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Can Remote Decentralised Clinical Trials enhance clinical research?

A Remote Decentralised Clinical Trial (RDCT) design can be a valuable option to make your clinical trial more efficient. Also called web-based or hybrid trials, they combine digital technologies with more “conventional” design elements to bring clinical research to patients’ homes [1]. RDCTs democratize the access to clinical trials by reaching population groups that would normally not have the possibility to enrol in a clinical trial. Web-based communication paths facilitate the participation of elderly, frail, disable people and people living in remote areas.

RDCTs may help achieving higher levels of sustainability, resilience and external validity in pivotal clinical research.

 

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

Posted by Prof. Dr. Freimut Schliess on Jun 2, 2021 5:00:00 PM
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Can serious games motivate teenagers with diabetes to adhere to their treatment?

Serious games are video games or digital games designed to promote educational content or behaviour changes rather than serving as pure entertainment. They could be a powerful tool to improve treatment adherence in teenagers with a chronic condition.

Type 1 Diabetes is one of the most common metabolic disorders affecting children and adolescents, and its worldwide incidence continues to increase [1]. Despite all the advancements in diabetes treatment, treating teenagers with diabetes type 1 remains a challenge.

Multiple factors such as increased insulin resistance, hormonal changes, changes in body composition and a lifestyle that is less regular (eating and exercise habits) play a role in the worsening of metabolic control during adolescence. The transition of therapy responsibility from parents to their growing children also contributes to a decrease in the frequency of self-testing blood glucose and adherence to therapy after teenagers start self-managing their diabetes. Adherence to treatment is crucial to achieve better therapeutic outcomes, especially when treating chronic diseases. However, adherence rates [2] among patients with chronic conditions tend to be much lower than amongst patients with acute conditions and teenagers need an even higher level of motivation to adhere to their treatment scheme.

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Topics: Treating Diabetes

Posted by Tatiana Dicenzo on Feb 9, 2021 4:15:00 PM
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β3-adrenoceptor agonist Mirabegron – a candidate anti-obesity drug?

The β3‐adrenoceptor (β3-AR) was initially an attractive target for several pharmaceutical companies due to its high expression in rodent adipose tissue, where its activation resulted in decreased adiposity and improved metabolic outcomes in animal models of obesity and type 2 diabetes. Despite the expression of β3-AR in human brown and white adipocytes, urinary bladder and potentially other tissues [1, 2, 3], the translation of rodent studies to humans was cumbersome as several drugs acting on the β3-AR failed in achieving weight loss targets.

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Topics: Treating Diabetes, Clinical trials in Obesity

Posted by Dr. Daniela Lamers on Dec 1, 2020 4:00:00 PM
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Once-weekly basal insulin analogue in clinical development

Once-weekly basal insulin icodec treatment may offer more convenience in people with type 2
diabetes and may improve outcomes.

Molecular and biological properties of once-weekly insulin icodec and promising phase 1 and 2 data
were presented at American Diabetes Association’s 80th Scientific Sessions and 56th European
Association for the Study of Diabetes (EASD) Annual Meeting 2020.

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Topics: Clinical Trials in Diabetes, Treating Diabetes

Posted by Dr. Ulrike Hövelmann on Nov 17, 2020 4:00:00 PM
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Glycaemic control in type 1 diabetes – effects of diabetes technology and socioeconomic status

The landmark trials DCCT/EDIC trials show how important good glycaemic control is for the prevention of late complications in type 1 diabetes (T1D). According to the American Diabetes Association (ADA) an HbA1c target value of less than 7% should be targeted throughout all age groups to reduce the risk of late complications unless safety issues for individual patients or patients groups indicate higher HbA1c goals. However, most patients have difficulties to reach this target value despite improvements in diabetes therapy options during the last years. Especially the age group between 15 and 25 years have significantly higher HbA1c levels as analysis of data of various countries show [1]. The analysis of an US database, the so-called T1D Exchange registry which contains data of more than 35000 patients with T1D, indicate that glycaemic control in adolescents and young adults seems to get even worse in the past years as from 2012 until 2018 the average HbA1c has increased, particularly in the younger age groups [2].

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Topics: Treating Diabetes, Diabetes Technology

Posted by Dr. Susanne Famulla on Nov 4, 2020 4:00:00 PM
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The rollercoaster life of inhaled insulin

From Nektar’s award-winning technology to its later commercial failure as Pfizer’s Exubera®. Followed by new hopes for Mannkind’s Afrezza® that suffered more commercial disappointment [1,2,3,4]. The life of pulmonary delivery of insulin (inhaled insulin) has been a thrilling rollercoaster ride. Experts have openly asked whether inhaled insulin has come to the end of its ride or whether there is still a place for inhaled insulin in the future [5]. In this blog article on inhaled insulin, we’ll have a look at what the future may look like and discuss the latest advances with a novel inhaled insulin.

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Topics: Clinical Trials in Diabetes, Treating Diabetes

Posted by Dr. Eric Zijlstra on Aug 4, 2020 4:15:00 PM
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Heart failure: SGLT2 inhibitors moving beyond diabetes

Sodium/glucose cotransporter 2 (SGLT2) inhibitors have gained momentum in the last few years due to their therapeutic effectivity and the potential to reduce cardiovascular (CV) risks in type 2 diabetes [1, 2, 3].

The mechanisms involved in the improved risk profile observed seem to be a combination of several factors, including blood pressure reduction, increased sodium excretion, weight reduction and improved heart function [4].

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Topics: Clinical Trials in Diabetes, Treating Diabetes

Posted by Dr. Jorge Arrubla on Jul 14, 2020 4:15:00 PM
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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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