225 research outputs found
Jean-Marie Gustave Le Clézio et Patrick Modiano dans le champ intellectuel européen
No full textCet article compare la situation des prix Nobels Le Clézio et Modiano dans le champ intellectuel européen, examinant d'abord le capital familial et social de départ, ensuite les sujets abordés dans les œuvres des deux écrivains, en tant qu’accélérateurs ou décélérateurs du cursus honorum, et enfin les stratégies promotionnelles et médiatiques de la réussite.This article compares the situation of two French Nobels, Le Clézio and Modiano, in the European literary field. The author deals first with the family and social capital, then with the topics treated in the books of both writers, as they slow or accelerate the path in the cursus honorum, finally with the promotional and media strategies needed to succeed
Comparing real-time and intermittently scanned continuous glucose monitoring in adults with type 1 diabetes:the six-month multicenter randomized controlled Alertt1 trial
No full textBackground People with type 1 diabetes can continuously monitor their glucose levels on demand (intermittently scanned continuous glucose monitoring [isCGM]), or in real time (real-time continuous glucose monitoring [rtCGM]). However, it is unclear whether switching from isCGM to rtCGM with alert functionality offers additional benefits. Therefore, we did a trial comparing rtCGM and isCGM in adults with type 1 diabetes (ALERTT1).Methods We did a prospective, double-arm, parallel-group, multicentre, randomised controlled trial in six hospitals in Belgium. Adults with type 1 diabetes who previously used isCGM were randomly assigned (1:1) to rtCGM (intervention) or isCGM (control). Randomisation was done centrally using minimisation dependent on study centre, age, gender, glycated haemoglobin (HbA(1c)), time in range (sensor glucose 3.9-10.0 mmol/L), insulin administration method, and hypoglycaemia awareness. Participants, investigators, and study teams were not masked to group allocation. Primary endpoint was mean between-group difference in time in range after 6 months assessed in the intention-to-treat sample. This trial is registered with ClinicalTrials.gov, NCT03772600.Findings Between Jan 29 and July 30, 2019, 269 participants were recruited, of whom 254 were randomly assigned to rtCGM (n=127) or isCGM (n=127); 124 and 122 participants completed the study, respectively. After 6 months, time in range was higher with rtCGM than with isCGM (59.6% vs 51.9%; mean difference 6.85 percentage points [95% CI 4.36-9.34]; p<0.0001). After 6 months HbA(1c) was lower (7.1% vs 7.4%; p<0.0001), as was time <3.0 mmol/L (0.47% vs 0.84%; p=0.0070), and Hypoglycaemia Fear Survey version II worry subscale score (15.4 vs 18.0; p=0.0071). Fewer participants on rtCGM experienced severe hypoglycaemia (n=3 vs n=13; p=0.0082). Skin reaction was more frequently observed with isCGM and bleeding after sensor insertion was more frequently reported by rtCGM users.Interpretation In an unselected adult type 1 diabetes population, switching from isCGM to rtCGM significantly improved time in range after 6 months of treatment, implying that clinicians should consider rtCGM instead of isCGM to improve the health and quality of life of people with type 1 diabetes. Copyright (C) 2021 Elsevier Ltd. All rights reserved
The conect4children (c4c) Consortium: Potential for Improving European Clinical Research into Medicines for Children
No full textThe need for information about new and existing drugs used in children was recognized in the European Union (EU) with the implementation of the Paediatric Regulation in 2007. In 2017, the 10-year review of the Paediatric Regulation identified barriers to the conduct of clinical trials, including delays in setting up and completing paediatric trials. Across Europe, the difficulties with clinical research are compounded by variation within countries and between countries. Ethics and regulatory review have national specificities. This paper describes the Collaborative Network for European Clinical Trials for Children (conect4children, c4c), which addresses selected difficulties in the design and conduct of paediatric clinical trials. c4c is a time-limited public–private consortium funded by the Innovative Medicines Initiative (IMI2). The elements of c4c are as follows: expert advice providing input on study design and/or paediatric development programmes (including patient involvement activities); a network of sites following harmonised procedures coordinated by National Hubs and a single point of contact for Europe; a facility for education and training for sites and trial teams; and support for managing data used by the network and a common paediatric data dictionary. c4c does not sponsor trials. c4c is taking a phased approach with careful piloting through industry and non-industry studies intended to demonstrate the viability of the network (proof-of-viability studies). c4c uses a co-design approach involving industry and academics within a clearly defined scope. A sustainable, successor organization open to all potential service users will be open for business before the end of IMI2 funding in 2024
Comparing real-time and intermittently scanned continuous glucose monitoring in adults with type 1 diabetes:the six-month multicenter randomized controlled Alertt1 trial
No full textBackground People with type 1 diabetes can continuously monitor their glucose levels on demand (intermittently scanned continuous glucose monitoring [isCGM]), or in real time (real-time continuous glucose monitoring [rtCGM]). However, it is unclear whether switching from isCGM to rtCGM with alert functionality offers additional benefits. Therefore, we did a trial comparing rtCGM and isCGM in adults with type 1 diabetes (ALERTT1).Methods We did a prospective, double-arm, parallel-group, multicentre, randomised controlled trial in six hospitals in Belgium. Adults with type 1 diabetes who previously used isCGM were randomly assigned (1:1) to rtCGM (intervention) or isCGM (control). Randomisation was done centrally using minimisation dependent on study centre, age, gender, glycated haemoglobin (HbA(1c)), time in range (sensor glucose 3.9-10.0 mmol/L), insulin administration method, and hypoglycaemia awareness. Participants, investigators, and study teams were not masked to group allocation. Primary endpoint was mean between-group difference in time in range after 6 months assessed in the intention-to-treat sample. This trial is registered with ClinicalTrials.gov, NCT03772600.Findings Between Jan 29 and July 30, 2019, 269 participants were recruited, of whom 254 were randomly assigned to rtCGM (n=127) or isCGM (n=127); 124 and 122 participants completed the study, respectively. After 6 months, time in range was higher with rtCGM than with isCGM (59.6% vs 51.9%; mean difference 6.85 percentage points [95% CI 4.36-9.34]; p<0.0001). After 6 months HbA(1c) was lower (7.1% vs 7.4%; p<0.0001), as was time <3.0 mmol/L (0.47% vs 0.84%; p=0.0070), and Hypoglycaemia Fear Survey version II worry subscale score (15.4 vs 18.0; p=0.0071). Fewer participants on rtCGM experienced severe hypoglycaemia (n=3 vs n=13; p=0.0082). Skin reaction was more frequently observed with isCGM and bleeding after sensor insertion was more frequently reported by rtCGM users.Interpretation In an unselected adult type 1 diabetes population, switching from isCGM to rtCGM significantly improved time in range after 6 months of treatment, implying that clinicians should consider rtCGM instead of isCGM to improve the health and quality of life of people with type 1 diabetes. Copyright (C) 2021 Elsevier Ltd. All rights reserved
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