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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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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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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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Type 1 Diabetes and mild cognitive impairment

Mild cognitive impairment: another complication of Diabetes mellitus type 1?

Diabetes Mellitus (DM) is often considered a risk factor for mild cognitive impairment (MCI) and the association between these pathologies has been well established by several clinical studies [1, 2]. However, this relationship has mainly been studied in patients suffering from Type 2 Diabetes.

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Topics: Clinical Trials in Diabetes, Treating Diabetes

Posted by Dr. Grit Andersen on Feb 4, 2020 5:17:00 PM
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Trustworthy AI in healthcare - it's TIME TO DELIVER

In Europe chronic diseases account for 86% of deaths and 77% of disease burden, thereby creating a tremendous challenge on societies. At the same time digitisation is bringing huge technological and cultural opportunities. In healthcare the usage of data-driven forecasts on individual and population health as by integration of artificial intelligence (AI)-enabled algorithms has the potential to revolutionise health protection and chronic care provision while securing the sustainability of healthcare systems.

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

Posted by Prof. Dr. Freimut Schliess on Jan 7, 2020 5:16:00 PM
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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.

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Topics: The Science behind Diabetes, Treating Diabetes

Posted by Dr. Jorge Arrubla on Oct 17, 2019 5:30:00 PM
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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%).

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

Posted by Prof. Dr. Freimut Schliess on Sep 3, 2019 5:17:00 PM
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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.

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

Posted by Dr. Ulrike Hövelmann on Jul 16, 2019 5:03:00 PM
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Applications of iontophoresis in studies investigating microvasculature

People suffering from Diabetes Mellitus can develop both macrovascular and microvascular complications. Retinopathy, nephropathy and neuropathy are the main microvascular complications occurring in Diabetes Mellitus. Mechanisms include structural and functional alterations resulting from chronically elevated glucose concentrations. Therefore, assessment of the microvasculature is important for studies investigating new treatment modalities in diabetes.

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Topics: Clinical Trials in Diabetes, Treating Diabetes, Clinical Trial Methods

Posted by Dr. Jorge Arrubla on Jun 4, 2019 5:21:00 PM
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