Slide 1: The PROMISE Study: Safety and Accuracy of the Next Generation 180-Day Eversense CGM System
The PROMISE Study: An Evaluation of the Safety and Accuracy of the Next Generation 180-Day Long-term Implantable Eversense CGM System Satish K. Garg1, David Liljenquist2, Bruce Bode3, Mark P. Christiansen4, Timothy S. Bailey5, Ronald L. Brazg6, Douglas Denham7, Anna R. Chang8, Halis K. Akturk1, Andr
Slide 2: Disclosure Information
Disclosure Information • Advisory Boards Consulting fees*: Medtronic, Novo-Nordisk, Zealand, Lifescan Diabetes Institute and Eli Lilly • Research grants*: Eli Lilly, Novo-Nordisk, Merck, Lexicon, Medtronic, Dario, NCI, T1D Exchange, NIDDK, JDRF, Animas, Dexcom, Sanofi and Senseonics • No stocks in a
Slide 3: Background
Background • The Eversense CGM system is the only long-term implantable CGM system approved for use • Pivotal studies have shown a MARD of • 8.5% for the 90-day US product • 9.4% for the 180-day European system • Key Eversense CGM system attributes include: • Fluorescent-based optical methodology •
Slide 4: Purpose, Materials and Methods
Purpose • The prospective, multi-center PROMISE Study evaluated the safety and accuracy of the next- generation Eversense CGM System for up to 180 days • A subset of subjects had a second sensor (Sacrificial Boronic Acid {SBA} sensor) inserted with a specific modification to reduce oxidation of the
Slide 5: Baseline Patient Characteristics
Baseline Patient Characteristics Demographic Value Gender n (%) Male 85 (47.0) Female 96 (53.0) Age (years)* 48.6 (14.9) Ethnicity n (%) Hispanic 23 (12.7) Non-Hispanic 158 (87.3) Race n(%) Caucasian 163 (90.1) Black or African American 10 (5.5) Asian 4 (2.2) American Indian or Alaska Native 2 (1.1)
Slide 6: Accuracy by Glucose Range: Primary Sensor
Accuracy by Glucose Range: Primary Sensor Number of Paired CGM Mean Percent Mean Absolute Relative Median Absolute Relative YSI Glucose and YSI Reference 20/20% of Difference, MARD (%) Difference (%) Range (mg/dL) Points Reference Overall 49613 92.9 9.1 6.7 40 – 60 2281 89.4 9.4 7.0 61 – 80 5270 92.
Slide 7: Accuracy by Day: Primary Sensor
Accuracy by Day: Primary Sensor Mean Median Number of Mean Percent Absolute Absolute Day Number Paired CGM and YSI 20/20% of Relative Relative Reference Points Reference Difference, MARD Difference (%) (%) Day 1 5584 89.0 11.0 8.0 Day 7 2724 91.3 9.6 7.2 Day 14 2318 91.7 9.2 6.8 Day 22 6198 93.6 9.1
Slide 8: Comparison between Primary and SBA Sensors
Comparison between Primary and SBA Sensors Primary Sensors SBA Sensors # of Paired Points – 49.613 # of Paired Points – 12,034 % with 20/20% 92.9% 93.9% MARD 9.1% 8.5% Confirmed alert detection rate 93% 94% 70 mg/dL Confirmed alert detection rate 99% 99% 180 mg/dL MAD between 40-60 mg/dL 9.4% 7.5% M
Slide 9: Safety
Safety • The HbA1c was 7.6% at baseline, 7.2% at 90 days, 7.3% at day 180 • No SAEs related to device or insertion/removal procedures • No unanticipated AEs or UADEs • 279 sensors (85 single sensors + 96 dual sensors + 2 replacements), resulting in 558 insertion/removal procedures • 2 mild skin infe
Slide 10: Summary
Summary • The effectiveness measurements for the primary sensors: • 92.9% of the CGM readings were within 20/20% of YSI values • 9.1% MARD-Overall • 8.8 - 9.4% MAD for hypoglycemia range • The effectiveness measurements for the subset of SBA sensors: • 93.9% of CGM readings were within 20/20% of YSI
Slide 11: Conclusion
Conclusion • As shown by the PROMISE study, the next-generation Eversense CGM system: • Safe and accurate for up to 180 days • Allows for a single calibration/day on most days of system wear • Should be considered a welcomed addition to options available for real-time CGM satish.garg@ucdenver.edu Ga