DiaGone™ is an endoscopic device which utilizes precisely controlled laser technology to target the duodenal submucosal neural plexi with the aim of improving glucose control by modulating the gastrointestinal neurohumoral axis.
Nine subjects (5 males) with obesity (BMI 34.0±4.6 kg/m2) and type 2 diabetes mellitus (T2DM) insufficiently controlled on metformin were included in this first-in-human trial in order to assess the efficacy and safety of DiaGone™. Biochemical and anthropometric parameters were assessed at baseline and 3 and 6 months after the procedure and a standard liquid meal test was performed at baseline and 3 months after the procedure.
DiaGone™ significantly decreased fasting glucose (12.4±3.5 vs. 9.5±2.0 vs. 9.7±2.7 mmol/l for baseline vs. 3 vs. 6 months, p<0.01) and HbA1C (78.3±13.3 vs. 64.9±6.4 vs. 64.8±7.1 mmol/mol, p<0.01) as well as. Glucose AUC during the 150 min meal test 3 months after the procedure showed a reduction of 20% from baseline (43,435 vs. 34,096, p<0.01). No significant changes were observed in AUC for insulin. No adverse events related to the procedure or significant changes in weight were reported throughout the 6-month period.
These pilot results suggest that endoscopic duodenal submucosal laser ablation using the DiaGone™ device is associated with improvements in both baseline and postprandial glycemia as well as HbA1C with no significant changes in insulin levels or body weight while having a favorable safety and tolerability profile.
Supported by MHCZ-DRO („Institute for Clinical and Experimental Medicine – IKEM, IN 00023001“) and RVO VFN64165.