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

Introduction: Efficacy of glucose-lowering agents (GLAs) for type 2 diabetes (T2D) is limited by the need for chronic polypharmacy, which contributes to patient burden and dissatisfaction. Additionally, clinical-trial efficacy may not fully translate to real-world (RW) effectiveness. Duodenal mucosal resurfacing (DMR) is a minimally invasive, endoscopic procedure using hydrothermal ablation to restore metabolic functionality to the duodenum. Previous trials in >300 patients have shown that DMR may safely and durably improve glycaemic control, insulin sensitivity, hepatic fat, and weight maintenance while reducing medication burden.

Objectives: We assessed whether DMR clinical trial outcomes can translate to RW effectiveness by evaluating safety, efficacy, and patient reported outcomes (PROs) from a single centre participating in a T2D post-market registry.

Methodology: The ongoing, 5-year registry is a non-interventional, prospective, observational study in ≤5 German centres including participants ≥18 years of age with body mass index ≤45 kg/m², HbA1c ≥7.0% and ≤10.0% and on oral and/or injectable GLAs and/or long-acting insulin. Single-centre participants utilized a telemedical diet and lifestyle intervention program (TeLiPro) as part of standard of care. HbA1c, fasting plasma glucose (FPG), weight, GLAs, and PROs were assessed at baseline and 3 months post-DMR. PROs were rated yes/no or on a 1-10 scale (10 as highest). Descriptive statistics (median [min,max]) are shown.

Result: Demographics and baseline characteristics are as follows (N=19): 63% male, age 62 (51,77) years, T2D duration 12 (4,38) years, HbA1c 9.0 (7.3,12.8)%, FPG 156 (101,355) mg/dL and weight 111 (66,139) kg; 68% of participants were on ≥2 GLAs. At 3 months post-DMR, the following metabolic improvements were observed (change from baseline): HbA1c -1.3 (-4.2,3.6)%, FPG -37 (-250,90) mg/dL and weight -7 (-20,0) kg. GLA usage remained stable or decreased in 95% of patients with 21% stopping ≥1 GLA and 11% eliminating all GLA usage. Ninety percent and 95% of patients reported they would undergo DMR again and would recommend DMR to a friend or relative, respectively. Ratings for improving T2D disease management and quality of life were both 10 (1,10). No device- or procedure-related serious adverse events were reported.

Conclusion: These real-world results suggest that DMR and lifestyle intervention may provide metabolic benefit and patient satisfaction while reducing treatment burden.

präsentiert in der Sitzung: Metabolische Endoskopie

Samstag, 05. Oktober 2024, 10:15 – 11:45, MZF 3

Publication History

Article published online:
26 September 2024