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Journal of Diabetes Science and Technology

Bernd Hehmke, Sabine Berg, Eckhard Salzsieder
Continuous standardized verification of the accuracy of blood glucose meter systems for self-monitoring after their introduction into the market is an important clinically tool to assure reliable performance of subsequently released lots of strips. Moreover, such published verification studies permit comparison of different blood glucose monitoring systems and, thus, are increasingly involved in the process of evidence-based purchase decision making.
October 4, 2016: Journal of Diabetes Science and Technology
Patricia M Cisarik, David L Smalley
No abstract text is available yet for this article.
October 4, 2016: Journal of Diabetes Science and Technology
Rosa Garcia-Verdugo, Michael Erbach, Oliver Schnell
Since the FDA requirement for cardiovascular safety of all new antihyperglycemic drugs to enter the market, the number and extent of phase 3 clinical trials has markedly increased. Unexpected trial results imply an enormous economic, personal and time cost and has deleterious effects over R&D. To prevent unforeseen developments in clinical trials, we recommend performing a comprehensive prospective outcome scenario analysis before launching the trial. In this commentary, we discuss the most important factors to take in consideration for prediction of clinical trial outcome scenarios and propose a theoretical model for decision making...
October 4, 2016: Journal of Diabetes Science and Technology
Laya Ekhlaspour, Debbie Mondesir, Norman Lautsch, Courtney Balliro, Mallory Hillard, Kendra Magyar, Laura Goergen Radocchia, Aryan Esmaeili, Manasi Sinha, Steven J Russell
BACKGROUND: The accuracy of point-of-care blood glucose (BG) meters is important for the detection of dysglycemia, calculation of insulin doses, and the calibration of continuous glucose monitors. The objective of this study was to compare the accuracy of commercially available glucose meters in a challenging laboratory study using samples with a wide range of reference BG and hemoglobin values. METHODS: Fresh, discarded blood samples from a hospital STAT laboratory were either used without modification, spiked with a glucose solution, or incubated at 37°C to produce 347 samples with an even distribution across reference BG levels from 20 to 440 mg/dl and hemoglobin values from 9 to 16 g/dl...
October 3, 2016: Journal of Diabetes Science and Technology
Neil E Hill, Christopher Campbell, Paul Buchanan, Midge Knight, Ian F Godsland, Nick S Oliver
BACKGROUND: Increasing numbers of people with diabetes are adopting exercise programs. Fear of hypoglycemia, hypoglycemia itself, and injuries are major issues for many people with diabetes undertaking physical activity. The purpose of this study was to investigate the effects of type 1 diabetes mellitus on the risk of hypoglycemia, glycemic variability, exercise performance, changes in body composition, changes in insulin dosage, and psychosocial well-being during a multiday endurance exercise event...
September 30, 2016: Journal of Diabetes Science and Technology
Harald Pohlmeier, Lori Berard, Claire Brulle-Wohlhueter, Junlong Wu, Raphael Dahmen, Irene Nowotny, David Klonoff
BACKGROUND: Insulin glargine 300 U/mL (Gla-300) contains the same active ingredient as glargine 100 U/mL (Gla-100), and provides the same number of units in one-third of the volume. The SoloSTAR(®) injector pen has been modified to ensure accurate administration of this reduced volume and to improve user experience. METHODS: Insulin- and pen-naïve adults with type 2 diabetes (T2DM) inadequately controlled with oral antihyperglycemic drugs, who had glycated hemoglobin (HbA1c) levels of 7...
September 23, 2016: Journal of Diabetes Science and Technology
Sivananthan Sampath, Pavlo Tkachenko, Eric Renard, Sergei V Pereverzev
BACKGROUND: Despite the risk associated with nocturnal hypoglycemia (NH) there are only a few methods aiming at the prediction of such events based on intermittent blood glucose monitoring data. One of the first methods that potentially can be used for NH prediction is based on the low blood glucose index (LBGI) and suggested, for example, in Accu-Chek® Connect as a hypoglycemia risk indicator. On the other hand, nowadays there are other glucose control indices (GCI), which could be used for NH prediction in the same spirit as LBGI...
