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https://www.readbyqxmd.com/read/28439847/the-role-of-the-fda-and-regulatory-approval-of-new-devices-for-diabetes-care
#1
REVIEW
Shelley A Jazowski, Aaron N Winn
PURPOSE OF REVIEW: The Food and Drug Administration (FDA) is responsible for assuring the safety, effectiveness, and quality of medical devices in the USA. Extensive review times coupled with the demand for necessary treatments have prompted the policymakers to implement measures to speed medical devices to market.The purpose of this review is to summarize the evolution of the regulatory pathways through which medical devices utilized in diabetes care gain market access. RECENT FINDINGS: Regulatory pathways, ranging from premarket notification to premarket approval, require distinct, yet necessary ("least burdensome") evidence demonstrating a device's safety and effectiveness...
June 2017: Current Diabetes Reports
https://www.readbyqxmd.com/read/28437809/reactive-rather-than-proactive-diabetes-management-in-the-perioperative-period
#2
Inge Hommel, Petra J van Gurp, Alfons A den Broeder, Hub Wollersheim, Femke Atsma, Marlies E J L Hulscher, Cees J Tack
As perioperative hyperglycemia is associated with poor postoperative patient outcomes, clinical guidelines provide recommendations for optimal perioperative glucose control. It is unclear to what extent recommended glucose levels are met in daily practice, and little is known about factors that influence these levels. We describe blood glucose levels throughout the hospital care pathway in 375 non-critically ill patients with diabetes who underwent major surgery (abdominal, cardiac, or orthopedic) in 6 hospitals, examine determinants of these levels including adherence to 9 quality indicators for optimal perioperative diabetes care, and perform qualitative interviews to identify barriers for optimal care...
April 24, 2017: Hormone and Metabolic Research, Hormon- und Stoffwechselforschung, Hormones et Métabolisme
https://www.readbyqxmd.com/read/28434870/maternal-socioeconomic-disadvantage-is-associated-with-transcriptional-indications-of-greater-immune-activation-and-slower-tissue-maturation-in-placental-biopsies-and-newborn-cord-blood
#3
Gregory E Miller, Ann E Borders, Amy H Crockett, Kharah M Ross, Sameen Qadir, Lauren Keenan-Devlin, Adam K Leigh, Paula Ham, Jeffrey Ma, Jesusa M G Arevalo, Linda M Ernst, Steve W Cole
Children from economically disadvantaged families experience worse cognitive, psychiatric, and medical outcomes compared to more affluent youth. Preclinical models suggest some of the adverse influence of disadvantage could be transmitted during gestation via maternal immune activation, but this hypothesis has not been tested in humans. It also remains unclear whether prenatal interventions can mitigate such effects. To fill these gaps, we conducted two studies. Study 1 characterized the socioeconomic conditions of 79 women during pregnancy...
April 20, 2017: Brain, Behavior, and Immunity
https://www.readbyqxmd.com/read/28393626/in-silico-modelling-and-molecular-dynamics-simulation-studies-of-thiazolidine-based-ptp1b-inhibitors
#4
Manoj Kumar Mahapatra, Krishnendu Bera, Durg Vijay Singh, Rajnish Kumar, Manoj Kumar
Protein tyrosine phosphatase 1B (PTP1B) has been identified as negative regulator of insulin and leptin signalling pathway, hence it can be considered as a new therapeutic target of intervention for the treatment of type2 diabetes. Inhibition of this molecular target takes care of both diabetes and obesity, i.e., diabestiy. In order to get more information on identification and optimisation of lead, pharmacophore modelling, atom-based 3D QSAR, docking and molecular dynamics studies were carried out on a set of ligands containing thiazolidine scaffold...
April 10, 2017: Journal of Biomolecular Structure & Dynamics
https://www.readbyqxmd.com/read/28389199/weight-change-patterns-and-healthcare-costs-in-patients-with-newly-diagnosed-type-2-diabetes-in-sweden
#5
Ugne Sabale, Johan Bodegard, Bodil Svennblad, Carl Johan Östgren, Gunnar Johansson, Mattias Ekman, Martin Henriksson, Peter Nilsson
AIMS: To describe weight-change pathways in patients with type 2 diabetes (T2D) and associated healthcare costs using repeated BMI measurements and healthcare utilization data. METHODS: Patients with newly-diagnosed T2D with body mass index (BMI, kg/m(2)) at diagnosis and subsequent measures at year 1-3 were identified. Based on three-year BMI change, patients were assigned to one of 27 BMI change pathways defined by annual BMI change: BMI↗ (≥1 BMI unit increase), BMI→ (<1 BMI unit change), and BMI↘ (≥1 BMI unit decrease)...
