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AIMS/HYPOTHESIS: The aim of this work was to examine the impact of hypoglycaemia on daily functioning among adults with type 1 diabetes or insulin-treated type 2 diabetes, using the novel Hypo-METRICS app. METHODS: For 70 consecutive days, 594 adults (type 1 diabetes, n=274; type 2 diabetes, n=320) completed brief morning and evening Hypo-METRICS 'check-ins' about their experienced hypoglycaemia and daily functioning. Participants wore a blinded glucose sensor (i.e. data unavailable to the participants) for the study duration. Days and nights with or without person-reported hypoglycaemia (PRH) and/or sensor-detected hypoglycaemia (SDH) were compared using multilevel regression models. RESULTS: Participants submitted a mean ± SD of 86.3±12.5% morning and 90.8±10.7% evening check-ins. For both types of diabetes, SDH alone had no significant associations with the changes in daily functioning scores. However, daytime and night-time PRH (with or without SDH) were significantly associated with worsening of energy levels, mood, cognitive functioning, negative affect and fear of hypoglycaemia later that day or while asleep. In addition, night-time PRH (with or without SDH) was significantly associated with worsening of sleep quality (type 1 and type 2 diabetes) and memory (type 2 diabetes). Further, daytime PRH (with or without SDH), was associated with worsening of fear of hyperglycaemia while asleep (type 1 diabetes), memory (type 1 and type 2 diabetes) and social functioning (type 2 diabetes). CONCLUSIONS/INTERPRETATION: This prospective, real-world study reveals impact on several domains of daily functioning following PRH but not following SDH alone. These data suggest that the observed negative impact is mainly driven by subjective awareness of hypoglycaemia (i.e. PRH), through either symptoms or sensor alerts/readings and/or the need to take action to prevent or treat episodes.
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OBJECTIVE: The aim of this analysis was to assess glycemic control before and during the coronavirus disease (COVID-19) pandemic. METHODS: Data from 64 (main analysis) and 80 (sensitivity analysis) people with type 1 diabetes (T1D) using intermittently scanned continuous glucose monitoring (isCGM) were investigated retrospectively. The baseline characteristics were collected from electronic medical records. The data were examined over three periods of three months each: from 16th of March 2019 until 16th of June 2019 (pre-pandemic), from 1st of December 2019 until 29th of February 2020 (pre-lockdown) and from 16th of March 2020 until 16th of June 2020 (lockdown 2020), representing the very beginning of the COVID-19 pandemic and the first Austrian-wide lockdown. RESULTS: For the main analysis, 64 individuals with T1D (22 female, 42 male), who had a mean glycated hemoglobin (HbA1c) of 58.5 mmol/mol (51.0 to 69.3 mmol/mol) and a mean diabetes duration 13.5 years (5.5 to 22.0 years) were included in the analysis. The time in range (TIR[70-180mg/dL]) was the highest percentage of measures within all three studied phases, but the lockdown 2020 phase delivered the best data in all these cases. Concerning the time below range (TBR[<70mg/dL]) and the time above range (TAR[>180mg/dL]), the lockdown 2020 phase also had the best values. Regarding the sensitivity analysis, 80 individuals with T1D (26 female, 54 male), who had a mean HbA1c of 57.5 mmol/mol (51.0 to 69.3 mmol/mol) and a mean diabetes duration of 12.5 years (5.5 to 20.7 years), were included. The TIR[70-180mg/dL] was also the highest percentage of measures within all three studied phases, with the lockdown 2020 phase also delivering the best data in all these cases. The TBR[<70mg/dL] and the TAR[>180mg/dL] underscored the data in the main analysis. CONCLUSION: Superior glycemic control, based on all parameters analyzed, was achieved during the first Austrian-wide lockdown compared to prior periods, which might be a result of reduced daily exertion or more time spent focusing on glycemic management.
