1. Teddy Ryder, 5yrs, 12.5 kg (1922) Teddy Ryder (1923) Dr. Best & Dr. Banting

2. 1922 2016

3. The gap(s) 3 Basu et al. DTT, 2016

4. JOANNEUM RESEARCH Forschungsgesellschaft mbH HEALTH – Institute for Biomedicine and Health Sciences Medical University of Graz, Austria Division of Endocrinology and Diabetology Graz, 22.03.2016 M. Rumpler, M. Hajnsek, I. Klimant, F. Sinner Phosphorescence-based Continuous Single-Port Glucose Sensing onto a Commercial Insulin Infusion Set in Subcutaneous Tissue Graz University of Technology, Graz Austria Institute of Analytical Chemistry and Food Chemistry A solution !?

5. Technical background 5 glucose sensor oxygen sensor 0.4 mm 7.0 mm PD‘sLED‘s

6. Technical background oxygen sensor glucose sensor reference dye layer (tbutPtNTBP) λabs: 637 nm λem: 860 nm glucose dye layer (PtTPTBPF) λabs: 617 nm λem: 775 nm GOx layer diffusion layer Δ pO2 ~ c glucose

7. In-vitro results 0.288 ±0.288 mmHg/h n=3n=6

8. Clinical trial First-in-man study of this type of sensor concept Primary objective 8 To assess the accuracy and reliability of the single-port system with regard to blood reference values (Super GL2, Hitado) Subject characteristics n12 Gender, f/m5/7 Age (years)33.3 ± 10.6 BMI (kg/m 2 )22.5 ± 2.4 Serum creatinine (mg/dl) 1.5 ± 1.0 HbA1c (%) 7.6 ± 1.1 Diabetes duration (years)16.8 ±11.7

9. 9 Day1: 9:00 sensor insertion (2x) 20:00 study end reference blood samples every 5 min Day 2: 8:00 reader mounted Clinical trial Single-center, open-label, non-controlled clinical trial Study design

10. peg_zoneFrequencyPercent Cumulative Frequency Cumulative Percent A51353.4451353.44 B32433.7583787.19 C11011.4694798.65 D131.35960100.00 E00.00960100.00 10 Clinical trial – total outcome Results  12 patients -> 23 sensors (1 accidently pulled out during day1)  retrospective glucose calculation  Median-ARD: 22.5% (n=960)  fabricated by manual drop-coating  no filtering or correction algorithm

11. 11 Clinical trial – exemplary outcome Median-ARD 7.9% (n = 42) Median-ARD 11.8% (n = 41)

12. 12 Conclusion Successful integration of a CGM system on a CSII set creating a single-port system. The single-port system offers great potential for an artificial pancreas (SPIDIMAN)

13. 13 Outlook Optimized/reproducible sensor production Optimizing sensor calibration / glucose calculation Clinical trial with active insulin infusion Combining the single-port system with an insulin calculating algorithm.

14. Thank you for your attention Markus Rumpler, BSc, MSc mail: ca.health@joanneum.atca.health@joanneum.at Prof. Klimant & Team JOANNEUM RESEARCH Forschungsgesellschaft mbH HEALTH – Institute for Biomedicine and Health Sciences Neue Stiftingtalstraße 2, 8010 Graz www.joanneum.at/health

15. platinum(II)-mesotetra(4-fluorophenyl)tetrabenzo-porphyrin (PtTPTBPF) 615 nm 770 nm 635 nm 860 nm platinum(II)-6-aza-13,20,27-triphenyltetra(tert-butylbenzo)porphyrin (tbutPtNTBP)

16. Background Inclusion criteria Informed consent obtained after being advised of the nature of the study Male or female aged ≥18 years Type 1 diabetes for at least 6 months according to the WHO definition Treatment with multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII) for at least 3 months Body Mass Index (BMI) < 35 kg/m² Willing and able to wear 5 CGM devices for the duration of the study and undergo all study procedures. HbA1c ≤ 86 mmol/mol 16

17. 17 sensor 1 MARD-median: 7.9% (n = 42) sensor 2 MARD-median: 11.8% (n = 41) Clinical trial

18. Sensors 1

19. Sensors 2

20. 20 Clinical trial – exemplary outcome subject 01 subject 03

21. 21 Median-ARD 11.8% (n = 41) Median-ARD 7.9% (n = 42) Median-ARD 14.7% (n = 43) Median-ARD 13.9% (n = 46) Clinical trial – exemplary outcome subject 01 subject 03

22. 22 Day1: 9:00 sensor insertion (2x) 20:00 study end Clinical trial Single-center, open-label, non-controlled clinical trial Study design

23. 23 Day1: 9:00 sensor insertion (2x) 20:00 study end reference blood samples every 5 min Day 2: 8:00 reader mounted Clinical trial Single-center, open-label, non-controlled clinical trial Study design

24. 24 Day1: 9:00 sensor insertion (2x) 20:00 study end reference blood samples every 5 min Day 2: 8:00 reader mounted Clinical trial Single-center, open-label, non-controlled clinical trial Study design