Content of review 1, reviewed on June 04, 2020
This paper reports on data related to cutaneous AEs from a primary RCT studying FGM compared to SMBG. The results are interesting and with some clarifications I think could be an important addition to the literature on skin reactions.
Methods:
You mention informed consent, and I assume you received ethics approval, can you please add a sentence stating that explicitly?
It would be helpful to me if you always refer to the AEs as “cutaneous AEs”, “non-cutaneous AEs”, or “all AEs”. throughout the manuscript. I had to read several sections multiple times to try to understand which of these categories you were speaking about. In the methods, for example, starting with “During the six-month trial, participants self-reported AEs via an electronic safety questionnaire. Each safety questionnaire collected information including the type of cutaneous issue, overall severity of the cutaneous issue…” I did not understand if you meant self-reported “cutaneous AEs” (which makes the next sentence cogent), or “all AEs”, to which the next sentence is a non-sequitur.
You do not explain your statistical comparison methods, or which variables you tested, please add. Also, how did you account for multiple comparisons?
It looks like there were significantly more participants with a history of atopy in the control group. Did you test or control for this in any of your comparisons?
How was mild, moderate, and severe defined? Were the pts given parameters of what each mean? It is difficult to compare AEs from fingersticks compared to sensors because the scales of severity are probably quite different. If it was truly a subjective assessment without guidelines or definitions, I would add this to the limitations. Also, were there any narrative descriptions of cutaneous AEs? These could bring additional descriptive insight.
Does figure 2 consist of participant photos? Or were these given as examples when participants rated their reactions? I would like more detail on the ratings (see comment above) and how the participants described their reactions (check boxes, free text, select photos etc.)
Discussion—1st paragraph, you mention a study that reported higher prevalence of severe AEs than you report, but you also mention that self-report studies (such as yours) have also shown higher severity than clinician assessed studies. What do you make of these seemingly disparate comments?
I think the paper has merit and could be improved significantly by clarifying the points mentioned above.
Source
© 2020 the Reviewer.
Content of review 2, reviewed on July 17, 2020
Thank you for your edits, they greatly improve clarity in the paper. My only additional comment is to state that this is a descriptive analysis in the statistics section. Perhaps add the word "descriptive" in the first sentence as follows:
"Data were DESCRIPTIVELY analyzed to determine frequency..."
This makes clear to the reader (and this reviewer) that there is no need to account for multiple comparisons.
Otherwise the edits are appropriate and make for a clear and interesting paper,
Source
© 2020 the Reviewer.
References
L., M. B., E., B. S., C., G. B., J., W. E., I., d. B. M., A., T. P., Jenny, R., E., M. K., Huan, C., J., W. B. 2020. Cutaneous adverse events in a randomized controlled trial of flash glucose monitoring among youth with type 1 diabetes mellitus. Pediatric Diabetes.
