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Bringing the real world to clinical research: the use of wearables in pivotal trials

From fitness trackers and health apps to sophisticated sensors and software that support clinical decision, wearables are reshaping the delivery of health care. The use of wearables allows patients to keep track and take control of their own health and can offer primary care professionals with day-to-day insights of patients’ health conditions, allowing early diagnosis and interventions to take place even outside of traditional care facilities. Wearables allow the collection of real-world data in everyday life settings and can be especially useful to enable a precision medicine approach and optimize treatment of chronic diseases [1].

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Topics: Treating Diabetes, Clinical Trial Methods, Diabetes Technology

Posted by Tatiana Dicenzo on Jun 23, 2020 4:00:00 PM
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Profil World - The clinical diabetes research newsletter - June 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 Jun 2, 2020 3:16:00 PM
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When Artificial Intelligence and Artificial Pancreas meet

How machine learning methods are changing diabetes research and diabetes care

When voice assistants tell us what the weather will be like, when self-driving cars steer through dense city traffic, or when computers sort our digital photo collections by the faces of our families and friends, whenever computers take over these tasks that would have required human intelligence only a few years back, artificial intelligence (AI) is the underlying technology.

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Topics: Diabetes Technology

Posted by Oliver Klein on May 26, 2020 5:14:00 PM
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Non invasive CGM; hope at the horizon?

Non-invasive Continuous Glucose Monitoring (niCGM) is the holy grail of glucose monitoring. But the quest has been arduous so far; research carried out over the past 35 years has not resulted in in a device with durable availability on the market [1, accessed March 23, 2020].

Two devices have briefly been commercially available. The first, called GlucoWatch Biographer, has been for sale from 2002 to 2007. Poor local tolerability and low accuracy were the limiting factors. The device applied a low voltage current to obtain interstitial fluid transcutaneously. Skin irritation, probably inherent to this technique, together with insufficient accuracy, resulted in withdrawal from the market and dissolvement of the manufacturer [2].

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Topics: Clinical Trials in Diabetes, Diabetes Technology

Posted by Prof. Hans de Vries on May 6, 2020 4:17:00 PM
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Free webinar on insulin biosimilars

Profil continues the successful series of scientific webinars. On My 19th, 2020 we will air our free webinar on insulin biosimilars. The session is presented by Dr. Tim Heise, Lead Scientist and Chairman of the Board of Directors at Profil. 

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Topics: About Profil

Posted by Svenya Meister on Apr 21, 2020 5:12:00 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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Fighting Corona: Profil's contribution

The pandemic of the coronavirus disease (COVID-19) has rapidly changed our lives. Most facilities of daily life are closed, many people try to get accustomed to home-office and in many countries people are gated. Despite all these measures infection rates still rise exponentially in nearly all countries affected. In these times everyone should do their part in fighting the pandemic. 

Profil, a CRO specialized on early phase clinical trials, is stepping up to this responsibility by offering support to companies developing vaccines against COVID-19. As one of the leading phase 1 units in Europe, we can offer experience with Europe's regulatory landscape as well as years of routine in conducting early phase trials in our two clinics in Germany. Combined with our team's previous experience working on novel vaccine developments this allows us to support companies looking for rapid and effective support in their clinical development.

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Topics: About Profil, Clinical Trial Methods

Posted by Dr. Tim Heise on Mar 20, 2020 12:01:27 PM
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Clinical study shows better clamp quality with Clamp-PID algorithm

Introduction

The glucose clamp is the gold standard for the determination of pharmacokinetic and pharmacodynamic effects of anti-diabetic drugs (e.g. insulins). During a typical glucose clamps the blood glucose (BG) lowering effect is antagonized by infusing glucose at a variable rate, so that BG is "clamped" at a pre-determined target level.  In automated glucose clamps the glucose infusion rate is calculated automatically by a pre-specified algorithm.

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Topics: Clinical Trials in Diabetes, Treating Diabetes

Posted by Dr. Carsten Benesch on Mar 17, 2020 5:17:00 PM
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A novel method to determine the pharmacodynamic onset of action of prandial insulins

Introduction

In order to improve postprandial glycemic control, new insulins are developed, with earlier glucose lowering action by advancing the time to onset of action [1, 2, 3]. The standard for investigating such pharmacodynamic properties of insulin preparations is the euglycemic clamp [4, 5]. The current method established for determining onset of insulin action requests a blood glucose (BG) decrease from baseline (DFB) by at least 5 mg/dl [6, 5]. Unfortunately, DFB under- or overestimates onset of action depending on whether baseline BG trends are decreasing or increasing.

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Topics: Clinical Trials in Diabetes, Treating Diabetes

Posted by Dr. Marc Stoffel on Mar 3, 2020 4:56:00 PM
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Profil World - The clinical diabetes research newsletter - February 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 Svenya Meister on Feb 18, 2020 3:32:00 PM
svenya-meister

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