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COVID-19 , Monitoreo Continuo de Glucosa , Diabetes Mellitus Tipo 1 , Control Glucémico , Monitoreo Continuo de Glucosa/métodos , Humanos , Masculino , Femenino , Adulto Joven , Adulto , Persona de Mediana Edad , Anciano , Diabetes Mellitus Tipo 1/sangre , Diabetes Mellitus Tipo 1/diagnóstico , Diabetes Mellitus Tipo 1/epidemiología , COVID-19/epidemiología , Austria/epidemiología , Glucemia/análisis , Automonitorización de la Glucosa Sanguínea/métodos , Estudios RetrospectivosRESUMEN
BACKGROUND: Incisional hernia remains a frequent problem after midline laparotomy. This study compared a short stitch to standard loop closure using an ultra-long-term absorbent elastic suture material. METHODS: A prospective, multicentre, parallel-group, double-blind, randomized, controlled superiority trial was designed for the elective setting. Adult patients were randomly assigned by computer-generated sequence to fascial closure using a short stitch (5 to 8â mm every 5â mm, USP 2-0, single thread HR 26â mm needle) or long stitch technique (10â mm every 10â mm, USP 1, double loop, HR 48â mm needle) with a poly-4-hydroxybutyrate-based suture material (Monomax®). Incisional hernia assessed by ultrasound 1 year after surgery was the primary outcome. RESULTS: The trial randomized 425 patients to short (n = 215) or long stitch technique (n = 210) of whom 414 (97.4 per cent) completed 1 year of follow-up. In the short stitch group, the fascia was closed with more stitches (46 (12 s.d.) versus 25 (7 s.d.); P < 0.001) and higher suture-to-wound length ratio (5.3 (2.2 s.d.) versus 4.0 (1.3 s.d.); P < 0.001). At 1 year, seven of 210 (3.3 per cent) patients in the short and 13 of 204 (6.4 per cent) patients in the long stitch group developed incisional hernia (odds ratio 1.97, 95 per cent confidence interval 0.77 to 5.05; P = 0.173). CONCLUSION: The 1-year incisional hernia development was relatively low with clinical but not statistical difference between short and long stitches. Registration number: NCT01965249 (http://www.clinicaltrials.gov).
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Técnicas de Cierre de Herida Abdominal , Hernia Incisional , Adulto , Humanos , Hernia Incisional/cirugía , Laparotomía/métodos , Estudios Prospectivos , Técnicas de Sutura , SuturasRESUMEN
OBJECTIVE: To determine the effects of exergaming (EXE) on quality of life (QOL), motor, and clinical symptoms in multiple sclerosis (MS). We compared the effects of EXE, balance (BAL), cycling (CYC), proprioceptive neuromuscular facilitation (PNF), and a standard care wait-listed control group on clinical and motor symptoms and quality of life (QOL) in people with MS (PwMS) and determined the effects of subsequent maintenance programs for 2 years in a hospital setting. DESIGN: A randomized controlled trial, using before-after test design. SETTING: University hospital setting. PARTICIPANTS: Of 82 outpatients with MS, 70 were randomized (N=70), and 68 completed the study. INTERVENTIONS: The initial high-intensity and high-frequency interventions consisted of 25 one-hour sessions over 5 weeks. After the 5-week-long initial intervention, the 2-year-long maintenance programs followed, consisting of 3 sessions per week, each for 1 hour. MAIN OUTCOME MEASURES: The primary outcome: Multiple Sclerosis Impact Scale (MSIS-29). SECONDARY OUTCOMES: Measures 5 aspects of health-related QOL (EuroQol 5-Dimension questionnaire), Beck Depression Inventory, 6-minute walk test (6MWT), Berg Balance Scale (BBS), Tinetti Assessment Tool (TAT), and static BAL (center of pressure). RESULTS: MSIS-29 improved most in EXE (11 points), BAL (6), and CYC (6) (all P<.05). QOL improved most in EXE (3 points), CYC, and BAL (2) (all P<.05). TAT and BBS improved significantly (P<.05) but similarly (P>.05) in EXE, BAL, and CYC. 6MWT improved most in EXE (57m), BAL (32m), and CYC (19m) (all P<.001). Standing sway did not change. Maintenance programs further increased the initial exercise-induced gains, robustly in EXE. CONCLUSIONS: A total of 25 sessions of EXE, BAL, CYC, and PNF, in this order, improved clinical and motor symptoms and QOL, and subsequent 2-year-long thrice weekly maintenance programs further slowed symptom worsening and improved QOL. EXE was the most and PNF was the least effective to improve clinical symptoms, motor function, and QOL in PwMS.
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Esclerosis Múltiple , Ejercicios de Estiramiento Muscular , Terapia por Ejercicio/métodos , Humanos , Equilibrio Postural , Calidad de Vida , Encuestas y CuestionariosRESUMEN
AIM: To evaluate the efficacy and safety of basal-bolus insulin therapy in managing glycaemia during fasting periods in hospitalized patients with type 2 diabetes. MATERIALS AND METHODS: We performed a post hoc analysis of two prospective, uncontrolled interventional trials that applied electronic decision support system-guided basal-bolus (meal-related and correction) insulin therapy. We searched for fasting periods (invasive or diagnostic procedures, medical condition) during inpatient stays. In a mixed model analysis, patients' glucose levels and insulin doses on days with regular food intake were compared with days with fasting periods. RESULTS: Out of 249 patients, 115 patients (33.9% female, age 68.3 ± 10.3 years, diabetes duration 15.1 ± 10.9 years, body mass index 30.1 ± 5.4 kg/m2 , HbA1c 69 ± 20 mmol/mol) had 194 days with fasting periods. Mean daily blood glucose (BG) was lower (modelled difference [ModDiff]: -0.5 ± 0.2 mmol/L, P = .006), and the proportion of glucose values within the target range (3.9-10.0 mmol/L) increased on days with fasting periods compared with days with regular food intake (ModDiff: +0.06 ± 0.02, P = .005). Glycaemic control on fasting days was driven by a reduction in daily bolus insulin doses (ModDiff: -11.0 ± 0.9 IU, P < .001), while basal insulin was similar (ModDiff: -1.1 ± 0.6 IU, P = .082) compared with non-fasting days. Regarding hypoglycaemic events (BG < 3.9 mmol/L), there was no difference between fasting and non-fasting days (χ2 0.9% vs. 1.7%, P = .174). CONCLUSIONS: When using well-titrated basal-bolus insulin therapy in hospitalized patients with type 2 diabetes, the basal insulin dose does not require adjustment during fasting periods to achieve safe glycaemic control, provided meal-related bolus insulin is omitted and correction bolus insulin is tailored to glucose levels.
