Duodenal Laser Ablation for Treatment of Type 2 Diabetes: Results of First in Human Study

Abstract

Background: 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. Methods: A prospective, single-arm, open-label study evaluated the safety and efficacy of the Digma System Endoscopic procedure for duodenal submucosal laser ablation in consecutive enrolled T2DM patients. Results: 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-therapeutic laser doses for training and safety. The Treatment Cohort (TC) of 25 patients received therapeutic doses, resulting in HbA1c reductions of −0.6% at 6 months (p = 0.014) and −0.4% at 12 months (p = 0.062). Fasting glucose dropped 17.3 mg/dL (p = 0.173) at 6 months and 28 mg/dL (p = 0.022) at 12 months. Post-prandial glucose improvements were also observed. HOMA-IR improved at 3 and 6 months. PAGI-SYM and PAGI-QOL showed stable to slightly improved GI symptoms and quality of life. Two severe adverse events were unrelated to the procedure. Conclusion: The study demonstrates the safety, feasibility, and potential efficacy of the Digma System Endoscopic procedure. Evidence suggests improvements in HbA1c, fasting and post-prandial glucose, and HOMA-IR levels could be attributed to the Digma System Endoscopic procedure.