Faculty Disclosure. No, nothing to disclose Yes, please specify: Medtronic Johnson & Johnson. Ownership/ Equity Position.

Transcription

1 Diabeloop Closed-Loop does better than Sensor-augmented Pump on blood glucose control during 3 days with gastronomic dinners: a randomized crossover trial in Patients with Type 1 Diabetes. Hélène Hanaire 1, MD, PhD, Pierre-Yves Benhamou MD, PhD, Sophie Borot, MD, PhD, Maeva Doron, PhD, Sylvia Franc, MD, Bruno Guerci, MD, PhD, Erik Huneker, MSc, Nathalie Jeandidier MD,PhD, Yves Reznik MD, PhD, Pauline Schaepelynck, MD, Ilham Xhaard, PhD, Alfred Penfornis, MD, PhD, Guillaume Charpentier, MD, Eric Renard, MD, PhD, on behalf of the Diabeloop Study Group. 1 CHU Toulouse - France ATTD Paris Feb 17th 2017

2 Faculty Disclosure No, nothing to disclose Yes, please specify: Honoraria/ Expenses Consulting/ Advisory Board Abbott x x Medtronic x Johnson & Johnson x Company Name Funded Research x Royalties/ Patent Stock Options Ownership/ Equity Position Employee Other (please specify)

3 Postprandial glucose control is an issue for type 1 diabetic patients CHO counting may be difficult High fat or protein content of meals induce marked late postprandial hyperglycemia Closed loop insulin delivery during the prandial and postprandial periods remains a challenge Type of algorithm Meal announcement Aim of the study To compare glucose control with Diabeloop Closed Loop vs Sensor Augmented Pump in type 1 diabetic patients enjoying gastronomic dinners during 3 days

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

5 Cloud connected & Therapeutic support Handset Glucose sensor Insulin dose Meals Activity Patient input Prescription Parameters Diabetologist Complex algorithms Insulin Pump Cloud Connected Telemedecine Dedicated nurses Monitoring 24/24

6 Patients (n=10) Age (years) 46.4 (±16.1) Type 1 Diabetes Duration (years) 23.6 (±13.1) BMI (Kg/m2) 24.5 (±4.0) HbA1c (%) 7.7 (±0.8) Minor Hypoglycaemic Events (Nb/week) 3.2 (±2.4)

7 Study Design 10 patients, 3 centers (Grenoble, Montpellier & Toulouse) Breakfast Lunch Breakfast Diner Hospital 07: 00 09: 00 D1 As Usual D2 As Usual D3 As Usual 12: 00 D1 Cafetaria D2 Cafetaria D3 Cafetaria 16:00 20: : 00 D1 Japanese Restaurant D2 French gastronomic Restaurant D3 Italian pizza-tiramisu Restaurant CL : patients announced the meals to the system OL : patients did as usual to adapt their boluses to the meals

8 Primary endpoint 1. Time in range ( mg/dl) during the 3 nights following the gastronomic dinners Secondary endpoints 1. Time in range ( mg/dl), in hypo- and in hyperglycemia during the 3 nights following the gastronomic dinners 2. Time in range ( mg/dl), in hypo- and in hyperglycemia, and mean glucose during the 72 hours of the experiment 3. Treatment satisfaction

9 During the nights, after gastronomic dinners : Diabeloop compared to sensor-augmented insulin pump : Triples the time spent in the mg/dl range Increases by 75% the time spent in the mg/dl range Reduces the time spent in hyperglycaemia without increasing hypoglycaemia P< P< Tests performed using a mixed model variance analysis for repeated measurements on log transformed outcome

10 During the whole 3 days with gastronomic dinners : Diabeloop compared to sensor-augmented insulin pump : increases the time in range ( mg/dl) improves the average BG without increasing hypoglycaemia P< P=0.053 Time above 250 mg/dl during 72 h : 12.8% (OL) v 2.9% (CL), p= Time above 300 mg/dl during 72 h : 4.0% (OL) v 0.7% (CL), p=0.01

11 Median CGM profile after 3 days with gastronomic dinners with or without Diabeloop system *

12 Conclusion In the situation of repeated meals with varying carbohydrate and fat content during 3 days, Diabeloop system, compared to sensoraugmented insulin pump: 1. Triples the time spent in the mg/dl range during the nights following the gastronomic dinners 2. Decreases by nearly 30 mg/dl the average BG during the whole 3 days period 3. Without increasing time below 70 mg/dl during nights or days