Efficacy of Patch Sensor-Augmented Pump (EOPatch) in Comparison to Other Intensive Insulin Therapies with Continuous Glucose Monitoring in Advanced Type 2 Diabetes: A Three-Arm, Multicenter, Randomized Controlled Trial

Background: Despite evidence supporting insulin pumps alone for type 2 diabetes (T2D) patients on multiple daily injections (MDI), the superiority of sensor-augmented pump (SAP) over intensive insulin therapy (IIT) with continuous glucose monitoring (CGM) remains uncertain. Additionally, the effectiveness of patch pumps compared to conventional pumps in this group lacks evidence. Our study assesses patch SAP's efficacy compared to other IIT in CGM settings for T2D. Methods: This multicenter, 12-week randomized controlled trial took place at 10 tertiary hospitals in Korea. Poorly-controlled T2D patients on MDI or multiple pre-mixed insulin were randomly assigned (1.5:1.5:1) to patch SAP (EOPatch, EOFlow), conventional pump, or the control group (maintaining previous treatment). All groups used CGM. The primary outcome measured the mean time spent in target range (TIR) of 70-180 mg/dL (3.9-10 mmol/L). Patch SAP was assessed against conventional pump and control for non-inferiority (margin 7.5%) and superiority. Findings: Among 141 participants assigned to three groups (patch SAP [n=53], conventional pump [n=53], control [n=35]), a total of 120 participants (85.1%) finished the study. 127 participants (90.1%) were included in modified intention-to-treat analysis. Baseline TIR was 46.5±22.1%, with improvements of 10.8±19.6% (patch SAP), 6.9±17.6% (conventional pump), and 3.9±13.6% (control). The adjusted mean difference compared to the conventional pump was 4.7% (95% CI -2.4 to 11.9; p<0.0001 for non-inferiority), and compared to the control group, it was 7.7% (95% CI 0.5 to 14.9; p=0.0371). The satisfaction questionnaire revealed significant improvements in the patch SAP group compared to the others. Interpretation: For poorly controlled T2D patients despite IIT with CGM, patch SAP offers an effective and less burdensome treatment option.Trial Registration: This study is registered with the Clinical Research Information Service (cris.nih.go.kr), a Korean clinical trial registration system, under number KCT0006405.Funding: Korea Medical Device Development Fund Grant funded by the Korea governmentDeclaration of Interest: No potential conflicts of interest relevant to this article are reported.Ethical Approval: All participants provided written informed consent. The study protocol received approval from the institutional ethics committees at each participating center