{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,23]],"date-time":"2026-09-23T18:09:57Z","timestamp":1790186997687,"version":"4.1.0"},"reference-count":34,"publisher":"SAGE Publications","issue":"8","license":[{"start":{"date-parts":[[2024,8,1]],"date-time":"2024-08-01T00:00:00Z","timestamp":1722470400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Diabetes Technology &amp; Therapeutics"],"published-print":{"date-parts":[[2024,8]]},"abstract":"<jats:sec>\n                    <jats:title>Objective:<\/jats:title>\n                    <jats:p>Examine gestational safety, glycemic and health outcomes, of a hybrid closed-loop (HCL) system without pregnancy-specific glucose targets.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Research Design:<\/jats:title>\n                    <jats:p>This was a pilot feasibility investigator-initiated, two-site, single-blind, randomized controlled trial of sensor-augmented pump therapy (SAPT) versus HCL therapy in type 1 diabetes pregnancies. Participants were enrolled in the first trimester and randomized at 14\u201318 weeks of gestation and used SAPT or HCL until 4\u20136 weeks postpartum. We compared continuous glucose monitoring (CGM) metrics, severe hypoglycemia (SH), diabetic ketoacidosis (DKA), adverse skin reactions, and pregnancy outcomes between groups.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>\n                      Baseline characteristics were similar between groups (\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      \u2009=\u200911 HCL and\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      \u2009=\u200912 SAPT). There was no SH or DKA episode after randomization. Time spent &lt;54\u2009mg\/dL did not differ between groups. Time spent &lt;63\u2009mg\/dL decreased in both groups, significantly in the HCL group (3.5% [1.3% standard error] second trimester and 2.8% [1.3%] third trimester vs. 7.9% [1.3%] run-in phase,\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      \u2009&lt;\u20090.05 for both). Mean sensor glucose was lower with SAPT compared to HCL therapy in the third trimester (119 [4] mg\/dL SAPT vs. 132 [4] mg\/dL HCL,\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      \u2009&lt;\u20090.05). Third trimester time-in-range (TIR; 63\u2013140\u2009mg\/dL) increased with SAPT (68.2% [3.1%] vs. 64.3% [3.1%] run-in phase,\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      \u2009&lt;\u20090.05). Gestational health outcomes did not differ between groups. The HCL group used assistive techniques, such as fake carbohydrate boluses and exiting HCL overnight.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>CGM within group differences were seen for time &lt;63\u2009mg\/dL favoring HCL therapy and TIR favoring SAPT (third trimester vs. baseline). Safety and adverse pregnancy outcomes were similar between groups.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1089\/dia.2024.0012","type":"journal-article","created":{"date-parts":[[2024,2,22]],"date-time":"2024-02-22T12:09:32Z","timestamp":1708603772000},"page":"547-555","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":38,"title":["Randomized Trial of Assisted Hybrid Closed-Loop Therapy Versus Sensor-Augmented Pump Therapy in Pregnancy"],"prefix":"10.1177","volume":"26","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7602-0396","authenticated-orcid":false,"given":"Sarit","family":"Polsky","sequence":"first","affiliation":[{"name":"Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6818-8925","authenticated-orcid":false,"given":"Elizabeth","family":"Buschur","sequence":"additional","affiliation":[{"name":"Division of Diabetes, Endocrinology and Metabolism, Ohio State University, Columbus, Ohio, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1289-1595","authenticated-orcid":false,"given":"Kathleen","family":"Dungan","sequence":"additional","affiliation":[{"name":"Division of Diabetes, Endocrinology and Metabolism, Ohio State University, Columbus, Ohio, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rachel","family":"Garcetti","sequence":"additional","affiliation":[{"name":"Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emily","family":"Nease","sequence":"additional","affiliation":[{"name":"Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emily","family":"Malecha","sequence":"additional","affiliation":[{"name":"Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna","family":"Bartholomew","sequence":"additional","affiliation":[{"name":"Division of Maternal and Fetal Medicine, Ohio State University, Columbus, Ohio, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0000-8100-1379","authenticated-orcid":false,"given":"Carly","family":"Johnson","sequence":"additional","affiliation":[{"name":"Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura","family":"Pyle","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA."