{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,25]],"date-time":"2026-09-25T21:59:51Z","timestamp":1790373591735,"version":"4.1.0"},"reference-count":32,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2026,9,5]],"date-time":"2026-09-05T00:00:00Z","timestamp":1788566400000},"content-version":"vor","delay-in-days":4,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T00:00:00Z","timestamp":1788220800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Endocrino Diabet &amp; Metabol"],"published-print":{"date-parts":[[2026,9]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Commercial automated insulin delivery (AID) systems are increasingly used in pregnancies complicated by Type 1 diabetes, but the evidence is dispersed across trials, observational studies, case series and qualitative research. Existing syntheses have largely emphasised glycaemic efficacy and selected perinatal outcomes, with less attention to device platform, timing of initiation, psychosocial burden, clinician workload and implementation context.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>To describe the protocol for a mixed\u2010methods systematic review and meta\u2010analysis evaluating the effectiveness, safety, feasibility, acceptability and implementation of commercial AID systems in Type 1 diabetes pregnancy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>MEDLINE, Embase, CINAHL, Scopus, Emcare, the Cochrane Library, CENTRAL and ClinicalTrials.gov will be searched from 1 January 2010, with an update search before final synthesis. Eligible evidence will include randomised and non\u2010randomised comparative studies, observational cohorts, case series, qualitative studies and mixed\u2010methods studies involving pregnant women with Type 1 diabetes using commercial AID systems, including off\u2010label pregnancy use. Two reviewers will independently screen, extract and appraise studies and inter\u2010rater agreement will be reported. Randomised and non\u2010randomised comparative evidence will be synthesised separately and, where studies are sufficiently comparable, meta\u2010analysed within study\u2010design and comparator strata. Quantitative outcomes will include pregnancy\u2010specific time in range, other continuous glucose monitoring (CGM) metrics, maternal and neonatal outcomes, diabetes\u2010specific adverse events, psychosocial measures, cost, resource use, feasibility, implementation and early postpartum outcomes. Qualitative evidence will be synthesised thematically and integrated with quantitative findings using a convergent segregated approach.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>The review will clarify what is known about commercial AID use in Type 1 diabetes pregnancy and identify patient\u2010, device\u2010, clinician\u2010 and service\u2010level factors relevant to implementation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial Registration<\/jats:title>\n                    <jats:p>This systematic review protocol is registered with PROSPERO: CRD420251025194<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/edm2.70309","type":"journal-article","created":{"date-parts":[[2026,9,5]],"date-time":"2026-09-05T15:09:40Z","timestamp":1788620980000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Commercial Automated Insulin Delivery Systems in Type 1 Diabetes Pregnancy: Protocol for a Mixed\u2010Methods Systematic Review and Meta\u2010Analysis of Glycaemic, Perinatal, Psychosocial and Implementation Outcomes"],"prefix":"10.1002","volume":"9","author":[{"ORCID":"https:\/\/orcid.org\/0009-0001-1416-5354","authenticated-orcid":false,"given":"Jieli","family":"Li","sequence":"first","affiliation":[{"name":"Monash Centre for Health Research and Implementation, Faculty of Medicine, Nursing and Health Sciences Monash University  Melbourne Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elahe","family":"Sheklabadi","sequence":"additional","affiliation":[{"name":"Monash Centre for Health Research and Implementation, Faculty of Medicine, Nursing and Health Sciences Monash University  Melbourne Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rebecca F.","family":"Goldstein","sequence":"additional","affiliation":[{"name":"Monash Centre for Health Research and Implementation, Faculty of Medicine, Nursing and Health Sciences Monash University  Melbourne Victoria Australia"},{"name":"Diabetes and Endocrinology Unit Monash Health  Melbourne Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8261-6006","authenticated-orcid":false,"given":"Ashley H.","family":"Ng","sequence":"additional","affiliation":[{"name":"Monash Centre for Health Research and Implementation, Faculty of Medicine, Nursing and Health Sciences Monash University  Melbourne Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7609-577X","authenticated-orcid":false,"given":"Helena","family":"Teede","sequence":"additional","affiliation":[{"name":"Monash Centre for Health Research and