Faculty Disclosure. No, nothing to disclose Yes, please specify: Novo-Nordisk. Roche. Abbott. Funded Research. Ownership/ Equity Position

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1 Diabeloop Closed-Loop does better than sensor-augmented-pump on blood glucose during 3 days with intensive physical eercises: a randomized crossover trial. Sylvia Franc 1, MD, Sophie Borot, MD, PhD, Pierre-Yves Benhamou MD, PhD, Maeva Doron, PhD, Bruno Guerci, MD, PhD, Hélène Hanaire, MD, PhD, Erik Huneker, Msc Nathalie Jeandidier MD, PhD, Eric Renard, MD, PhD, Yves Reznik MD, PhD, Ilham Xhaard, PhD, Alfred Penfornis, MD, PhD, Guillaume Charpentier, MD, Pauline Schaepelynck, MD, on behalf of the Diabeloop Study Group. 1 CERITD Evry & CHSF Corbeil - France ATTD Paris Feb 17th 2017

2 Faculty Disclosure No, nothing to disclose Yes, please specify: Honoraria/ Epenses Consulting/ Advisory Board Novo-Nordisk Sanofi Company Name Roche Funded Research Stock Options Ownership/ Equity Position Employee Other (please specify) MSD Abbott Eli Lilly Royalties/ Patent speaker

3 Physical eercice: a real challenge for patients with T1D How to cope with this kind of results? Even for epert patients, maintaining BG level in the range in case of physical activity most often remains very hard

4 Diabeloop system Safety on Insulin delivery Hypo minimizer Epert system Physiological model Hovorka Self-learning long time-frame Self-learning short time-frame

5 Diabeloop system Handset Glucose sensor Insulin dose Meals Activity Patient input Interaction man/machine Prescription Parameters Diabetologist Comple algorithms Insulin Pump

6 DIABELOOP: a system connected to the cloud with a therapeutic support Handset Glucose sensor Insulin dose Meals Activity Patient input Prescription Parameters Comple algorithms Insulin Pump Cloud Connected 1) Continuous transmission of data Diabetologist Telemedecine Dedicated nurses Monitoring 24/24 2) Automatic analysis of the data with alerts in case of pb + A TLM system 24/7

7 Design of the Study 14 patients, 3 centers (Corbeil, Besançon, Marseille) A cross-over design Lunch Breakfast Dinner 70 g CHO 40g CHO Breakfast 70 g CHO Night at Hospital 07: 00 09: 00 Program of eercice during the 3 days Day 1 Day 2 Day 3 12: 00 MORNING 20: 00 16:00 08 : 00 AFTERNOON Rest min, 75% VO2ma Rest min, 50% VO2ma 30 min, 50% VO2ma min, 75% VO2ma CL : patients announced to the system the occurrence of physical activity (moderate or intense) 30 min before eercising OL : patients were asked to do as usual in case of physical activity

8 Characteristics of the population at baseline (n=14) Age (years) 48.7 (±11.8) T1 diabetes duration (years) 20.9 (±10.6) BMI (Kg/m2) 24.5 (±3.1) HbA1c (%) mmol/mol 8.0 (±0.5) c-peptid (ng/ml) 0.0 (±0.0) Minor hypoglycaemic events (Nb/week) 3.1 (±3.9) 64

9 Primary endpoint 1. Time in range ( mg/dl) during the 3 nights following the days with eercise sessions Secondary endpoints 1. Time in range ( mg/dl), in hypo- and in hyperglycemia during the 3 nights following the eercise days 2. Time in range ( mg/dl), in hypo- and in hyperglycemia, and mean glucose during the 72 hours of the eperiment 3. Treatment satisfaction

10 During the 3 Nights : Diabeloop is able to double time spent in range [ mg/dl] compared to sensor-augmented insulin pump DIABELOOP increased by 40% the time in range DIABELOOP doubled the time spent in the range DIABELOOP reduced by 75% the time > 180 mg/dl Primary end-point Secondary end-points.. without increasing time in hypoglycaemia

11 During the whole 3 days : Diabeloop improves the average BG compared to sensor-augmented insulin pump, without increasing hypoglycaemia - 20 mg/dl mg/dl A reduction of more than 50% of the time spent in hyperglycemia during 72 h with CL vs OL : - Time > 250 mg/dl : 3.8% (CL) vs 8.7% (OL), p= Time > 300 mg/dl : 0.4% (CL) vs 2.3% (OL), p=0.01 Evaluation by patients: tendency towards a higher level of satisfaction (p=0.0565), a greater ease of use (p=0.0526) and clearly, a higher confort with the system (p=0.0251), with Diabeloop CL vs SAP (Visual Analogic scales)

12 Median CGM profil after 3 days of repeated physical eercises with or without Diabeloop system

13 Conclusion In well educated patients, After repeated announced physical eercises during 3 days, Diabeloop system, compared to sensor-augmented insulin pump : 1. Doubled the time spent in the range [ mg/dl] during the nights 2. Decreased by nearly 20 mg/dl the average BG during the whole period 3. without increasing time below 70 mg/dl during nights or days 4. Tendency towards an increased treatment satisfaction

14 Thank you for your attention