Blood glucose and subcutaneous continuous glucose monitoring in critically ill horses: A pilot study

Valentina Vitale; Lise C. Berg; Bettina Birch Larsen; Andrea Hannesdottir; Preben Dybdahl Thomsen; Sigrid Hyldahl Laursen; Denis Verwilghen; Gaby van Galen

doi:10.1371/journal.pone.0247561

Peer Review History

Original SubmissionNovember 8, 2020
7 Dec 2020 Decision Letter - Arianna Miglio, Editor PONE-D-20-35138 Blood glucose and subcutaneous continuous glucose monitoring in critically ill horses: a pilot study PLOS ONE Dear Dr. Gaby Van Galen, Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process. The article is well written and the scientific purpose and methodologies are deeply described. Minor changes are needed as recommended by reviewer 2 The reviewers are in agreement with the review of the manuscript and minor changes has been proposed. Please submit your revised manuscript by Gaby Van Galen. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. 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The PLOS ONE style templates can be found at https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf 2. Please note that PLOS ONE uses a single-blind peer review procedure. We would therefore be grateful if you could include in the information that has been redacted for peer review in the manuscript. [Note: HTML markup is below. Please do not edit.] Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. Is the manuscript technically sound, and do the data support the conclusions? The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. Reviewer #1: Yes Reviewer #2: Yes ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: I Don't Know Reviewer #2: Yes ****** 3. Have the authors made all data underlying the findings in their manuscript fully available? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified. Reviewer #1: Yes Reviewer #2: Yes ****** 4. Is the manuscript presented in an intelligible fashion and written in standard English? PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here. Reviewer #1: Yes Reviewer #2: Yes ****** 5. Review Comments to the Author Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: This pilot study reports the application of a continuous monitoring system for glucose evaluation in critically ill horses and foals. The glucose concentrations obtained were compared with blood glucose concentration. The idea is interesting and original. Material and methods are consistent with the study. Results reported refer only to one foal and four adult horses, despite the system was applied on more animals. In some of them for causes reported in the results, the system failed. This low number of cases can be accepted for a pilot study, as the values obtained are homogenous and well supported by the explanation in the discussion section. Also the economic impact and costs of this evaluation system are reported and discussed. Study limitations are indicated and discussed Reviewer #2: The authors’ aim was to verify the feasibility of use a new devise to dose interstitial glucose concentration and the correlation between interstitial and blood glucose (evaluated by PC and blood gas analyzer). The paper is interesting and well structured, but it needs some corrections to be suitable for publication. Lines 79-84: SIRS in foals: Please you need to use the SIRS score proposed by Roy et al 2017 for adult horse and the one by Wong and Wilkins in 2015 (and 2018 for sepsis) for foals. Please correct and verify if your population can still be included as SIRS positive horses and foals. I see the data have been collected in 2016, thus maybe you can add tìsome explanation about why you have used a not recent paper for the adult SIRS parameters, but the paper by Wong and Wilkins has been published in the 2015, thus you need to use these parameters for foals’ inclusion in SIRS positive group. Line 89: was the catheter used only for blood samples? Please add information. Line 95: what do you mean for “validated”? Please add information. Line 98: PCV has been evaluated as microhematocrit? Please clarify. After you never discuss this parameter, and this is not relevant for the SIRS inclusion/exclusion. So why did you report this parameter? Line 113: are the cut-off supported by literature or the cut-off have been chosen by you? Please clarify. Line 128-129: compared applying what? Bland altman? I think yes (see lines 131-133). If so, in this case you need to better rephrase the sentence in order to have a more understandable and “easy to read” sentence. Line 131-132: why? This is not one of the aims of the study. In my opinion it should be erased, or you need to change the aim and the title. Line 136: please add literature for glucose ranges. Lines 138-139: you say what you did but not haw statistically. Please add. Table 1: please change “range” with minimum and maximum values. Please add “total number of sensors used until….” in the first row. Lines 172-173: as my previous comment, this is not one of the aims of the study. In my opinion it should be erased, or you need to change the aim and the title. Line 174-175: this sentence needs to be moved to mat and met section. Line 178: fair correlation: both for POC and BGA? You need to specify and discuss both. Table 2 and Fig. 2. Please erase the comparison between the POC and the blood gas because this is not the aim you stated. The aim was to compare the CGM with BGA or the POC, thus the comparison must be done between CGM vs BGA or POC, not between BGA and POC. Lines 204-205: again, comparison between BGA and POC is not an aim of your study. Lines 234 and 247: as previously said. Lines 261: differs Line 273: add human patient. Line 297: in the discussion you said the use of the devise is very difficult in foals, thus this consideration seems to be in contrast with your previous idea. Please clarify or change or erase. Literature Corley is 2005 and not 2015. ****** 6. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review?** For information about this choice, including consent withdrawal, please see our Privacy Policy. Reviewer #1: No Reviewer #2: No [NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.] While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step. Attachments Attachment Submitted filename: Revision PONE-D-20-35136.docx https://doi.org/10.1371/journal.pone.0247561.r001
Revision 1
