title: Prevention of Hypoglycemia With Predictive Low Glucose Insulin Suspension in Children With Type 1 Diabetes: A Randomized Controlled Trial.
abstract: To investigate whether predictive low glucose management (PLGM) of the MiniMed 640G system significantly reduces the rate of hypoglycemia compared with the sensor-augmented insulin pump in children with type 1 diabetes.
  
  
  
  This randomized, two-arm, parallel, controlled, two-center open-label study included 100 children and adolescents with type 1 diabetes and glycated hemoglobin A1c≤10% (≤86 mmol/mol) and using continuous subcutaneous insulin infusion. Patients were randomly assigned to either an intervention group with PLGM features enabled (PLGM ON) or a control group (PLGM OFF), in a 1:1 ratio, all using the same type of sensor-augmented insulin pump. The primary end point was the number of hypoglycemic events below 65 mg/dL (3.6 mmol/L), based on sensor glucose readings, during a 14-day study treatment. The analysis was performed by intention to treat for all randomized patients.
  
  
  
  The number of hypoglycemic events below 65 mg/dL (3.6 mmol/L) was significantly smaller in the PLGM ON compared with the PLGM OFF group (mean ± SD 4.4 ± 4.5 and 7.4 ± 6.3, respectively;P= 0.008). This was also true when calculated separately for night (P= 0.025) and day (P= 0.022). No severe hypoglycemic events occurred; however, there was a significant increase in time spent above 140 mg/dL (7.8 mmol/L) in the PLGM ON group (P= 0.0165).
  
  
  
  The PLGM insulin suspension was associated with a significantly reduced number of hypoglycemic events. Although this was achieved at the expense of increased time in moderate hyperglycemia, there were no serious adverse effects in young patients with type 1 diabetes.
authors.affiliation: Department of Pediatric Endocrinology, Diabetes and Metabolism, University Medical Centre-University Children's Hospital, Ljubljana, Slovenia tadej.battelino@mf.uni-lj.si.|Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.
authors.forename: Tadej
authors.identifier: 0000-0002-0273-4732
authors.initials: T
authors.lastname: Battelino
authors.affiliation: The Jesse Z and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center, Petah Tikva, Israel.
authors.forename: Revital
authors.initials: R
authors.lastname: Nimri
authors.affiliation: Department of Pediatric Endocrinology, Diabetes and Metabolism, University Medical Centre-University Children's Hospital, Ljubljana, Slovenia.
authors.forename: Klemen
authors.initials: K
authors.lastname: Dovc
authors.affiliation: The Jesse Z and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center, Petah Tikva, Israel.|Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
authors.forename: Moshe
authors.initials: M
authors.lastname: Phillip
authors.affiliation: Department of Pediatric Endocrinology, Diabetes and Metabolism, University Medical Centre-University Children's Hospital, Ljubljana, Slovenia.
authors.forename: Natasa
authors.initials: N
authors.lastname: Bratina
mesh_terms: D000293:Adolescent; D001786:Blood Glucose / Q000378:metabolism*; D015190:Blood Glucose Self-Monitoring / Q000379:methods; D002648:Child; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy*; D023381:Endpoint Determination; D005260:Female; D006801:Humans; D007003:Hypoglycemia / Q000097:blood / Q000517:prevention & control*; D007328:Insulin / Q000097:blood / Q000627:therapeutic use*; D007332:Insulin Infusion Systems; D008297:Male
chemical_list: D001786:Blood Glucose; D007328:Insulin