Senseonics Holdings, Inc. · NASDAQ:SENS
Senseonics — Technical Presentation (June 2021)
11 slides from Senseonics's technical presentation, Jun 27, 2021
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 Abstract OR-149 Session 3-CT-OR06, 0800-1000 Sunday, June 27, 2021 Authors: Satish K. Garg1, David Liljenquist2, Bruce Bode3, Mark P. Christiansen4, Timothy S. Bailey
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 • Key attributes include: • Fluorescent-based optical methodology • Transmitter placed on the skin over the sensor allows for • On-body vibratory alerts • Mild silicone-based adhesive with low rates o
Slide 4: Purpose
Purpose • To evaluate the safety and accuracy of the next-generation Eversense CGM System for up to 180 days, the PROMISE Study was conducted at 8 clinical research sites in the USA. • Two sensor systems were studied • Materials and Methods • 181 subjects with 10 clinic visits, between day 1-180, la
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: 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% Overall MARD 9.1% 8.5% Day 1 MARD 11.0% 11.2% Day 180 MARD 10.4% 7.4% MAD between 40-60 mg/dL 9.4% 7.5% MAD between 61-80 mg/dL 8.8% 7.7% Survival
Slide 8: Alert Rate Performance Comparing Primary and SBA Sensors
Alert Rate Performance Comparing Primary and SBA Sensors Glucose Level Event Detection Rate % True Alert Rate % mg/dL Primary Sensor SBA Sensor Primary Sensor SBA Sensor 60 87 90 68 73 70 93 94 87 84 180 99 99 94 93 240 98 98 92 91
Slide 9: Safety
Safety • HbA1c • 7.6% at baseline, 7.2% at day 90, 7.3% at day 180 • Adverse Events • No SAEs related to device or insertion/removal procedures • No unanticipated AEs or UADEs • Procedure • 279 sensors (85 single sensors + 96 dual sensors + 2 replacements) • 558 insertion/removal procedures • No fai
Slide 10: Summary
Summary • The effectiveness measurements for the primary sensors: • 9.1% Overall MARD • 92.9% of the CGM readings within 20/20% of YSI values • 8.8 - 9.4% MAD for hypoglycemia range • 87-99% event detection rates • The effectiveness measurements for the subset of SBA sensors: • 8.5% Overall MARD • 9
Slide 11: Conclusion
Conclusion • As shown by the PROMISE study, the next-generation Eversense CGM system: • Safe and accurate for up to 180 days, particularly in hypoglycemia ranges • Allows for a single calibration/day on most days of system wear • With many unique features, this system should be considered a welcomed
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