Customization of home closed-loop insulin delivery in adult patients with type 1 diabetes, assisted with structured remote monitoring: the pilot WP7 Diabeloop study
Improvement in closed-loop insulin delivery systems could result from customization of settings to individual needs and remote monitoring. This pilot home study evaluated the efficacy and relevance of this approach.
A bicentric clinical trial was conducted for 3 weeks, using an MPC-based algorithm (Diabeloop Artificial Pancreas system) featuring five settings designed to modulate the reactivity of regulation. Remote monitoring was ensured by expert nurses with a web platform generating automatic Secured Information Messages (SIMs) and with a structured procedure. Endpoints were glucose metrics and description of impact of monitoring on regulation parameters.
Eight patients with type 1 diabetes (six men, age 41.8 ± 11.4 years, HbA1c 7.7 ± 1.0%) were included. Time spent in the 70–180 mg/dl range was 70.2% [67.5; 76.9]. Time in hypoglycemia < 70 mg/dl was 2.9% [2.1; 3.4]. Eleven SIMs led to phone intervention. Original default settings were modified in all patients by the intervention of the nurses.
This pilot trial suggests that the Diabeloop closed-loop system could be efficient regarding metabolic outcomes, whereas its telemedical monitoring feature could contribute to enhanced efficacy and safety.
This study is registered at ClinicalTrials.gov with trial registration number NCT02987556.
KeywordsType 1 diabetes mellitus Artificial pancreas Closed-loop insulin therapy Telemedicine Remote monitoring
CERITD (Centre d’Études et de Recherches pour l’Intensification du Traitement du Diabète) is a nonprofit clinical translational research center located in Corbeil hospital. CERITD as the sole sponsor was fully involved in the design and coordination of the study. Part of the investigations was conducted within the Grenoble Clinical Research Centre (CIC-INSERM, Grenoble University Hospital) under the supervision of Pr Jean Luc Cracowski. The authors would like to thank Ilham Xhaard, Caroline Peschard, Dina Ingrao Lecante, Laurent Orlando, Delphine Coto, Anne Cecile Gully, Steeve Mounier, Marie Helene Petit from CERITD, Adeline Paris, Claire Cracowski, Enkelejda Hodaj, Justine Cristante, Manon Jalbert from Grenoble University Hospital, for involvement in the management of the study, and all engineers from DIABELOOP S.A. and from CEA-LETI. Statistical analysis was performed by Didier Not (www.rcts.fr). Financial support of the study was provided by a contract grant from AVIESAN and by CERITD.
Compliance with ethical standards
Conflict of interest
The authors declare the following disclosures: Erik Huneker is CEO of Diabeloop S.A. Guillaume Charpentier is chairman of Diabeloop S.A. Erik Huneker, Guillaume Charpentier and Sylvia Franc are shareholders in Diabeloop S.A. The other authors (Pierre Y. Benhamou, Maeva Doron, and all other members of the Diabeloop consortium) declare no conflict of interest.
Human and animal rights
All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2008.
Informed consent was obtained from all patients prior to their inclusion in the study.
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