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Journal of Diabetes Science and Technology

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https://www.readbyqxmd.com/read/30394807/diabetes-technology-society-report-on-the-fda-digital-health-software-precertification-program-meeting
#1
Fraya King, David C Klonoff, David Ahn, Saleh Adi, Erika Gebel Berg, Jiang Bian, Kong Chen, Andjela Drincic, Michael Heyl, Michelle Magee, Shelagh Mulvaney, Yarmela Pavlovic, Priya Prahalad, Michael Ryan, Ashutosh Sabharwal, Shahid Shah, Elias Spanakis, Bradley Merrill Thompson, Michael Thompson, Jing Wang
Diabetes Technology Society (DTS) convened a meeting about the US Food and Drug Administration (FDA) Digital Health Software Precertification Program on August 28, 2018. Forty-eight attendees participated from clinical and academic endocrinology (both adult and pediatric), nursing, behavioral health, engineering, and law, as well as representatives of FDA, National Institutes of Health (NIH), National Telecommunications and Information Administration (NTIA), and industry. The meeting was intended to provide ideas to FDA about their plan to launch a Digital Health Software Precertification Program...
November 5, 2018: Journal of Diabetes Science and Technology
https://www.readbyqxmd.com/read/30394789/building-bridges-through-collaboration-and-consensus-expanding-awareness-and-use-of-peer-support-and-peer-support-communities-among-people-with-diabetes-caregivers-and-health-care-providers
#2
Hope Warshaw, David Edelman
Diabetes, regardless of type, is a complex disease. Successful management to achieve both short- and long-term health goals and outcomes is highly dependent on learning, mastery, and regular implementation and execution of self-care behaviors. The importance of a positive mental outlook and minimization of psychosocial barriers to care is increasingly identified as important in managing the whole person with diabetes and, as appropriate, the caregivers. Ongoing support from HCP and increasingly ongoing support from peers are critical elements of quality diabetes care...
November 4, 2018: Journal of Diabetes Science and Technology
https://www.readbyqxmd.com/read/30381961/developing-a-simple-3-day-insulin-delivery-device-to-meet-the-needs-of-people-with-type-2-diabetes
#3
Leslie C Lilly, Julia K Mader, Jay Warner
AIM: We sought to design an insulin delivery method that would overcome barriers to insulin therapy and meet the needs of the users, adults with diabetes, and their health care providers (HCPs). METHODS: We conducted focus groups and human factors studies with users to learn about their needs and requirements. We then designed an insulin delivery device, PAQ, with features that met the user's requirements. Iterative design and human factors testing (HFT) was performed with adults with diabetes on ⩾2 injections/day and HCPs...
November 1, 2018: Journal of Diabetes Science and Technology
https://www.readbyqxmd.com/read/30348023/electronic-consultation-an-effective-alternative-to-in-person-clinical-care-for-patients-with-diabetes-mellitus
#4
Payal S Patel, Bryan Jiang, Marco Marcelli, Sanjay N Mediwala, Madhuri M Vasudevan
No abstract text is available yet for this article.
October 22, 2018: Journal of Diabetes Science and Technology
https://www.readbyqxmd.com/read/30348013/history-and-perspective-on-diy-closed-looping
#5
Dana Lewis
People with diabetes have been experimenting and self-modifying diabetes devices and technologies for many decades, in order to achieve the best possible quality of life and improving their long-term outcomes. There are now hundreds of individuals using DIY closed loop systems globally. They work similarly to commercial systems at a basic level, automatically adjusting and controlling insulin dosing, but are different in terms of transparency, access, customization, and usability. The potential downsides to DIY closed looping include varying responses from individual HCPs, who may be concerned about their own liability...
October 22, 2018: Journal of Diabetes Science and Technology
https://www.readbyqxmd.com/read/30328716/why-the-details-of-glucose-meter-evaluations-matters
#6
Jan S Krouwer
In an article in the Journal of Diabetes Science and Technology, Macleod and coworkers describe an evaluation of LifeScan glucose meters that focus on the effects of sample types and comparison methods. They make a valid point that these factors influence the accuracy observed in evaluations and recommend the comparison method be the one recommended by the manufacturer for the sample type in the intended use statement. Yet, the recommended comparison method is not a reference method. The accuracy hierarchy of definitive, reference, and field methods originally described by Tietz should remind one that virtually all glucose meter evaluations use commercially available field methods as the comparison method...
October 17, 2018: Journal of Diabetes Science and Technology
https://www.readbyqxmd.com/read/30328708/mechanical-noise-improves-the-vibration-perception-threshold-of-the-foot-in-people-with-diabetic-neuropathy
#7
Jennefer B J Zwaferink, Juha M Hijmans, Claudia M Schrijver, Laura K Schrijver, Klaas Postema, Jaap J van Netten
BACKGROUND: Mechanical noise may improve somatosensation at the dorsal side of the foot, but the effect at the plantar side of the foot, the side most at risk for foot ulceration, is unknown. Moreover, techniques used in research so far have several problems that limit applicability in daily practice. Piezoelectric actuators may provide mechanical noise with better clinical applicability. We assessed the effects of piezoelectric actuators generating mechanical noise on the vibration perception threshold (VPT) at the plantar side of the foot in people with diabetic neuropathy...