},{"name":"Department of Biostatistics and Informatics, Colorado School of Public Health, Aurora, Colorado, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Janet","family":"Snell-Bergeon","sequence":"additional","affiliation":[{"name":"Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2024,8,8]]},"reference":[{"key":"e_1_3_6_2_2","doi-asserted-by":"publisher","DOI":"10.2337\/dc23-S015"},{"key":"e_1_3_6_3_2","doi-asserted-by":"publisher","DOI":"10.1210\/clinem\/dgaa931"},{"key":"e_1_3_6_4_2","doi-asserted-by":"publisher","DOI":"10.2337\/dc11-1687dc11-dc1687[pii]"},{"key":"e_1_3_6_5_2","doi-asserted-by":"publisher","DOI":"10.2337\/dci19-0028"},{"key":"e_1_3_6_6_2","doi-asserted-by":"publisher","DOI":"10.1007\/s00125-019-4904-3"},{"key":"e_1_3_6_7_2","doi-asserted-by":"publisher","DOI":"10.2337\/dc15-0070"},{"key":"e_1_3_6_8_2","doi-asserted-by":"publisher","DOI":"10.1089\/dia.2021.0138"},{"key":"e_1_3_6_9_2","doi-asserted-by":"publisher","DOI":"10.1089\/dia.2016.0421"},{"key":"e_1_3_6_10_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1907863"},{"key":"e_1_3_6_11_2","doi-asserted-by":"publisher","DOI":"10.2337\/dc21-0172"},{"key":"e_1_3_6_12_2","doi-asserted-by":"publisher","DOI":"10.1089\/dia.2021.0097"},{"key":"e_1_3_6_13_2","doi-asserted-by":"publisher","DOI":"10.1089\/dia.2018.0306"},{"key":"e_1_3_6_14_2","doi-asserted-by":"publisher","DOI":"10.1001\/jamapediatrics.2021.3965"},{"key":"e_1_3_6_15_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1602494"},{"key":"e_1_3_6_16_2","doi-asserted-by":"publisher","DOI":"10.2337\/dc17-2534"},{"key":"e_1_3_6_17_2","doi-asserted-by":"publisher","DOI":"10.1111\/dme.13406"},{"key":"e_1_3_6_18_2","doi-asserted-by":"publisher","DOI":"10.1177\/1932296818800065"},{"key":"e_1_3_6_19_2","doi-asserted-by":"publisher","DOI":"10.1089\/dia.2021.0521"},{"key":"e_1_3_6_20_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2303911"},{"key":"e_1_3_6_21_2","doi-asserted-by":"publisher","DOI":"10.1002\/dmrr.3248"},{"key":"e_1_3_6_22_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.aace.2020.11.039"},{"key":"e_1_3_6_23_2","doi-asserted-by":"publisher","DOI":"10.1155\/2021\/7310176"},{"key":"e_1_3_6_24_2","doi-asserted-by":"publisher","DOI":"10.1089\/dia.2015.0410"},{"key":"e_1_3_6_25_2","unstructured":"Medtronic. Indications Safety and Warnings: Diabetes. Available from: https:\/\/www.medtronic.com\/us-en\/healthcare-professionals\/products\/diabetes\/indications-safety-warnings.html#:\u223c:text=Taking%20medications%20with%20acetaminophen%20while be%20different%20for%20each%20person [Last accessed: September19 2023]."},{"key":"e_1_3_6_26_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajog.2017.12.011"},{"key":"e_1_3_6_27_2","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0216851"},{"key":"e_1_3_6_28_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ecl.2010.05.005"},{"key":"e_1_3_6_29_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(17)32400-5"},{"key":"e_1_3_6_30_2","doi-asserted-by":"publisher","DOI":"10.1007\/s00125-019-4850-0"},{"key":"e_1_3_6_31_2","doi-asserted-by":"publisher","DOI":"10.2337\/dc22-0078"},{"key":"e_1_3_6_32_2","doi-asserted-by":"publisher","DOI":"10.1089\/dia.2022.0540"},{"key":"e_1_3_6_33_2","doi-asserted-by":"publisher","DOI":"10.1210\/endrev\/bnac022"},{"key":"e_1_3_6_34_2","doi-asserted-by":"publisher","DOI":"10.1016\/S2213-8587(23)00116-X"},{"key":"e_1_3_6_35_2","doi-asserted-by":"publisher","DOI":"10.2337\/dc23-0173"}],"container-title":["Diabetes Technology &amp; Therapeutics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1089\/dia.2024.0012","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1089\/dia.2024.0012","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1089\/dia.2024.0012","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T18:14:41Z","timestamp":1777400081000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1089\/dia.2024.0012"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,8]]},"references-count":34,"journal-issue":{"issue":"8","published-print":{"date-parts":[[2024,8]]}},"alternative-id":["10.1089\/dia.2024.0012"],"URL":"https:\/\/doi.org\/10.1089\/dia.2024.0012","relation":{},"ISSN":["1520-9156","1557-8593"],"issn-type":[{"value":"1520-9156","type":"print"},{"value":"1557-8593","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,8]]}}}