8 Feb 2021 Author Response Dear reviewers, Thank you for reviewing our manuscript and providing us with very helpful and constructive feedback. This has allowed us to further strengthen the manuscript. Below we have replied to all your comments. We are looking forward to hear from you again on this manuscript! kind regards the authors The authors’ aim was to verify the feasibility of use a new devise to dose interstitial glucose concentration and the correlation between interstitial and blood glucose (evaluated by PC and blood gas analyzer). The paper is interesting and well structured, but it needs some corrections to be suitable for publication. Thank you for the comments. We have changed the manuscript accordingly, please find below the replies to your suggestions. Lines 79-84: SIRS in foals: Please you need to use the SIRS score proposed by Roy et al 2017 for adult horse and the one by Wong and Wilkins in 2015 (and 2018 for sepsis) for foals. Please correct and verify if your population can still be included as SIRS positive horses and foals. I see the data have been collected in 2016, thus maybe you can add tìsome explanation about why you have used a not recent paper for the adult SIRS parameters, but the paper by Wong and Wilkins has been published in the 2015, thus you need to use these parameters for foals’ inclusion in SIRS positive group. This has been adapted to the reference suggested and the citations have been added to the list. Line 89: was the catheter used only for blood samples? Please add information. Information has now been added. Line 95: what do you mean for “validated”? Please add information. It was tested for accuracy as described accordingly to the manufacturer. The word “validated” has been changed for “tested for accuracy”. Line 98: PCV has been evaluated as microhematocrit? Please clarify. After you never discuss this parameter, and this is not relevant for the SIRS inclusion/exclusion. So why did you report this parameter? PCV and other parameters (pH, electrolytes, lactate) where included in the blood gas analysis and performed as routine examination in ICU patients. These values had no influence on the SIRS score but helped to determine when the patient was not in need of glucose monitoring anymore. Line 113: are the cut-off supported by literature or the cut-off have been chosen by you? Please clarify. These cut-offs as mentioned were only used to set an alarm on the device. The cut-off used to indicate hypo or hyperglycemia are mentioned later on and are based on the range reported on the blood gas machine. Line 128-129: compared applying what? Bland altman? I think yes (see lines 131-133). If so, in this case you need to better rephrase the sentence in order to have a more understandable and “easy to read” sentence. Yes, the sentence has been clarified. Line 131-132: why? This is not one of the aims of the study. In my opinion it should be erased, or you need to change the aim and the title. The results of the glucometer and blood gas analysis were compared to double check the results obtained and to give more strength to the comparison with the continuous glucose monitoring system as it was the only one showing some differences. Line 136: please add literature for glucose ranges. The glucose ranges used where those of our lab. Lines 138-139: you say what you did but not haw statistically. Please add. The information has been added. Table 1: please change “range” with minimum and maximum values. Please add “total number of sensors used until….” in the first row. This has been changed. Lines 172-173: as my previous comment, this is not one of the aims of the study. In my opinion it should be erased, or you need to change the aim and the title. The comparison between the glucometer and the blood gas analysis is not the aim of the study this should not be added in the introduction nor in the title. Nevertheless, it supports the data obtained thus need to be mentioned in the results and discussion. Line 174-175: this sentence needs to be moved to mat and met section. It has been moved to the section of Materials and methods. Line 178: fair correlation: both for POC and BGA? You need to specify and discuss both. As POC and BGA results were almost identical, the comparison with the CGM system and each of them would be the same that’s why it has been summarized in the text, more details can be find in table 2 as mentioned in the results section. Table 2 and Fig. 2. Please erase the comparison between the POC and the blood gas because this is not the aim you stated. The aim was to compare the CGM with BGA or the POC, thus the comparison must be done between CGM vs BGA or POC, not between BGA and POC. Again, although this was not the aim of the study as it has already been done in previous study and the POC as been validated as a reliable method to evaluate the blood glucose concentration in horses, it need to be mentioned to complete and support the data obtained with the CGM system. Lines 204-205: again, comparison between BGA and POC is not an aim of your study. As previous replied. Lines 234 and 247: as previously said. As previously, this has already been addressed. Lines 261: differs Blood and interstitial fluid are two fluids (plural) thus they differ not differs. Line 273: add human patient. The phrase is in general, not only in human patients as glucose metabolism physiology in critical illness, although may vary, can still be applied to humans and animals. Line 297: in the discussion you said the use of the devise is very difficult in foals, thus this consideration seems to be in contrast with your previous idea. Please clarify or change or erase. It has been clarified. Literature Corley is 2005 and not 2015. This reference has been deleted. Attachments Attachment Submitted filename: Rebuttal letter.docx https://doi.org/10.1371/journal.pone.0247561.r002
10 Feb 2021 Decision Letter - Arianna Miglio, Editor Blood glucose and subcutaneous continuous glucose monitoring in critically ill horses: a pilot study PONE-D-20-35138R1 Dear Dr. van Galen, We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements. Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication. An invoice for payment will follow shortly after the formal acceptance. To ensure an efficient process, please log into Editorial Manager at http://www.editorialmanager.com/pone/, click the 'Update My Information' link at the top of the page, and double check that your user information is up-to-date. If you have any billing related questions, please contact our Author Billing department directly at authorbilling@plos.org. If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org. Kind regards, Arianna Miglio Academic Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: https://doi.org/10.1371/journal.pone.0247561.r003
Formally Accepted
15 Feb 2021 Acceptance Letter - Arianna Miglio, Editor PONE-D-20-35138R1 Blood glucose and subcutaneous continuous glucose monitoring in critically ill horses: a pilot study Dear Dr. van Galen: I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department. If your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information please contact onepress@plos.org. If we can help with anything else, please email us at plosone@plos.org. Thank you for submitting your work to PLOS ONE and supporting open access. Kind regards, PLOS ONE Editorial Office Staff on behalf of Dr. Arianna Miglio Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0247561.r004

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