Katherine S. Tweden, United States of America

Senseonics Inc Clinical Sciences

Presenter Of 3 Presentations

ACCURACY OF THE EVERSENSE CGM SYSTEM OVER MULTIPLE CYCLES

Session Name
GLUCOSE SENSORS
Session Type
E-POSTER VIEWING (EXHIBITION HOURS)
Date
20.02.2020, Thursday
Session Time
09:30 - 15:30
Channel
E-Poster Area
Lecture Time
09:30 - 09:30

Abstract

Background and Aims

Background: The long-term implantable Eversense CGM System was first commericalized in 2016 in Europe and South Africa for adults with diabetes. Sensor performance over sequential 90- or 180-day cycles has not been published.

Methods

Methods: Sensor glucose (SG) and SMBG measurements obtained from the Eversense data managment system from 6/2016 to 8/2019 were used to evaluate accuracy in Eversense patients with at least four sensor cycles from European and South African clinics. Twenty-four hour transmitter wear time, mean SG with variability metrics, glucose management indicator (GMI), and percent and time in various glycemic ranges were calculated over each cycle.

Results

Results: Among the 945 users included in the analysis (Table), the mean absolute relative difference (MARD) using 152,206 to 206,024 calibration-matched pairs against SMBG ranged from 11.5 to 11.9% over the four sensor cycles. Mean values of the CGM metrics ranged from 156.5 mg/dL to 158.2 mg/dL for SG, 54.7 mg/dL to 55.8 mg/dL for SD, 0.35 to 0.36 for CV, and 7.04% to 7.08% for GMI. The range of %SG across the 4 cycles in the various glycemic ranges was as follows: 1.1-1.3% (<54 mg/dL), 4.6-5.0% (<70 mg/dL), 63.2-64.5% ( ≥70 to 180 mg/dL), 22.4-23.2% (>180-250 mg/dL) and 8.1-8.8% (>250 mg/dL). Median transmitter wear time ranged from 83.2-85.8%.

Conclusions

cgm metrics and accuracy chart.pngConclusion: This real-world longitudinal evaluation of the implantable Eversense CGM System demonstrated that the accuracy and glucometrics are stable over multiple, consecutive sensor cycles with no degradation of performance.

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THE GLYCEMIC OUTCOMES OF THE EVERSENSE CGM SYSTEM IN AN EXPANDED COHORT OF 582 REAL-WORLD US COMMERCIAL USERS

Session Name
E-POSTER DISCUSSION 11
Session Type
E-POSTER DISCUSSION
Date
21.02.2020, Friday
Session Time
10:05 - 10:25
Channel
Station 5 (E-Poster Area)
Lecture Time
10:05 - 10:10

Abstract

Background and Aims

The first long term implantable Eversense CGM system was approved for US commercialization in 2018. Accuracy and safety have been demonstrated in multiple clinical trials and real-world studies. The first US real-world data publication reported on 205 users with a 90-day sensor wear cycle. Using the same analytic methodology, a larger user base of 582 was subsequently analyzed.

Methods

De‐identified sensor glucose (SG) data from the Eversense data management system were analyzed for the first 582 patients who reached a 90‐day wear period and compared to the first 205 patients previously reported. Mean SG, variability measures (SD, CV), GMI, and glucometrics were computed. Median transmitter wear time was assessed.

Results

The makeup of the 582 cohort was similar to the 205 cohort with ~1/3 naïve CGM users and ~80-85% T1D. Glucometric data were similar between the larger cohort and the original population (Table). The mean SG was 162 and 161 mg/dL, CV was .35, GMI was 7.18% and 7.16%, and time in range was 62 and 63% in the 205 and 582 user groups, respectively. Mean percent SG <70mg/dL approached the targeted value of <4% (4.2 and 4.0%). Median transmitter wear time was 84 and 85%.

Conclusions

These data show that the promising glycemic outcomes and system usage obtained in the first 205 users was sustained in a larger cohort of US commercial Eversense CGM system users and likely represents the real-world population outcomes to be expected when using the system as a tool for diabetes management.expanded cohort.png

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THE EFFECT OF AGE ON GLYCEMIC OUTCOMES IN A LARGE COHORT OF EVERSENSE CGM SYSTEM ADULT USERS

Session Type
ORAL PRESENTATION SESSION
Date
22.02.2020, Saturday
Session Time
10:30 - 12:00
Channel
La Paz
Lecture Time
11:10 - 11:20

Abstract

Background and Aims

Accuracy and safety of the implantable Eversense CGM system, approved by the FDA in 2018, have been demonstrated in multiple clinical trials and real-world analyses. No glucometric outcomes by age have been reported.

Methods

Anonymized sensor glucose (SG) data from Eversense data management system (DMS) were analyzed for the first 582 patients with a 90‐day wear period. Mean SG, GMI, and percent time across glucose ranges were calculated for various age ranges from young adult to Medicare-age populations.

Results

Among 582 patients, ~85 identified as TID, and ~1/3 reported being CGM naïve. Percent of time in various ranges demonstrated time in range (TIR, 70-180 mg/dL), time below ranges (<70 mg/dL and <54 mg/dL), and time above ranges (>180 mg/dL and >250 mg/dL) improved with age, with a 50% TIR in patients 18-24 years of age to 68% and 70% TIR in patients >60 and ≥65 years of age, respectively (Table). Mean GMI and SG also decreased with age. Hypoglycemia did not increase with age.

Conclusions

These data demonstrated that glycemic outcomes improve with age in Eversense CGM system users. The older, Medicare cohort did not have an increase in hypoglycemia compared to other adult groups, despite the lowest GMI and highest TIR. While glucometrics in young adults are not optimal, these results (in a small cohort) suggest that a long-term implantable sensor might offer this age group the opportunity to attain A1C results, as supported by GMI data, less than 8% with an acceptable risk of hypoglycemia. age on glycemic outcomes.png

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