Patient initiated research – How involvement of patients could help improve diabetes research

Background and current status

Patient involvement in clinical research

These days patients are getting a more active role in health care systems. A British Medical Journal article stated public involvement in research should be “second nature” by 2025 [1]. Since 2006 the National Institute for Health Research (NIHR) has been supporting the initiative “INVOLVE” [2] aiming at involving the public and patients to improve health research in the UK. The strategic goals of “INVOLVE” include ensuring that opportunities to engage with research are made visible to the public and seized; that the public’s contribution is valued and required as part of high quality research; and that evidence of what works is collected and disseminated.

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Topics: Clinical Trials in Diabetes

Posted by Dr. Sabine Arnolds on Mar 24, 2017 5:41:00 PM

Glucose clamps: 2 steps towards insulin sensitivity adjusted for glucose effectiveness


When adopting a glucocentric view on diabetes the hyperinsulinemic euglycemic clamp sets the gold standard for recording insulin sensitivity and time-action profiles in clinical trials (deFronzo et al., 1979; Heise & Heinemann, 2001; Heise et al., 2016). Both assessments capture the decrease of blood glucose levels following administration of exogenous insulin which again reflects the modulation of cellular glucose uptake and metabolism exerted by the hormone. Compensating for the insulin-induced decrease of blood glucose levels by clamping a defined blood glucose concentration helps to avoid effects related to fluctuating blood glucose concentrations and the physiological response to hypoglycemic states which would confound insulin sensitivity assessment. 

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Topics: The Science behind Diabetes

Posted by Prof. Dr. Freimut Schliess on Mar 16, 2017 4:53:00 PM

The New Clinical Trials Regulation EU No 536/2014 - Amendments to the German Drug Law


Since the new clinical trial regulation has been adopted on 16 April 2014, Profil has been anticipating the changes to be compliant with the new regulation as soon as necessary.   Through our blog, we have been updating you about the changes on clinical trials, the pilot project in Germany- which allows sponsors to submit clinical trials according the new regulation before it will become applicable (October 2018) - and the challenges Germany is facing due to the implementation of this project.

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Topics: Clinical Trials in Diabetes

Posted by Dr. Grit Andersen on Mar 9, 2017 5:02:00 PM

New Biosimilar Insulin Study Published

Profil is an expert on biosimilar insulins

In the past Profil has worked on biosimilar insulins a lot. We are the leading provider of bioequivalence trials for these insulins and with our next generation glucose clamp technology, ClampArt, we offer several advantages for carrying out such trials. Especially for fast acting insulins the advantages of using automated glucose clamping become apparent and easy to understand. With the much better time-resolution, important time points can get resolved better and results are more reliable. 

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Topics: Clinical Trials in Diabetes

Posted by Dr. Lars Bochmann on Mar 2, 2017 5:01:00 PM

Oral insulins still under development

With oral insulin type 1 diabetes treatment may see higher compliance

Even today, after decades of intense work on developing new insulins and novel methods of delivery, subcutaneous injection remains to be the only method available for most patients with diabetes. Such injections can be unpleasant, but for many patients even more troublesome is the discomfort of injecting themselves in public spaces potentially leading to skipped doses. This may be the case even more for young patients, mostly suffering from type 1 diabetes, who suffer higher social pressures. Lastly, undesirable aesthetic side effects such as lipohypertrophy further drive the patients' desire for alternative ways to administer the much needed insulin. If oral insulin pills were available, increased patient compliance may be observed and better metabolic control could be achieved in more patients. 

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Topics: Clinical Trials in Diabetes

Posted by Dr. Lars Bochmann on Feb 23, 2017 5:00:00 PM

Profil Webinar Series on Diabetes and Obesity

Are you interested in the best glucose clamp method to improve your clinical trial or are you eager to learn about sophisticated devices, such as an artificial pancreas?  Maybe you focus on other topics related to clinical trials, technology or diabetes drug development?

The Profil webinar series brings the information you need right to your doorstep.  Launched in May 2015 our series of webinars covers a wide variety of topics on the diabetes and obesity fields.

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Topics: The Science behind Diabetes, About Profil Germany

Posted by Tatiana Dicenzo on Feb 16, 2017 5:07:00 PM

"Profil World" - The clinical diabetes research newsletter's January 2017 edition

Dear Reader,

We are happy to share with you our winter edition of "Profil World", our newsletter packed with relevant information about clinical trials!

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Topics: About Profil Germany

Posted by Tatiana Dicenzo on Feb 1, 2017 5:15:00 PM

Improved Algorithm for Automated Glucose Clamps

What is Glucose Clamping

The glucose clamp is a method for the determination of pharmacokinetic and pharmacodynamic (PK/PD) effects of anti-diabetic drugs (e.g. insulin) where the blood glucose (BG) concentration lowering effect is antagonized by variable glucose infusion rates (GIRs). Any device used for automated glucose clamps consists of a glucose sensor and a glucose infusion pump as well as an appropriate algorithm that calculates the amount of glucose solution that has to be infused to keep the blood glucose level at a pre-defined target level. In contrast to manual techniques automated glucose clamps (e.g. using the Biostator) offer the advantage of a bias-free assessment of the pharmacodynamic properties of blood-glucose lowering agents and a minute-by-minute adaptation of glucose infusion rates thereby keeping blood glucose concentrations very close to the clamp target level. However, the Biostator algorithm leads to pronounced oscillations of both BG and GIR requiring mathematical smoothing procedures for the determination of time-related parameters. As ClampArt, our novel automated clamp device, offers the option to modify the clamp algorithm we compared the unmodified Biostator algorithm (UBA) and a potentially improved clamp algorithm (ICA) regarding GIR/BG oscillations and clamp quality.

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Topics: Clinical Trials in Diabetes, About Profil Germany

Posted by Dr. Carsten Benesch on Jan 10, 2017 5:30:00 PM

Dr. Tim Heise about Profil's 2016 Science Report

Dear all,

I am very proud to present the Profil Science Report 2016. As in the last years, our Science Report impressively documents the sound scientific expertise of Profil Germany.

With 45 scientific publications (cumulated impact factor of > 187) and more than 100 scientific
presentations at international meetings in 2016 alone, our publication record at Profil Germany can easily
compete with that of many academic institutions.

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Topics: About Profil Germany

Posted by Dr. Tim Heise on Dec 23, 2016 2:44:50 PM

Liver first ? Part III: Medical Needs

In part II and part I of this series you read about the lessons learnt from preclinical work with respect to NASH and NAFLD. In this last part we will look at the medical needs, possible interventions and clinical trials in this area. Enjoy reading and don't forget to register for our monthly blog mailer (to the right of this page) so you won't miss future posts. 

Medical needs

Lifestyle interventions. Although lifestyle changes have been recognised to be a cornerstone in the prevention of diabetes, fatty liver, NASH and cardiovascular disease (Barb et al., 2016) sustainable regimes are difficult to implement and often hamper from a limited compliance of targeted people. There is a general gap between the broad availability of quality information on the impact of livestyle for health promotion and chronic disease prevention on the one hand, and the translation of into behavioural attitudes on the other.

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Topics: The Science behind Diabetes

Posted by Prof. Dr. Freimut Schliess on Dec 9, 2016 5:01:00 PM