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Emerging Outcomes for Treatment of Obesity with Type 2 Diabetes Mellitus: Novel Swallowable Balloon Process

Mohit Bhandari, Manoel Galvao Neto, Susmit Kosta, Winni Mathur, Mahak Bhandari, Manoj Reddy, Vinod Bhandari

Background: Swallowable balloon process is a new way for the treatment of obesity and type 2 diabetes (T2DM). The aim of this study was to assess the outcomes of the novel swallowable balloon on T2DM remission, weight loss, and adverse events in individuals with T2DM and obesity.

Methodology: We treated forty-two T2DM patients with obesity at our center with a swallowable balloon. During the 6-month follow-up diabetes remission was defined as HbA1c<6.5% without T2DM medication and diabetic improvement was HbA1c<7.0% with decreased usage of oral diabetes medications.

Results: At 6 months of follow-up, 87.8% of the cohort treated by swallowable balloon experienced diabetes remission. The highest diabetes remission was 66.7% (HbA1c 6.43%; 95%CI 6.2-6.5 and FPG 120.3; 95% CI 111.6- 124.9) occurred between 3-and 4-months post balloon insertion, and 12.5% recrudescence of diabetes during the end of follow-up. Improvement of diabetes without full remission was observed in 27.8% and 36.1% of patients at 4 and 6 months (HbA1c, 6.8% 95% CI 6.5-7.0). These patients achieved diabetes control (HbA1c, 6.8% 95%CI 6.5- 7.0) with decreased usage of oral diabetes medications and withdrawal of insulin when previously used. Significant (p<0.001) improvements in %TWL were 6.5 %,10.1 %, 12.7%, 15.14%,14.7%, and 14.4% at 1-2-3-4-5-6 months, respectively were noted after the insertion of the balloon. There was a significant (p<0.001) resolution in diabetesrelated comorbidities (75% HTN and 73.3% DLP).

Conclusion: New emerging swallowable balloon process is an effective tool to reduce HbA1c and put T2DM into remission and weight loss.