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Diabetes Mellitus Tipo 2 , Anciano , Glucemia , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Ayuno , Femenino , Hemoglobina Glucada/análisis , Control Glucémico , Humanos , Hipoglucemiantes , Insulina , Masculino , Persona de Mediana Edad , Estudios ProspectivosRESUMEN
BACKGROUND: Physical inactivity is a global phenomenon in European welfare countries. Proper monitoring is essential to measure the physical activity level of the population. METHODS: In the Hungarian cohort of the European Physical Activity and Sport Monitoring System (EUPASMOS) project, our participants (N = 598) completed sociodemographic questions and the International Physical Activity Questionnaire - short form (IPAQ-SF) survey. The validity and reliability of the subjective measurement tool were examined, IPAQ-SF outcomes were contrasted against triaxial RM42 accelerometer wore for 7 consecutive days. RESULTS: The IPAQ-SF showed moderate internal consistency (Cronbach Alpha = 0.647). The concurrent validity of the IPAQ-SF to triaxial accelerometer indicated a significant weak-to-moderate correlation (R = 0.111-0.338, p = 0.042; p < 0.001). The test-retest reliability showed a significant correlation between two measurements (R = 0.788-0.981, p < 0.001). CONCLUSION: The Hungarian version of the IPAQ-SF had excellent test-retest reliability, but low-to-fair concurrent validity for moderate and vigorous physical activity, walking and sitting time, as compared to the objective criterion measure among Hungarian adults.
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Acelerometría , Ejercicio Físico , Adulto , Europa (Continente) , Humanos , Hungría , Reproducibilidad de los Resultados , Encuestas y CuestionariosRESUMEN
BACKGROUND: Chronic non-specific low back pain syndrome (cnsLBP) is a severe health problem in developed countries, which has an important effect on patients' quality of life and is highly determined by socio-demographic factors and low back pain specific knowledge. We examined patients' health-related quality of life according to the results of the Short Form Health Survey (SF-36), low back pain knowledge (LBPKQ) and the social determinants of the participants. METHODS: We carried out our research in the first half of 2015 in Southern Transdanubia, Hungary. The examination included 1155 respondents living with chronic non-specific low back pain. The confidence interval of 95% was used, and the level of. significance was p < 0.05 using SPSS 22.0 software. RESULTS: The SF-36 questionnaire is suitable for the examination of patients' health-related quality of life (Cronbach's Alpha> 0.76), as the LBPKQ's Cronbach's Alpha was 0.726 also, which showed good validity. Longer-term disease meant a lower health-related quality of life (p < 0.05). A greater decrease of function (Roland Morris scores (RM)) accounts for a lower HRQoL and higher knowledge level. We found significant differences in LBPKQ scores according to sociodemographic parameters. The general health status was positively correlated with LBPKQ (p = 0.024) adjusted for demographic and pain and functional status. CONCLUSION: The negative effect of the symptoms on patients' quality of life is proved, which is determined by different socio-demographic parameters furthermore by knowledge. Above all could be useful information for professionals to adopt the right interventions.