June 2017: Primary Care Diabetes
https://www.readbyqxmd.com/read/28370206/adjuvant-psychological-therapy-in-long-term-endocrine-conditions
#6
J Daniels, J M Turner-Cobb
Consideration of psychological distress in long term endocrine conditions is of vital importance given the prevalence of anxiety and depression in such disorders. Poor mental health can lead to compromised self-care, higher utilisation of health services, lower rates of adherence, reduced quality of life and ultimately poorer outcomes. Adjuvant psychological therapy offers an effective resource to reduce distress in endocrinological disorders. While the vast majority of work in this area has focused on psychological screening and intervention in diabetes, identification and recognition of psychological distress is equally important in other endocrinological conditions, with supportive evidence in Polycystic Ovary Syndrome and Addison's disease...
March 30, 2017: Clinical Endocrinology
https://www.readbyqxmd.com/read/28340010/non-proteinuric-rather-than-proteinuric-renal-diseases-are-the-leading-cause-of-end-stage-kidney-disease
#7
Davide Bolignano, Carmine Zoccali
Proteinuria is a distinguishing feature in primary and secondary forms of chronic glomerulonephritis, which contribute to no more than the 20% of the end-stage kidney disease (ESKD) population. The contribution of non-proteinuric nephropathies to the global ESKD burden is still poorly focused and scarce research efforts are dedicated to the elucidation of risk factors and mechanistic pathways triggering ESKD in these diseases. We abstracted information on proteinuria in the main renal diseases other than glomerulonephritides that may evolve into ESKD...
April 1, 2017: Nephrology, Dialysis, Transplantation
https://www.readbyqxmd.com/read/28328996/diaphragmatic-function-is-enhanced-in-fatty-and-diabetic-fatty-rats
#8
Audrey De Jong, Serge Carreira, Na Na, Aude Carillion, Cheng Jiang, Maud Beuvin, Jean-Marc Lacorte, Dominique Bonnefont-Rousselot, Bruno Riou, Catherine Coirault
BACKGROUND: Obesity is associated with a decrease in mortality in the intensive care unit (ICU) (the "obesity paradox"). We hypothesized that obesity may paradoxically improve diaphragmatic function. METHODS: Diaphragm contractility was prospectively recorded in vitro in adult male Zucker lean (control), fatty, and diabetic fatty rats, at rest, after 12h mechanical ventilation and after fatigue. We analyzed diaphragm morphology, cytokines, and protein expression of the protein kinase signaling pathways...
2017: PloS One
https://www.readbyqxmd.com/read/28321553/enhanced-recovery-after-surgery-eras-%C3%A2-in-individuals-with-diabetes-a-systematic-review
#9
Zaina Albalawi, Michael Laffin, Leah Gramlich, Peter Senior, Finlay A McAlister
BACKGROUND: Prevalence of diabetes in surgical patients is 10-40%. It is well recognized that they have higher rates of complications, and longer stays in hospital compared to patients without diabetes. Enhanced recovery after surgery (ERAS) is an evidence-based multimodal surgical care pathway that improves postoperative complications and length of stay in patients without diabetes. This review evaluates the evidence on whether individuals with diabetes would benefit from ERAS implementation...
March 20, 2017: World Journal of Surgery
https://www.readbyqxmd.com/read/28320415/the-development-of-integrated-diabetes-care-in-the-netherlands-a-multiplayer-self-assessment-analysis
#10
Nick Zonneveld, Lidewij E Vat, Hans Vlek, Mirella M N Minkman
BACKGROUND: Since recent years Dutch diabetes care has increasingly focused on improving the quality of care by introducing the concept of care groups (in Dutch: 'zorggroepen'), care pathways and improving cooperation with involved care professionals and patients. This study examined how participating actors in care groups assess the development of their diabetes services and the differences and similarities between different stakeholder groups. METHODS: A self-evaluation study was performed within 36 diabetes care groups in the Netherlands...
