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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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Beer or wine or both – and if both, in which order?

Recent study investigates the impact of the combination and order of beer and wine on hangover severity

“Beer before wine and you’ll feel fine, wine before beer and you’ll feel queer” or in German “Bier auf Wein, das lass sein; Wein auf Bier, das rat’ ich dir” – this seems to be a common folk wisdom and regularly used recommendation with regards to alcohol beverage consumption in many countries and languages.

But is this just a saying or do we have scientific proof for this concept? Scientists from the University of Witten/Herdecke and the University of Cambridge investigated this old folklore and published the results in the American Journal of Clinical Nutrition early this year [1].

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Topics: Clinical Trials in Diabetes

Posted by Dr. Daniela Lamers on Dec 10, 2019 5:11:00 PM
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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].

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Topics: Clinical Trials in Diabetes, Diabetes Technology

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

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Topics: Clinical Trials in Diabetes, Diabetes Technology

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

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

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

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

Posted by Dr. Carsten Benesch on Aug 21, 2019 5:19:00 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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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.

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Topics: Clinical Trials in Diabetes, Clinical Trial Methods

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