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Journal of Diabetes Science and Technology

Ulrike Kamecke, Delia Waldenmaier, Cornelia Haug, Ralph Ziegler, Guido Freckmann
BACKGROUND: Adequate testing of delivery accuracy of insulin pumps is under discussion. Especially for patch pumps, test settings are challenging. In addition, evaluation and presentation of accuracy results in a way that is reasonable and useful for clinicians, not only for technicians, is important. METHODS: Test setups based on IEC 60601-2-24 were used and, in addition, different setups for patch pumps were compared to identify an adequate alternative for pumps without external infusion set...
July 1, 2018: Journal of Diabetes Science and Technology
Katharina Fritzen, Lutz Heinemann, Oliver Schnell
Understanding all aspects of diabetes treatment is hindered by the complexity of this chronic disease and its multifaceted complications and comorbidities, including social and financial impacts. In vivo studies as well as clinical trials provided invaluable information for unraveling not only metabolic processes but also risk estimations of, for example, complications. These approaches are often time- and cost-consuming and have frequently been supported by simulation models. Simulation models provide the opportunity to investigate diabetes treatment from additional viewpoints and with alternative objectives...
July 1, 2018: Journal of Diabetes Science and Technology
Delia Waldenmaier, Eva Zschornack, Lucas Kalt, Andreas Buhr, Stefan Pleus, Cornelia Haug, Guido Freckmann
INTRODUCTION: A new insulin pump system was tested under everyday conditions for user evaluation and safety assessment prior to its launch in Europe. This insulin pump is focused on easy handling and uses prefilled cartridges. METHODS: The pump system was used by 35 adult subjects with type 1 diabetes, experienced in insulin pump therapy, under everyday conditions for approximately one month each. All subjects rated various aspects of the system after home use; technical issues and safety parameters were assessed throughout the study...
July 1, 2018: Journal of Diabetes Science and Technology
Ricardo Sánchez-Peña, Patricio Colmegna, Fabricio Garelli, Hernán De Battista, Demián García-Violini, Marcela Moscoso-Vásquez, Nicolás Rosales, Emilia Fushimi, Enrique Campos-Náñez, Marc Breton, Valeria Beruto, Paula Scibona, Cintia Rodriguez, Javier Giunta, Ventura Simonovich, Waldo H Belloso, Daniel Cherñavvsky, Luis Grosembacher
BACKGROUND: Emerging therapies such as closed-loop (CL) glucose control, also known as artificial pancreas (AP) systems, have shown significant improvement in type 1 diabetes mellitus (T1DM) management. However, demanding patient intervention is still required, particularly at meal times. To reduce treatment burden, the automatic regulation of glucose (ARG) algorithm mitigates postprandial glucose excursions without feedforward insulin boluses. This work assesses feasibility of this new strategy in a clinical trial...
July 1, 2018: Journal of Diabetes Science and Technology
Kent W Stewart, Christopher G Pretty, Geoffrey M Shaw, J Geoffrey Chase
BACKGROUND: This study investigates blood glucose (BG) measurement interpolation techniques to represent intermediate BG dynamics, and the effect resampling of retrospective BG data has on key glycemic control (GC) performance results. GC protocols in the ICU have varying BG measurement intervals ranging from 0.5 to 4 hours. Sparse data pose problems, particularly in comparing GC performance or model fitting, and thus interpolation is required. METHODS: Retrospective data from SPRINT in Christchurch Hospital Intensive Care Unit (ICU) (2005-2007) were used to analyze several interpolation techniques...
July 1, 2018: Journal of Diabetes Science and Technology
Elena Gamarra, Claudia Baffoni, Giorgio Borretta, Mauro Feola, Francesco Tassone
No abstract text is available yet for this article.