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Dolor Crónico , Dolor de la Región Lumbar , Dolor Crónico/epidemiología , Evaluación de la Discapacidad , Encuestas Epidemiológicas , Humanos , Hungría , Calidad de Vida , Encuestas y CuestionariosRESUMEN
BACKGROUND: This clinical trial evaluated the performance of a newly released fast-absorbable braided synthetic suture (Novosyn® Quick) in adults and paediatric patients undergoing elective skin closures. METHODS: This was a prospective international multicentre observational study. Two centres enrolled 100 patients, of which 50 were adults (visceral surgery, France) and 50 were paediatric patients (paediatric surgery, Germany). Surgeons used a 5-point Likert scale to assess handling characteristics of the suture. Patients and professionals used the Patient-Observer-Scar-Assessment-Scale (POSAS) to rate scar quality. Adverse events were monitored until 3 months postoperatively. RESULTS: Handling characteristics of Novosyn® Quick were in median rated very good by both general surgeons and paediatric surgeons. Patient components of POSAS (six questions; ten-level Likert scale; best possible score six) scored in median (range) 8.5 (6-28) in the paediatric group versus 12 (6-38) in the adult group, P = 0.01. Patients` overall opinions of POSAS were similar in both groups [mean (SD), 1.86 (0.99) in the paediatric group versus 2.08 (1.35) in the adult group, P = 0.3536]. Observer component of POSAS (six parameters; ten-level numeric rating scale, best possible score six) scored comparably in both groups [median (range), 8 (6-29) in the paediatric group versus 10 (6-28) in the adult group, P = 0.1403]. Observers overall opinion of POSAS favoured the paediatric patients group [mean (SD), 1.48 (0.61) versus 1.92 (1.06) in the adult group, P = 0.0131]. Adverse events in relation to wound healing were not observed in both patient groups. CONCLUSIONS: Our findings indicate, that Novosyn® Quick is safe and reliable for skin closure in adults and paediatric patients and can be regarded as a viable alternative to Vicryl® Rapide. TRIAL REGISTRATION: This trial was registered prospectively with ClinicalTrials.gov under the registration number NCT02680886 on 5 February 2016. The trial was approved by the Institutional Review Boards of both study locations (France: CCTIRS N° 16-103 and CNIL:MMS/CWR/AR163920; Germany: 398/15).
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Materiales Biocompatibles , Copolímero de Ácido Poliláctico-Ácido Poliglicólico , Técnicas de Sutura , Suturas , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Niño , Preescolar , Cicatriz/prevención & control , Femenino , Alemania , Humanos , Lactante , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Técnicas de Sutura/efectos adversos , Técnicas de Sutura/instrumentación , Suturas/efectos adversos , Cicatrización de HeridasRESUMEN
Continuous and flash glucose monitoring (GM) systems have been established in diabetes care. We compared the sensor performance of 3 commercially available GM systems. A total of 12 patients with type 1 diabetes were included in a single-centre, open-label study in which the sensor performance of the Abbott FreeStyle libre (Abbott), Dexcom G4 Platinum (Dexcom) and Medtronic MiniMed 640G (Medtronic) systems over 12 hours was compared during mimicked real-life conditions (meals, exercise, hypo- and hyperglycaemia). Sensor performance was determined by fulfilment of ISO 15197:2013 criteria, calculating mean absolute relative difference (MARD), and was also illustrated using Parkes error grid and Bland-Altman plots. Sensor performance during changes in metabolic variables (lactate, betahydroxybutyrate, glucagon, non-esterified-fatty-acids) was determined by Spearman's rank correlation coefficient testing. The systems fulfilled ISO 15197:2013 criteria by 73.2% (Abbott), 56.1% (Dexcom) and 52.0% (Medtronic). The MARDs ± standard deviation in the entire glycaemic range were 13.2% ± 10.9% (Abbott), 16.8% ± 12.3% (Dexcom) and 21.4% ± 17.6% (Medtronic), respectively. All sensors performed less accurately during hypoglycaemia and best during hyperglycaemia. We did not observe an influence of metabolic variables on sensor performance.
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Actividades Cotidianas , Diabetes Mellitus Tipo 1/metabolismo , Glucosa/metabolismo , Hiperglucemia/diagnóstico , Hipoglucemia/diagnóstico , Monitoreo Ambulatorio/instrumentación , Tejido Subcutáneo/metabolismo , Adulto , Austria , Diabetes Mellitus Tipo 1/sangre , Diabetes Mellitus Tipo 1/tratamiento farmacológico , Ejercicio Físico , Hemoglobina Glucada/análisis , Humanos , Hiperglucemia/metabolismo , Hipoglucemia/inducido químicamente , Hipoglucemia/metabolismo , Hipoglucemiantes/administración & dosificación , Hipoglucemiantes/efectos adversos , Hipoglucemiantes/uso terapéutico , Inyecciones Subcutáneas , Insulina/administración & dosificación , Insulina/efectos adversos , Insulina/uso terapéutico , Sistemas de Infusión de Insulina/efectos adversos , Ensayo de Materiales , Comidas , Persona de Mediana Edad , Monitoreo Ambulatorio/normas , Adulto JovenRESUMEN
BACKGROUND: Automated insulin delivery (AID) systems have shown to improve glycemic control in a range of populations and settings. At the start of this study, only one commercial AID system had entered the Austrian market (MiniMed 670G, Medtronic). However, there is an ever-growing community of people living with type 1 diabetes (PWT1D) using open-source (OS) AID systems. MATERIALS AND METHODS: A total of 144 PWT1D who used either the MiniMed 670G (670G) or OS-AID systems routinely for a period of at least three to a maximum of six months, between February 18, 2020 and January 15, 2023, were retrospectively analyzed (116 670G aged from 2.6 to 71.8 years and 28 OS-AID aged from 3.4 to 53.5 years). The goal is to evaluate and compare the quality of glycemic control of commercially available AID and OS-AID systems and to present all data by an in-depth descriptive analysis of the population. No statistical tests were performed. RESULTS: The PWT1D using OS-AID systems spent more time in range (TIR)70-180 mg/dL (81.7% vs 73.9%), less time above range (TAR)181-250 mg/dL (11.1% vs 19.6%), less TAR>250 mg/dL (2.5% vs 4.3%), and more time below range (TBR)54-69 mg/dL (2.2% vs 1.7%) than PWT1D using the 670G system. The TBR<54 mg/dL was comparable in both groups (0.3% vs 0.4%). In the OS-AID group, median glucose level and glycated hemoglobin (HbA1c) were lower than in the 670G system group (130 vs 150 mg/dL; 6.2% vs 7.0%). CONCLUSION: In conclusion, both groups were able to achieve satisfactory glycemic outcomes independent of age, gender, and diabetes duration. However, the PWT1D using OS-AID systems attained an even better glycemic control with no clinical safety concerns.
