This record was last updated August 13, 2025 (before its estimated March 31, 2026 completion). Its status may not reflect the trial's current state.
Summary
This is a non-blinded, prospective, multi-center, single arm longitudinal cohort study (patient serving as their own control), to evaluate the effectiveness of diabetes with the Eversense CGM System non-adjunctively compared to self-monitoring of blood glucose (SMBG) using a blood glucose (BG) meter in participants with either Type 1 or Type 2 diabetes. Subjects will serve as their own control, with their baseline based on using SMBG to manage their diabetes for the first 6 months followed by using Eversense CGM System non-adjunctively for the second 6 months. Total follow-up duration is 12 months. The investigation will include both clinic visits and home use of Eversense CGM System. The nonadjunctive phase will have two sensors, up to 90-day duration, inserted sequentially. All care decisions specific to diabetes will be based on blood glucose (BG) values in the first phase and the Eversense CGM system values in the second phase.
Protocol Amendment History
14 amendments
This ClinicalTrials.gov record has been amended 14 times since 2021-04-05; most recent amendment 2025-08-08.
Status change: Recruiting → Active, Not Recruiting2025-08-08