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EU Clinical Trials Regulation (EU-CTR) enters application on 31 January 2022

On the 2nd of August 2021 EMA published the start of the countdown to go-live for the Clinical Trials Information System (CTIS) (1). The countdown comprises 6 months and will end on 31 January 2022. As the application of the Clinical Trials Regulation depended on the confirmation of functionality of the clinical trial EU portal and database (one of the key components of CTIS) this confirmation has been long awaited. After announcing the CTR on 16 June 2014 the expectation was that CTIS would be available in December 2015. However, due to technical difficulties the “portal’s go-live date” was delayed several times over the past years, but was now confirmed on 31 July 2021. 

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Topics: The Science behind Diabetes, Clinical Trials in Diabetes, Clinical Trial Methods

Posted by Dr. Grit Andersen on Aug 9, 2021 4:00:00 PM
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Can Remote Decentralised Clinical Trials enhance clinical research?

A Remote Decentralised Clinical Trial (RDCT) design can be a valuable option to make your clinical trial more efficient. Also called web-based or hybrid trials, they combine digital technologies with more “conventional” design elements to bring clinical research to patients’ homes [1]. RDCTs democratize the access to clinical trials by reaching population groups that would normally not have the possibility to enrol in a clinical trial. Web-based communication paths facilitate the participation of elderly, frail, disable people and people living in remote areas.

RDCTs may help achieving higher levels of sustainability, resilience and external validity in pivotal clinical research.

 

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Topics: The Science behind Diabetes, Treating Diabetes, Diabetes Technology

Posted by Prof. Dr. Freimut Schliess on Jun 2, 2021 5:00:00 PM
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Reporting of study results: a challenge?

Since 2007 there is a legal obligation to report results of registered clinical studies in a timely manner. Now more than 10 years later, how is compliance with this regulation? Problematic, according to a recent publication in the Deutsche Ärzteblatt (Richter-Kuhlmann, E., Deutsches Ärzteblatt | Jg. 117 | Heft 31–32 | 3. August 2020, A1492-A1497). Especially academic centers lag behind when it comes to the reporting of study results. The Cochrane foundation Germany published an analysis in The Lancet, stating that out of 4.200 clinical studies in the (US-based) study register ClinicalTrials.gov [1], for only around 40% results have been communicated.

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Topics: The Science behind Diabetes, Clinical Trials in Diabetes, Clinical Trial Methods

Posted by Dr. Grit Andersen on Apr 6, 2021 4:00:00 PM
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Think Tank highlights CROs role the adoption of AI-powered health innovation

In recent years there has been rapid growth in the field of medical and health technology. Not only the number of players in this sector has increased over time, but the type of products and services including those that integrate artificial intelligence (AI)-powered components has changed too. These novel health technologies face new challenges in terms of development, validation, implementation, usability and adoption. Innovators can face hurdles not only to obtain regulatory approval but also to achieve sustainable adoption to meet stakeholders’ expectations, as they often require substantial evidence of impact and value before deciding to invest on a novel product. This has implications for the route that companies including Contract Research Organizations (CROs) need to navigate to bring an innovative idea to market.

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Topics: The Science behind Diabetes, Treating Diabetes, Diabetes Technology

Posted by Prof. Dr. Freimut Schliess on Mar 31, 2020 5:12:00 PM
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Trustworthy AI in healthcare - it's TIME TO DELIVER

In Europe chronic diseases account for 86% of deaths and 77% of disease burden, thereby creating a tremendous challenge on societies. At the same time digitisation is bringing huge technological and cultural opportunities. In healthcare the usage of data-driven forecasts on individual and population health as by integration of artificial intelligence (AI)-enabled algorithms has the potential to revolutionise health protection and chronic care provision while securing the sustainability of healthcare systems.

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Topics: The Science behind Diabetes, Treating Diabetes, Diabetes Technology

Posted by Prof. Dr. Freimut Schliess on Jan 7, 2020 5:16:00 PM
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What news in the treatment of Type 2 diabetes was presented at EASD 2019?

