Background: The trans-membrane protease serine 2 (TMPRSS2) is essential for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) cell entry and infection. Efficacy and safety of TMPRSS2 inhibitors in patients with coronavirus disease 2019 (Covid-19) have not been evaluated in randomized trials. Methods: We conducted an investigator-initiated, double-blind, randomized, placebo-controlled multicenter trial in patients hospitalized with confirmed SARS-CoV-2 infection from April 4, to December 31, 2020. Within 48 h of admission, participants were randomly assigned in a 2:1 ratio to receive the TMPRSS2 inhibitor camostat mesilate 200 mg three times daily for 5 days or placebo. The primary outcome was time to discharge or clinical improvement measured as 2 points improvement on a 7-point ordinal scale. Other outcomes included 30-day mortality, safety and change in oropharyngeal viral load.
Background: Intensive insulin therapy has documented benefits but may also come at the expense of a higher risk of hypoglycemia. Hypoglycemia is associated with higher all-cause mortality and nocturnal hypoglycemia has been associated with the sudden dead-in-bed syndrome. This proof-of-concept study sought to investigate if nocturnal hypoglycemia can be predicted. Method: Continuous glucose monitoring, meal, insulin, and demographics data from 463 people with type 1 diabetes were obtained from a clinical trial. A total of 4721 nights without or with hypoglycemia (429) were available including data from three consecutive days before the night. Thirty-two features were calculated based on these data. Data were split into 20% participants for evaluation and 80% for training. The optimal feature subset was found from forward selection of the 80% participants with linear discriminant analysis as basis for the classifier. Results: The forward selection resulted in a feature subset of four features. The evaluation resulted in an area under the receiver operating characteristics curve (ROC-AUC) of 0.79 leading to a sensitivity and a specificity of, e.g., 75% and 70%. Conclusions: It was possible to predict nocturnal hypoglycemic episodes with a ROC-AUC of 0.79. A warning at bedtime about nocturnal hypoglycemia could be of great help for people with diabetes to enable preventive actions. Further development of the proposed algorithm is needed for implementation in everyday practice.
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