Background and Aim: Sodium-glucose co-transporter-2 (SGLT2) inhibitors are effective in improving glycemic control in both type 2 (T2D) and type 1 diabetes (T1D). Despite dapaglifozin has been recently approved as an adjunctive therapy in T1D, its use is still limited due to the increased risk of diabetic ketoacidosis (DKA). Aim of this study was to assess the effectiveness of SGLT2 inhibitors in combination with insulin in poorly controlled T1D patients.

Methods: In this retrospective observational study, data from 46 adults [M/F 29/17] affected by T1D treated with insulin plus dapaglifozin were collected. Glycated hemoglobin (A1c), anthropometrics, insulin daily requirement and time in range (TIR) were studied at baseline, 3 and 6 months after starting of treatment.

Results: At baseline, mean ± SD age was 32.7 ± 10.2 years, disease duration was 21.4 ± 9.3 years, A1c was 8.3 % ± 1.6. Insulin daily requirement was 0.9 ± 0.38 UI/Kg, whereas BMI was 26.7 ± 1.6 Kg/m2. After 6 months, Dapaglifozin 5 mg/day had significantly decreased A1c levels (change [Δ] -0.86%, p < 0.01), body weight (Δ -2.5 kg, p < 0.001) and insulin daily requirement (Δ -0.17 UI/kg, p < 0.01) from baseline. Moreover, in a subgroup of patients (n=16) using continuous glucose monitoring (CGM) systems, statistically significant improvement of TIR (Δ +9%, p < 0.01) has been observed, while time spent in hypoglycaemia did not change. No significant changes in C-peptide levels was observed (p = 0.09). No serious adverse events occurred during the study period. Discontinuation (10%) was mainly related to genitourinary infections, polyuria or limited effectiveness perceived.

Conclusion: Our real world experience confirms clinical benefits of SGLT2 inhibitors as an adjunctive therapy in poorly controlled T1D patients, ameliorating overall glycometabolic control as well as glycemic variability. Clinical characterization and proper education remain essential in order to identify the right candidate and to minimize DKA risk.


S. Pieralice: None. D. Tuccinardi: None. S. Kyanvash: None. D. Maggi: None. L. Monte: None. S. Briganti: None. S. Manfrini: None. P. Pozzilli: Advisory Panel; Self; Abbott, AstraZeneca, Eli Lilly and Company. Research Support; Self; Medtronic, Sanofi.

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