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Introduction: Nocturnal hypoglycemia is generally calculated between 00:00 and 06:00. However, those hours may not accurately reflect sleeping patterns and it is unknown whether this leads to bias. We therefore compared hypoglycemia rates while asleep with those of clock-based nocturnal hypoglycemia in adults with type 1 diabetes (T1D) or insulin-treated type 2 diabetes (T2D). Methods: Participants from the Hypo-METRICS study wore a blinded continuous glucose monitor and a Fitbit Charge 4 activity monitor for 10 weeks. They recorded details of episodes of hypoglycemia using a smartphone app. Sensor-detected hypoglycemia (SDH) and person-reported hypoglycemia (PRH) were categorized as nocturnal (00:00-06:00 h) versus diurnal and while asleep versus awake defined by Fitbit sleeping intervals. Paired-sample Wilcoxon tests were used to examine the differences in hypoglycemia rates. Results: A total of 574 participants [47% T1D, 45% women, 89% white, median (interquartile range) age 56 (45-66) years, and hemoglobin A1c 7.3% (6.8-8.0)] were included. Median sleep duration was 6.1 h (5.2-6.8), bedtime and waking time â¼23:30 and 07:30, respectively. There were higher median weekly rates of SDH and PRH while asleep than clock-based nocturnal SDH and PRH among people with T1D, especially for SDH <70 mg/dL (1.7 vs. 1.4, P < 0.001). Higher weekly rates of SDH while asleep than nocturnal SDH were found among people with T2D, especially for SDH <70 mg/dL (0.8 vs. 0.7, P < 0.001). Conclusion: Using 00:00 to 06:00 as a proxy for sleeping hours may underestimate hypoglycemia while asleep. Future hypoglycemia research should consider the use of sleep trackers to record sleep and reflect hypoglycemia while asleep more accurately. The trial registration number is NCT04304963.
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Automonitorización de la Glucosa Sanguínea , Glucemia , Diabetes Mellitus Tipo 1 , Diabetes Mellitus Tipo 2 , Hipoglucemia , Sueño , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Glucemia/análisis , Ritmo Circadiano/fisiología , Diabetes Mellitus Tipo 1/sangre , Diabetes Mellitus Tipo 1/complicaciones , Diabetes Mellitus Tipo 2/complicaciones , Diabetes Mellitus Tipo 2/sangre , Hipoglucemia/sangre , Hipoglucemiantes/uso terapéutico , Insulina/administración & dosificación , Insulina/uso terapéutico , Sueño/fisiologíaRESUMEN
Introduction: This study examined associations between hypoglycemia awareness status and hypoglycemia symptoms reported in real-time using the novel Hypoglycaemia-MEasurement, ThResholds and ImpaCtS (Hypo-METRICS) smartphone application (app) among adults with insulin-treated type 1 (T1D) or type 2 diabetes (T2D). Methods: Adults who experienced at least one hypoglycemic episode in the previous 3 months were recruited to the Hypo-METRICS study. They prospectively reported hypoglycemia episodes using the app for 10 weeks. Any of eight hypoglycemia symptoms were considered present if intensity was rated between "A little bit" to "Very much" and absent if rated "Not at all." Associations between hypoglycemia awareness (as defined by Gold score) and hypoglycemia symptoms were modeled using mixed-effects binary logistic regression, adjusting for glucose monitoring method and diabetes duration. Results: Of 531 participants (48% T1D, 52% T2D), 45% were women, 91% white, and 59% used Flash or continuous glucose monitoring. Impaired awareness of hypoglycemia (IAH) was associated with lower odds of reporting autonomic symptoms than normal awareness of hypoglycemia (NAH) (T1D odds ratio [OR] 0.43 [95% confidence interval {CI} 0.25-0.73], P = 0.002); T2D OR 0.51 [95% CI 0.26-0.99], P = 0.048), with no differences in neuroglycopenic symptoms. In T1D, relative to NAH, IAH was associated with higher odds of reporting autonomic symptoms at a glucose concentration <54 than >70 mg/dL (OR 2.18 [95% CI 1.21-3.94], P = 0.010). Conclusion: The Hypo-METRICS app is sensitive to differences in hypoglycemia symptoms according to hypoglycemia awareness in both diabetes types. Given its high ecological validity and low recall bias, the app may be a useful tool in research and clinical settings. The clinical trial registration number is NCT04304963.