September 22, 2016: Journal of Diabetes Science and Technology
Marie Moth Henriksen, Louise Færch, Birger Thorsteinsson, Ulrik Pedersen-Bjergaard
BACKGROUND: Prediction of risk of severe hypoglycemia (SH) in patients with type 1 diabetes is important to prevent future episodes, but it is unknown if it is possible to predict the long-term risk of SH. The aim of the study is to assess if long-term prediction of SH is possible in type 1 diabetes. METHODS: A follow-up study was performed with 98 patients with type 1 diabetes. At baseline and at follow-up, the patients filled in a questionnaire about diabetes history and complications, number of SH in the preceding year and state of awareness, and HbA1c and C-peptide levels were measured...
September 19, 2016: Journal of Diabetes Science and Technology
Mei-Fen Tsao, Hui-Wen Chang, Chien-Hsi Chang, Chi-Hsuan Cheng, Hsiu-Chen Lin
Neonatal hypoglycemia may cause severe neurological damages; therefore, tight glycemic control is crucial to identify neonate at risk. Previous blood glucose monitoring system (BGMS) failed to perform well in neonates; there are calls for the tightening of accuracy requirements. It remains a need for accurate BGMS for effective bedside diabetes management in neonatal care within a hospital population. A total of 300 neonates were recruited from local hospitals. Accuracy performance of a commercially available BGMS was evaluated against reference instrument in screening for neonatal hypoglycemia, and assessment was made based on the ISO15197:2013 and a tighter standard...
September 14, 2016: Journal of Diabetes Science and Technology
Steven V Edelman
The FDA recently conducted an Advisory Panel meeting to evaluate the safety, efficacy, and benefits of granting a nonadjunctive label claim for the DEXCOM G5 Mobile continuous glucose monitoring (CGM) system. If approved, this claim will allow users to make day-to-day treatment decisions, including insulin dosing directly from the glucose values and rate of changes arrows generated by the CGM device, without the requirement of a confirmatory measurement with a self-monitoring blood glucose (SMBG) meter. Sporadic SMBG testing gives limited data, while CGM gives a value every 5 minutes and has alerts, alarms, trending information and allows caregivers to follow the user in real time 24/7...
September 13, 2016: Journal of Diabetes Science and Technology
Peter van Dijk, Annette Bouma, Gijs Landman, Klaas H Groenier, Henk Bilo, Nanne Kleefstra, Kornelis J J van Hateren
No abstract text is available yet for this article.
September 12, 2016: Journal of Diabetes Science and Technology
Christopher G Parkin, Stephanie Schwenke, Anna Katharina Ossege, Torsten Gruchmann
BACKGROUND: Manufacturers now incorporate blood glucose (bG) value interpretation tools into their monitoring systems; however, usability of these support tools has not been well studied. We evaluated the utility and perceived benefits of support tool use by individuals with type 1 (T1D) and type 2 diabetes (T2D). METHODS: This 3-arm, randomized, simulation study assessed the impact of use of bG value interpretation support tools on participants' ability to correctly interpret bG values, using 1 of 3 tools: a new tool that uses colored scales with target range indicator (TRI), Colors and Smiley icons (already available)...
September 12, 2016: Journal of Diabetes Science and Technology
Martin de Bock, Julie Dart, Anirban Roy, Raymond Davey, Wayne Soon, Carolyn Berthold, Adam Retterath, Benyamin Grosman, Natalie Kurtz, Elizabeth Davis, Timothy Jones
BACKGROUND: Hypoglycemia remains a risk for closed loop insulin delivery particularly following exercise or if the glucose sensor is inaccurate. The aim of this study was to test whether an algorithm that includes a limit to insulin delivery is effective at protecting against hypoglycemia under those circumstances. METHODS: An observational study on 8 participants with type 1 diabetes was conducted, where a hybrid closed loop system (HCL) (Medtronic™ 670G) was challenged with hypoglycemic stimuli: exercise and an overreading glucose sensor...
