Efficacy and Safety of SGLT2 Inhibitors in Type 1 Diabetes After the Introduction of an Off-Label Use Protocol for Clinical Practice.

Aims: We evaluated the real-life efficacy and safety of empagliflozin in combination with optimized insulin therapy in patients with type 1 diabetes (T1D). Methods: This was a prospective study, including 27 patients with T1D treated with insulin therapy to whom empagliflozin was added according to an off-label protocol approved for use in clinical practice. The primary end point was the change in HbA1c 52 weeks after the addition of empagliflozin to insulin therapy. Blood pressure (BP), weight, and safety were also assessed. Results: At week 52, the addition of empagliflozin significantly reduced HbA1c from 8.0% ± 0.7% to 7.2% ± 0.8% (P < 0.001). The mean percentage of time in range for capillary glucose monitoring increased from 50% to 62% (P = 0.008) in parallel to a -0.08 IU/(kg·day) reduction in insulin requirements (P = 0.031). There was also a reduction in the body weight (-8 kg) and in systolic BP from 134 to 127 mmHg (P < 0.001). The most commonly reported adverse events were genitourinary infections (10 episodes in 52 weeks of follow-up). One patient developed an episode of mild diabetic ketoacidosis that motivated empagliflozin withdrawal. No severe hypoglycemic events were registered. Conclusions: Our results suggested that the use of empagliflozin following a strict off-label protocol may represent an effective and safe option in real life among patients with T1D, improving metabolic control, and ameliorating some cardiovascular risk factors.