Abstract

Background: Multiple studies have confirmed the safety and accuracy of implantable Eversense CGM Systems.
Methods: A prospective, multicenter one-year post-market study comparing SMBG to CGM in adults with diabetes naive to CGM was initiated in the US. Following screening, patients used SMBG for 6 months followed by Eversense for 6 months. Visits occurred every 90 days to collect SMBG/CGM and safety data. HbA1c was measured at baseline, 6 and 12 months. Glucometrics were calculated.
Result: One-hundred users have completed the study (9% type 1 diabetes, 57 years age). Mean HbA1c was <7% by end of study. Time In Range(70-180mg/dL), Time Below Range(<70mg/dL) and Time Above Range (>180mg/dL, >250mg/dL) improved with CGM compared to SMBG.
Conclusion: CGM naïve patients met mean HbA1c target by study end. TIR (70-180mg/dL) increased and both TBR(<70mg/dL) and TAR (>180, >250mg/dL) decreased with CGM use. These data suggest that Eversense CGM improves glucose management compared to SMBG.

Keywords:CGM naïve; Continuous glucose monitoring; Glucometrics; Implantable sensor; Type 1 diabetes; Type 2 diabetes

Abbreviations:CGM: Continuous Glucose Monitoring: HbA1c: Glycated Hemoglobin; SMBG: Self-Monitoring of Blood Glucose; TIR: Time in Range; TBR: Time Below Range; TAR: Time Above Range; MARD: Mean Absolute Relative Deviation; T1D: Type 1 Diabetes; T2D: Type 2 Diabetes; AE: Adverse Event; BG: Blood Glucose; SAEs: Serious Adverse Events; SD: Standard Deviation; CV: Coefficient of Variation; GMI: Glucose Management Indicator