{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,18]],"date-time":"2026-09-18T06:06:28Z","timestamp":1789711588030,"version":"4.0.1"},"reference-count":41,"publisher":"Wiley","license":[{"start":{"date-parts":[[2026,9,17]],"date-time":"2026-09-17T00:00:00Z","timestamp":1789603200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,9,17]],"date-time":"2026-09-17T00:00:00Z","timestamp":1789603200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["dom-pubs.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Diabetes Obesity Metabolism"],"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To evaluate whether the myLoop powered by CamAPS FX hybrid closed\u2010loop (HCL) system improves glycaemic control and to explore selected psychological outcomes in adults with Type 1 diabetes (T1DM), markedly elevated HbA1c, and predefined psychological burden.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Research Design and Methods<\/jats:title>\n                    <jats:p>In a 3\u2010month multicentre, open\u2010label, randomised, controlled, parallel\u2010group clinical trial, adults with T1DM, HbA1c \u2265\u20099.0%, and psychological vulnerability were randomly assigned to myLoop CamAPS FX or optimised pre\u2010study insulin therapy with Dexcom G6. Primary outcomes were between\u2010group differences in changes in HbA1c and time in range (TIR) at 3\u2009months. Psychological outcomes were prespecified as descriptive, exploratory within\u2010group changes using validated questionnaires.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Thirty participants were randomised (mean age 32.7\u2009\u00b1\u200912.8\u2009years; diabetes duration 13.3\u2009\u00b1\u20098.5\u2009years; baseline HbA1c 10.5%\u2009\u00b1\u20091.3%, TIR 29.6%\u2009\u00b1\u200918.9%). From baseline to 3\u2009months, mean HbA1c and TIR changed by \u22122.5% and +27.4% in the myLoop CamAPS FX group and by \u22120.9% and \u22122.7% in the control group, with adjusted differences of \u22121.7% (95% CI: \u22122.6; \u22120.8) for HbA1c and 28.8% (95% CI: 16.8; 40.9) for TIR in favour of myLoop CamAPS FX. Diabetes burnout decreased in both groups, but only the myLoop CamAPS FX group moved from above to at or below the prespecified study threshold (median 3.5\u20132.0;\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.012). Psychological well\u2010being increased in the mylife CamAPS FX group (World Health Organization Five Well\u2010Being Index [WHO\u20105]: 12.0\u201314.0;\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.031), while anxiety\u2010related symptoms decreased in both groups. Changes in diabetes distress and depressive symptoms were modest; reductions in PHQ\u20109 and PAID scores were observed only in the control group. These psychological findings are exploratory and are not based on formal between\u2010group efficacy testing.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>In adults with T1DM, markedly elevated HbA1c, and substantial psychological burden, myLoop CamAPS FX significantly improved glycaemic control compared with standard therapy. During HCL use, decreases in diabetes burnout and anxiety\u2010related symptoms and an improvement in psychological well\u2010being were observed; these exploratory psychological findings require confirmation in adequately powered between\u2010group analyses.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/dom.71339","type":"journal-article","created":{"date-parts":[[2026,9,18]],"date-time":"2026-09-18T05:23:06Z","timestamp":1789708986000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Metabolic and Psychological Effects of Mylife\n                    <scp>CamAPS FX<\/scp>\n                    Hybrid Closed\u2010Loop Therapy in Adults With Type 1 Diabetes, Markedly Elevated\n                    <scp>HbA1c<\/scp>\n                    , and Psychological Vulnerability: The Hi\u2010Loop Randomised Clinical Trial"],"prefix":"10.1111","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1153-8669","authenticated-orcid":false,"given":"J.","family":"Hohendorff","sequence":"first","affiliation":[{"name":"Department of Metabolic Diseases Jagiellonian University Medical College  Krakow Poland"},{"name":"University Hospital in Krakow  Krakow Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"T.","family":"Klupa","sequence":"additional","affiliation":[{"name":"Department of Metabolic Diseases Jagiellonian University Medical College  Krakow Poland"},{"name":"University Hospital in Krakow  Krakow Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"Wrobel","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Diabetology and Cardiometabolic Disorders, Faculty of Medical Sciences Zabrze Medical University of Silesia  Katowice Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A.","family":"Grzelka\u2010Wozniak","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine and Diabetology Poznan University of Medical Sciences  Poznan Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"E.","family":"Sochacka\u2010Tatara","sequence":"additional","affiliation":[{"name":"Department of Epidemiology and Preventive Medicine Jagiellonian University Medical College  Krakow Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"Plonka\u2010Stepien","sequence":"additional","affiliation":[{"name":"Department of Metabolic Diseases Jagiellonian University Medical College  Krakow Poland"},{"name":"University Hospital in Krakow  Krakow Poland"},{"name":"Doctoral School of Medical and Health Sciences, Faculty of Medicine Jagiellonian University Medical College  Krak\u00f3w Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Z.","family":"Zych","sequence":"additional","affiliation":[{"name":"Department of Metabolic Diseases Jagiellonian University Medical College  Krakow Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6938-352X","authenticated-orcid":false,"given":"B.","family":"Matejko","sequence":"additional","affiliation":[{"name":"Department of Metabolic Diseases Jagiellonian University Medical College  Krakow Poland"},{"name":"University Hospital in Krakow  Krakow Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"Adamczyk\u2010Hohendorff","sequence":"additional","affiliation":[{"name":"University Hospital in Krakow  Krakow Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"D.","family":"Rokicka","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Diabetology and Cardiometabolic Disorders, Faculty of Medical Sciences Zabrze Medical University of Silesia  Katowice Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"K.","family":"Strojek","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Diabetology and Cardiometabolic Disorders, Faculty of Medical Sciences Zabrze Medical University of Silesia  Katowice Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"D.","family":"Zozulinska\u2010Ziolkiewicz","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine and Diabetology Poznan University of Medical Sciences  Poznan Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M. 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