Performance and patients’ satisfaction with the A7+TouchCare insulin patch pump system: A randomized controlled non-inferiority study

Coralie Amadou; Vincent Melki; Jennifer Allain; Sylvaine Clavel; Didier Gouet; Lucy Chaillous; Bogdan Catargi; Pauline Schaeplynck-Belicard; Catherine Petit; Charles Thivolet; Alfred Penfornis

doi:10.1371/journal.pone.0289684

Peer Review History

Original SubmissionJuly 16, 2022
4 Nov 2022 Decision Letter - Maria Elisabeth Johanna Zalm, Editor PONE-D-22-17489Performance and patients’satisfaction with the A7+TouchCare insulin patch pump system: a randomized controlled non-inferiority studyPLOS ONE Dear Dr. Amadou, 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. Your manuscript has been assessed by two reviewers and their reports are appended below. The reviewers comment that the discussion section should comment on device disfunction and other adverse events reported for the pump. In addition, the reviewers have requested further detail and/or clarifications regarding the statistical analyses reported in this study. Furthermore, the journal's editorial team has noted that the ethics statement in this article reports that "The study was approved by an independent ethic committee" only. Please provide more details regarding the ethics committee that approved this study. Could you please revise the manuscript to carefully address the concerns raised? Please submit your revised manuscript by Dec 16 2022 11:59PM. 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. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file. Please include the following items when submitting your revised manuscript: A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'. A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'. An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'. If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter. If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: https://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols. Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-email&utm_source=authorletters&utm_campaign=protocols. We look forward to receiving your revised manuscript. Kind regards, Maria Elisabeth Johanna Zalm, Ph.D Editorial Office PLOS ONE Journal Requirements: When submitting your revision, we need you to address these additional requirements. 1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. 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. Thank you for stating the following financial disclosure: YES. The study was funded by Medtrum France (Boulogne Billancourt, France). Please state what role the funders took in the study. If the funders had no role, please state: "The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript." If this statement is not correct you must amend it as needed. Please include this amended Role of Funder statement in your cover letter; we will change the online submission form on your behalf. 3. Thank you for stating the following in the Competing Interests section: I have read the journal's policy and the authors of this manuscript have the following competing interests: C.A. has received writing/consulting honoraria from Medtrum for the present study, declares congress invitations from Eli Lilly, Astrazeneca, and Sanofi; has received speaker honoraria from Diabeloop SA and Eli Lilly; has served on advisory board panels for Eli Lilly. V.M. has received congress invitations from: Novo-Nordisk, Isis, Sadir, Vitalaire, Orkyn, Medtronic, and speaker fees or consultancy for expertise from: Medtrum, ISIS, Novo-Nordis. J.A. has received congress invitations, speaker honoraria, and consultancy fees from Lilly, Sanofi and Medtronic and has served on advisory board panels for Novonordisk, Ypsomed, Medtrum and Glooko. S.C. has received no congress invitations, speaker honoraria, and consultancy fees over the last 24 months. D.G. has received congress invitations, speaker honoraria, and consultancy fees from Eli-Lilly, Novo-Nordisk, Sanofi-Diabète, Abbott, Medtronic, Astra Zeneca. L.C. declares that she has no engagement, fees or honoraria conflicting with her participation to the project. B.C. has received congress invitations, speaker honoraria, and consultancy fees from Medtronic Dexcom and Abbott. P.S.-B. has received conference invitations, honoraria and consultancies from Abbott Diabetes Care, Eli-Lilly, Novo-Nordisk, Roche Diabetes Care and Ypsomed. C.P. has received no congress invitations, speaker honoraria, and consultancy fees over the last 24 months. C.T. has received honoraria for consultancy, speaker for conferences and congress invitations, from Abbott, Janssen, Lilly, Medtronic, Roche Diabetes Care, Sanofi. A.P. has received congress invitations, speaker honoraria, and consultancy fees from Abbott, Eli Lilly and Company, Lifescan, Medtronic, Novo Nordisk, and Sanofi, and has served on advisory board panels for Abbott, Insulet, Medtrum, Novo Nordisk, and Sanofi. Please confirm that this does not alter your adherence to all PLOS ONE policies on sharing data and materials, by including the following statement: "This does not alter our adherence to PLOS ONE policies on sharing data and materials.” (as detailed online in our guide for authors http://journals.plos.org/plosone/s/competing-interests). If there are restrictions on sharing of data and/or materials, please state these. Please note that we cannot proceed with consideration of your article until this information has been declared. Please include your updated Competing Interests statement in your cover letter; we will change the online submission form on your behalf. 