Not Yet RecruitingNot Applicable

G-POEM for Glycemic Control in Diabetic Gastroparesis

40 participantsStarted 2025-07

Plain-language summary

Gastroparesis, commonly caused by diabetes, affects 30-50% of diabetic individuals and complicates glycemic control due to its bidirectional relationship with blood glucose levels. Current treatments are often ineffective. G-POEM, a minimally invasive endoscopic technique, has demonstrated promising results in improving digestive symptoms, particularly in diabetic patients, with over 80% success. However, its impact on glycemic control has not yet been investigated, highlighting the need for further research.

Who can participate

Age range18 Years – 90 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Aged 18 to 90 years; * Diagnosed with diabetes for at least 5 years and be treated with optimized insulin therapy; * Severe gastroparesis with gastric retention \>20% at 4h (confirmed by scintigraphy); * Failure of conventional gastroparesis treatment; * Continuous glucose monitoring (CGM) in use or willingness to use during study * Time in range (70-180 mg/dL) \<70% Exclusion Criteria: * Are treated with an automated insulin therapy system (closed-loop); * Have previously undergone gastric neurostimulation therapy with Enterra (Medtronic ©); * Have been treated with erythromycin in the past three months; * Do not provide informed consent; * Are pregnant or breastfeeding during the study period; * Are under legal guardianship; * Have contraindications to the POEM procedure, including contraindications to anesthesia and/or active anticoagulation that cannot be paused; * Have severe chronic constipation, defined by a Cleveland score \>15 (Agachan et al., Dis Colon Rectum, 1996); * Have a history of esophagogastric surgery (excluding anti-reflux surgery), including esophagogastric resection or any type of bariatric surgery; * Have chronic intestinal pseudo-obstruction; * Have a clinical suspicion of chronic mesenteric ischemia, indicated by severe malnutrition, postprandial pain, and signs of digestive atherosclerosis; * Refuse to share CGM data via the Libre Link platform; * Plan or undergo changes in antidiabetic therapy or insulin delivery systems dur…

What they're measuring

Percentage of time spent in target glycemic range >10%

Timeframe: 3 months after randomization

Trial details

NCT IDNCT06965543

SponsorFrench Society of Digestive Endoscopy

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-07