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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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Profil World - The clinical diabetes research newsletter - March 2021

Dear all,

Greetings from Germany! I am happy to share with you the newest edition of "Profil World" - our newsletter filled with information about clinical research in diabetes and obesity.

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Topics: About Profil

Posted by Maria Andresen on Mar 16, 2021 4:00:00 PM
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Profil leads the way in establishing audit trail review procedures in clinical studies using visual data analytics

Background

For the last few years, one of the hottest topics in clinical research has been data integrity. An important part of ensuring data integrity - that is now mandated by the authorities - is the structured review of audit trails. Unfortunately, there is little guidance on how to perform such review. As it is virtually impossible to read all lines in an audit trail (and it would not make much sense either), other means of review need to be applied.
The solution for this problem is visual data analytics. We have created an interactive environment that enables the reviewer to dig into the data and learn what actually happened during a study. With this novel approach, audit trail review not only becomes possible, but it actually becomes meaningful.

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Topics: Clinical Trials in Diabetes, Clinical Trial Methods, Clinical trials in Obesity

Posted by Sascha Heckermann on Mar 8, 2021 4:00:00 PM
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Free Online Seminar: Audit trail review in clinical studies using visual data analytics

Profil continues the successful series of scientific online seminars. On March 23th, 2021 at 4 PM CEST we will air our next free online seminar. The session is presented by Sascha Heckermann, Chief Executive Officer at Profil. 

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Topics: Clinical Trials in Diabetes, Clinical Trial Methods, Clinical trials in Obesity

Posted by Dr. Lars Bochmann on Feb 23, 2021 4:00:00 PM
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Can serious games motivate teenagers with diabetes to adhere to their treatment?

Serious games are video games or digital games designed to promote educational content or behaviour changes rather than serving as pure entertainment. They could be a powerful tool to improve treatment adherence in teenagers with a chronic condition.

Type 1 Diabetes is one of the most common metabolic disorders affecting children and adolescents, and its worldwide incidence continues to increase [1]. Despite all the advancements in diabetes treatment, treating teenagers with diabetes type 1 remains a challenge.

Multiple factors such as increased insulin resistance, hormonal changes, changes in body composition and a lifestyle that is less regular (eating and exercise habits) play a role in the worsening of metabolic control during adolescence. The transition of therapy responsibility from parents to their growing children also contributes to a decrease in the frequency of self-testing blood glucose and adherence to therapy after teenagers start self-managing their diabetes. Adherence to treatment is crucial to achieve better therapeutic outcomes, especially when treating chronic diseases. However, adherence rates [2] among patients with chronic conditions tend to be much lower than amongst patients with acute conditions and teenagers need an even higher level of motivation to adhere to their treatment scheme.

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Topics: Treating Diabetes

Posted by Tatiana Dicenzo on Feb 9, 2021 4:15:00 PM
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Running clinical trials at Profil during pandemic times

Impact of COVID-19 on clinical trials

In December 2019, China was affected by several cases of what was considered a fatal viral pneumonia (1). The numbers of affected patients were exponentially increasing and on January 9th 2020 Chinese authorities made a preliminary determination of a novel coronavirus which became known as SARS-CoV-2 or COVID-19 (1). Not long after, on January 30th 2020 the World Health Organisation (WHO) declared the COVID-19 outbreak as a global emergency (2). This was just the beginning of a pandemic that has come to challenge all what we thought to be normal and forced us to adapt to a new reality - a new lifestyle. This new reality has also affected clinical research as resources given to human trials were diverted towards the pandemic response resulting in the termination, suspension or withdrawal of more than 1700 clinical trials worldwide (3). In addition, most of the ongoing studies have undergone substantial modifications in order to address the safety of participants, staff and investigators (4) and here at Profil we are proud to be at the forefront of finding answers to these new challenges.

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Topics: Clinical Trials in Diabetes, About Profil

Posted by Javiera Villagra on Jan 7, 2021 4:00:00 PM
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Profil World - The clinical diabetes research newsletter - December 2020

Dear all,

Greetings from Germany! I am happy to share with you the newest edition of "Profil World" - our newsletter filled with information about clinical research in diabetes and obesity.

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Topics: About Profil

Posted by Dr. Lars Bochmann on Dec 17, 2020 10:19:00 AM
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β3-adrenoceptor agonist Mirabegron – a candidate anti-obesity drug?

The β3‐adrenoceptor (β3-AR) was initially an attractive target for several pharmaceutical companies due to its high expression in rodent adipose tissue, where its activation resulted in decreased adiposity and improved metabolic outcomes in animal models of obesity and type 2 diabetes. Despite the expression of β3-AR in human brown and white adipocytes, urinary bladder and potentially other tissues [1, 2, 3], the translation of rodent studies to humans was cumbersome as several drugs acting on the β3-AR failed in achieving weight loss targets.

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Topics: Treating Diabetes, Clinical trials in Obesity

Posted by Dr. Daniela Lamers on Dec 1, 2020 4:00:00 PM
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Once-weekly basal insulin analogue in clinical development

Once-weekly basal insulin icodec treatment may offer more convenience in people with type 2
diabetes and may improve outcomes.

Molecular and biological properties of once-weekly insulin icodec and promising phase 1 and 2 data
were presented at American Diabetes Association’s 80th Scientific Sessions and 56th European
Association for the Study of Diabetes (EASD) Annual Meeting 2020.

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Topics: Clinical Trials in Diabetes, Treating Diabetes

Posted by Dr. Ulrike Hövelmann on Nov 17, 2020 4:00:00 PM
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Glycaemic control in type 1 diabetes – effects of diabetes technology and socioeconomic status

The landmark trials DCCT/EDIC trials show how important good glycaemic control is for the prevention of late complications in type 1 diabetes (T1D). According to the American Diabetes Association (ADA) an HbA1c target value of less than 7% should be targeted throughout all age groups to reduce the risk of late complications unless safety issues for individual patients or patients groups indicate higher HbA1c goals. However, most patients have difficulties to reach this target value despite improvements in diabetes therapy options during the last years. Especially the age group between 15 and 25 years have significantly higher HbA1c levels as analysis of data of various countries show [1]. The analysis of an US database, the so-called T1D Exchange registry which contains data of more than 35000 patients with T1D, indicate that glycaemic control in adolescents and young adults seems to get even worse in the past years as from 2012 until 2018 the average HbA1c has increased, particularly in the younger age groups [2].

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Topics: Treating Diabetes, Diabetes Technology

Posted by Dr. Susanne Famulla on Nov 4, 2020 4:00:00 PM
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