4. We note that you have indicated that data from this study are available upon request. PLOS only allows data to be available upon request if there are legal or ethical restrictions on sharing data publicly. For information on unacceptable data access restrictions, please see http://journals.plos.org/plosone/s/data-availability#loc-unacceptable-data-access-restrictions. In your revised cover letter, please address the following prompts: a) If there are ethical or legal restrictions on sharing a de-identified data set, please explain them in detail (e.g., data contain potentially identifying or sensitive patient information) and who has imposed them (e.g., an ethics committee). Please also provide contact information for a data access committee, ethics committee, or other institutional body to which data requests may be sent. b) If there are no restrictions, please upload the minimal anonymized data set necessary to replicate your study findings as either Supporting Information files or to a stable, public repository and provide us with the relevant URLs, DOIs, or accession numbers. Please see http://www.bmj.com/content/340/bmj.c181.long for guidelines on how to de-identify and prepare clinical data for publication. For a list of acceptable repositories, please see http://journals.plos.org/plosone/s/data-availability#loc-recommended-repositories. We will update your Data Availability statement on your behalf to reflect the information you provide. 5. Your ethics statement should only appear in the Methods section of your manuscript. If your ethics statement is written in any section besides the Methods, please delete it from any other section. 6. Please include captions for your Supporting Information files at the end of your manuscript, and update any in-text citations to match accordingly. Please see our Supporting Information guidelines for more information: http://journals.plos.org/plosone/s/supporting-information. [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: Partly ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes 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: No ****** 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: The article “Performance and patients’satisfaction with the A7+TouchCare insulin patch pump system: a randomized controlled non-inferiority study” by Amadou and colleagues describes a clinical study with insulin pumps. The study is well-designed and results are presented in a comprehensive manner. Thank you for this nice contribution. I only have some minor comments: General: I would recommend using the term “glucose management indicator (GMI)” instead of “estimated A1C” as this is state of the art and the methods section references the article by Bergenstal et al. that introduced the GMI Methods: Obviously there was no inclusion criterion that describes a minimum required duration of pump use before study start. According to Table 1 the minimum duration was 0.1 years. This appears too short to be able to differentiate study outcomes from improvements in HbA1c due to change from MDI to CSII. Results and Discussion: It seems like there is a kind of safety issue with the A7+TouchCare pumps, because 7 patients dropped out due to intolerance or device dysfunction and in general, there were more adverse events with this pump. I think this is should be paid more attention in the discussion of the article. Author contributions: All investigators all listed as authors, but most of them did not make any further contributions to the manuscript. This is not conform with the ICMJE authorship criteria; e.g. critically revising the manuscript is another required contribution. Reviewer #2: Here are some comments: Statistical methods: “In addition, univariate analyses were performed on age in class (according to the median value), gender, diabetes mellitus type, center, and duration of diabetes.Variables with a p-value less than 0.05 were included in the multivariate model using a stepwise strategy.” My comment here is that conclusions on these variables should be drawn from a full model i.e. a multiple model including all variables. The stepwise strategy is not needed and if any adjustment for the primary analysis is done, why not adjust for all? Table 1. Why include statistical tests. Since this is a randomized trial this is not needed. Read about “the table 1 fallacy” and point 15 in the consort checklist http://www.consort-statement.org/checklists/view/32--consort-2010/510-baseline-data. How was the p-value for non-inferiority calculated (table 2)? Probably through the lsmeans statement, include this in the methods. Table S1: Please indicate which test that is used and double check the p-values, is the result for “Redness” correct? Why is the “other adverse events” not discussed and is the conclusion “Overall, the A7+TouchCare may be a safe and valuable alternative to Omnipod..” correct? Minor: The following sentence is repeated: “The inclusion of patients already using a pump was done to facilitate recruitment into the study. The inclusion of patients already using a pump was done to facilitate recruitment into the study.” ****** 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. https://doi.org/10.1371/journal.pone.0289684.r001