The annual meeting of the European Association for the Study of Diabetes (EASD) took place this year in Barcelona, Spain. The present text offers a selection of topics relevant for the field of type 2 diabetes mellitus (T2DM) discussed during that meeting.

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Topics: The Science behind Diabetes, Treating Diabetes

Posted by Dr. Jorge Arrubla on Oct 17, 2019 5:30:00 PM
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Current developments in approaches to bridging studies

Waiving Bridging studies under certain circumstances for biosimilar applications?

A bridging study is a study performed in a new region to provide pharmacodynamic or clinical data on efficacy, safety, dosage and dose regimen that will allow extrapolation of foreign clinical data to the population in the new region [1]. However, in most cases bridging studies between an original product versus a so called foreign reference or a local reference product generate costs without providing any notable benefit for the specific patient, nor notable scientific output. 

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Topics: The Science behind Diabetes, Clinical Trials in Diabetes, Diabetes Technology

Posted by Dr. Grit Andersen on Sep 17, 2019 5:25:00 PM
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iPDM Goes Europe: tangible impact on diabetes patients and care

Treatment inertia calls for an integrated personalized diabetes management: iPDM

Diabetes represents a huge and multidimensional challenge for European societes. It not only leads to premature ageing and frailty but also promotes chronic conditions like cardiovascular disease, blindness, dementia and even cancer. Despite the availability of numerous treatment options treatment inertia is still a common problem: many patents still fail to reach their treatment goals. According to the UK National Diabetes Audit data 2016- 2017, only 30% of people with type 1 diabetes and 67% of people with type 2 diabetes achieved a HbA1c target of not more than 58 mmol/l (7.5%).

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Topics: The Science behind Diabetes, Treating Diabetes, Diabetes Technology

Posted by Prof. Dr. Freimut Schliess on Sep 3, 2019 5:17:00 PM
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Dual-hormone artificial pancreas systems

Dual-hormone artificial pancreas systems use insulin and glucagon to control glucose in patients with diabetes - a dream is about to come true

Insulin-only closed-loop AP systems hold promise for reducing the burden of diabetes self-management, but there is still potential for improvement regarding both hypoglycaemia and hyperglycaemia. A dual-hormone AP system achieves closed–loop glycaemic control by subcutaneous infusion of insulin and of glucagon in response to glucose values detected by a continuous glucose monitoring device mimicking the physiological pattern of insulin and glucagon secretion of a healthy pancreas more closely than an insulin infusion-only system.

To reverse the insulin action when blood glucose shows a tendency to fall, glucagon is given as mini-boluses to prevent and to treat any imminent hypoglycemia [1]. Glucagon leads to a rapid conversion of hepatic glycogen (the stored form of glucose) into glucose which is then released into the bloodstream. The comprehensive technology of control algorithms and hardware and the development of long-term stable glucagon formulations have so far provided some development challenges.

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Topics: The Science behind Diabetes, Clinical Trials in Diabetes, Treating Diabetes

Posted by Dr. Ulrike Hövelmann on Jul 16, 2019 5:03:00 PM
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Profil is co-founder of KomIT

KomIT - the new Center of Competence for Innovative Diabetes Therapy

Profil is co-founder of a new consortium of partners from industry and academia focusing on the development and clinical implementation of new diabetes therapies. 
 

During the next three years KomIT, the new Center of Competence for Innovative Diabetes Therapy, will be established at the German Diabetes Center (DDZ) based on a total funding of about 3.5 Mio Euro. This funding is jointly provided by the Land North Rhine-Westphalia and the European Union. KomIT is coordinated by Professor Michael Roden, the scientific Managing Director of the DDZ.

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Topics: The Science behind Diabetes, Treating Diabetes, Diabetes Technology

Posted by Svenya Meister on Apr 30, 2019 5:09:00 PM
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