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Automonitorización de la Glucosa Sanguínea , Diabetes Mellitus Tipo 1 , Diabetes Mellitus Tipo 2 , Hipoglucemia , Hipoglucemiantes , Insulina , Aplicaciones Móviles , Teléfono Inteligente , Humanos , Hipoglucemia/inducido químicamente , Femenino , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Diabetes Mellitus Tipo 2/complicaciones , Diabetes Mellitus Tipo 2/sangre , Masculino , Persona de Mediana Edad , Diabetes Mellitus Tipo 1/tratamiento farmacológico , Diabetes Mellitus Tipo 1/complicaciones , Diabetes Mellitus Tipo 1/sangre , Insulina/uso terapéutico , Insulina/administración & dosificación , Insulina/efectos adversos , Hipoglucemiantes/uso terapéutico , Hipoglucemiantes/efectos adversos , Adulto , Concienciación , Glucemia/análisis , Anciano , Estudios ProspectivosRESUMEN
Expression of the glycosylphosphatidylinositol-anchored membrane protein CD24 correlates with a poor prognosis for many human cancers, and in experimental tumors can promote metastasis. However, the mechanism by which CD24 contributes to tumor progression remains unclear. Here we report that in MTLy breast cancer cells CD24 interacts with and augments the kinase activity of c-src, a protein strongly implicated in promoting invasion and metastasis. This occurs within and is dependent upon intact lipid rafts. CD24-augmented c-src kinase activity increased formation of focal adhesion complexes, accelerated phosphorylation of FAK and paxillin and consequently enhanced integrin-mediated adhesion. Loss and gain of function approaches showed that c-src activity is necessary and sufficient to mediate the effects of CD24 on integrin-dependent adhesion and cell spreading, as well as on invasion. Together these results indicate that c-src is a CD24-activated mediator that promotes integrin-mediated adhesion and invasion, and suggest a mechanism by which CD24 might contribute to tumor progression through stimulating the activity of c-src or another member of the Src family.
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Neoplasias de la Mama/enzimología , Neoplasias de la Mama/patología , Antígeno CD24/metabolismo , Integrinas/metabolismo , Microdominios de Membrana/enzimología , Microdominios de Membrana/metabolismo , Proteínas Tirosina Quinasas/metabolismo , Antibacterianos/farmacología , Neoplasias de la Mama/metabolismo , Proteína Tirosina Quinasa CSK , Adhesión Celular , Línea Celular Tumoral , Movimiento Celular , Doxiciclina/farmacología , Femenino , Fibronectinas/metabolismo , Quinasa 1 de Adhesión Focal/metabolismo , Humanos , Paxillin/metabolismo , Fosforilación , Unión Proteica , Proteínas Tirosina Quinasas/antagonistas & inhibidores , Pirimidinas/farmacología , Familia-src QuinasasRESUMEN
The most common age-related heart valve diseases include aortic valve stenosis and mitral valve insufficiency. The suture material is not the focus of most studies. The aim of the study was to assess the performance of PremiCron suture material for cardiac valve reconstruction and/or replacement under clinical routine. Performance was evaluated using the incidence of major adverse cardiac and cerebrovascular events (MACCE) combined with endocarditis. Materials and methods: The study was designed as an international, prospective, bicentric, observational, single-arm study to evaluate the PremiCron suture material in cardiac valve surgery and compare the outcome with literature data regarding postoperative complications. The primary endpoint was a composite of MACCE acquired in the hospital, combined with endocarditis occurring up to 6 months postoperatively. The secondary parameters were intraoperative handling of the suture, incidence of MACCE and other relevant complications and quality of life up to 6 months after surgery. Patients were examined at discharge, 30 days, and 6 months postoperatively. Results: A total of 198 patients were enrolled in two centers in Europe. The cumulative primary endpoint event rate was 5.0%, lower than the reference value of 8.2% from the literature. Comparison of the incidence of individual MACCE until discharge and endocarditis rate 6 months postoperatively also showed that our data were within the range of the published rates. Quality of life significantly increased from preoperatively to 6 months after surgery. Ease of handling of the suture material was rated as very good. Conclusion: The PremiCron suture material is safe and very eligible for cardiac valve replacement and/or cardiac valve reconstruction in a broad patient population with a cardiac valve disorder treated under daily clinical practice.
