To demonstrate the performance and safety of a bihormonal (insulin and glucagon) artificial pancreas (AP) in adults with type 1 diabetes. RESEARCH DESIGN AND METHODSIn this outpatient, randomized, crossover trial, 2-week fully closed loop glucose control (AP therapy) was compared with 2-week open loop control (patient's normal insulin pump therapy with a glucose sensor if they had one). RESULTSA total of 23 patients were included in the analysis. Time in range (70-180 mg/dL [3.9-10 mmol/L]) was significantly higher during closed loop (median 86.6% of time [interquartile range 84.9-88.5]) compared with open loop (53.9% [49.7-67.2]; P < 0.0001). CONCLUSIONSCompared with insulin pump therapy, the bihormonal AP provided superior glucose control, without meal or exercise announcements, and was safe in adults with type 1 diabetes.Hybrid closed loop therapy has been demonstrated to improve glucose control compared with standard insulin therapies in type 1 diabetes (1-4). Bihormonal closed loop systems may further improve glucose control, as the addition of glucagon more closely mimics physiologic glucose control and enables tighter glucose control by adding a "brake" to the control system (5). In addition, bihormonal closed loop systems may relieve patients from carbohydrate counting (6,7).After our previous study (7), the prototype of our bihormonal artificial pancreas (AP) was further developed into a product version intended to obtain CE (Conformit é Européenne) marking. The aim of this trial was to demonstrate the performance and safety of this AP in patients with type 1 diabetes during a 2-week period. RESEARCH DESIGN AND METHODSThis study was a single-center, randomized, unblinded, crossover trial (clinical trial reg. no. NCT03858062, ClinicalTrials.gov) to compare home treatment with the AP (closed loop period) with the patients' normal insulin pump therapy (open loop period).

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OBJECTIVE <p>To demonstrate the performance and safety of a bihormonal (insulin and glucagon) artificial pancreas in adults with type 1 diabetes.</p> <p> </p>RESEARCH DESIGN AND METHODS <p>In this outpatient, randomized, crossover trial, two-week fully closed loop glucose control (artificial pancreas therapy) was compared to two-week open loop control (patient’s normal insulin pump therapy with a glucose sensor if they had one). </p> <p> </p>RESULTS <p>Twenty three patients were included in the analysis. Median (IQR) time in range (70-180 mg/dL [3.9-10 mmol/L]) was significantly higher during closed loop (86.6% [84.9-88.5]) compared with open loop (53.9% [49.7-67.2]; p<0.0001).</p> <p> </p>CONCLUSIONS <p>Compared to insulin pump therapy, the bihormonal artificial pancreas provided superior glucose control, without meal or exercise announcements, and was safe in adults with type 1 diabetes.</p>

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The (local) environmental conditions have a significant effect on the interaction between skin and products. Plasticisation of the stratum corneum occurs at high humidity, causing this layer to soften and change its surface free energy. In this work we study the effects of the micro-climate on the frictional behaviour of skin in contact with materials with varying wettability. Friction measurements are performed under a range of micro-climate conditions using four different materials with a smooth surface finish. All measurements are performed twice on a single subject in order to minimise variation in skin properties. Results show that materials with a higher wettability show a larger increase in friction coefficient when exposed to warm, moist conditions. The friction force is modelled using the skin micro-relief, the elastic properties of the different skin layers, the surface chemistry of both skin and counter surface, and the environment, as input parameters