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The MELISSA trial aims to clinically validate the artificial intelligence (AI)\u2010based MELISSA system to support people with Type 1 diabetes on multiple daily insulin injections (MDI) with personalised insulin dose recommendations and an innovative approach for automatic carbohydrate estimation. In addition, feasibility will be explored in people with Type 2 diabetes.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Materials and Methods<\/jats:title>\n                    <jats:p>\n                      The MELISSA trial is a 22\u2010week European multicentre, prospective randomised open\u2010label blinded endpoint trial including people with Type 1 (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u2009278) and an exploratory cohort of people with Type 2 diabetes (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200950) on MDI. The MELISSA system consists of two AI\u2010driven features: an adaptive basal\u2010bolus advisor (ABBA), which can be supported by an automated dietary assessment system, goFOOD\n                      <jats:sup>TM<\/jats:sup>\n                      . ABBA provides personalised suggestions for basal insulin and mealtime insulin doses, while goFOOD\n                      <jats:sup>TM<\/jats:sup>\n                      converts food images into carbohydrate content estimations. After the initialisation period (Weeks 0\u20136), participants will be randomised 1:1 to either the MELISSA system or the continuation of usual care.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The primary endpoint is the between\u2010group change in percentage of time spent in the target range (3.9\u201310.0\u2009mmol\/L [70\u2013180\u2009mg\/dL]) from baseline to study end. Secondary outcomes include additional glycaemic metrics, patient\u2010reported\u2010outcomes, and safety information. The trial was approved by the Sponsor's Medical Ethics Research Committee (NL\u2010009099).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The MELISSA system will potentially improve glycaemic control and quality of life in people with Type 1 diabetes on MDI. The trial outcomes will provide necessary input for obtaining Conformit\u00e9 Europ\u00e9enne certification (class IIb) for the MELISSA system.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/dom.70879","type":"journal-article","created":{"date-parts":[[2026,5,20]],"date-time":"2026-05-20T01:12:16Z","timestamp":1779239536000},"page":"6576-6583","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Randomised Controlled Multicentre Trial to Investigate the Effectiveness of a\n                    <scp>Mobile Artificial<\/scp>\n                    Intelligence Solution for\n                    <scp>Diabetes<\/scp>\n                    Adapted Care: The\n                    <scp>MELISSA<\/scp>\n                    Trial Protocol"],"prefix":"10.1111","volume":"28","author":[{"ORCID":"https:\/\/orcid.org\/0009-0002-5289-8070","authenticated-orcid":false,"given":"Elisabeth J.","family":"den Brok","sequence":"first","affiliation":[{"name":"CARIM School for Cardiovascular Disease Maastricht University  Maastricht the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cecilie H.","family":"Svensson","sequence":"additional","affiliation":[{"name":"Department of Endocrinology and Nephrology Copenhagen University Hospital\u2013North Zealand  Hillerod Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mikkel T.","family":"Olsen","sequence":"additional","affiliation":[{"name":"Department of Endocrinology and Nephrology Copenhagen University Hospital\u2013North Zealand  Hillerod Denmark"},{"name":"Steno Diabetes Center Copenhagen  Herlev Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nefeli M.","family":"Dimitropoulou","sequence":"additional","affiliation":[{"name":"CARIM School for Cardiovascular Disease Maastricht University  Maastricht the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sander M. 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