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INTRODUCTION: The aim of this study was to determine the acceptability and psychometric properties of the Hypo-METRICS (Hypoglycemia MEasurement, ThResholds and ImpaCtS) application (app): a novel tool designed to assess the direct impact of symptomatic and asymptomatic hypoglycemia on daily functioning in people with insulin-treated diabetes. MATERIALS AND METHODS: 100 adults with type 1 diabetes mellitus (T1DM, n = 64) or insulin-treated type 2 diabetes mellitus (T2DM, n = 36) completed three daily 'check-ins' (morning, afternoon and evening) via the Hypo-METRICs app across 10 weeks, to respond to 29 unique questions about their subjective daily functioning. Questions addressed sleep quality, energy level, mood, affect, cognitive functioning, fear of hypoglycemia and hyperglycemia, social functioning, and work/productivity. Completion rates, structural validity, internal consistency, and test-retest reliability were explored. App responses were correlated with validated person-reported outcome measures to investigate convergent (rs>±0.3) and divergent (rs<±0.3) validity. RESULTS: Participants' mean±SD age was 54±16 years, diabetes duration was 23±13 years, and most recent HbA1c was 56.6±9.8 mmol/mol. Participants submitted mean±SD 191±16 out of 210 possible 'check-ins' (91%). Structural validity was confirmed with multi-level confirmatory factor analysis showing good model fit on the adjusted model (Comparative Fit Index >0.95, Root-Mean-Square Error of Approximation <0.06, Standardized Root-Mean-square Residual<0.08). Scales had satisfactory internal consistency (all ω≥0.5), and high test-retest reliability (rs≥0.7). Convergent and divergent validity were demonstrated for most scales. CONCLUSION: High completion rates and satisfactory psychometric properties demonstrated that the Hypo-METRICS app is acceptable to adults with T1DM and T2DM, and a reliable and valid tool to explore the daily impact of hypoglycemia.
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Diabetes Mellitus Tipo 1 , Diabetes Mellitus Tipo 2 , Hipoglucemia , Aplicaciones Móviles , Adulto , Humanos , Persona de Mediana Edad , Anciano , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Diabetes Mellitus Tipo 2/psicología , Diabetes Mellitus Tipo 1/tratamiento farmacológico , Diabetes Mellitus Tipo 1/psicología , Psicometría , Reproducibilidad de los Resultados , Benchmarking , Teléfono Inteligente , Hipoglucemia/psicología , Insulina , Encuestas y CuestionariosRESUMEN
PURPOSE: Different suture techniques and various suture materials are in use to close midline incisions after primary laparotomy. The ISSAAC study aimed to assess the safety and efficacy of the new ultra-long-term absorbable, elastic monofilament suture material MonoMax® for abdominal wall closure. METHODS: This is a single-arm, multicentre prospective study that included 150 patients undergoing a primary elective midline incision. The control group consists of 141 patients from the INSECT study who received MonoPlus® or PDS® for abdominal wall closure. The incidences of burst abdomen and wound infection until the day of discharge were defined as the primary composite endpoints. The rate of incisional hernias 1 year after surgery, the length of postoperative hospital stay and safety parameters served as secondary endpoints. The study has been registered under www.clinicaltrials.gov [NCT005725079]. RESULTS: Eleven patients in the ISSAAC study [7.3%; 95% CI = (3.9; 13.1%)] experienced wound infection or burst abdomen until the day of discharge as compared to 16 [11.3%; 95% CI = (6.6; 17.8%)] patients in the INSECT control group (p = 0.31). The length of postoperative hospital stay was comparable in both study groups. One year after surgery, incisional hernias were observed in 21 ISSAAC patients (14.0%) in contrast to 30 hernias (21.3%) in the INSECT control group. CONCLUSIONS: The ultra-long-term absorbable, elastic monofilament suture material MonoMax® is safe and efficient for abdominal wall closure.
