Patricia Sanchez, United States of AmericaSenseonics Inc Product Development
Presenter Of 2 Presentations
PERCENT OF PATIENTS WITH TARGETED TIME IN RANGE AND TIME IN HYPOGLYCEMIA WITH THE EVERSENSE CGM SYSTEM
Background and Aims
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.
CORRELATION BETWEEN TIME IN RANGE AND GLUCOSE MANAGEMENT INDICATOR WITH THE EVERSENSE CGM SYSTEM
Background and Aims
The safety and accuracy outcomes from multiple clinical studies of the implantable Eversense CGM System allowed for CE Marking in 2016 and FDA approval in 2018. Glucometric, accuracy, and safety data from the first 205 US real-world users has been reported and shown to corroborate clinical study results.
De‐identified sensor glucose (SG) data from the Eversense data management system (DMS) from an expanded cohort of 582 real-world commercial users who reached the end of the 90‐day sensor wear period were analyzed. Correlations between Glucose Management Indicator (GMI, an SG-derived assessment of A1C) and percent of SG values between 70-180mg/dL (TIR), percent SG values >180mg/dL, and percent SG values <70mg/dL were made.
As shown in the graphs, GMI had a strong negative correlation with TIR with an R2 value of 0.87. The R2 values were 0.96 for time >180mg/dL, and 0.20 for time <70mg/dL. It was calculated that a TIR increase of 10% was associated with a decrease in GMI of 0.43%.
Data from a large cohort of Eversense CGM system users showed a strong correlation between TIR and GMI, a mathematical assessment of A1C. Monitoring and targeting TIR, in addition to percent of SG values in the hyperglycemic range, should help patients improve diabetes long-term outcomes, particularly in between laboratory assessments of A1C.