October 17, 2018: Journal of Diabetes Science and Technology
https://www.readbyqxmd.com/read/30322281/response-to-blood-glucose-monitoring-data-should-be-reported-in-detail-when-studies-about-efficacy-of-continuous-glucose-monitoring-systems-are-published
#8
Michel Grino, Quentin Alitta, Charles Oliver
No abstract text is available yet for this article.
October 16, 2018: Journal of Diabetes Science and Technology
https://www.readbyqxmd.com/read/30318910/insulin-units-and-conversion-factors-a-story-of-truth-boots-and-faster-half-truths
#9
Jennifer L Knopp, Lui Holder-Pearson, J Geoffrey Chase
Conventional insulin concentration units (IU/mL or just U/mL) are bioefficacy based, whereas the Système International (SI) units (pmol/L) are mass based. In converting between these two different approaches, there are at least 2 well-accepted conversion factors, where there should be only 1. The correct value is not the most-used or well-accepted using online calculators, some journal styles, laboratory reports, and published articles. In short, an incorrect insulin conversion factor is widely used which underreports insulin concentrations by ~15%, with potentially significant research and clinical implications...
October 13, 2018: Journal of Diabetes Science and Technology
https://www.readbyqxmd.com/read/30317860/letter-to-the-editor-insulin-pump-adherence-behaviors-do-not-correlate-with-glycemic-variability-among-youth-with-type-1-diabetes-t1d
#10
Emily Paprocki, Vincent Staggs, Susan Patton, Mark Clements
No abstract text is available yet for this article.
October 13, 2018: Journal of Diabetes Science and Technology
https://www.readbyqxmd.com/read/30311794/reporting-insulin-pump-accuracy-trumpet-curves-according-to-iec-60601-2-24-and-beyond
#11
Stefan Pleus, Ulrike Kamecke, Delia Waldenmaier, Guido Freckmann
Accuracy of insulin pump basal rate delivery, if tested according to the standard IEC 60601-2-24 for infusion pumps, shall be presented as a trumpet curve. This way of graphical presentation is common; however, it is often misunderstood and misinterpreted by people. It is often assumed that a trumpet curve shows the error rate as a function of time, thus implying an increasing accuracy in the course of time. On the contrary, the horizontal axis of a trumpet curve shows increasingly long observation windows...
October 12, 2018: Journal of Diabetes Science and Technology
https://www.readbyqxmd.com/read/30295046/technological-support-to-intensive-insulin-therapy-by-a-novel-smartphone-application-in-young-adults-with-type-1-diabetes-one-center-s-experience
#12
Ilaria Barchetta, Maria Gisella Cavallo
No abstract text is available yet for this article.
October 7, 2018: Journal of Diabetes Science and Technology
https://www.readbyqxmd.com/read/30295040/the-accuracy-of-continuous-glucose-monitoring-and-flash-glucose-monitoring-during-aerobic-exercise-in-type-1-diabetes
#13
Dessi P Zaharieva, Michael C Riddell, Joseph Henske
No abstract text is available yet for this article.
October 7, 2018: Journal of Diabetes Science and Technology
https://www.readbyqxmd.com/read/30286620/evaluation-of-analytical-performance-of-three-blood-glucose-monitoring-systems-system-accuracy-measurement-repeatability-and-intermediate-measurement-precision
#14
Stefan Pleus, Nina Jendrike, Annette Baumstark, Jochen Mende, Cornelia Haug, Guido Freckmann
INTRODUCTION: Blood glucose monitoring systems (BGMS) should provide sufficient analytical quality to allow adequate therapy for diabetes patients. Besides system accuracy, measurement precision is an important aspect of a BGMS' analytical quality. METHODS: Based on ISO 15197:2013/EN ISO 15197:2015, system accuracy, measurement repeatability, and intermediate measurement precision were assessed. ISO 15197:2013 system accuracy criteria require that ⩾95% of individual BGMS' test strip lot results shall fall within ±15 mg/dl or ±15% of corresponding comparison method results (at glucose concentrations <100 mg/dl and ⩾100 mg/dl, respectively), and that ⩾99% of results fall within consensus error grid (CEG) zones A and B...
October 5, 2018: Journal of Diabetes Science and Technology
https://www.readbyqxmd.com/read/30264585/diadigital-apps-evaluation-of-smartphone-apps-using-a-quality-rating-methodology-for-use-by-patients-and-diabetologists-in-germany
#15
Matthias Kaltheuner, Diana Drossel, Lutz Heinemann
There are several computer applications (apps) that can be installed on smartphones to assist patients with diabetes in treating their disease. Not only does the range of use of such apps vary greatly, their quality does as well. As part of the DiaDigital initiative of the German Working Group for Diabetes Technology (AGDT), apps are evaluated using a set of criteria and a seal of distinction is then awarded ( www.diadigital.de ). The information collected in this review process is made public on this website to ensure both the necessary transparency as well as to be able to rapidly adapt voting on further app development...