Implementation, Faculty of Medicine, Nursing and Health Sciences Monash University  Melbourne Victoria Australia"},{"name":"Diabetes and Endocrinology Unit Monash Health  Melbourne Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Negar","family":"Naderpoor","sequence":"additional","affiliation":[{"name":"Monash Centre for Health Research and Implementation, Faculty of Medicine, Nursing and Health Sciences Monash University  Melbourne Victoria Australia"},{"name":"Diabetes and Endocrinology Unit Monash Health  Melbourne Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,9,5]]},"reference":[{"key":"e_1_2_15_2_1","volume-title":"National Pregnancy in Diabetes Audit\u2014Hybrid Closed Loop 2025 (01 January 2025 to 31 December 2025)","author":"NHS England","year":"2026"},{"key":"e_1_2_15_3_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.38043.583160.EE"},{"key":"e_1_2_15_4_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00125\u2010017\u20104314\u20103"},{"key":"e_1_2_15_5_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc26\u2010S015"},{"key":"e_1_2_15_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2213\u20108587(23)00116\u2010X"},{"key":"e_1_2_15_7_1","unstructured":"National Institute for Health and Care Excellence \u201cDiabetes in Pregnancy: Management From Preconception to the Postnatal Period \u201d(2020) https:\/\/www.nice.org.uk\/guidance\/ng3."},{"key":"e_1_2_15_8_1","doi-asserted-by":"publisher","DOI":"10.1093\/ejendo\/lvaf116"},{"key":"e_1_2_15_9_1","doi-asserted-by":"publisher","DOI":"10.2337\/dci19\u20100028"},{"key":"e_1_2_15_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140\u20106736(17)32400\u20105"},{"key":"e_1_2_15_11_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00125\u2010019\u20104850\u20100"},{"key":"e_1_2_15_12_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc22\u20100078"},{"key":"e_1_2_15_13_1","doi-asserted-by":"publisher","DOI":"10.1177\/19322968231223934"},{"key":"e_1_2_15_14_1","doi-asserted-by":"publisher","DOI":"10.4093\/dmj.2024.0130"},{"key":"e_1_2_15_15_1","doi-asserted-by":"publisher","DOI":"10.1089\/dia.2022.0540"},{"key":"e_1_2_15_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2213\u20108587(24)00089\u20105"},{"key":"e_1_2_15_17_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12884\u2010025\u201008420\u20103"},{"key":"e_1_2_15_18_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2025.19578"},{"key":"e_1_2_15_19_1","doi-asserted-by":"publisher","DOI":"10.1089\/dia.2023.0323"},{"key":"e_1_2_15_20_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2303911"},{"key":"e_1_2_15_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jdiacomp.2024.108795"},{"key":"e_1_2_15_22_1","doi-asserted-by":"publisher","DOI":"10.7759\/cureus.52369"},{"key":"e_1_2_15_23_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.diabres.2025.112454"},{"key":"e_1_2_15_24_1","doi-asserted-by":"publisher","DOI":"10.1089\/dia.2022.0479"},{"key":"e_1_2_15_25_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejogrb.2025.113969"},{"key":"e_1_2_15_26_1","unstructured":"U.S. Food and Drug Administration \u201c510(k) Premarket Notification K232603: CamAPS FX Decision Summary \u201d(2024) https:\/\/www.accessdata.fda.gov\/cdrh_docs\/reviews\/K232603.pdf."},{"key":"e_1_2_15_27_1","doi-asserted-by":"publisher","DOI":"10.1186\/2046\u20104053\u20104\u20101"},{"key":"e_1_2_15_28_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.n71"},{"key":"e_1_2_15_29_1","doi-asserted-by":"publisher","DOI":"10.46658\/JBIMES-24-07"},{"key":"e_1_2_15_30_1","volume-title":"Critical Appraisal Tools","author":"JBI"},{"key":"e_1_2_15_31_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.39489.470347.AD"},{"key":"e_1_2_15_32_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.1001895"},{"key":"e_1_2_15_33_1","doi-asserted-by":"publisher","DOI":"10.1186\/1471\u20102288\u20108\u201045"}],"container-title":["Endocrinology, Diabetes &amp; Metabolism"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/edm2.70309","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/edm2.70309","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/edm2.70309","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,25]],"date-time":"2026-09-25T21:10:35Z","timestamp":1790370635000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/edm2.70309"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,9]]},"references-count":32,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2026,9]]}},"alternative-id":["10.1002\/edm2.70309"],"URL":"https:\/\/doi.org\/10.1002\/edm2.70309","archive":["Portico"],"relation":{},"ISSN":["2398-9238","2398-9238"],"issn-type":[{"value":"2398-9238","type":"print"},{"value":"2398-9238","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,9]]},"assertion":[{"value":"2026-06-17","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-08-07","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-09-05","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70309"}}