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
Abstract
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…
How strong is the evidence?
Evidence Hub reads this as a meta-analysis, done in people. Its evidence level is 1 of 5 (Highest · pooled evidence). Pooled evidence from several studies sits at the top of the evidence pyramid. Reported size: 2,916 participants or records.
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