July 1, 2018: Journal of Diabetes Science and Technology
Molly L Tanenbaum, Rebecca N Adams, Monica S Lanning, Sarah J Hanes, Bianca I Agustin, Diana Naranjo, Korey K Hood
BACKGROUND: Background:Many people with type 1 diabetes (T1D) report barriers to using continuous glucose monitoring (CGM). Diabetes care providers may have their own barriers to promoting CGM uptake. The goal of this study was to develop clinician "personas" with regard to readiness to promote CGM uptake. METHODS: Diabetes care providers who treat people with T1D (N = 209) completed a survey on perceived patient barriers to device uptake, technology attitudes, and characteristics and barriers specific to their clinical practice...
July 1, 2018: Journal of Diabetes Science and Technology
Eduardo Rodriguez-Diaz, Ivania Rizo, Catherine Sullivan, Devin W Steenkamp
No abstract text is available yet for this article.
June 1, 2018: Journal of Diabetes Science and Technology
Alan Moses, Jesper Bjerrum, Morten Hach, Lars Holm Wæhrens, Anders Dyhr Toft
BACKGROUND: The article by Carter and Heinemann raised serious concerns about the concentrations of insulin in vials being sold in US pharmacies. To study the claims made in the manuscript, we reviewed Novo Nordisk data on insulin concentration. METHODS: Insulin concentrations within vials from three different sources along the distribution chain were evaluated utilizing currently accepted US Pharmacopeia methodology: (1) insulin content and stability based on production batches covering 7 years of insulin production, (2) insulin content in samples returned to Novo Nordisk over the last three years in the United States, and (3) data from eight years of independent EMA testing...
June 1, 2018: Journal of Diabetes Science and Technology
Helen Lunt, Helen Heenan, Huan Chan
No abstract text is available yet for this article.
June 1, 2018: Journal of Diabetes Science and Technology
Erna Lenters-Westra, Emma English
BACKGROUND: Point-of-care (POC) testing is becoming increasingly valuable in health care delivery, and it is important that the devices used meet the same quality criteria as main laboratory analyzers. While external quality assessment (EQA) provides a great tool for assessing quality, many POC devices are not enrolled in these schemes and standard laboratory evaluations are needed to assess performance. METHODS: The Clinical and Laboratory Standards Institute (CLSI) protocols EP-5 and EP-9 were applied to investigate imprecision, accuracy and bias...
June 1, 2018: Journal of Diabetes Science and Technology
Gunnar Nordin
BACKGROUND: The accuracy and trueness of results from a laboratory test, such as the HbA1c test, should not be taken for granted but must be checked continuously. A tool for this is the participation in external quality assessment (EQA) for all laboratories performing the HbA1c-test. An additional possibility to detect changes in trueness is to monitor variations in patient cohort mean or median values that is not explained by changes in treatment or selection of patients. METHODS: Results reported to an EQA scheme for HbA1c during 20 years have been extracted from Equalis database...
June 1, 2018: Journal of Diabetes Science and Technology
Richard E Pratley, Julio Rosenstock, Simon R Heller, Alan Sinclair, Robert J Heine, Jacek Kiljański, Cynthia S Brusko, Ran Duan, Andreas Festa
BACKGROUND: Few studies have evaluated continuous glucose monitoring (CGM) in older patients with type 2 diabetes mellitus (T2DM) not using injectable therapy. CGM is useful for investigating hypoglycemia and glycemic variability, which is associated with complications in T2DM. METHODS: A CGM substudy of Individualized treatMent aPproach for oldER patIents in a randomized trial in type 2 diabetes Mellitus (IMPERIUM)) was conducted. Patients were vulnerable (moderately ill and/or frail) older (≥65 years) individuals with suboptimally controlled T2DM...
June 1, 2018: Journal of Diabetes Science and Technology
Arwen M Marker, Amy E Noser, Nicole Knecht, Mark A Clements, Susana R Patton
BACKGROUND: Greater knowledge about nutrition and carbohydrate counting are associated with improved glycemic control and quality of life in youth with type 1 diabetes (T1D). However, limited assessments of nutrition and carbohydrate knowledge have been developed, and existing measures can be time-consuming, overly broad, or not conducive to routine clinical use. To fill this gap, we developed and examined the feasibility of administering the electronic Nutrition and Carbohydrate Counting Quiz (eNCQ)...
