glucose Monitoring System
Conclusions: The study showed the Dexcom G4 Platinum CGM System is one of the most accurate CGMs. The significant reduction in nocturnal time spent in a hypoglycemic state observed during this study suggests that a longer term study of CGM use, especially nocturnal use, could be beneficial for patients with hypoglycemia unawareness. (Source: Journal of Diabetes Science and Technology)
Source: Journal of Diabetes Science and Technology - September 1, 2015 Category: Endocrinology Authors: Nakamura, K., Balo, A. Tags: Original Articles Source Type: research

Predictors of Hypoglycemia in the ASPIRE In-Home Study and Effects of Automatic Suspension of Insulin Delivery
Conclusions: Routine use of the TS feature and the bolus estimation calculator are strategies that may reduce the risk of NH. (Source: Journal of Diabetes Science and Technology)
Source: Journal of Diabetes Science and Technology - September 1, 2015 Category: Endocrinology Authors: Weiss, R., Garg, S. K., Bergenstal, R. M., Klonoff, D. C., Bode, B. W., Bailey, T. S., Thrasher, J., Schwartz, F., Welsh, J. B., Kaufman, F. R., ASPIRE In-Home Study Group, Brazg, Casaubon, Horowitz, Liljenquist, Odugbesan, Bhargava, Goland, Weinstock Tags: Original Articles Source Type: research

Time Delay of CGM Sensors: Relevance, Causes, and Countermeasures
Conclusions: Prediction algorithms should be used to provide real-time CGM readings more consistent with simultaneous measurements by SMBG. Patient specificity may play an important role in improving prediction quality. (Source: Journal of Diabetes Science and Technology)
Source: Journal of Diabetes Science and Technology - September 1, 2015 Category: Endocrinology Authors: Schmelzeisen-Redeker, G., Schoemaker, M., Kirchsteiger, H., Freckmann, G., Heinemann, L., del Re, L. Tags: Original Articles Source Type: research

Hypoglycemia in Type 2 Diabetes - More Common Than You Think: A Continuous Glucose Monitoring Study
Conclusions: CGMS can provide rich data that show glucose excursions in diabetes patients throughout the day. Consequently, unwarranted onset of hypo- and hyperglycemic events can be detected, intervened, and prevented by using CGMS. Hypoglycemia was frequently unrecognized by the patients in this study (75%), which increases their potential risk of significant adverse events. Incorporation of CGMS into the routine management of T2DM would increase the detection and self-awareness of hypoglycemia resulting in safer and potentially better overall control. (Source: Journal of Diabetes Science and Technology)
Source: Journal of Diabetes Science and Technology - September 1, 2015 Category: Endocrinology Authors: Gehlaut, R. R., Dogbey, G. Y., Schwartz, F. L., Marling, C. R., Shubrook, J. H. Tags: Original Articles Source Type: research

Modeling the Physiological Factors Affecting Glucose Sensor Function in Vivo
For implantable sensors to become a more viable option for continuous glucose monitoring strategies, they must be able to persist in vivo for periods longer than the 3- to 7-day window that is the current industry standard. Recent studies have attributed such limited performance to tissue reactions resulting from implantation. While in vivo biocompatibility studies have provided much in the way of understanding histology surrounding an implanted sensor, little is known about how each constituent of the foreign body response affects sensor function. Due to the ordered composition and geometry of implant-associated tissue re...
Source: Journal of Diabetes Science and Technology - September 1, 2015 Category: Endocrinology Authors: Novak, M. T., Reichert, W. M. Tags: Articles Source Type: research

Preclinical Evaluation of Poly(HEMA-co-acrylamide) Hydrogels Encapsulating Glucose Oxidase and Palladium Benzoporphyrin as Fully Implantable Glucose Sensors
Conclusions: The hydrogel-based sensors exhibited excellent sensitivity and sufficiently rapid response to the glucose levels achieved in vivo, proving feasibility of these materials for use in real-time glucose tracking. Extending the dynamic range and assessing long-term effects in vivo are ongoing efforts. (Source: Journal of Diabetes Science and Technology)
Source: Journal of Diabetes Science and Technology - September 1, 2015 Category: Endocrinology Authors: Unruh, R. M., Roberts, J. R., Nichols, S. P., Gamsey, S., Wisniewski, N. A., McShane, M. J. Tags: Articles Source Type: research

Preclinical Performance Evaluation of Percutaneous Glucose Biosensors: Experimental Considerations and Recommendations
The utility of continuous glucose monitoring devices remains limited by an obstinate foreign body response (FBR) that degrades the analytical performance of the in vivo sensor. A number of novel materials that resist or delay the FBR have been proposed as outer, tissue-contacting glucose sensor membranes as a strategy to improve sensor accuracy. Traditionally, researchers have examined the ability of a material to minimize the host response by assessing adsorbed cell morphology and tissue histology. However, these techniques do not adequately predict in vivo glucose sensor function, necessitating sensor performance evaluat...
Source: Journal of Diabetes Science and Technology - September 1, 2015 Category: Endocrinology Authors: Soto, R. J., Schoenfisch, M. H. Tags: Articles Source Type: research

Foreign Body Reaction to Implantable Biosensors: Effects of Tissue Trauma and Implant Size
Conclusions: The results of the current study indicate that the extent of the inflammatory response post–sensor implantation varies as a function of the initial tissue trauma as well as the sensor size. Accordingly, miniaturization of implantable biosensors together with the utilization of a drug-eluting biocompatible composite coating may be a promising strategy to achieve long-term reliable continuous glucose monitoring. (Source: Journal of Diabetes Science and Technology)
Source: Journal of Diabetes Science and Technology - September 1, 2015 Category: Endocrinology Authors: Wang, Y., Vaddiraju, S., Gu, B., Papadimitrakopoulos, F., Burgess, D. J. Tags: Articles Source Type: research

Basement Membrane-Based Glucose Sensor Coatings Enhance Continuous Glucose Monitoring in Vivo
Conclusion: Basement-membrane-based sensor coatings enhance glucose sensor function in vivo, by minimizing or preventing sensor-induced tissues reactions. (Source: Journal of Diabetes Science and Technology)
Source: Journal of Diabetes Science and Technology - September 1, 2015 Category: Endocrinology Authors: Klueh, U., Qiao, Y., Czajkowski, C., Ludzinska, I., Antar, O., Kreutzer, D. L. Tags: Articles Source Type: research

Multisite Study of an Implanted Continuous Glucose Sensor Over 90 Days in Patients With Diabetes Mellitus
Conclusions: The Senseonics CGM, composed of an implantable sensor, external smart transmitter, and smartphone app, is the first system that uses a single sensor for continuous display of accurate glucose values for 3 months. (Source: Journal of Diabetes Science and Technology)
Source: Journal of Diabetes Science and Technology - September 1, 2015 Category: Endocrinology Authors: Dehennis, A., Mortellaro, M. A., Ioacara, S. Tags: Articles Source Type: research