Introduction and Objective: Proximal Intestinal Mucosal Ablation (PIMA) is a new endoscopic procedure to treat type 2 diabetes (T2D). PIMA replicates the metabolic benefits of gastric bypass surgery by ablating up to 75 cm of the post-ampullary intestinal mucosa with radiofrequency vapor ablation (RFVA). Similar technologies, limited to 15cm of duodenal mucosa, have attempted to eliminate exogenous insulin in combination with glucagon-like peptide-1 receptor agonists (GLP-1RA) in insulin-requiring (IR)-T2D. We aimed to determine whether PIMA could eliminate exogenous insulin without concomitant GLP-1RA.Methods: A prospective, single-center study (NCT06655740) recruiting patients with IR-T2D on daily long-acting insulin for ≥3 months and glycated hemoglobin (HbA1c) ≤8%. Patients start continuous glucose monitoring (CGM) and then enter a 4-week run-in to ensure stable control. Post run-in, insulin is stopped, and PIMA performed with an endoscope under general anesthesia with a RFVA catheter. RFVA is delivered at a set dose with overlapping (2X) application. Primary outcomes are number of serious adverse events (SAE) and the proportion of patients free of insulin without GLP-1RA at 24 weeks.Results: To date, five patients (median age 52 [IQR 48-56], 60% male) have undergone PIMA. Baseline HbA1c was 6.9% (SD 0.5), body mass index 33.3 kg/m2 (SD 5.7), and diabetes duration 5.2 years. The average insulin dose was 22.4 IU/day (SD 5.9), and median oral diabetic drugs was 1 (IQR 1-2). PIMA was successful in all patients with an average ablation length of 61 cm (SD 2) and procedure time of 51 mins (SD 23). All patients were discharged the next day with no SAEs. All patients are off insulin at a mean follow-up of 30 days (SD 16). The average CGM time in range is 93.2% (SD 7.8) and estimated HbA1c 6.2% (SD 0.5) without GLP-1RA.Conclusion: On early follow-up, PIMA is safe and effective at eliminating exogenous insulin in IR-T2D without need for GLP-1RA.
B. Norton: Other Relationship; Cook Medical. Research Support; Aqua Medical. A. Papaefthymiou: None. A. Telese: None. P. Vignolo: Research Support; AQUA MEDICAL. P. Marin: None. R. Simons-Linares: None. L. Rodriguez G: None. R. Haidry: None.
Aqua Medical
Source link
Leave a Reply