N-of-1 trialsDownloads

A 21-year-old man presents to the office for a follow-up visit. He was recently diagnosed with type 1 diabetes mellitus after being hospitalized for diabetic ketoacidosis following a respiratory infection. He is here today to discuss treatment options available for his condition. The doctor mentions a recent study in which researchers have developed a new version of the insulin pump that appears efficacious in type 1 diabetics. They are currently comparing it to insulin injection therapy. This new pump is not yet available, but it looks very promising. At what stage of clinical trials is this current treatment most likely at?

A researcher is trying to determine whether a newly discovered substance X can be useful in promoting wound healing after surgery. She conducts this study by enrolling the next 100 patients that will be undergoing this surgery and separating them into 2 groups. She decides which patient will be in which group by using a random number generator. Subsequently, she prepares 1 set of syringes with the novel substance X and 1 set of syringes with a saline control. Both of these sets of syringes are unlabeled and the substances inside cannot be distinguished. She gives the surgeon performing the surgery 1 of the syringes and does not inform him nor the patient which syringe was used. After the study is complete, she analyzes all the data that was collected and performs statistical analysis. This study most likely provides which level of evidence for use of substance X?