Asunto(s)
Técnicas de Cierre de Herida Abdominal/instrumentación , Suturas , Anciano , Diseño de Equipo , Femenino , Hernia Abdominal/cirugía , Humanos , Análisis de Intención de Tratar , Laparotomía , Tiempo de Internación , Modelos Logísticos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Reoperación/estadística & datos numéricos , Infección de la Herida Quirúrgica/epidemiologíaRESUMEN
BACKGROUND: Anastomotic leakage (AL) after oesophagectomy and oesophageal perforations are associated with significant morbidity and mortality. Minimally invasive endoscopy is often used as first-line treatment, particularly endoluminal vacuum therapy (EVT). The aim was to assess the performance of the first commercially available endoluminal vacuum device (Eso-Sponge®) in the management of AL and perforation of the upper gastrointestinal tract (GIT). METHODS: The Eso-Sponge® registry was designed in 2014 as a prospective, observational, national, multicentre registry. Patients were recruited with either AL or perforation within the upper GIT. Data were collected with a standardized form and transferred into a web-based platform. Twenty hospitals were enrolled at the beginning of the study (registration number NCT02662777; http://www.clinicaltrials.gov). The primary endpoint was successful closure of the oesophageal defect. RESULTS: Eleven out of 20 centres recruited patients. A total of 102 patients were included in this interim analysis; 69 patients with AL and 33 with a perforation were treated by EVT. In the AL group, a closure of 91 per cent was observed and 76 per cent was observed in the perforation group. The occurrence of mediastinitis (P = 0.002) and the location of the defect (P = 0.008) were identified as significant predictors of defect closure. CONCLUSIONS: The Eso-Sponge® registry offers the opportunity to collate data on EVT with a uniform, commercially available product to improve standardization. Our data show that EVT with the Eso-Sponge® is an option for the management of AL and perforation within the upper GIT.
Asunto(s)
Fuga Anastomótica , Terapia de Presión Negativa para Heridas , Fuga Anastomótica/etiología , Fuga Anastomótica/cirugía , Endoscopía Gastrointestinal , Esofagectomía/efectos adversos , Humanos , Terapia de Presión Negativa para Heridas/efectos adversos , Estudios Prospectivos , Sistema de RegistrosRESUMEN
BACKGROUND: Randomised controlled trials with a long term follow-up (3 to 10 years) have demonstrated that mesh repair is superior to suture closure of incisional hernia with lower recurrence rates (5 to 20% versus 20 to 63%). Yet, the ideal size and material of the mesh are not defined. So far, there are few prospective studies that evaluate the influence of the mesh texture on patient's satisfaction, recurrence and complication rate. The aim of this study is to evaluate, if a non-absorbable mesh (Optilene Mesh Elastic) will result in better health outcomes compared to a partly absorbable mesh (Ultrapro Mesh). METHODS/DESIGN: In this prospective, randomised, double blind study, eighty patients with incisional hernia after a midline laparotomy will be included. Primary objective of this study is to investigate differences in the physical functioning score from the SF-36 questionnaire 21 days after mesh insertion. Secondary objectives include the evaluation of the patients' daily activity, pain, wound complication and other surgical complications (hematomas, seromas), and safety within six months after intervention. DISCUSSION: This study investigates mainly from the patient perspective differences between meshes for treatment of incisional hernias. Whether partly absorbable meshes improve quality of life better than non-absorbable meshes is unclear and therefore, this trial will generate further evidence for a better treatment of patients. TRIAL REGISTRATION: NCT00646334.
Asunto(s)
Implantes Absorbibles , Materiales Biocompatibles/uso terapéutico , Hernia Ventral/cirugía , Mallas Quirúrgicas , Adulto , Protocolos Clínicos , Dioxanos , Método Doble Ciego , Femenino , Humanos , Masculino , Satisfacción del Paciente , Proyectos Piloto , Poliésteres , Polipropilenos , Estudios Prospectivos , Resultado del TratamientoRESUMEN
BACKGROUND: Postoperative adhesions occur when fibrous strands of internal scar tissue bind anatomical structures to one another. The most common cause of intra-abdominal adhesions is previous intra-abdominal surgical intervention. Up to 74% of intestinal obstructions are caused by post surgical adhesions. Although a variety of methods and agents have been investigated to prevent post surgical adhesions, the problem of peritoneal adhesions remains largely unsolved. Materials serving as an adhesion barrier are much needed. METHODS/DESIGN: This is a prospective, randomised, controlled, patient blinded and observer blinded, single centre phase I-II trial, which evaluates the safety of A-Part Gel as an adhesion prophylaxis after major abdominal wall surgery, in comparison to an untreated control group. 60 patients undergoing an elective median laparotomy without prior abdominal surgery are randomly allocated into two groups of a 1:1- ratio. Safety parameter and primary endpoint of the study is the occurrence of wound healing impairment or peritonitis within 28 (+10) days after surgery. The frequency of anastomotic leakage within 28 days after operation, occurrence of adverse and serious adverse events during hospital stay up to 3 months and the rate of adhesions along the scar within 3 months are defined as secondary endpoints. After hospital discharge the investigator will examine the enrolled patients at 28 (+10) days and 3 months (+/-14 days) after surgery. DISCUSSION: This trial aims to assess, whether the intra-peritoneal application of A-Part Gel is safe and efficacious in the prevention of post-surgical adhesions after median laparotomy, in comparison to untreated controls.