Home Use of Day-and-Night Hybrid Closed-Loop Insulin Delivery in Suboptimally Controlled Adolescents With Type 1 Diabetes: A 3-Week, Free-Living, Randomized Crossover Trial.
This study evaluated the feasibility, safety, and efficacy of day-and-night hybrid closed-loop insulin delivery in adolescents with type 1 diabetes under free-living conditions.



In an open-label randomized crossover study, 12 suboptimally controlled adolescents on insulin pump therapy (mean ± SD age 14.6 ± 3.1 years; HbA1c69 ± 8 mmol/mol [8.5 ± 0.7%]; duration of diabetes 7.8 ± 3.5 years) underwent two 21-day periods in which hybrid closed-loop insulin delivery was compared with sensor-augmented insulin pump therapy in random order. During the closed-loop intervention, a model predictive algorithm automatically directed insulin delivery between meals and overnight. Participants used a bolus calculator to administer prandial boluses.



The proportion of time that sensor glucose was in the target range (3.9-10 mmol/L; primary end point) was increased during the closed-loop intervention compared with sensor-augmented insulin pump therapy by 18.8 ± 9.8 percentage points (mean ± SD; P < 0.001), the mean sensor glucose level was reduced by 1.8 ± 1.3 mmol/L (P = 0.001), and the time spent above target was reduced by 19.3 ± 11.3 percentage points (P < 0.001). The time spent with sensor glucose levels below 3.9 mmol/L was low and comparable between interventions (median difference 0.4 [interquartile range -2.2 to 1.3] percentage points; P = 0.33). Improved glucose control during closed-loop was associated with increased variability of basal insulin delivery (P < 0.001) and an increase in the total daily insulin dose (53.5 [39.5-72.1] vs. 51.5 [37.6-64.3] units/day; P = 0.006). Participants expressed positive attitudes and experience with the closed-loop system.



Free-living home use of day-and-night closed-loop in suboptimally controlled adolescents with type 1 diabetes is safe, feasible, and improves glucose control without increasing the risk of hypoglycemia. Larger and longer studies are warranted.
Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, U.K.|Department of Paediatrics, University of Cambridge, Cambridge, U.K.
Martin
M
Tauschmann
Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, U.K.|Department of Paediatrics, University of Cambridge, Cambridge, U.K.
Janet M
JM
Allen
Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, U.K.|Department of Paediatrics, University of Cambridge, Cambridge, U.K.
Malgorzata E
ME
Wilinska
Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, U.K.
Hood
H
Thabit
Department of Paediatrics, University of Cambridge, Cambridge, U.K.
Carlo L
CL
Acerini
Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, U.K.|Department of Paediatrics, University of Cambridge, Cambridge, U.K.
David B
DB
Dunger
Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, U.K. rh347@cam.ac.uk.|Department of Paediatrics, University of Cambridge, Cambridge, U.K.
Roman
R
Hovorka
D000293:Adolescent; D001786:Blood Glucose / Q000378:metabolism; D002096:C-Peptide / Q000097:blood; D002648:Child; D018592:Cross-Over Studies; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy*; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007328:Insulin / Q000008:administration & dosage* / Q000627:therapeutic use*; D008297:Male; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D016482:Urinalysis
D001786:Blood Glucose; D002096:C-Peptide; D006442:Glycated Hemoglobin; D007328:Insulin