G-POEM for Glycemic Control in Diabetic Gastroparesis

Launched by FRENCH SOCIETY OF DIGESTIVE ENDOSCOPY · May 2, 2025

Keywords

ClinConnect Summary

This clinical trial, called G-POEM for Glycemic Control in Diabetic Gastroparesis, is studying a new procedure called G-POEM, which is designed to help people with diabetic gastroparesis—a condition that affects how the stomach empties and can make controlling blood sugar levels very difficult. Gastroparesis is often experienced by people with diabetes and can lead to a range of digestive issues. The goal of this trial is to see if the G-POEM procedure can not only improve digestive symptoms but also help with blood sugar control.

To be eligible for this trial, participants must be between 18 and 90 years old, have had diabetes for at least five years while using insulin therapy, and have severe gastroparesis that hasn't improved with standard treatments. They should also be using or willing to use a continuous glucose monitor (CGM) to track their blood sugar levels. Participants will have the opportunity to receive the G-POEM procedure, which is minimally invasive, and they will be closely monitored throughout the study. It's important to note that certain health conditions and treatments may prevent someone from participating, so a thorough screening will be conducted before enrollment.

Gender

ALL

Eligibility criteria

• 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 during the study period;
• • Are being treated with any gastric-emptying delaying agents, including GLP-1 receptor agonists;
• • Are undergoing treatment with ascorbic acid during the study;
• • Have not previously attempted therapy with at least one prokinetic drug;
• • Are actively treated with opioids;
• • Have had prior pyloromyotomy or pyloroplasty;
• • Have known eosinophilic gastroenteritis;
• • Have an organic obstruction of the pylorus or intestinal tract (e.g., fibrotic stenosis);
• • Have a severe coagulopathy;
• • Have esophageal or gastric varices and/or portal hypertension gastropathy;
• • Have decompensated liver cirrhosis (Child B or Child C);
• • Have an active gastroduodenal ulcer;
• • Have active cancer or precancerous conditions of the stomach or duodenum (dysplasia, gastric cancer, GIST).
• • Have a known medical condition that, in the investigator's opinion, could interfere with the study protocol;
• • Have experienced diabetic ketoacidosis requiring hospitalization within six months prior to enrollment;
• • Have had a severe hypoglycemic episode requiring hospitalization within six months prior to enrollment.