Day-and-Night Closed-Loop Glucose Control in Patients With Type 1 Diabetes Under Free-Living Conditions: Results of a Single-Arm 1-Month Experience Compared With a Previously Reported Feasibility Study of Evening and Night at Home

Eric Renard (1, 2, 3) , Anne Farret (1, 2, 3) , Jort Kropff , Daniela Bruttomesso , Mirko Messori , Jérôme Place (1, 2, 3) , Roberto Visentin , Roberta Calore , Chiara Toffanin , Federico Di Palma , Giordano Lanzola , Paolo Magni , Federico Boscari , Silvia Galasso , Angelo Avogaro , Patrick Keith-Hynes , Boris Kovatchev , Simone del Favero , Claudio Cobelli , Lalo Magni , J. Hans Devries , Ap@home Consortium

1 CHRU Montpellier - Centre Hospitalier Régional Universitaire [Montpellier]
2 CIC Montpellier
3 IGF - Institut de Génomique Fonctionnelle

OBJECTIVE:After testing of a wearable artificial pancreas (AP) during evening and night (E/N-AP) under free-living conditions in patients with type 1 diabetes (T1D), we investigated AP during day and night (D/N-AP) for 1 month.RESEARCH DESIGN AND METHODS:Twenty adult patients with T1D who completed a previous randomized crossover study comparing 2-month E/N-AP versus 2-month sensor augmented pump (SAP) volunteered for 1-month D/N-AP nonrandomized extension. AP was executed by a model predictive control algorithm run by a modified smartphone wirelessly connected to a continuous glucose monitor (CGM) and insulin pump. CGM data were analyzed by intention-to-treat with percentage time-in-target (3.9-10 mmol/L) over 24 h as the primary end point.RESULTS:Time-in-target (mean ± SD, %) was similar over 24 h with D/N-AP versus E/N-AP: 64.7 ± 7.6 vs. 63.6 ± 9.9 (P = 0.79), and both were higher than with SAP: 59.7 ± 9.6 (P = 0.01 and P = 0.06, respectively). Time below 3.9 mmol/L was similarly and significantly reduced by D/N-AP and E/N-AP versus SAP (both P < 0.001). SD of blood glucose concentration (mmol/L) was lower with D/N-AP versus E/N-AP during whole daytime: 3.2 ± 0.6 vs. 3.4 ± 0.7 (P = 0.003), morning: 2.7 ± 0.5 vs. 3.1 ± 0.5 (P = 0.02), and afternoon: 3.3 ± 0.6 vs. 3.5 ± 0.8 (P = 0.07), and was lower with D/N-AP versus SAP over 24 h: 3.1 ± 0.5 vs. 3.3 ± 0.6 (P = 0.049). Insulin delivery (IU) over 24 h was higher with D/N-AP and SAP than with E/N-AP: 40.6 ± 15.5 and 42.3 ± 15.5 vs. 36.6 ± 11.6 (P = 0.03 and P = 0.0004, respectively).CONCLUSIONS:D/N-AP and E/N-AP both achieved better glucose control than SAP under free-living conditions. Although time in the different glycemic ranges was similar between D/N-AP and E/N-AP, D/N-AP further reduces glucose variability.TRIAL REGISTRATION:ClinicalTrials.gov NCT02153190.

Domaines: Endocrinologie et métabolisme

Eric Renard, Anne Farret, Jort Kropff, Daniela Bruttomesso, Mirko Messori, et al.. Day-and-Night Closed-Loop Glucose Control in Patients With Type 1 Diabetes Under Free-Living Conditions: Results of a Single-Arm 1-Month Experience Compared With a Previously Reported Feasibility Study of Evening and Night at Home. Diabetes Care, 2016, 39 (7), pp.1151 - 1160. ⟨10.2337/dc16-0008⟩. ⟨hal-01868146⟩