Efficacy and Safety of Sodium-Glucose Cotransporter-2 Inhibitors as Add-On Therapy to Insulin Pumps for Type 1 Diabetes: A Systematic Review and Meta-Analysis.

OBJECTIVE

Although the efficacy of sodium-glucose cotransporter-2 (SGLT2) inhibitors has been investigated broadly in type 1 diabetes (T1D), evidence regarding their combined use with insulin pumps remains limited. Therefore, we summarized the efficacy and safety of SGLT2 inhibitors as add-on therapy to insulin pumps in T1D.

METHODS

Randomized controlled trials on SGLT2 inhibitors combined with insulin pump therapy published up to September 18, 2025, were searched on Scopus, PubMed, Cochrane Library, Web of Science, and ClinicalTrials.gov. Data on continuous glucose monitoring metrics, glycated hemoglobin, and diabetic ketoacidosis (DKA) were extracted. Pooled analyses were conducted using mean differences (MDs) or odds ratios (ORs) with 95% CIs.

RESULTS

Seventeen trials involving 2916 participants were included. SGLT2 inhibitors significantly increased time-in-range compared with insulin pump therapy alone (MD 11.89%, [9.38 to 14.40]; I2 = 43.1%, P < .001). Low- and high-dose SGLT2 inhibitors caused a comparable increase in the time-in-range (11.89% and 12.22%, respectively). Glycated hemoglobin decreased significantly (MD -0.30%, [-0.41 to -0.20]); however, SGLT2 inhibitors increased DKA risk (OR 3.33 [2.10 to 5.27]; number needed to harm = 27). Subgroup analysis by dose showed that low- and high-dose groups have similar DKA risk (OR 2.90 and OR 3.66, respectively).

CONCLUSION

SGLT2 inhibitors combined with insulin pump therapy improve glycemic outcomes in T1D but elevate DKA risk, underscoring the need for individualized treatment, careful dosing, and vigilant monitoring.