University of Amsterdam The `PRECISE´ Study Senseonics implantable CGM PART 1 | Accuracy and lifetime PART 2 | Experience from German patients University of Amsterdam University of London University of Cambridge PI: J. Kropff / J. H. DeVries PI: P. Choudhary PI: R. Hovorka Swansea University Profil Mainz Profil Neuss University of Ulm Senseonics Incorporated 1 PI: S.C. Bain PI: C. Kapitza, T. Forst PI: M. Link

Study objective Investigate the accuracy of the Eversense CGM System up to 180 days

Participant Baseline Characteristics 3-month cohort (n= 71) Age (years) 41.7 ± 12.6 Sex, male (n)(%) 42 (59.2%) BMI (kg/m2) 27.0 ± 4.2 Diabetes duration (years) 22.2 ± 12.5 HbA1c (%) 7.6 ± 1.1 Insulin pump users (n)(%) CGM user before study (n)(%) 32 (45.1%) ± SD

Accuracy throughout 90-day period MARD (days 0-90) 11.5% MARD (%)

Lifetime of the sensors 90 days, 88%

Accuracy of the sensor A: 84.8% B: 14.5% C: 0.0% D: 0.7% E: 0.0%

HbA1c improvement 0.5%(percent points) HbA1c-decrease from day 0 to day 90

Transmitter Wear Compliance Wear Compliance (hours/day) 71 Enrolled subjects Median Wear Time: 23.5 Hours/Day 25th Percentile: 22.0 Hours/Day

Conclusions (Part 1) Successful study with an implantable CGM system The system measures glucose accurately and reliably during up to 90 days The results are similar or better than other CGM- Systems already in the market Data from the 6-months analysis available soon

Part 2 | PRECISE Study Experience from German patients University of Amsterdam University of London University of Cambridge Swansea University University of Ulm Profil Mainz Profil Neuss 06. März 2016

Patient Feedback from the PRECISE Study After 90 days patients were asked to share their experiences with the usage of the system

month day, year Implantation in 5-minute procedure At the doctor‘s office under local anesthesia 1. Make Incision 2. Insert Sensor 3. Cover Incision 5 to 8 mm Incision made in Upper Arm (Lidocaine) Sensor Inserted with Custom Inserter Steri-Strips™ to Close Sensor holder Sensor holder frame Sensor Insertion tools The sensor is replaced after 90 days The transmitter can be taken off/put back on (for example, when swimming, bathing, etc.) HEADER AND FOOTER: INSERT > HEADER AND FOOTER

Patient Feedback Implantation and pain `The sensor insertion was painless´  90% - Yes, I agree!  3% - Neither agree nor disagree  8% - No, I disagree!

Infections Altogether 166 sensors were inserted in the PRECISE study Three patients had local infections 2 after insertion (1.2 %) 1 after removal One infection had to be treated and the sensor was removed

Scars

The Transmitter 4.0 x 3.8 x 1.3 cm

Patient Feedback Transmitter `The transmitter was comfortable to wear´  78% - Yes, I agree!  3% - Neither agree nor disagree  20% - No, I disagree

Mobile App

Patient Feedback Low/high glucose alarm `The alarms warned me of low/high glucose´  95% - Yes, I agree!  3% - Neither agree nor disagree  3% - No, I disagree!

Patient Feedback “Deutlich weniger Hypos durch eine frühzeitige Warnungmehr Sicherheit Lebensqualität!!!! Ich mache jetzt viel mehr Sport” Eversense CGM System

Doing now what patients need next