Background: Multiple pivotal and post market studies have confirmed the safety and accuracy of implantable Eversense CGM Systems. A post market study was initiated to compare Eversense 90-day and 180-day systems to SMBG in CGM naïve patients. Methods: This post market study is a prospective, multicenter, one year comparison of SMBG to Eversense in CGM naïve adults with diabetes in US sites (up to 925 users). After baseline assessment including HbA1c, patients used SMBG for 6 months (phase 1) followed by Eversense for 6 months (phase 2). Sensors were inserted at the start of phase 2. Visits occurred q 90 days to collect SMBG or CGM data and assess adverse events. HbA1c was measured at 6 and 12 months. Glucometrics were calculated in both phases. Enrollment and follow-up visits are ongoing.
Results: In 15 sites, 84 users have completed the study (mean 47.6% male, 90.5% type 2 diabetes, 57.2 years age). In the initial users, reductions in HbA1c were seen in both phases and improvements in glucometrics were observed (Table) with CGM compared to SMBG.
Conclusion: In a CGM naïve population, 6 months of SMBG use reduced HbA1c. There was a further significant reduction after 6 months of using Eversense CGM, as well as significant improvement in glucometrics - an increase in Time in Range (70-180 mg/dL) with no increase Time below Range. These data suggest that Eversense CGM improves glucose management compared to SMBG.
K.S.Tweden: Employee; Senseonics. B.Romarowski: Employee; Senseonics. C.Mdingi: Employee; Senseonics. F.R.Kaufman: Consultant; MannKind Corporation, Twin Health, Stock/Shareholder; Senseonics.
