Accuracy and safety of the implantable Eversense CGM System has been demonstrated in 3 pivotal trials. Analysis of the first 205 US commercial users who completed a 90-day sensor wear cycle has been recently published and results demonstrated accuracy and safety consistent with pivotal trial outcomes.
Ninety-day de‐identified sensor glucose (SG) data from the Eversense Data Management System (DMS) were analyzed for these first 205 patients to determine the percent of patients meeting the recommended targets of 1) 70% of time in range (TIR) between 70-180mg/dL, 2) <4% of time below 70mg/dL, and 3) <1% of time below 54mg/dL.
Analyses showed the following: 1) 42% of the users achieved a TIR > 70% with a mean TIR of 62.3%. 2) 62% of users achieved <4% of time <70 mg/dL with a mean time < 70 mg/dL of 4.1%. 3) 64% achieved <1% of time <54 mg/dL with a mean time <54 mg/dL of 1.2%. Percent of the 205 users achieving all three targets of TIR>70%, time <70mg/dL of 4%, and time <54mg/dL of <1% was 23.4%.
In the real-world setting, the Eversense CGM System was shown to assist patients in achieving recommended glucose goals regarding hypoglycemia, with ~64% of patients avoiding what has been defined as an excess of very low SG values. In addition, over 40% achieved targeted TIR. These data support the use of the first long-term implanted CGM system as a viable tool to manage diabetes.