Intact Fish Skin Graft vs. Standard of Care in Patients with Neuroischaemic Diabetic Foot Ulcers (KereFish Study) : An International, Multicentre, Double-Blind, Randomised, Controlled Trial Study Design and Rationale

Publisher Copyright: © 2022 by the authors.Background: Cell and/or tissue-based wound care products have slowly advanced in the treatment of non-healing ulcers, however, few studies have evaluated the effectiveness of these devices in the management of severe diabetic foot ulcers. Method: This study (KereFish) is part of a multi-national, multi-centre, randomised, controlled clinical investigation (Odin) with patients suffering from deep diabetic wounds, allowing peripheral artery disease as evaluated by an ankle brachial index equal or higher than 0.6. The study has parallel treatment groups: Group 1 treatment with Kerecis® Omega3 Wound™ versus Group 2 treatment with standard of care. The primary objective is to test the hypothesis that a larger number of severe diabetic ulcers and amputation wounds, including those with moderate arterial disease, will heal in 16 weeks when treated with Kerecis® Omega3 Wound™ than with standard of care. Conclusion: This study has received the ethics committee approval of each participating country. Inclusion of participants began in March 2020 and ended in July 2022. The first results will be presented in March 2023. The study is registered in ClinicalTrials.gov as Identifier: NCT04537520.Peer reviewe

Diabète de la mucoviscidose

La mucoviscidose est la maladie génétique autosomique dominante la plus fréquente. L espérance de vie des sujets atteints augmente avec l amélioration de la prise en charge pulmonaire et nutritionnelle. Le diabète lié à la mucoviscidose (CFRD), dont la prévalence est liée à l âge augmente également, touchant 50% des patients de plus de 35 ans. Nous avons étudié rétrospectivement dans la population mucoviscidosique suivie à Nantes l épidémiologie des patients atteints de CFRD et d intolérance au glucose, leur évolution par rapport aux normoglucidiques au niveau de l état général, des paramètres nutritionnels et pulmonaires. Nous avons également colligé les données dans les deux ans ayant précédé le diagnostic de troubles métaboliques. Les enfants étaient étudiés séparément des adultes. Sur 97 mucoviscidosiques de plus de 10 ans, il y a 40 enfants dont 15% diabétiques, et 57 adultes dont 24,56% diabétiques et 17,54% intolérants au glucose. Les CFRD adultes étaient plus âgés que les normoglucidiques. Pas de différence de sex ratio. Pas de différence dans les mutations mais tous les CFRD portaient Delta F 508. Il existe une diminution du poids plus importante chez les adultes diabétiques, un infléchissement de la courbe de croissance et une diminution de la fonction respiratoire chez l enfant. Dans l année précédant le diagnostic, l adulte CFRD présente un poids inférieur et diminuant plus vite. Dans les deux ans précédant le diagnostic, l enfant a une vitesse de croissance altérée et une diminution rapide du VEMS. Le diagnostic se fait conformément aux recommandations de l ANAES sur une hyperglycémie provoquée orale annuelle chez les sujets de plus de 15 ans, et entre 10 et 15 ans en cas de symptomatologie évocatrice. La prise en charge est surtout basée sur l insulinothérapie, pas de complications microangiopathiques du diabète dans notre population.NANTES-BU Médecine pharmacie (441092101) / SudocPARIS-BIUM (751062103) / SudocSudocFranceF

ETUDE DES ISOTYPES DES ANTICORPS ANTI-INSULINE AU COURS DU DIABETE CHEZ L'HOMME (EFFETS DE L'ADMINISTRATION SOUS-CUTANEE ET ORALE D'INSULINE)

NANTES-BU Médecine pharmacie (441092101) / SudocPARIS-BIUM (751062103) / SudocSudocFranceF

A metamodel-based flexible insulin therapy for type 1 diabetes patients subjected to aerobic physical activity

