New data on cardiovascular outcomes with dapagliflozin

Putting effects of SGLT2 inhibitors into perspective

The DECLARE-TIMI 58 trial [1] investigated the effects of treatment with dapagliflozin on cardiovascular outcomes in people with type 2 diabetes in a double blind randomized placebo controlled manner. It is the third published trial investigating cardiovascular outcomes of SGLT2 inhibitors, following EMPA-REG (for empagliflozin) [2] in 2015 and CANVAS (canagliflozin) [3] in 2017. Of these three trials, DECLARE-TIMI 58 has been the largest by a fair margin, including more than 17000 patients with type 2 diabetes who either had multiple risk factors for atherosclerotic cardiovascular disease or established cardiovascular disease.

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

Posted by Oliver Klein on Dec 4, 2018 5:09:00 PM

What news in the treatment of Type 2 diabetes was presented at EASD 2018?

The annual meeting of the European Association for the Study of Diabetes (EASD) took place this year in Berlin, Germany. 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, Diabetes Technology, Clinical Trial Methods

Posted by Dr. Jorge Arrubla on Nov 6, 2018 5:09:00 PM

Profil at 18th Annual Diabetes Technology Meeting

Profil will be present at the 18th Annual Diabetes Technology Meeting with two posters and a presentation as invited speaker. The Annual DTM will take place from November 8 to November 10, 2018, in North Bethesda, Maryland. We are looking forward to this exciting event.

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Topics: The Science behind Diabetes, Diabetes Technology, Clinical Trial Methods

Posted by Svenya Meister on Oct 29, 2018 5:15:00 PM

Artificial Intelligence to Screen for Diabetic Retinopathy; The Times They Are A-Changin‘.

The far majority of clinical trials in diabetes exclude patients with active retinal disease, as interventions that lower glucose rapidly can temporarily worsen retinopathy. This was originally shown in type 1 diabetes [1] but more recently also in type 2 diabetes [2, 3]. Screening for diabetic retinopathy before inclusion in a clinical trial is relatively cumbersome, also because it often involves a separate visit to an ophthalmologist. The use of a fundus camera with offline interpretation by an ophthalmologist has gained widespread use in clinical practice, but not so much in the field of clinical trials.

In this blog I will briefly describe four recent studies on artificial intelligence approaches to automate the interpretation of retinal images. I will conclude with an outlook on how this may facilitate the screening of potential trial participants for diabetic retinopathy. But first a brief introduction to deep learning, the methodology applied in all these papers.

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

Posted by Prof. Hans de Vries on Oct 23, 2018 5:18:00 PM

54th EASD Annual Meeting – Profil’s contributions to the scientific sessions

Berlin, Germany, 1-5 October 2018

Last week our team joined an exciting and busy 54th EASD Annual Meeting in Berlin. We would like to give you a brief overview about those orals and posters presenting results from clinical trials Profil had been involved in.

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

Posted by Dr. Sabine Arnolds on Oct 10, 2018 4:15:43 PM

Profil explores opportunities for artificial pancreas in type 2 diabetes

Highlighting the role of open and trans-sectoral collaboration in the advancement of artificial pancreas solutions

Profil has recently published a peer-reviewed article on the topic of “Artificial Pancreas Systems for People With Type 2 Diabetes: Conception and Design of the European CLOSE Project ” in the Journal of Diabetes Science and Technology. Profil is the organisation coordinating CLOSE. The article is authored by CLOSE industry and academic partners, representatives of the EIT Health public-private partnership management boards, and key opinion leaders in the field.

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

Posted by Prof. Dr. Freimut Schliess on Oct 2, 2018 5:18:00 PM

Do-It-Yourself Artificial Pancreas systems (DIY APS)

The way forward to closed-loop metabolic control in diabetes care?

The challenge

Diabetes represents a huge and multidimensional challenge. Despite the availability of numerous treatment options, many patents still fail to reach their treatment goals. Administration of  the right amount of insulin at the right time still poses a great challenge for the self-management of many people with diabetes.

Accordingly there is a huge need to implement new innovative products and services improving both the effectiveness of diabetes care and the quality of life for people with diabetes. Particularly user-centered products and sercvices co-created with stakeholders including people with diabetes may have a high potential to increase treatment adherence thereby reducing the enormous pressure on healthcare systems.

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

Posted by Prof. Dr. Freimut Schliess on Sep 5, 2018 5:16:00 PM

Clamp studies with ultra-long-acting insulins – New challenges for an old procedure

The euglycemic clamp technique has been used as a standard method for assessing time action profiles of insulins for decades. In recent years, new challenges have emerged for investigators performing glucose clamp trials. These are driven by two opposing trends in the development of novel insulins: On the one hand, drug developers are formulating insulin products with a very rapid onset of action and a short duration of action – often referred to as “ultra-rapid insulins” [1,2]. On the other hand, novel basal insulins are being developed with an “ultra-long” duration of action with flatter activity profiles than previously available products [3,4,5].


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

Posted by Oliver Klein on Jul 24, 2018 5:11:00 PM

Vitamin D supplementation – is there a role in type 1 diabetes?

The possible ‘non-calcemic’ effects of Vitamin D in numerous diseases has become a large area of research. Historically, Vitamin D is known for its regulatory role in calcium absorption and bone metabolism but the identification of vitamin D receptor (VDR) expression in more than 30 tissues led to the possibility of pleiotropic effects of vitamin D [Diabetes Forouhi 2008]. In vitro and animal studies suggested an anti-inflammatory and immunomodulatory effect of Vitamin D [The Review of Diabetic Studies, Gregoriu 2017]. Moreover, preclinical studies uncovered a potential regulatory role of Vitamin D in insulin secretion, β-cell survival and calcium flux in pancreatic β-cells [Mitri J, Endocrinol Metab Clin North Am 2014].

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Topics: The Science behind Diabetes

Posted by Dr. Susanne Famulla on May 30, 2018 4:52:37 PM

Pancreatic ß-cell function changes in response to pharmacological or life-style interventions

Many different approaches are available for measuring Pancreatic ß-cell function (BCF). The choice of testing methodology will ultimately be determined by the research question.

Metabolic dysfunction in pre-diabetes and type 2 diabetes (T2D) leads to a decline in insulin sensitivity (IS) [capacity for glucose disposal and ability to suppress hepatic glucose production in response to insulin]. As an appropriate physiological response, insulin secretion increases in a compensatory manner. Circulating insulin concentrations are reciprocally related to IS through a hyperbolic relationship and are expressed as the “disposition index” [DI: IS * first phase (acute) insulin secretion], which was shown to be highly related to the conversion to T2D [[1]] [[2]] (Figure 1).

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Topics: The Science behind Diabetes

Posted by Dr. Ulrike Hövelmann on Feb 21, 2018 9:27:57 AM

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