March 21, 2017: BMC Health Services Research
https://www.readbyqxmd.com/read/28316793/development-and-validation-of-an-instrument-to-measure-collaborative-goal-setting-in-the-care-of-patients-with-diabetes
#11
Heather L Morris, Levent Dumenci, Jennifer E Lafata
OBJECTIVE: Despite known benefits of patient-perceived collaborative goal setting, we have a limited ability to monitor this process in practice. We developed the Patient Measure of Collaborative Goal Setting (PM-CGS) to evaluate the use of collaborative goal setting from the patient's perspective. RESEARCH DESIGN AND METHODS: A random sample of 400 patients aged 40 years or older, receiving diabetes care from the Virginia Commonwealth University Health System between 8/2012 and 8/2013, were mailed a survey containing potential PM-CGS items (n=44) as well as measures of patient demographics, perceived self-management competence, trust in their physician, and self-management behaviors...
2017: BMJ Open Diabetes Research & Care
https://www.readbyqxmd.com/read/28292206/mhealth-and-the-management-of-chronic-conditions-in-rural-areas-a-note-of-caution-from-southern-india
#12
Papreen Nahar, Nanda Kishore Kannuri, Sitamma Mikkilineni, G V S Murthy, Peter Phillimore
This article examines challenges facing implementation of likely mHealth programmes in rural India. Based on fieldwork in Andhra Pradesh in 2014, and taking as exemplars two chronic medical 'conditions' - type 2 diabetes and depression - we look at ways in which people in one rural area currently access medical treatment; we also explore how adults there currently use mobile phones in daily life, to gauge the realistic likelihood of uptake for possible mHealth initiatives. We identify the very different pathways to care for these two medical conditions, and we highlight the importance to the rural population of healthcare outside the formal health system provided by those known as registered medical practitioners (RMP), who despite their title are neither registered nor trained...
April 2017: Anthropology & Medicine
https://www.readbyqxmd.com/read/28283260/-methodological-aspects-of-integrated-care-pathways
#13
R Gomis, M Mata Cases, D Mauricio Puente, S Artola Menéndez, J Ena Muñoz, J J Mediavilla Bravo, C Miranda Fernández-Santos, D Orozco Beltrán, L Rodríguez Mañas, C Sánchez Villalba, J A Martínez
An Integrated Healthcare Pathway (PAI) is a tool which has as its aim to increase the effectiveness of clinical performance through greater coordination and to ensure continuity of care. PAI places the patient as the central focus of the organisation of health services. It is defined as the set of activities carried out by the health care providers in order to increase the level of health and satisfaction of the population receiving services. The development of a PAI requires the analysis of the flow of activities, the inter-relationships between professionals and care teams, and patient expectations...
March 7, 2017: Revista de Calidad Asistencial: Organo de la Sociedad Española de Calidad Asistencial
https://www.readbyqxmd.com/read/28210868/cognitive-impairment-and-dementia-a-new-emerging-complication-of-type-2-diabetes-the-diabetologist-s-perspective
#14
Rafael Simó, Andreea Ciudin, Olga Simó-Servat, Cristina Hernández
Type 2 diabetes mellitus (T2D) and Alzheimer's disease (AD) are two of the most common diseases of aging around the world. Given the frequency with which T2D and AD occur, the notion that people with T2D may be at increased risk for AD has large societal consequences, and understanding the mechanistic links between these diseases is imperative for the development of effective AD prevention and treatment strategies. Apart from being an accelerator of AD, T2D is associated with a progressive cognitive decline...
February 16, 2017: Acta Diabetologica
https://www.readbyqxmd.com/read/28207728/discharge-outcomes-of-patients-referred-to-specialist-eye-clinic-from-diabetic-retinopathy-screening-in-northland-2014-15
#15
Pragnya Jagadish, David Dalziel
AIMS: To determine the discharge outcomes of patients seen in specialist eye clinic after referral from diabetic retinopathy screening (DRS). METHODS: Retrospective analysis of outcomes of a sample of 98 patients referred from DRS to specialist eye clinic. RESULTS: A sample of 98 patients were analysed following referral by DRS to specialist eye clinic from 16/4/14 to 16/4/15. Age at screening ranged from 13-88 years, with the main ethnic groups being Māori (57...
