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The ideal basal insulin?

Long-acting insulins have been developed for patients with diabetes to provide a basal insulin cover during the day and night. The first slow-release formulations used protamine and/or zinc to achieve a duration of action up to 16 hours. Since 2000 insulin analogues with different mechanisms of protraction are available and achieve a predictable glucose lowering effect with one daily injection. Currently, ultra-long acting insulin analogues are available that have a duration of action beyond 24 hours. This prolonged duration of action reduces day-to-day variability and offers daily dosing flexibility [1]. What further improvements in basal insulin therapy can be expected in the future and what exactly does the ideal basal insulin look like?

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Topics: Treating Diabetes

Posted by Dr. Eric Zijlstra on May 21, 2019 4:57:00 PM
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Glucose-Responsive Insulin

The first idea [1] for a glucose-responsive insulin (GRI, commonly referred to as smart insulin) was pitched almost 40 years ago, but to our knowledge only one compound has since undergone clinical evaluation. It seems a little surprising that it takes such a long time to develop a functioning GRI because its concept is actually relatively simple: At normal glucose concentrations, small amounts of insulin are released to keep blood glucose (BG) fairly constant. In response to rising glucose concentrations, for example after a meal, more insulin is released to limit the glucose rise and to return glucose concentrations back to normal. This closed-loop insulin release should limit BG variability and because insulin is only released when it is needed, it should also reduce the risk of over- and underdosing insulin. Two key elements are needed for a GRI: (1) A component that can ‘sense’ glucose and (2) a component that can respond and control the release of insulin. The concept may be simple, suggested solutions are complex and diverse [2].

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

Posted by Dr. Eric Zijlstra on Nov 28, 2018 5:19:00 PM
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Smart ideas for noninvasive glucose monitoring

Last year I asked the question, Will noninvasive glucose monitoring end in tears? That article described the measurement of blood glucose without needles, without pain and without injury as the holy grail of glucose monitoring in diabetes. The hype that formed after Google’s announcement of their smart contact lens project raised huge expectations that a noninvasive solution was finally realistic and near. Since the initial project announcement in 2014, information on its progress has been scarce and a delay in clinical testing of the contact lens has fed speculations that the whole project will end in bitter disappointment. In this article, an update of the status of the smart contact lens project is given and new smart ideas for noninvasive glucose monitoring are discussed.

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Topics: Treating Diabetes, Diabetes Technology

Posted by Dr. Eric Zijlstra on Jun 13, 2018 4:53:00 PM
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Insulin injection: recent improvements and alternatives

The most common way for patients with diabetes to self-administer insulin is subcutaneously via a needle injection. Patients with type 1 diabetes require multiple daily injections (MDI), adding up to some 1500 injections per year per patient, to control their glucose level. Also, many patients with type 2 diabetes would benefit from (intensive) insulin therapy to achieve their glycaemic target. Painful insulin injections or fear thereof present a barrier to treatment initiation and long-term adherence in patients. Not surprisingly, research into alternative ways of administering insulin, without the need to break the skin barrier, such as via the oral [1], buccal [2], nasal or pulmonary route, has gained interest for decades. Despite these efforts, research into alternative insulin administration has not yet produced any commercially viable products and subcutaneous injection remains the only option for almost all patients.

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Topics: Treating Diabetes, Diabetes Technology

Posted by Dr. Eric Zijlstra on Apr 4, 2018 5:11:00 PM
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The need for speed

The aim of insulin replacement therapy is to mimic endogenous insulin secretion profiles.  A mealtime insulin should ideally be absorbed very fast after injection to counteract the rise in blood glucose with food consumption. After almost 100 years of insulin development, another major milestone in insulin development has been achieved with the 2017 market approval of the first ultra-fast acting insulin.

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Topics: Treating Diabetes

Posted by Dr. Eric Zijlstra on Dec 1, 2017 3:27:09 PM
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HbA1c, a diabetes marker for the past and for the future?

Ever since large clinical outcome studies in the 1990’s demonstrated that tight blood glucose control, as measured by glycated haemoglobin (HbA1c), is able to slow down the progress of diabetes-related complications, HbA1c is regarded as the gold standard to evaluate the clinical efficacy of new anti-diabetes compounds in clinical trials as well as the most important biomarker to guide the individual treatment of patients with diabetes.  Furthermore, much more recently (since 2010), various diabetes societies and the World Health Organization (WHO) have accepted the use of HbA1c in screenings to diagnose diabetes, mainly type 2 diabetes (T2D). Despite its long-time status as gold standard parameter to assess diabetes therapy, many limitations of the HbA1c-value have been discussed in literature and experts in the field of diabetes are now saying that HbA1c alone is not enough and other parameters have to be considered for drug approval and treatment success. In this text the strengths and limitations of HbA1c and its role in future diabetes therapy are discussed.

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Topics: The Science behind Diabetes, Clinical Trials in Diabetes

Posted by Dr. Eric Zijlstra on Aug 28, 2017 5:03:00 PM
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Will noninvasive glucose monitoring end in tears?

Controlling blood glucose levels within a normal range is the objective of diabetes management and will help to prevent long-term complications such as damages to the eye, kidneys and the nervous system and may also reduce the risk of cardiovascular events such as a heart attack or stroke. To achieve good glucose control in a safe manner without hypo- or hyperglycaemia, many patients with diabetes need to check their blood glucose level several times per day before making a treatment decision. The standard self-measurement requires patients to perform a finger prick with a lancet needle and measure the glucose content of the obtained capillary blood drop with a handheld glucose meter system. A patient diagnosed with diabetes type 1 at age 20 may easily have to perform more than 75.000 of these painful finger pricks during a lifetime, each causing a small injury to the skin.

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Topics: The Science behind Diabetes, Clinical Trials in Diabetes

Posted by Dr. Eric Zijlstra on May 24, 2017 1:59:00 PM
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Your blood glucose meter might not be sufficiently accurate! (Update 03/2017)

Are blood glucose meters sufficiently accurate to detect hypoglycaemia?

A year ago Diabetes Care published our research letter [1] addressing the performance of current blood glucose meters (BGMs) in the low-glucose range. The initiative to write the letter was taken after studies showed considerable differences in performance in the low-glucose range between current BGMs [23].

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Topics: Treating Diabetes

Posted by Dr. Eric Zijlstra on Apr 6, 2017 5:08:00 PM
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Profil scientists publish new clamp method to evaluate glucose measurement performance

The glucose clamp methodology can be used in different configurations to investigate a variety of research questions and is regarded as gold standard for insulin sensitivity assessments and time-action profiling of glucose-lowering drugs.  At Profil, we are always thinking of innovative ways to answer specific research questions with this unique methodology. The combination of glucose clamp methodology and blood glucose systems (meters and test strips) may not seem obvious, but can actually provide special opportunities for performance evaluation testing of glucose measurements as Profil scientists show in their recent publication in the Journal of Diabetes, Science and Technology [1].

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Topics: Clinical Trials in Diabetes

Posted by Dr. Eric Zijlstra on Sep 27, 2016 5:00:00 PM
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Profil congratulates Senseonics on CE Mark for 90-day implantable CGM sensor

Last week the medical device manufacturer Senseonics announced the CE Mark approval for their 90-day implantable glucose sensor system called Eversense. The CE Mark is a proof that the sensor system complies with relevant European directives, meets technical safety requirements and has shown clinical performance. The two Profil sites in Germany (Neuss and Mainz) participated in the pivotal clinical trial to generate the clinical data needed for CE Marking.

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Topics: Clinical Trials in Diabetes

Posted by Dr. Eric Zijlstra on May 19, 2016 12:07:31 PM
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