Abstract
Rickels et al. (1) report the results of a randomized crossover noninferiority study, making the firm assertion that intranasal glucagon was highly effective in treating insulin-induced hypoglycemia in type 1 diabetes. Unfortunately, the methods described in their article fail to support such a strong claim. We have several concerns about their ambitious conclusion. First, because of the controlled and artificial environment, this was not an effectiveness but an efficacy trial. Testing effectiveness requires carrying out the comparison in a “real-world setting” of severe hypoglycemia. Second, the design of the study does not seem appropriate considering that the intention was to prove intranasal glucagon was clinically equivalent to …
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