The title includes ‘eCGM’, an abbreviation that is not defined in the manuscript.

This commentary/advocacy document, written by clinical experts on the topic of continuous glucose monitoring (CGM), makes a persuasive argument that “current and proposed guidance documents and/or standards utilized in the CE marking process should provide clearer guidance for adequate CGM-specific evaluation of safety and accuracy in the population of people with diabetes in which the product may be used.”

The authors state that there is “an immediate need for a minimum set of requirements for accuracy and performance for CGM systems to ensure the safety of users with diabetes.”

As a clinical endocrinologist, my response to the commentary is “this is a no brainer”. A device MUST be thoroughly tested (as described in detail in the commentary) before it is released into the marketplace.

Prescribers and users MUST have confidence in the accuracy and safety of the device.

Users have to be able to trust the device or they will not use it. Clinically important diabetes management decisions are dependent on the accuracy of the device and consistent performance over the usable life of the device. Inaccurate devices will lead to severe harm and, possibly, to death.

Minor comments:

Pages were not numbered. Assuming title page is #1 …

Page 2 line 32 can the term “conformity” in this context be explained?

Line 36 apply to CGM devices

Lines 39-44 The authors’ meaning here is unclear. What consideration may also be paid?

P3 line 6 omit both - 3 types of diabetes are mentioned here

P5 lines 21-24 Can you better explain what this sentence means?

P.6 line 23 “Each of these metrics is influenced …”

P.6 lines 57-58 “ It is accepted that CGM devices not meeting … may exceptionally be accepted as safe and effective , for example … “ I have difficulty understanding this statement.

P.10 line 5 Who does SH refer to?

Table 1 <70 mg/dL … performance against reference reading “Within ± 40 mg/dL” Is this really what you are proposing or was this a typo?

The authors have addressed my queries and suggestions.

A minor comment pertains to the abbreviation used in Box 1: what does QMS mean?