Contact
Header_1077x260px_About_Profil.jpg

Lipohypertrophy – New insights into an old issue?

Lipohypertrophy (LH) is a common side effect of insulin therapy in patients with diabetes mellitus. The prevalence of lipohypertrophy is high with cross-sectional studies reporting up to 64% of patients being affected, with higher numbers in type 1 diabetes. Predisposing factors for the development of lipohypertrophy include duration of insulin treatment, needle reuse frequency, BMI and incorrect injection and site rotation techniques. Particularly the latter seem to be of major importance as re-education of patients in proper injection site rotation with avoidance of LH tissue was reported to improve glycaemic control [1].

Read More

Topics: Clinical Trials in Diabetes, Diabetes Technology

Posted by Dr. Susanne Famulla on Nov 14, 2019, 5:16:00 PM
dr-susanne-famulla

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.

Read More

Topics: The Science behind Diabetes, Treating Diabetes

Posted by Dr. Jorge Arrubla on Oct 17, 2019, 5:30:00 PM
dr-jorge-arrubla

Finally breakthrough in the immunological approach to type 1 diabetes

Type 1 diabetes is a T-cell mediated autoimmune disease. For more than 40 years, researchers have tried to intervene in the autoimmune process to halt or perhaps even reverse the slow destruction of insulin producing beta cells [1]. This has proven an elusive goal, but very recently FDA granted a breakthrough therapy designation to teplizumab, an anti-CD3 monoclonal antibody  [2]. The drug modifies CD8+ T lymphocytes, which are thought to be the key effector cells that kill beta cells.

Read More

Topics: Clinical Trials in Diabetes, Diabetes Technology

Posted by Prof. Hans de Vries on Oct 1, 2019, 4:58:00 PM
prof-hans-de-vries

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. 

Read More

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

Posted by Dr. Grit Andersen on Sep 17, 2019, 5:25:00 PM
dr-grit-andersen

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%).

Read More

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

Posted by Prof. Dr. Freimut Schliess on Sep 3, 2019, 5:17:00 PM
prof-dr-freimut-schliess

New PID-algorithm for automated glucose clamps

Introduction

The euglycemic, hyperinsulinemic glucose clamp is the gold standard for the determination of pharmacokinetic and pharmacodynamic (PK/PD) effects of new anti-diabetic drugs, in particular insulins. In a typical glucose clamp experiment, a drug-induced decline in blood glucose (BG) concentrations is prevented by infusing glucose at a variable rate, so that BG is "clamped" at a pre-determined target level.

Read More

Topics: Clinical Trials in Diabetes, About Profil, Diabetes Technology

Posted by Dr. Carsten Benesch on Aug 21, 2019, 5:19:00 PM
dr-carsten-benesch

"Profil World" - The clinical diabetes research newsletter - July 2019

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.

Read More

Topics: About Profil

Posted by Svenya Meister on Jul 23, 2019, 5:17:00 PM
svenya-meister

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.

Read More

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

Posted by Dr. Ulrike Hövelmann on Jul 16, 2019, 5:03:00 PM
dr-ulrike-hövelmann

Dr. Tim Heise about Profil's 2018 Science Report

Dear all,

It is my great honour and pride to present the Profil Science Report 2018. Altogether, Profil’s scientific experts published 29 scientific publications (cumulated impact factor of > 150) and 56 scientific presentations at international meetings in 2018. The wide variety of topics reflects the versatility of our scientists and our expertise in many areas of metabolic research. Our publications cover our main focus areas of diabetes technology and pharmacology, but you will also find papers on the metabolic effects of drugs treating hypertension and heart failure, and on more broader topics such as digital health and value-based healthcare.


Read More

Topics: About Profil

Posted by Dr. Tim Heise on Jul 2, 2019, 5:21:00 PM
dr-tim-heise

Is there a ‘true’ insulin time action profile?

The impact of different study populations in glucose clamp studies

Over the last decade, the euglycemic clamp technique has evolved to the reference method for assessing time action profiles of insulins, and regulatory agencies require glucose clamp trials as part of the clinical development of novel and biosimilar insulin products [1, 2]. Of course the experimental set-up of glucose clamp trials can vary, depending for example on whether a long-acting or a rapid-acting insulin is tested. However, one of the most important decisions when planning glucose clamp trials is the choice of a suitable study population. The choice is between patients with type 1 diabetes, type 2 diabetes, or healthy people. Indeed, healthy volunteers can be the preferable option. Each of these groups comes with their own specific advantages and disadvantages.

Read More

Topics: Clinical Trials in Diabetes, Clinical Trial Methods

Posted by Oliver Klein on Jun 18, 2019, 5:21:00 PM
oliver-klein

Subscribe to our monthly blog updates

Find out more: Glucose Clamp Webinar

Subscribe to Email Updates

Our most popular Posts