Content of review 1, reviewed on June 16, 2020
Thanks for a very well-made and brilliant study, which clearly shed lights on this under-reported problem: skin changes. The design is great as well as the results, and the manuscript is well-prepared and easy to understand. I only have a couple of concerns and questions:
1. Do you have results on the treatment options? What did you do and adviced them to, and how did it work? Was this the reason why many FGM-users only reported 1 AE?
2. How would you assume the results to continue after the 6 months? My experience is that skin problems arise after 6-8 months of use, but your study show how many reactions are there already after 6 months, I would expect that number and as well maybe severity to increase after 6 months, if not a treatment program with prevention potential will be used.
3. I like the design by comparing skin changes from usual care (SMBG) to FGM, but I miss a comment on not only the severity but maybe also the consequences of skin problems in both groups. Are the consequences of hardening skin and erythema, completely different skin problems, the same on life quality, later cosmetic issues, tolerance towards allergens etc?
Figure 1: a small mistake, I think: "recruited into study (n=64)" and not n=34
Source
© 2020 the Reviewer.
Content of review 2, reviewed on August 03, 2020
Thanks for a great answer to my comments. I do not have further concerns.
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.