May 1, 2018: Journal of Diabetes Science and Technology
Lars Kaltheuner, Matthias Kaltheuner, Lutz Heinemann
BACKGROUND: Many patients with diabetes on insulin therapy develop lipohypertrophies (LHTs). So far, LHTs are diagnosed by conventional methods (CM; visual inspection, palpation and/or ultrasound). In everyday life, it would be advantageous to have a quick, simple and inexpensive alternative, for example, diagnosing them by obtaining infrared (IR) images. METHODS: We obtained IR images from 43 subjects (21 patients with type 1 diabetes, conventional subcutaneous insulin therapy and known LHTs, 8 patients with CSII and LHTs, 7 patients without LHTs, and 7 healthy people), all from one specialized diabetes practice...
May 1, 2018: Journal of Diabetes Science and Technology
Mike Grady, Laurence B Katz, Brian L Levy
BACKGROUND: The ability of patients to improve glycemic control depends partly on their ability to interpret and act on blood glucose results. We investigated whether switching people with diabetes to blood glucose meters (BGMs) featuring a color range indicator (CRI) could improve glycemic control compared to remaining on their current BGM without color. METHODS: 163 adults with type 1 (T1D) or type 2 diabetes (T2D) and a hemoglobin A1c (A1c) of 7.5-11% were randomized to: One Touch Verio™ (Verio), OneTouch Verio Flex™ (Flex), or controls remaining on their current BGM...
May 1, 2018: Journal of Diabetes Science and Technology
Guojun Chen, Jicheng Yu, Zhen Gu
Antidiabetic therapeutics, including insulin as well as glucagon-like peptide 1 (GLP-1) and its analogs, are essential for people with diabetes to regulate their blood glucose levels. Nevertheless, conventional treatments based on hypodermic administration is commonly associated with poor blood glucose control, a lack of patient compliance, and a high risk of hypoglycemia. Closed-loop drug delivery strategies, also known as self-regulated administration, which can intelligently govern the drug release kinetics in response to the fluctuation in blood glucose levels, show tremendous promise in diabetes therapy...
May 1, 2018: Journal of Diabetes Science and Technology
Giacomo Cappon, Francesca Marturano, Martina Vettoretti, Andrea Facchinetti, Giovanni Sparacino
BACKGROUND: The standard formula (SF) used in bolus calculators (BCs) determines meal insulin bolus using "static" measurement of blood glucose concentration (BG) obtained by self-monitoring of blood glucose (SMBG) fingerprick device. Some methods have been proposed to improve efficacy of SF using "dynamic" information provided by continuous glucose monitoring (CGM), and, in particular, glucose rate of change (ROC). This article compares, in silico and in an ideal framework limiting the exposition to possibly confounding factors (such as CGM noise), the performance of three popular techniques devised for such a scope, that is, the methods of Buckingham et al (BU), Scheiner (SC), and Pettus and Edelman (PE)...
May 1, 2018: Journal of Diabetes Science and Technology
Steven Setford, Mike Grady, Stephen Mackintosh, Robert Donald, Brian Levy
BACKGROUND: MARD (mean absolute relative difference) is increasingly used to describe performance of glucose monitoring systems, providing a single-value quantitative measure of accuracy and allowing comparisons between different monitoring systems. This study reports MARDs for the OneTouch Verio® glucose meter clinical data set of 80 258 data points (671 individual batches) gathered as part of a 7.5-year self-surveillance program Methods: Test strips were routinely sampled from randomly selected manufacturer's production batches and sent to one of 3 clinic sites for clinical accuracy assessment using fresh capillary blood from patients with diabetes, using both the meter system and standard laboratory reference instrument...
May 1, 2018: Journal of Diabetes Science and Technology
Quang Nguyen, Shalin Pandya, Kai Chin, Christopher G Parkin
No abstract text is available yet for this article.
May 1, 2018: Journal of Diabetes Science and Technology
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