1. 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

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

3. 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

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

5. Lifetime of the sensors
90 days,
88%

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

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

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

9. 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

10. 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

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

12. 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

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

14. 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

15. Scars

16. The Transmitter
4.0 x 3.8 x 1.3 cm

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

18. Mobile App

19. 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!

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

21. Doing now what patients need next