Emanuele Bosi, Italy
San Raffaele Hospital MedicinePresenter of 1 Presentation
EFFECT OF FLASH GLUCOSE MONITORING ON GLYCAEMIC CONTROL IN TYPE 2 DIABETES COMPARED TO SMBG; A PROSPECTIVE OBSERVATIONAL STUDY FROM ITALY
Abstract
Background and Aims
This prospective, observational cohort study was designed to measure the change in HbA1c over 3-6 months in adults with T2DM on a basal-bolus insulin regimen using the FreeStyle Libre Flash Glucose Monitoring SystemTM compared to self-monitoring blood glucose (SMBG), in a real-world setting.
Methods
A total of 322 patients (109 intervention, 213 control) with T2DM from 16 hospital sites in Italy were enrolled. To minimise selection bias, all eligible FreeStyle Libre users were included, matched to SMBG patients by HbA1c (within ±0.5%) and study site. The study population included adults on a basal-bolus insulin regimen for ≥1 year, with HbA1c 8.0-12.0% (64-108 mmol/mol), who were either new to FreeStyle Libre and planned to use it for ≥3 months (intervention) or planned to continue with SMBG (control) in a 1:2 ratio. On average, HbA1c was 8.9±0.8% (73.9±8.8 mmol/mol), age 67.2±10.0 years, BMI 30.5±6.5 kg/m2 and average duration of insulin use 8.6±6.6 years (mean±SD), 56.2% were male.
Results
After 3-6 months, 234 complete case patients (83 intervention, 151 control) demonstrated significantly reduced HbA1c for FreeStyle Libre users compared to SMBG by 0.30% (95%CI: -0.53, -0.07), p=0.0113. Considering all 322 patients (109 intervention, 213 control), with imputed missing HbA1c values, HbA1c was also significantly reduced for FreeStyle Libre users vs. SMBG by 0.28% (95%CI: -0.50, -0.05), p=0.0199. The difference remains statistically significant after adjusting for the confounders.
Conclusions
This real-world, prospective cohort study concluded that people with T2DM on basal-bolus insulin, using FreeStyle Libre for 3-6 months significantly reduced HbA1c compared to SMBG.