List of questions

What is foreseen to be the future requirements on accuracy and adjunct calibration for continuous glucose monitors (CGMs)?

Advances in sensor chemistry and continuous glucose monitor (CGM) algorithms have enabled factory-calibrated systems to have greater accuracy than previous generations of CGM technology. Despite these advances many are hesitant about the idea of removing fingerstick testing as calibration technique.
Ascilion is developing a painless method to extract interstitial fluid (ISF) from a person's skin, using a proprietary array of tiny hollow microneedles. The sampled volume could be used for spot measurement of glucose and hence a more convenient way to calibrate a CGM.

How well are markers such as c-peptide response and HbA1c correlated with complications? Which complications in type 1 and type 2 diabetes respectively carry the largest burden on the patient and socioeconomic impact?

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How is beta cell function and stress best quantified, and what population of type 2 diabetes is most suited for evaluating the efficacy of an intervention on beta cell regeneration?

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2381: What is the best design for a prevention study in type 1 and type 2 diabetes respectively, and which markers should be used to measure efficacy? How is prediabetes and impaired glucose tolerance classified/identified

2382: Do different endotypes (patient subgroups) exist in type 1 diabetes and how do they differ? If so, should they be treated differently?

2381: none

2382: none

With new surrogate clinical endpoints being discussed for end stage renal disease, does this open for introduction of novel pre-clinical/experimental end-points or reinterpretation of existing end-points?

A lot of work is ongoing between pharma, clinicians and authorities to validate surrogate endpoints for ESRD for use in clinical trials.
Advantage of these would be 1) that trials can be shorter and 2) improved translation from PhII to PhIII if the same endpoints are used.
Surrogate endpoints include the classical measurement of albuminuria, which is currently not FDA-approved.

Are the requirements to pre-clinical animal models of Diabetic Nephropathy changing with the increased focus on elucidating the mechanisms behind SGLT2 inhibitors and other novel drug classes?

Data are accumulating from several large Cardiovascular Outcomes Trials (CVOTs) in Type 2 Diabetes that SGLT2 inhibition may not only be safe in diabetic kidney disease patients, but that it may even improve renal function and cardiovascular endpoints.
SGLT2 and GLP-1R agonists are the first new drug classes in more than a decade that holds this kind of promise for diabetic nephropathy (DN) patients.

How can input of diet for capturing amount of carbohydrates and calories be simplified in a mobile application for diabetic patients?

MaishaBit designs and develop digital health solutios for people living with diabetes and hypertension as well as for healthcare providers. Our goal is to empower patients and improve QoL as well as to make the healthcare more effective via simplification!

Will glucagon will be a clinical marker in the future for other diagnoses than glucagonomas or neuroendocrine tumors?

The interest in glucagon and its many functions is somewhat in a revival phase. Glucagon is not only a counter-regulatory hormone for insulin that acts on the liver to enhance glucose production, it has also been shown to increase energy expenditure, decrease food intake and have effects on amino acid and lipid metabolism in the liver.
Hyperglucagonemia is associated with T2D, but also with NAFLD/NASH independently of diabetes. The existence of a liver-alpha cell feedback loop has been proposed by Jens Holst and other research groups, and when the liver-pancreas axis is disrupted by glucagon resistance it leads to hyperaminoacidemia and hyperglucagonemia (Solloway et al., Cell Reports (2015) 12, 495–510 Wewer Albrechtsen et al., Diabetologia (2018) 61:671–680).
Also, in T1D like T2D patients fail to suppress glucagon secretion in response to glucose intake and show enhanced glucagon secretion in response to mixed meals compared with healthy controls (Adeva-Andany et al., Journal of Clinical & Translational Endocrinology 15 (2019) 45–53).

Is there a need for biomarkers that describe and monitor the interplay between diabetes and its related metabolic diseases?

