{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,31]],"date-time":"2026-07-31T23:46:43Z","timestamp":1785541603622,"version":"3.56.0"},"reference-count":34,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2025,2,20]],"date-time":"2025-02-20T00:00:00Z","timestamp":1740009600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["UEG Journal"],"published-print":{"date-parts":[[2025,6]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Diabetes mellitus (DM) significantly impacts global health and economies. Despite various therapies, managing DM remains challenging. Bariatric surgery has shown efficacy in obese patients with type 2 diabetes mellitus (T2DM), but its utilization remains low. Innovative, less invasive endoscopic approaches such as duodenal mucosal resurfacing show potential in treating T2DM. This article presents the results of a First in Human (FIH) study using a duodenal submucosal laser ablation investigational device for T2DM treatment.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A prospective, single\u2010arm, open\u2010label study evaluated the safety and efficacy of the Digma System Endoscopic procedure for duodenal submucosal laser ablation in consecutive enrolled T2DM patients.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      The study was conducted from July 2017 to December 2020 and enrolled 31 patients for the Digma System Endoscopic procedure. The Dose Escalation Cohort (DEC) used sub\u2010therapeutic laser doses for training and safety. The Treatment Cohort (TC) of 25 patients received therapeutic doses, resulting in HbA1c reductions of \u22120.6% at 6\u00a0months (\n                      <jats:italic>p<\/jats:italic>\n                      \u00a0=\u00a00.014) and \u22120.4% at 12\u00a0months (\n                      <jats:italic>p<\/jats:italic>\n                      \u00a0=\u00a00.062). Fasting glucose dropped 17.3\u00a0mg\/dL (\n                      <jats:italic>p<\/jats:italic>\n                      \u00a0=\u00a00.173) at 6\u00a0months and 28\u00a0mg\/dL (\n                      <jats:italic>p<\/jats:italic>\n                      \u00a0=\u00a00.022) at 12\u00a0months. Post\u2010prandial glucose improvements were also observed. HOMA\u2010IR improved at 3 and 6\u00a0months. PAGI\u2010SYM and PAGI\u2010QOL showed stable to slightly improved GI symptoms and quality of life. Two severe adverse events were unrelated to the procedure.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The study demonstrates the safety, feasibility, and potential efficacy of the Digma System Endoscopic procedure. Evidence suggests improvements in HbA1c, fasting and post\u2010prandial glucose, and HOMA\u2010IR levels could be attributed to the Digma System Endoscopic procedure.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/ueg2.12762","type":"journal-article","created":{"date-parts":[[2025,2,20]],"date-time":"2025-02-20T11:13:52Z","timestamp":1740050032000},"page":"750-758","source":"Crossref","is-referenced-by-count":8,"title":["Duodenal Laser Ablation for Treatment of Type 2 Diabetes: Results of First in Human Study"],"prefix":"10.1002","volume":"13","author":[{"given":"Viktorie","family":"Kovarova","sequence":"first","affiliation":[{"name":"Department of Diabetes Diabetes Centre Institute for Clinical and Experimental Medicine  Prague Czech Republic"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ivana","family":"Lankova","sequence":"additional","affiliation":[{"name":"Department of Diabetes Diabetes Centre Institute for Clinical and Experimental Medicine  Prague 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