Revision 1
28 Feb 2023 Author Response Dear Editor, The manuscript has been revised. You will find answers to each comment below (italics and bold). Major and minor corrections (responding to comments) have been highlighted in yellow in the revised manuscript (“Revised Manuscript with Track Changes”). We also provide a final clean version (“'Manuscript”). We are confident that the quality of the manuscript is now improved, and we hope our revised version will be considered suitable for publication. “The reviewers comment that the discussion section should comment on device dysfunction and other adverse events reported for the pump. In addition, the reviewers have requested further detail and/or clarifications regarding the statistical analyses reported in this study.” We made a detailed response for each comment. Furthermore, the journal's editorial team has noted that the ethics statement in this article reports that "The study was approved by an independent ethic committee" only. Please provide more details regarding the ethics committee that approved this study. The study was approved by the following French ethics committee: CPP VI CHU G. MONTPIED – Administration centrale – 58 rue Montalembert BP 69 – 63003 CLERMONT FERRAND cedex 1, FRANCE Tél : +33 4 73 75 10 73 – Fax : +33 4 73 75 10 69 mail : cpp-sudest6@chu-clermontferrand.fr When submitting your revision, we need you to address these additional requirements. 1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. 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 The manuscript and attached files have been revised in accordance with Plos One’s style requirement. 2. Thank you for stating the following financial disclosure: YES. The study was funded by Medtrum France (Boulogne Billancourt, France). Please state what role the funders took in the study. If the funders had no role, please state: "The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript." If this statement is not correct, you must amend it as needed. Please include this amended Role of Funder statement in your cover letter; we will change the online submission form on your behalf. Amended statement “Medtrum Technologies Inc. Shanghai supported this study. The funders had no role in study design, data collection and analysis. AP (principal investigator) takes full responsibility for the work, including the decision to submit and publish the manuscript. The findings and conclusions in this study are those of the authors and do not necessarily represent the sponsors' views” 3. Thank you for stating the following in the Competing Interests section: I have read the journal's policy and the authors of this manuscript have the following competing interests: C.A. has received writing/consulting honoraria from Medtrum for the present study, declares congress invitations from Eli Lilly, Astrazeneca, and Sanofi; has received speaker honoraria from Diabeloop SA and Eli Lilly; has served on advisory board panels for Eli Lilly. V.M. has received congress invitations from: Novo-Nordisk, Isis, Sadir, Vitalaire, Orkyn, Medtronic, and speaker fees or consultancy for expertise from: Medtrum, ISIS, Novo-Nordis. J.A. has received congress invitations, speaker honoraria, and consultancy fees from Lilly, Sanofi and Medtronic and has served on advisory board panels for Novonordisk, Ypsomed, Medtrum and Glooko. S.C. has received no congress invitations, speaker honoraria, and consultancy fees over the last 24 months. D.G. has received congress invitations, speaker honoraria, and consultancy fees from Eli-Lilly, Novo-Nordisk, Sanofi-Diabète, Abbott, Medtronic, Astra Zeneca. L.C. declares that she has no engagement, fees or honoraria conflicting with her participation to the project. B.C. has received congress invitations, speaker honoraria, and consultancy fees from Medtronic Dexcom and Abbott. P.S.-B. has received conference invitations, honoraria and consultancies from Abbott Diabetes Care, Eli-Lilly, Novo-Nordisk, Roche Diabetes Care and Ypsomed. C.P. has received no congress invitations, speaker honoraria, and consultancy fees over the last 24 months. C.T. has received honoraria for consultancy, speaker for conferences and congress invitations, from Abbott, Janssen, Lilly, Medtronic, Roche Diabetes Care, Sanofi. A.P. has received congress invitations, speaker honoraria, and consultancy fees from Abbott, Diabeloop, Eli Lilly and Company, Insulet, Lifescan, Medtronic, Novo Nordisk, and Sanofi, and has served on advisory board panels for Abbott, Insulet, Medtrum, Novo Nordisk, and Sanofi. Please confirm that this does not alter your adherence to all PLOS ONE policies on sharing data and materials, by including the following statement: "This does not alter our adherence to PLOS ONE policies on sharing data and materials.” (as detailed online in our guide for authors http://journals.plos.org/plosone/s/competing-interests). If there are restrictions on sharing of data and/or materials, please state these. Please note that we cannot proceed with consideration of your article until this information has been declared. Please include your updated Competing Interests statement in your cover letter; we will change the online submission form on your behalf. The competing interests section has been updated in line with Plos One requirement. 