A prospective post-market clinical follow-up registry to evaluate real-world effectiveness of duodenal mucosal resurfacing in patients with type 2 diabetes

Background: Despite the multitude of potent glucose-lowering agents (GLAs) available for type 2 diabetes (T2D), efficacy is limited by the need for chronic polypharmacy which contributes to patient burden and dissatisfaction. Additionally, T2D clinical trial efficacy may not fully translate to treatment effectiveness in the real world (RW). Duodenal mucosal resurfacing (DMR) is a minimally invasive endoscopic procedure using hydrothermal ablation to target the dysfunctional duodenal mucosa toward restoration of metabolic function. Previous trials in >300 patients have shown that DMR can safely and durably improve glycaemic control, insulin sensitivity, hepatic fat, and weight maintenance while reducing medication burden. DMR has reimbursement in select centers in Germany, providing a first-time opportunity for patients to undergo DMR in a RW setting. Here, we address the question of whether DMR T2D clinical trial findings can translate to RW effectiveness by evaluating initial safety and efficacy from a single center participating in a post-market registry.

Methodology: The ongoing, 5-year registry is a non-interventional, prospective, observational study in ≤5 German centers including pts ≥18 years of age, with body mass index of ≤45 kg/m2, HbA1c of ≥7.0% and ≤10.0%, and on oral and/or injectable GLAs and/or long-acting insulin. Single-center patients utilized the Telemedical Lifestyle intervention Program (TeLiPro) as part of standard of care. Demographics, HbA1c, fasting plasma glucose (FPG), weight, and GLAs were assessed at baseline and 3-months post-DMR via descriptive statistics (median [min, max]).

Results: Demographics and baseline characteristics are as follows (N=14): 64% male, age 62 (51,70) years, T2D duration 13 (4,35) years, HbA1c 9.2 (5.6,12.8)%, FPG 153 (101,355) mg/dL, weight 111 (66,139) kg, 64% of patients were on ≥3 GLAs. At 3-months post-DMR, the following metabolic improvements were observed (change from baseline): HbA1c -1.3 (-4.2,3.6)%, FPG -33 (-250,90) mg/dL, and weight -6.5 (-20,0) kg. GLA usage remained stable or decreased in all patients with 29% stopping ≥1 GLA and 14% eliminating GLA usage altogether. No device or procedure-related serious adverse events were reported.

Conclusions: Results suggest that DMR and lifestyle intervention can provide metabolic benefit while reducing treatment burden and demonstrate that DMR as an endoscopic therapy for T2D can bridge the gap between clinical-trial efficacy and RW effectiveness.

Interessenkonflikt

S.M.: Consultant for Fractyl. Thomas Veiser: none. Emily Cozzi: employee and shareholder of Fractyl Health, Inc. Harith Rajagopalan: employee and shareholder of Fractyl Health, Inc. Kelly White: employee and shareholder of Fractyl Health, Inc. Torsten Beyna: Consultant for Fractyl.

Publication History

Article published online:
18 April 2024