ESPE2021 Free Communications Diabetes (6 abstracts)
A Randomised Controlled Cross-Over Trial of the Hybrid Closed-Loop Insulin Delivery System Diabeloop vs. Sensor-Augmented Pump Therapy in Children Aged 6-12 Years
Dulanjalee Kariyawasam 1 , Carole Morin 2 , Kristina Casteels 3,4 , Claire Le Tallec 2 , Annie Sfez 5 , Cécile Godot 1 , Erik Huneker 6 , Nathalie Garrec 5 , Michel Polak 1,7 , Guillaume Charpentier 8 , Sylvia Franc 8,9,10 & Jacques Beltrand 1,7
1Necker-Enfants Malades University Hospital, Assistance Publique des Hôpitaux de Paris – Centre, Paris, France.;2Children Hospital, University Hospital Center of Toulouse, Toulouse, France.;3University Hospitals Leuven, Leuven, Belgium.;4Development and Regeneration, KU Leuven, Leuven, Belgium.;5Grand Hôpital de l’Est Francilien, Marne - la - Vallée, France.;6Diabeloop SA, Grenoble, France.;7Université de Paris, Paris, France.;8Centre d’Etudes et de Recherches pour l’Intensification du Traitement du Diabète (CERITD), Evry, France.;9Hôpital Sud-Francilien, Corbeil - Essonnes, France.;10LBEPS (Laboratoire de Biologie de l’Exercice pour la Performance et la Santé), Université d’Évry, IRBA (Institut de Recherches Biomédicales des Armées, Université Paris Saclay, Evry, France
Introduction: HbA1C goals are rarely achieved in children with Type 1 diabetes (T1D) except at the cost of increased hypoglycaemia episodes. The Diabeloop Hybrid Closed-Loop system improves time in range and glycemic control in adults. However, the efficacy and safety of the system had not yet been evaluated in children. Our objective was to evaluate the safety and efficiency of the Diabeloop hybrid closed-loop system in prepubescent children (DBL4K).
Materials and methods: We performed an open-label, multicentre, randomised, controlled, two-session crossover study in patients aged 6-12 years with T1D, HbA1C <9%, and insulin pump treatment. Patients were randomised to the closed-loop ((Kaleido pump + Dexcom G6 = CL) device or sensor-augmented pump (open loop = OL) therapy. The CL and OL were worn for 4 days in hospital, followed by 6 weeks at home. Questionnaires on satisfaction, quality of life, and acceptance were completed independently by the children and parents.
Results: Twenty-one patients (mean age: 8.3+/- 1.6 years; 10 boys) were included between March and December 2019. The percentage of time spent in hypoglycemia (< 3.85 mmol/L) was significantly lower in the CL group during the 72 hours in hospital (2.04% in CL vs 7.06% in OL, P < 0.001) and the 6 weeks at home (2.62% in CL vs 5.24% in OL, P < 0.0001). The percentage of time spent in range (4-10 mmol/L) was identical in both groups during the 72-hour phase in hospital (68.73% in CL vs 70.53% in OL, P = 0.539) and then significantly higher in the CL group during the 6 weeks at home (66.19% in CL vs 58.68% in OL, P < 0.001). No events of ketoacidosis or severe hypoglycemia were recorded. Acceptance of and adherence to the CL device were good, and most patients and parents wanted to continue using this device.
Conclusions: The DBL4K Closed-Loop System is suitable for prepubescent children. It decreases hypoglycaemic episodes and provides good metabolic control in pre-pubescent children with type 1 diabetes, under real-life conditions. It also decreases the burden of diabetes management. It could allow for better long-term glucose control in children with diabetes.
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