4. We note that you have indicated that data from this study are available upon request. PLOS only allows data to be available upon request if there are legal or ethical restrictions on sharing data publicly. For information on unacceptable data access restrictions, please see http://journals.plos.org/plosone/s/data-availability#loc-unacceptable-data-access-restrictions. In your revised cover letter, please address the following prompts: a) If there are ethical or legal restrictions on sharing a de-identified data set, please explain them in detail (e.g., data contain potentially identifying or sensitive patient information) and who has imposed them (e.g., an ethics committee). Please also provide contact information for a data access committee, ethics committee, or other institutional body to which data requests may be sent. Ethical and legal restrictions apply to the data as public data-sharing was not planned in the information letter given to and signed by participants at inclusion in the study. Data-sharing would therefore require an amendment of the information given to patients after acceptance by the ethics committee and then participants. Here is the contact access for the ethics committee that approved the study: CPP VI CHU G. MONTPIED – Administration centrale – 58 rue Montalembert BP 69 – 63003 CLERMONT FERRAND cedex 1, FRANCE Tél : +33 4 73 75 10 73 – Fax : +33 4 73 75 10 69 mail : cpp-sudest6@chu-clermontferrand.fr b) If there are no restrictions, please upload the minimal anonymized data set necessary to replicate your study findings as either Supporting Information files or to a stable, public repository and provide us with the relevant URLs, DOIs, or accession numbers. Please see http://www.bmj.com/content/340/bmj.c181.long for guidelines on how to de-identify and prepare clinical data for publication. For a list of acceptable repositories, please see http://journals.plos.org/plosone/s/data-availability#loc-recommended-repositories. We will update your Data Availability statement on your behalf to reflect the information you provide. 5. Your ethics statement should only appear in the Methods section of your manuscript. If your ethics statement is written in any section besides the Methods, please delete it from any other section. The ethics statement appears only in the Methods section now. 6. Please include captions for your Supporting Information files at the end of your manuscript, and update any in-text citations to match accordingly. Please see our Supporting Information guidelines for more information: http://journals.plos.org/plosone/s/supporting-information. The caption for supporting information (supplemental table one) has been listed at the end of the manuscript as required. 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: Partly 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes 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: No 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: The article “Performance and patients’ satisfaction with the A7+TouchCare insulin patch pump system: a randomized controlled non-inferiority study” by Amadou and colleagues describes a clinical study with insulin pumps. The study is well-designed and results are presented in a comprehensive manner. Thank you for this nice contribution. I only have some minor comments: General: I would recommend using the term “glucose management indicator (GMI)” instead of “estimated A1C” as this is state of the art and the methods section references the article by Bergenstal et al. that introduced the GMI This has been corrected in the text. Methods: Obviously there was no inclusion criterion that describes a minimum required duration of pump use before study start. According to Table 1 the minimum duration was 0.1 years. This appears too short to be able to differentiate study outcomes from improvements in HbA1c due to change from MDI to CSII. We understand your concern, but the participants were randomized at baseline, so the effect of the switch from MDI to CSII is supposed to be the same in the two groups. Most patients had been using a pump for 5-7 months. The patients' motivation was to have the opportunity to test an innovative and smaller device. The aim of the study was not to demonstrate superiority of the Medtrum device but to show that the results were similar to Insulet under comparable conditions. Results and Discussion: It seems like there is a kind of safety issue with the