International audiencePatients with type 1 diabetes are subject to exogenous insulin injections, whether manually or through (semi)automated insulin pumps. Basic knowledge of the patient’s characteristics and flexible insulin therapy (FIT) parameters are then needed. Specifically, artificial pancreas-like closed-loop insulin delivery systems are some of the most promising devices for substituting for endogenous insulin secretion in type 1 diabetes patients. However, these devices require self-reported information such as carbohydrates or physical activity from the patient, introducing potential miscalculations and delays that can have life-threatening consequences. Here, we display a metamodel for glucose-insulin dynamics that is subject to carbohydrate ingestion and aerobic physical activity. This metamodel incorporates major existing knowledge-based models. We derive comprehensive and universal definitions of the underlying FIT parameters to form an insulin sensitivity factor ( ISF ). In addition, the relevance of physical activity modelling is assessed, and the FIT is updated to take physical exercise into account. Specifically, we cope with physical activity by using heart rate sensors (watches) with a fully automated closed insulin loop, aiming to maximize the time spent in the glycaemic range (75.5% in the range and 1.3% below the range for hypoglycaemia on a virtual patient simulator).These mathematical parameter definitions are interesting on their own, may be new tools for assessing mathematical models and can ultimately be used in closed-loop artificial pancreas algorithms or to extend distinguished FIT

Clinical assessment of a new biomatical model for decision making in functional insulin therapy

International audienc

Clinical assessment of a new biomatical model for decision making in functional insulin therapy

International audienc

A relevant glucose-insulin dynamics model for type 1 diabetes

International audienceSeveral models have been developed for decades. These models have an inherent drawback: for each blood glucose value, a different insulin infusion rate is needed to maintain constant blood glucose level. The objective is to review the elementary modelling to eliminate this contradiction with real life.A new model is derived for type-I diabetics. It has realistic asymptotic properties as there is one single constant insulin infusion rate, known as the basal rate, independent on the glycemia, and which ensures the equilibrium of any value of the glycemia in fasting periods as it is in real life. A standard identification algorithm is used to get the patients’ individual characteristics.Standard clinical data (CGM, injection, CHO uptake) were analyzed for a typical type-I diabetic outpatient. A long term fit over two days with constant parameters is realized. Moreover, the new model provides the computation of the tools for the functional insulin therapy like basal infusion rate, the insulin sensitivity factor (ISF) or insulin to carbo ration (I:C). This is a major outcome as it can be used for the education of type-I diabetics

A Long-term Model of the Glucose-Insulin Dynamics of Type 1 Diabetes

International audienceA new glucose-insulin model is introduced which fits with the clinical data from in- and outpatients for two days. Its stability propertiy is consistent with the glycemia behavior for type 1 diabetes. This is in contrast to traditional glucose-insulin models. Prior models fits with clinical data for a few hours only or display some non-natural equilibria. The parameters of this new model are identifiable from standard clinical data as continuous glucose monitoring, insulin injection and carbohydrate estimate. Moreover, it is shown that the parameters from the model allow the computation of the standard tools used in functional insulin therapy as the basal rate of insulin and the insulin sensitivity factor. This is a major outcome as they are required in therapeutic education of type 1 diabetic patient.Cet article présente un nouveau modèle de l'action de l'insuline sur la glycémie. Les propriétés de ses points d'équilibre sont réalistes et les dynamiques de ce modèle s'ajustent aux données cliniques sur 2 jours. Cela est à comparer aux modèles précédents dont les dynamiques s'ajustent sur quelques heures et qui présentent des points d'équilibre non-naturels. Les paramètres de ce nouveau modèle sont identifiables d'après les données cliniques standard (mesure en continu de glycémie, injection d'insuline, glucides dans l'assiette). Bien plus encore, les paramètres de ce modèle permettent de calculer les outils de l'insulinothérapie tels que le débit basal, les unités-portion, le compensatoire. Cela est une avancée majeure car ces outils sont très utiles dans l'éducation thérapeutique du patient atteint de diabète de type 1