PT  - JOURNAL ARTICLE
AU  - Tauschmann, Martin
AU  - Allen, Janet M.
AU  - Nagl, Katrin
AU  - Fritsch, Maria
AU  - Yong, James
AU  - Metcalfe, Emily
AU  - Schaeffer, Dominique
AU  - Fichelle, Muriel
AU  - Schierloh, Ulrike
AU  - Thiele, Alena G.
AU  - Abt, Daniela
AU  - Kojzar, Harald
AU  - Mader, Julia K.
AU  - Slegtenhorst, Sonja
AU  - Barber, Nicole
AU  - Wilinska, Malgorzata E.
AU  - Boughton, Charlotte
AU  - Musolino, Gianluca
AU  - Sibayan, Judy
AU  - Cohen, Nathan
AU  - Kollman, Craig
AU  - Hofer, Sabine E.
AU  - Fröhlich-Reiterer, Elke
AU  - Kapellen, Thomas M.
AU  - Acerini, Carlo L.
AU  - de Beaufort, Carine
AU  - Campbell, Fiona
AU  - Rami-Merhar, Birgit
AU  - Hovorka, Roman
TI  - Home Use of Day-and-Night Hybrid Closed-Loop Insulin Delivery in Very Young Children: A Multicenter, 3-Week, Randomized Trial
AID  - 10.2337/dc18-1881
DP  - 2019 Apr 01
TA  - Diabetes Care
PG  - 594--600
VI  - 42
IP  - 4
4099  - http://care.diabetesjournals.org/content/42/4/594.short
4100  - http://care.diabetesjournals.org/content/42/4/594.full
SO  - Diabetes Care2019 Apr 01; 42
AB  - OBJECTIVE We aimed to assess the feasibility and safety of hybrid closed-loop insulin delivery in children with type 1 diabetes aged 1–7 years as well as evaluate the role of diluted insulin on glucose control.RESEARCH DESIGN AND METHODS In an open-label, multicenter, multinational, randomized crossover study, 24 children with type 1 diabetes on insulin pump therapy (median age 5 years [interquartile range 3–6] and mean ± SD HbA1c 7.4 ± 0.7% [57 ± 8 mmol/mol] and total insulin 13.2 ± 4.8 units/day) underwent two 21-day periods of unrestricted living and we compared hybrid closed-loop with diluted insulin (U20) and hybrid closed-loop with standard strength insulin (U100) in random order. During both interventions, the Cambridge model predictive control algorithm was used.RESULTS The proportion of time that sensor glucose was in the target range between 3.9 and 10 mmol/L (primary end point) was not different between interventions (mean ± SD 72 ± 8% vs. 70 ± 7% for closed-loop with diluted insulin vs. closed-loop with standard insulin, respectively; P = 0.16). There was no difference in mean glucose levels (8.0 ± 0.8 vs. 8.2 ± 0.6 mmol/L; P = 0.14), glucose variability (SD of sensor glucose 3.1 ± 0.5 vs. 3.2 ± 0.4 mmol/L; P = 0.16), or the proportion of time spent with sensor glucose <3.9 mmol/L (4.5 ± 1.7% vs. 4.7 ± 1.4%; P = 0.47) or <2.8 mmol/L (0.6 ± 0.5% vs. 0.6 ± 0.4%; P > 0.99). Total daily insulin delivery did not differ (17.3 ± 5.6 vs. 18.9 ± 6.9 units/day; P = 0.07). No closed-loop–related severe hypoglycemia or ketoacidosis occurred.CONCLUSIONS Unrestricted home use of day-and-night closed-loop in very young children with type 1 diabetes is feasible and safe. The use of diluted insulin during closed-loop does not provide additional benefits compared with standard strength insulin.