A7+TouchCare pumps, because 7 patients dropped out due to intolerance or device dysfunction and in general, there were more adverse events with this pump. I think this is should be paid more attention in the discussion of the article. There are indeed more AEs and dysfunctions reported in the A7+ Touchcare group. It appeared after discussion with the centres that patients who had already been using the Omnipod pump for several months did not report all events because they were used to their occurrence. On the other hand, in the A7+ Touchcare group, patients who received minimal and rapid training did not always have a perfect mastery of the devices and probably had a more systematic notification of events. Furthermore, it should be remembered that the study was carried out in the context of the covid epidemic, with support from the health care teams that was somewhat different from a normal context, which may have increased the anxiety of the patients in the A7+ Touchcare group when events occurred. Author contributions: All investigators all listed as authors, but most of them did not make any further contributions to the manuscript. This is not conform with the ICMJE authorship criteria; e.g. critically revising the manuscript is another required contribution. The manuscript has been sent for review and validation to all co-investigators. The author contribution statement has now been updated. Reviewer #2: Here are some comments: Statistical methods: “In addition, univariate analyses were performed on age in class (according to the median value), gender, diabetes mellitus type, center, and duration of diabetes. Variables with a p-value less than 0.05 were included in the multivariate model using a stepwise strategy.” My comment here is that conclusions on these variables should be drawn from a full model i.e. a multiple model including all variables. The stepwise strategy is not needed and if any adjustment for the primary analysis is done, why not adjust for all? Indeed, only one variable was significant at the 5% level, so we removed the stepwise strategy in the article since it was considered but not used. Table 1. Why include statistical tests. Since this is a randomized trial this is not needed. Read about “the table 1 fallacy” and point 15 in the consort checklist http://www.consort-statement.org/checklists/view/32--consort-2010/510-baseline-data. You are right, the p-values should not be displayed in table 1. We removed it from the table. How was the p-value for non-inferiority calculated (table 2)? Probably through the lsmeans statement, include this in the methods. We have added this precision in the text. Table S1: Please indicate which test that is used and double check the p-values, is the result for “Redness” correct? Thank you for your attention. The value for redness was wrong (but still not significant) and has been modified. Why is the “other adverse events” not discussed and is the conclusion “Overall, the A7+TouchCare may be a safe and valuable alternative to Omnipod..” correct? Only the main adverse events usually described in the use of pumps and sensors were retained, the other AEs being minor. In addition, it should be noted that there is a potential bias because the patients in the Omnipod pump group had all been using the system for several months prior to inclusion and were therefore already sufficiently tolerant. This had the consequence of reducing or even not reporting tolerance problems that patients in this group are used to. We agree to change the conclusion sentence to “Overall, the A7+TouchCare may be a valuable alternative to Omnipod or other insulin patch pumps in some patients with diabetes.” Minor: The following sentence is repeated: “The inclusion of patients already using a pump was done to facilitate recruitment into the study. The inclusion of patients already using a pump was done to facilitate recruitment into the study.” This has now been corrected in the text. 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 Attachments Attachment Submitted filename: Response to editor and reviewers.docx https://doi.org/10.1371/journal.pone.0289684.r002
16 Jun 2023 Decision Letter - Aleksandra Klisic, Editor PONE-D-22-17489R1Performance and patients’satisfaction with the A7+TouchCare insulin patch pump system: a randomized controlled non-inferiority studyPLOS ONE Dear Dr. Amadou, 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. Please submit your revised manuscript by Jul 31 2023 11:59PM. 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. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file. Please include the following items when submitting your revised manuscript: A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'. A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'. An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'. If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter. If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: https://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols. Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-email&utm_source=authorletters&utm_campaign=protocols. We look forward to receiving your revised manuscript. Kind regards, Aleksandra Klisic Academic Editor PLOS ONE Journal Requirements: Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice. [Note: HTML markup is below. Please do not edit.] Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation. Reviewer #2: All comments have been addressed Reviewer #3: All comments have been addressed ******** 2. 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 #2: (No Response) Reviewer #3: Yes ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #2: (No Response) Reviewer #3: Yes ****** 4. 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 #2: (No Response) Reviewer #3: Yes ****** 5. 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 #2: (No Response) Reviewer #3: Yes ****** 6. 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 #2: (No Response) Reviewer #3: PONE-D-22-17489R1 This is an interesting and well written study, as we lack RCTs regarding the achievements of insulin patch pumps. The current report adresses both performance and satisfaction with a new insulin patch pump in an appopriate, randomized design. My main concern is that the abstract does not mention about the flow chart and premature study withdrawals, which were more frequent in the Touchcare group, leading to a desequilibrium between the two groups in the per protocol analysis. Regarding satisfaction, the sentence on page 12 about the preference score is unclear, as the insulin management system, opposed to the patch insulin delivery system and the PDM, have not been clearly defined in the Materials section. Minor comment: in the Method section, please state whether the fast insulin analog URLI was allowed or not. ****** 7. 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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. https://doi.org/10.1371/journal.pone.0289684.r003
Revision 2
6 Jul 2023 Author Response Dear Editor, The manuscript has been revised. You will find answers to each comment below (italics and bold). Major and minor corrections (responding to comments) have been highlighted in yellow in the revised manuscript (“Revised Manuscript with Track Changes”). We also provide a final clean version (“'Manuscript”). We are confident that the quality of the manuscript is now improved, and we hope our revised version will be considered suitable for publication. The original comments of reviewers are written in blue and our response in black just below. This is an interesting and well written study, as we lack RCTs regarding the achievements of insulin patch pumps. The current report adresses both performance and satisfaction with a new insulin patch pump in an appopriate, randomized design. My main concern is that the abstract does not mention about the flow chart and premature study withdrawals, which were more frequent in the Touchcare group, leading to a desequilibrium between the two groups in the per protocol analysis. � We have modified the abstract and added the number of premature withdrawals in each group. Regarding satisfaction, the sentence on page 12 about the preference score is unclear, as the insulin management system, opposed to the patch insulin delivery system and the PDM, have not been clearly defined in the Materials section. � We agree that the sentence is not clear. The insulin management system designs the patch insulin delivery system and the PDM as a whole. We propose to modify the sentence by writing: “The preference score was 3.7±1.5 for the patch insulin delivery system, 1.9±1.3 for the PDM and 3.2±1.4 for the insulin management system (designing the patch insulin delivery and PDM as a whole). Minor comment: in the Method section, please state whether the fast insulin analog URLI was allowed or not. � The fast insulin analog URLI was not allowed in this study as it was not available in France at the moment of the study protocol development. Dr Coralie Amadou, for all authors. Attachments Attachment Submitted filename: Response to Reviewers.docx https://doi.org/10.1371/journal.pone.0289684.r004
25 Jul 2023 Decision Letter - Aleksandra Klisic, Editor Performance and patients’satisfaction with the A7+TouchCare insulin patch pump system: a randomized controlled non-inferiority study PONE-D-22-17489R2 Dear Dr. Amadou, 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, Aleksandra Klisic Academic Editor PLOS ONE Additional Editor Comments (optional): Dear Author, The manuscript PONE-D-22-17489R2 "Performance and patients’ satisfaction with the A7+TouchCare insulin patch pump system: a randomized controlled non-inferiority study" by Dr Coralie Amadou is accepted for publication in PLOS ONE. Sincerely, Aleksandra Klisic https://doi.org/10.1371/journal.pone.0289684.r005
Formally Accepted
14 Aug 2023 Acceptance Letter - Aleksandra Klisic, Editor PONE-D-22-17489R2 Performance and patients’satisfaction with the A7+TouchCare insulin patch pump system: a randomized controlled non-inferiority study Dear Dr. Amadou: 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. Aleksandra Klisic Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0289684.r006

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