title: MD-Logic overnight type 1 diabetes control in home settings: A multicentre, multinational, single blind randomized trial.
abstract: To evaluate the safety, efficacy and need for remote monitoring of the MD-Logic closed-loop system during short-term overnight use at home.
  
  
  
  Seventy-five patients (38 male; aged 10-54 years; average A1c, 7.8% ± 0.7%, 61.8 ± 7.2 mmol/mol) were enrolled from 3 clinical sites. Patients were randomly assigned to participate in 2 overnight crossover periods, each including 4 consecutive nights, 1 under closed-loop control and 1 under sensor-augmented pump (SAP) therapy in the patient's home. Both study arms were supervised using a remote-monitoring system in a blinded manner. Primary endpoints were time spent with glucose levels below 70 mg/dL and percentage of nights in which mean overnight glucose levels were within 90 to 140 mg/dL.
  
  
  
  The median [interquartile range] percentage of time spent in hypoglycaemia was significantly lower on nights when MD-Logic was used, compared to SAP therapy (2.07 [0, 4.78] and 2.6 [0, 10.34], respectively; P = .004) and the percentage of individual nights with a mean overnight glucose level in target was significantly greater (75 [42, 75] and 50 [25,75], respectively; P = .008). The time spent in target range was increased by a median of 28% (P = .001), with the same amount of insulin (10.69 [7.28, 13.94] and 10.41[6.9, 14.07], respectively; P = .087). The remote monitoring triggered calls for hypoglycaemia at twice the rate during SAP therapy compared to closed-loop control (62 and 29, respectively; P = .002).
  
  
  
  The MD-Logic system demonstrated a safe and efficient profile during overnight use by children, adolescents and adults with type 1 diabetes and, therefore, provides an effective means of mitigating the risk of nocturnal hypoglycaemia.
authors.affiliation: The Jesse Z and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva, Israel.
authors.forename: Revital
authors.initials: R
authors.lastname: Nimri
authors.affiliation: Department of Pediatric Endocrinology, Diabetes and Metabolism, University Children's Hospital, Ljubljana, Slovenia.
authors.forename: Natasa
authors.initials: N
authors.lastname: Bratina
authors.affiliation: Diabetes Centre for Children and Adolescents, AUF DER BULT, Kinder- und Jugendkrankenhaus, Hannover, Germany.
authors.forename: Olga
authors.initials: O
authors.lastname: Kordonouri
authors.affiliation: Department of Pediatric Endocrinology, Diabetes and Metabolism, University Children's Hospital, Ljubljana, Slovenia.
authors.forename: Magdalena
authors.initials: M
authors.lastname: Avbelj Stefanija
authors.affiliation: Diabetes Centre for Children and Adolescents, AUF DER BULT, Kinder- und Jugendkrankenhaus, Hannover, Germany.
authors.forename: Maryam
authors.initials: M
authors.lastname: Fath
authors.affiliation: Diabetes Centre for Children and Adolescents, AUF DER BULT, Kinder- und Jugendkrankenhaus, Hannover, Germany.
authors.forename: Torben
authors.initials: T
authors.lastname: Biester
authors.affiliation: The Jesse Z and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva, Israel.
authors.forename: Ido
authors.initials: I
authors.lastname: Muller
authors.affiliation: The Jesse Z and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva, Israel.
authors.forename: Eran
authors.initials: E
authors.lastname: Atlas
authors.affiliation: The Jesse Z and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva, Israel.
authors.forename: Shahar
authors.initials: S
authors.lastname: Miller
authors.affiliation: The Jesse Z and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva, Israel.
authors.forename: Aviel
authors.initials: A
authors.lastname: Fogel
authors.affiliation: The Jesse Z and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva, Israel.|Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
authors.forename: Moshe
authors.initials: M
authors.lastname: Phillip
authors.affiliation: Diabetes Centre for Children and Adolescents, AUF DER BULT, Kinder- und Jugendkrankenhaus, Hannover, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Danne
authors.affiliation: Department of Pediatric Endocrinology, Diabetes and Metabolism, University Children's Hospital, Ljubljana, Slovenia.|Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.
authors.forename: Tadej
authors.initials: T
authors.lastname: Battelino
mesh_terms: D000293:Adolescent; D000328:Adult; D001786:Blood Glucose / Q000032:analysis; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation*; D002648:Child; D018592:Cross-Over Studies; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D055870:Drug Chronotherapy; D005260:Female; D006801:Humans; D007003:Hypoglycemia / Q000097:blood / Q000188:drug therapy / Q000209:etiology; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D007328:Insulin / Q000008:administration & dosage*; D007332:Insulin Infusion Systems; D008297:Male; D008875:Middle Aged; D016037:Single-Blind Method; D013686:Telemetry / Q000379:methods; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents; D007328:Insulin
keywords: 
  MD-Logic; closed-loop; nocturnal hypoglycaemia; remote-monitoring; type 1