September 12, 2016: Journal of Diabetes Science and Technology
Marzia Cescon, Daniel J DeSalvo, Trang T Ly, David M Maahs, Laurel H Messer, Bruce A Buckingham, Francis J Doyle, Eyal Dassau
BACKGROUND: Insulin infusion set failure resulting in prolonged hyperglycemia or diabetic ketoacidosis can occur with pump therapy in type 1 diabetes. Set failures are frequently characterized by variable and unpredictable patterns of increasing glucose values despite increased insulin infusion. Early detection may minimize the risk of prolonged hyperglycemia, an important consideration for automated insulin delivery and closed-loop applications. METHODS: A novel algorithm designed to alert the patient to the onset of infusion set failure was developed based upon continuous glucose sensor values and insulin delivered from an insulin pump...
September 12, 2016: Journal of Diabetes Science and Technology
Ohad Cohen, William Valentine
BACKGROUND: Continuous subcutaneous insulin infusion (CSII) is used less for type 2 than for type 1 diabetes because of inconsistencies in evidence of effectiveness. We reviewed published guidelines on intensive insulin therapy in type 2 diabetes to assess whether updating of guidance is needed with respect to evidence used and recommendations for CSII in diabetes management. METHODS: A literature review was performed to identify published national and international guidelines on type 2 diabetes management...
September 12, 2016: Journal of Diabetes Science and Technology
Dimitri Boiroux, Tinna Björk Aradóttir, Kirsten Nørgaard, Niels Kjølstad Poulsen, Henrik Madsen, John Bagterp Jørgensen
BACKGROUND: Bolus calculators help patients with type 1 diabetes to mitigate the effect of meals on their blood glucose by administering a large amount of insulin at mealtime. Intraindividual changes in patients physiology and nonlinearity in insulin-glucose dynamics pose a challenge to the accuracy of such calculators. METHOD: We propose a method based on a continuous-discrete unscented Kalman filter to continuously track the postprandial glucose dynamics and the insulin sensitivity...
September 8, 2016: Journal of Diabetes Science and Technology
Marc C Torjman
The study by Grady et al is timely and exciting striving toward better understanding of relevant human factors in the design of their glucose meter displays. Their investigation focused on meaningful device optimization objectives that could be important to improving diabetes self-management. Grady et al are to be complimented for their development of a PC-based computer simulator to further our understanding of how patients interpret their glucose meter readings. What is interesting is that important, and hopefully more appropriate decisions, can be made daily or hourly when a meter is capable of displaying the most relevant information in a manner that will prompt the user toward more favorable glucose management decisions...
September 6, 2016: Journal of Diabetes Science and Technology
Lutz Heinemann, Diana Drossel, Guido Freckmann, Bernhard Kulzer
The estimation is that every third to fourth patient with diabetes suffers from some degree of diabetic retinopathy. Medical products for insulin administration (such as insulin pens and pumps) or glucose monitoring not optimized to the needs of these patients' represent a high barrier for optimal diabetes therapy in daily practice. To date, the number of devices suitable for visually impaired and blind patients with diabetes is scarce. This manuscript outlines the specific needs of this patient group with regard to systems for insulin administration, blood glucose measurement, and continuous glucose monitoring...
September 6, 2016: Journal of Diabetes Science and Technology
Eric Zijlstra, Lutz Heinemann, Annelie Fischer, Christoph Kapitza
BACKGROUND: The objective was to evaluate the performance (in terms of accuracy, precision, and trueness) of 5 CE-certified and commercially available blood glucose (BG) systems (meters plus test strips) using an innovative clinical-experimental study design with a 3-step glucose clamp approach and frequent capillary BG measurements. METHODS: Sixteen subjects with type 1 diabetes participated in this open label, single center trial. BG was clamped at 3 levels for 60 minutes each: 60-100-200 mg/dL...
September 6, 2016: Journal of Diabetes Science and Technology
Guido Freckmann, Stephan Arndt, Albrecht Fießelmann, Gerhard Klausmann, Kristina Pralle, Thomas Künsting, Bettina Petersen
BACKGROUND: Continuous subcutaneous insulin infusion (CSII) therapy is a valuable option especially for people with type 1 diabetes. Although insulin infusion sets (IIS) are essential components of most insulin pump systems, only few studies have been conducted on their performance and safety. In this study 2 IIS with soft cannulas were compared. METHODS: In an open-label, randomized, crossover, multicenter 8-week study 80 type 1 diabetic subjects on CSII (20-74 years, mean 46...
September 6, 2016: Journal of Diabetes Science and Technology
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