{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,20]],"date-time":"2026-10-20T00:40:12Z","timestamp":1792456812733,"version":"4.5.0"},"reference-count":28,"publisher":"Wiley","license":[{"start":{"date-parts":[[2026,10,19]],"date-time":"2026-10-19T00:00:00Z","timestamp":1792368000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2026,10,19]],"date-time":"2026-10-19T00:00:00Z","timestamp":1792368000000},"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>Aims<\/jats:title>\n                    <jats:p>The aim was to assess the efficacy and safety of the smart multiple daily injections (MDI) system versus MDI plus continuous glucose monitor (CGM) in people with Type 1 diabetes and HbA1c \u2265\u20098%.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Material and Methods<\/jats:title>\n                    <jats:p>After a 3\u2010week run\u2010in, 143 participants were randomized to Smart MDI or MDI\u2009+\u2009CGM. The primary endpoint was between\u2010group difference (\u0394) in time\u2010in\u2010range (TIR) at 6\u2009months, adjusted for baseline glycaemia and assessed for non\u2010inferiority (margin 7.5%). Secondary endpoints included HbA1c (non\u2010inferiority margin 0.4%) and superiority analyses for TIR and HbA1c. Smart MDI alerts prompt insulin bolus actions (in contrast to traditional CGM alerts), and post hoc analyses were performed to evaluate \u2018alert\u2010responsiveness\u2019 on glycaemia. Alert\u2010responsiveness findings were validated in a real\u2010world cohort of 5507 users. Safety endpoints were assessed.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      At 6\u2009months, \u0394 TIR between groups was 0.19 percentage points (95% confidence interval: \u22124.9 to 5.3), thus meeting non\u2010inferiority; HbA1c also met non\u2010inferiority (\u0394: \u22120.13 percentage points, \u22120.46 to 0.19) but neither showed superiority. Post hoc analyses showed higher responders to alerts (those responding more than the median response rate of 28.3%,\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200931) had greater TIR gains than lower responders (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200928) (+8.12 percentage points;\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.04) and HbA1c reduction (\u22120.6 percentage points;\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.02). TIR benefits in higher responders were confirmed in the real\u2010world cohort. One episode of diabetic ketoacidosis occurred (run\u2010in) and one severe hypoglycaemic event occurred (control arm).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Smart MDI is safe and non\u2010inferior, achieving non\u2010inferiority to MDI\u2009+\u2009CGM regarding TIR and HbA1c. Responding to as few as 28% of alerts resulted in glycaemic improvements.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/dom.71431","type":"journal-article","created":{"date-parts":[[2026,10,20]],"date-time":"2026-10-20T00:06:43Z","timestamp":1792454803000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["The Smart MDI System in People With Type 1 Diabetes and High HBA1C: A Randomized Controlled Trial Demonstrating That Response to Alerts Drives Outcomes"],"prefix":"10.1111","author":[{"given":"Laurent","family":"Crenier","sequence":"first","affiliation":[{"name":"Department of Endocrinology HUB\u2014H\u00f4pital Erasme  Brussels Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0201-6888","authenticated-orcid":false,"given":"Martin","family":"Haluzik","sequence":"additional","affiliation":[{"name":"Diabetes Center, Institute for Clinical and Experimental Medicine  Prague Czech Republic"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marcus","family":"Lind","sequence":"additional","affiliation":[{"name":"Department of Molecular and Clinical Medicine Sahlgrenska Academy, Institute of Medicine, University of Gothenburg  Gothenburg Sweden"},{"name":"Department of Medicine NU Hospital Group  Uddevalla Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9111-4561","authenticated-orcid":false,"given":"Pieter","family":"Gillard","sequence":"additional","affiliation":[{"name":"Department of Endocrinology University Hospitals Leuven \u2010 KU Leuven  Leuven Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Regis P.","family":"Radermecker","sequence":"additional","affiliation":[{"name":"Department of Diabetology, Nutrition and Metabolic Diseases and Clinical Pharmacology Unit University Hospital of Li\u00e8ge  Li\u00e8ge 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