Intragastric balloon (IGB) therapy is a minimally invasive endoscopic intervention for weight reduction in patients with Class I-II obesity and in lower BMI patients with obesity-related comorbidities such as diabetes mellitus. Diabetes mellitus is associated with vascular complications, increased susceptibility to infection and delayed gastric emptying, underscoring the need to evaluate procedural safety and device tolerance in this population. However, evidence regarding short-term safety in this higher-risk population remains limited. This study aims to compare 30-day safety outcomes after IGB placement in patients with and without diabetes mellitus. This was a retrospective cohort study of 4,555 patients undergoing primary IGB placement using the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) database from 2015 to 2023. Propensity score-matching was performed in R version 4.5.0 to balance baseline characteristics in two matched analyses: (1) patients with diabetes mellitus matched to patients without diabetes mellitus, and (2) non-insulin dependent diabetes mellitus (NIDDM) versus insulin-dependent diabetes mellitus (IDDM). Outcomes included 30-day rates of outpatient intravenous (IV) treatments, emergency department (ED) visits, hospital readmissions, reoperations, procedural interventions, and serious adverse events (SAEs). Patients with diabetes, particularly those with insulin dependence, were older, more frequently male, and had a higher burden of cardiometabolic-associated medical problems compared to patients without diabetes. Among 424 propensity-matched patients with and without diabetes, rates of 30-day healthcare utilization including outpatient IV treatment, ED visit, hospital readmission, reoperation, and procedural intervention were comparable. Postoperative SAEs were rare, with no observed significant differences in rates of organ space infection, pneumonia, unplanned intubation, pulmonary embolism, deep vein thrombosis, prolonged mechanical ventilation, urinary tract infection, renal insufficiency, acute renal failure, cerebrovascular accident, cardiac arrest, myocardial infarction, sepsis, septic shock, unplanned intensive care unit admission and mortality. In a sub-analysis of 106 matched patients with NIDDM and IDDM, 30-day healthcare utilization and all postoperative SAEs were likewise similar, with no observed statistically significant differences between cohorts. Patients with diabetes exhibited a greater burden of associated medical problems but demonstrated comparable rates of short-term healthcare utilization, safety outcomes and tolerability to those without diabetes after adjustment for baseline differences. These findings support the safety of IGB placement in patients with diabetes and suggest it may be considered both as a safe option for primary weight loss intervention or as a bridge therapy to Metabolic and Bariatric Surgery (MBS) in this population. Patients with diabetes were older, had higher BMI, and carried a greater burden of associated medical problems compared with those without diabetes. After propensity score-matching, rates of 30-day healthcare utilization including outpatient IV treatments, emergency department visits, hospital readmissions, reoperations, procedural interventions, and postoperative serious adverse events were similar between patients with and without diabetes undergoing IGB placement. Among patients with diabetes, those with insulin-dependent diabetes had more cardiometabolic-associated medical problems than those with non–insulin-dependent diabetes yet observed rates of 30-day healthcare utilization and postoperative serious adverse events were comparable across subgroups.
Hamamah et al. (Mon,) studied this question.