February 17, 2017: New Zealand Medical Journal
https://www.readbyqxmd.com/read/28201967/dipeptidyl-peptidase-4-inhibitor-induced-angioedema-an-overlooked-and-potentially-lethal-adverse-drug-reaction
#16
Susanne Irene Scott, Michelle Fog Andersen, Lise Aagaard, Christian Von Buchwald, Eva Rye Rasmussen
Introduction Angioedema is a potentially fatal adverse drug reaction of some medications, as swellings of the upper airways can cause death by asphyxiation. Angiotensin converting enzyme-inhibitors are widely known to cause angioedema but less is known about the association between dipeptidyl peptidase-4 inhibitors (gliptins) and angioedema. Dipeptidyl peptidase-4 inhibitors are anti-diabetic drugs used to improve glycaemic control. They, as a class effect, inadvertently affect the degradation of the vasoactive kinins bradykinin and substance P, both of which can cause angioedema due to vasodilatation and increase in vascular permeability in the capillaries...
February 14, 2017: Current Diabetes Reviews
https://www.readbyqxmd.com/read/28132967/kidney-cadmium-toxicity-diabetes-and-high-blood-pressure-the-perfect-storm
#17
REVIEW
Soisungwan Satarug, David A Vesey, Glenda C Gobe
Cadmium (Cd) is an environmental toxicant of widespread exposure and pervasive toxicity. Absorption, systemic transport and uptake of Cd are mediated by metal transporters that the body uses for acquisition of physiologically-essential elements, notably of iron, zinc and calcium. Currently, human exposure to Cd is known to damage the kidneys, especially the proximal tubular cells that actively reabsorb Cd along with zinc, glucose and amino acids in the glomerular filtrate. Severe kidney damage, glycosuria and proteinuria are known outcomes after high dietary Cd intake (> 200 µg/day)...
January 2017: Tohoku Journal of Experimental Medicine
https://www.readbyqxmd.com/read/28118838/the-cost-effectiveness-of-changes-to-the-care-pathway-used-to-identify-depression-and-provide-treatment-amongst-people-with-diabetes-in-england-a-model-based-economic-evaluation
#18
Ben Kearns, R Rafia, J Leaviss, L Preston, J E Brazier, S Palmer, R Ara
BACKGROUND: Diabetes is associated with premature death and a number of serious complications. The presence of comorbid depression makes these outcomes more likely and results in increased healthcare costs. The aim of this work was to assess the health economic outcomes associated with having both diabetes and depression, and assess the cost-effectiveness of potential policy changes to improve the care pathway: improved opportunistic screening for depression, collaborative care for depression treatment, and the combination of both...
January 24, 2017: BMC Health Services Research
https://www.readbyqxmd.com/read/28112704/evaluation-and-treatment-of-hyperglycemia-in-critically-ill-patients
#19
Andrea Balloni, Federico Lari, Fabrizio Giostra
The hyperglycemic reaction to stress is part of adaptive metabolic response to critical illness, especially hypoxia, hemorrhage and sepsis. It involves neuro-endocrine and immune pathways leading to the development of insulin resistance and hepatic glucose production by gluconeogenesis and glycogenolysis. Over the last years the concept of stress related hyperglycemia has been replaced by the concept of dysglycemia and its three domains: hyperglycemia, hypoglycemia and glycemic variability. Each of the three domains is independently associated with increased risk of mortality in patients admitted in intensive care unit and non critically ill patients, both medical and surgical...
January 16, 2017: Acta Bio-medica: Atenei Parmensis
https://www.readbyqxmd.com/read/28105778/psychosocial-screening-and-management-of-young-people-aged-18-25-years-with-diabetes
#20
Helen d'Emden, Brett McDermott, Neisha D'Silva, Tom Dover, Tatjana Ewais, Kristen Gibbons, Trisha O'Moore-Sullivan
BACKGROUND: Routine psychosocial screening and management of people with diabetes is recommended. AIMS: To profile demographic, medical and psychosocial characteristics of young people with diabetes, and to develop a screening tool and care pathway for routine use. METHODS: Indices of diabetes control and recorded diabetes complications were complimented by psychosocial screening tools assessing psychological, diabetes specific, and perceived stress (K10, PAID, PSS), well-being (WHO-5), disordered eating ((EDI-3RC), compensatory behaviour questionnaire, social support (MSPSS), resilience (CD-2) and financial concerns...
January 20, 2017: Internal Medicine Journal
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