A Systematic Review and Meta-Analysis of Randomised Controlled Trials, Contrasting the Safety Profile between Sodium-Glucose Cotransporter-2 Inhibitors and Placebo in Type 1 Diabetes Mellitus Patients

Background: This study aims to contrast the side effects of treatment with sodium-glucose cotransporter-2 inhibitors (SGLT2i) and placebo in insulin-treated adult type 1 diabetes mellitus (T1DM) patients. Methods: Double-blinded randomized controlled trials that compare the above outcome were searched in electronic databases. Next, the risk of bias in eligible studies was assessed, and comparable outcomes were compared by a random-effects meta-analysis. Results: Seven eligible papers comprising about 3,900 participants were studied. All trials suffered from an unclear risk of detection bias and performance bias. In comparison with the placebo group, the risk of genital infection (RR = 3.22, p < 0.001, 95% CI 2.31–4.49, I ² = 0%) and diabetic ketoacidosis (RR = 2.66, p = 0.002, 95% CI 1.45–4.89, I ² = 0%) was higher in the SGLT2i-treated group. Conclusion: SGLT2i treatment increased the risk of genital infection and diabetic ketoacidosis in adult insulin-treated T1DM patients.