Diabetes
Conditions
Interventions
The endomina (sponsor EndoTools Therapeutics, Gosselies, Belgium) is a device
that can be attached to an endoscope and allows remote actuation of the device
during a peroral intervention. It offers
Sponsors
Universitair Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Age between 18-65 years; - Diagnosed with DM2 o since at least 1 year o but diagnosed no longer than 10 years ago o currently under stable dose of insulin for at least 6 months - HbA1c level of 7.0-11.0% (53-75 mmol/mol) - BMI of 30-40 kg/m² with or without hypertension
Exclusion criteria
Exclusion criteria: - Achalasia and any other esophageal motility disorders - Severe esophagitis (grade C or D) - Gastro-duodenal ulcer - GI stenosis or obstruction - Any history of esophageal or gastric surgery - Heart diseases: unstable angina, myocardial infarction within the past year, or heart disease classified within the New York Heart Association*s Class III or IV functional capacity - Uncontrolled hypertension (systolic blood pressure >180 mm Hg and/or diastolic blood pressure >100 mm Hg under medication) during last 3 months; - Severe renal, hepatic, pulmonary disease or cancer (cancer in the past 5 years, except basal cell carcinoma - Pregnancy, breast feeding or desire for pregnancy in the coming 12 months - Any previous bariatric surgery, or endoscopic obesity-related intervention (including POSE, OverStitch, etc.). Intragastric balloon removed within the last 6 months - Planned gastric surgery 60 days post intervention - Anticoagulant therapy that cannot be temporarily stopped at the time of the procedure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is a reduction of HbA1C of at least 0.7% one year after ESG. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety: 1. Rate of Serious Adverse Events (SAE) and Serious Adverse Device Effects (SADE) during and post procedure 2. Adverse events up to 1-month follow-up for subjects undergoing the procedure under procedural sedation with propofol 3. Cardiovascular events (stroke/TIA, myocardial infarction, admission for heart failure) and all-cause mortality DM2: 4. Reduction of HbA1C at 14 days, 1 month, 3, 6, and 9 months after ESG 5. Reduction in fasting plasma glucose levels at 14 days, 1 month, 3, 6, 9 and 12 months after ESG 6. Proportion of subjects with reduced number and/or reduced dose(s) of diabetes medication at 14 days, 1 month, 3, 6, 9 and 12 months after ESG Weight Loss: 7. Proportion of subjects with mean % excess weight loss (EWL) of more than 25% at 14 days, 1 month, 3, 6, 9 and 12 months after ESG 8. Proportion of subjects with mean % total body weight loss (TBWL) of more than 5% at 14 days, 1 month, 3, 6, 9 and 12 months after ESG Comorbidity: 9. Decrease in blood pressure expressed in mmHg at 14 days, 1 month, 3, 6, 9 and 12 months after ESG Quality of Life: 10. EQ-5D-5L at 14 days, 1 month, 3, 6 and 12 months after ESG 11. Diabetes Treatment Satisfaction Questionnaire at 14 days, 1 month, 3, 6, 9 and 12 months after ESG 12. Quality adjusted life years (QALYs) Costs: 13. Costs and cost-effectiveness. Costs including health care recourses used (including intervention including endomina device and TAPES, hospital admissions, visits to specialists and GP, emergency room visits, medications used), costs for insulin therapy (including medication, administration, glycemia measurement material) | — |
Countries
Netherlands
Outcome results
None listed