September 28, 2018: Journal of Diabetes Science and Technology
https://www.readbyqxmd.com/read/30264583/the-influence-of-the-smart-glucose-manager-mobile-application-on-diabetes-management
#16
Kasun C Gunawardena, Renee Jackson, Iva Robinett, Lahiru Dhaniska, Shaluka Jayamanne, Sumedha Kalpani, Dimuthu Muthukuda
BACKGROUND: Smartphone use is rapidly growing in developing countries, providing opportunity for development of new health-based mobile applications. The present study investigated the efficacy of a newly designed mobile application, Smart Glucose Manager (SGM), in Sri Lankan patients with diabetes. METHODS: A total of 67 patients with access to Android smartphones were randomized into an SGM (n = 27) and a control group (n = 25). Glycosylated hemoglobin (A1c) levels were measured at baseline and every 3 months afterward...
September 28, 2018: Journal of Diabetes Science and Technology
https://www.readbyqxmd.com/read/30255722/is-thermal-imaging-a-useful-predictor-of-the-healing-status-of-diabetes-related-foot-ulcers-a-pilot-study
#17
Behzad Aliahmad, Aye Nyein Tint, Sridhar Poosapadi Arjunan, Priya Rani, Dinesh Kant Kumar, Julie Miller, Jeffrey D Zajac, Gayathiri Wang, Elif Ilhan Ekinci
INTRODUCTION: In clinical practice, both area and temperature of the ulcer have been shown to be effective in tracking the healing status of diabetes-related foot ulcer (DRFU). However, traditionally, the area of the DRFU is measured regardless of the temperature distribution. The current prospective, observational study used thermal imaging, as a more accurate tool, to measure both the area and the temperature of DRFU. We aimed to predict healing of DRFU using thermal imaging within the first 4 weeks of ulceration...
September 26, 2018: Journal of Diabetes Science and Technology
https://www.readbyqxmd.com/read/30255710/considering-blood-dilution-improves-the-precision-of-continuous-whole-blood-glucose-measurements
#18
Carsten Benesch, Mareike Kuhlenkötter, Tim Heise
BACKGROUND: One major advantage of automated over manual clamps are continuous measurements of blood glucose concentrations (BG) allowing frequent adaptations in glucose infusion rates (GIR). However, BG measurements might be affected by changes in blood dilution. ClampArt®, a modern automated clamp device, corrects BG measurements for blood dilution, but the impact of this correction is unclear. METHODS: The authors performed a retrospective analysis of BG during glucose clamps comparing values with a fixed dilution factor with those corrected for the actual blood dilution...
September 26, 2018: Journal of Diabetes Science and Technology
https://www.readbyqxmd.com/read/30255709/glycemic-control-maintained-over-time-and-joint-stiffness-in-young-type-1-patients-what-is-the-mathematical-relationship
#19
Piergiorgio Francia, Michele Sorelli, Barbara Piccini, Giulia Iannone, Laura Capirchio, Sonia Toni, Massimo Gulisano, Leonardo Bocchi
BACKGROUND: It is widely known that diabetes can induce stiffness and adversely affect joint mobility even in young patients with type 1 diabetes mellitus (T1D). The aim of this study was to identify a mathematical model of diabetes mellitus long-term effects on young T1D patients. METHODS: Ankle joint mobility (AJM) was evaluated using an inclinometer in 48 patients and 146 healthy, sex- BMI-, and age-matched controls. Assuming time invariance and linear superposition of the effects of hyperglycemia, the influence of T1D on AJM was formalized as an impulse response putting into relationship past supernormal HbA1c concentrations with the ankle total range of motion...
September 26, 2018: Journal of Diabetes Science and Technology
https://www.readbyqxmd.com/read/30247069/admission-glucose-number-agn-a-point-of-admission-score-associated-with-inpatient-glucose-variability-hypoglycemia-and-mortality
#20
Jennifer McKechnie, Rahat Maitland, Christopher A R Sainsbury, Gregory C Jones
AIMS: We investigated a point of admission metric of glycemia, the Admission Glucose Number (AGN), and its relationship with both high risk inpatient glucose patterns and mortality in hospital inpatients with type 2 diabetes (T2DM). METHODS: Inpatient capillary blood glucose (CBG) data for patients with T2DM in our health board were identified for a 5-year period and associated with most recent preadmission HbA1c. AGN was calculated as first CBG measured during admission (mmol/L), subtracted from most recent preadmission HbA1c (converted to estimated median glucose mmol/l) within 15 months preadmission...
September 24, 2018: Journal of Diabetes Science and Technology
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