There is a strong link between diabetes, obesity, insulin resistance and excessive lipids in the liver parenchyma (NAFLD). By targeting one, effects on several of these diseases can be achieved but not always in a positive way. For example, when targeting hyperglucagonemia in diabetic patients by a glucagon antagonist, an increase in hepatic fat and aminotransferases were found (Guzman et al,. Diabetes Obes Metab. 2017;19:1521–1528). Should diabetes and its related diseases be targeted interdisciplinary or not, and what markers would be of outmost importance for this?

What analytical challenges do you have when measuring diabetes related biomarkers and what new tools would you like to see developed?• What set of different biomarkers are important to your specific line or research? And what would a perfect multiplex panel look like to you?

In diabetes research and related diseases there is often a need to measure multiple metabolic biomarkers, e.g. in pancreatic islet transplantations, response to treatment or early diagnosis. However, this need can be challenged by insufficient sample volume, lack of sensitivity, cost, degradation of biomarkers etc.

Is the Mixed Meal Tolerance test (MMTT) a suitable method to evaluate our product? Which mixed meal would be the best to use? Apart from information on the level of insulin produced by the pancreas, which other information could be obtained with this method?

Our Company is developing SiPore15™, an orally-administered medical device for the safe reduction of blood sugar levels in people at risk of developing diabetes, prediabetics, and newly diagnosed type 2 diabetics. It is made of highly engineered synthetic amorphous silicon dioxide (SAS) particles designed to act locally in the gut without being absorbed by the body. The device is a tasteless and odourless white powder taken with water. A First in Man clinical trial of SiPore15™ showed significant reductions in a range of metabolic parameters and an excellent safety profile. SiPore15™ is currently being investigated in a clinical trial called STAR01 in Uppsala and Kuopio.

Our oral product aims to reduce blood sugar levels. To evaluate the impact of our product on glucose metabolism, we are going to measure Glycated haemoglobin (A1C). Does that test can determine at which stage of the disease the patient is? Can we compare HbA1C values between patients at different stages of the disease? Besides Fasting glucose tolerance test, Oral Glucose Tolerance Test and Glycated haemoglobin (A1C) test is there another blood marker available to assess the stage of the disease?

Our Company is developing SiPore15™, an orally-administered medical device for the safe reduction of blood sugar levels in people at risk of developing diabetes, prediabetics, and newly diagnosed type 2 diabetics. It is made of highly engineered synthetic amorphous silicon dioxide (SAS) particles designed to act locally in the gut without being absorbed by the body. The device is a tasteless and odourless white powder taken with water. A First in Man clinical trial of SiPore15™ showed significant reductions in a range of metabolic parameters and an excellent safety profile. SiPore15™ is currently being investigated in a clinical trial called STAR01 in Uppsala and Kuopio.

2348: To what extent is type 2 diabetes reversible? Which components of the disease are reversible? How do you define reversible in the context of type 2 diabetes?

2351: Would a treatment that lowers several metabolic risk factors (LDL-cholesterol, HbA1c and body fat%) be more beneficial for newly diagnosed T2D or high-risk prediabetics?

2348: Our Company is developing SiPore15™, an orally-administered medical device for the safe reduction of blood sugar levels in people at risk of developing diabetes, prediabetics, and newly diagnosed type 2 diabetics. It is made of highly engineered synthetic amorphous silicon dioxide (SAS) particles designed to act locally in the gut without being absorbed by the body. The device is a tasteless and odourless white powder taken with water. A First in Man clinical trial of SiPore15™ showed significant reductions in a range of metabolic parameters and an excellent safety profile. SiPore15™ is currently being investigated in a clinical trial called STAR01 in Uppsala and Kuopio

2351: Our Company is developing SiPore15™, an orally-administered medical device for the safe reduction of blood sugar levels in people at risk of developing diabetes, prediabetics, and newly diagnosed type 2 diabetics. It is made of highly engineered synthetic amorphous silicon dioxide (SAS) particles designed to act locally in the gut without being absorbed by the body. The device is a tasteless and odourless white powder taken with water. A First in Man clinical trial of SiPore15™ showed significant reductions in a range of metabolic parameters and an excellent safety profile. SiPore15™ is currently being investigated in a clinical trial called STAR01 in Uppsala and Kuopio.