title: Decrease in clinical hypoglycemia in young children with type 1 diabetes treated with free-mixed aspart and detemir insulin: an open labeled randomized trial.
abstract: OBJECTIVE
  To compare the effectiveness of a free-mix of aspart (A) and detemir (D) insulins (ADIM) with a commonly used premixed fixed-ratio aspart and neutral protamine Hagedorn (NPH) insulin mixture (ANIM) in young children with type 1 diabetes (T1D) treated with twice-daily injections. The trial thus compares not only D vs. NPH, but also flexible, personalized insulin preparations vs. a fixed premixed preparation.
  
  
  METHODS
  This single-center, open-label, randomized trial included 82 children with T1D. Patients stayed on ANIM for 1 yr of optimization of disease management, then were randomized to either ANIM (N = 41) or ADIM (N = 41) for another year.
  
  
  RESULTS
  Frequency of severe or symptomatic episodes, glycated hemoglobin A1c (HbA1c), and blood glucose (BG) values.
  
  
  RESULTS
  Compared with ANIM, ADIM decreases symptomatic hypoglycemia by approximately 2 fold (p < 0.001) and severe hypoglycemia by 7-10 fold (p = 0.04). ADIM somewhat reduced BG variation. Mean HbA1c was comparable on ADIM (7.9 ± 0.8 %; 63 ± 9 mmol/mol) and ANIM (8.2 ± 0.7 %; 66 ± 8 mmol/mol).
  
  
  CONCLUSIONS
  Using a free-mixing preparation of aspart and detemir insulin decreases hypoglycemia in young children with type 1 diabetes.
authors.affiliation: AP-HP, Department of Pediatric Endocrinology, Bicêtre Hospital, Paris Sud University, Pôle I3E, 94275, Le Kremlin Bicetre, France.
authors.forename: C
authors.initials: C
authors.lastname: Petit-Bibal
authors.affiliation: AP-HP, Department of Pediatric Endocrinology, Bicêtre Hospital, Paris Sud University, Pôle I3E, 94275, Le Kremlin Bicetre, France.
authors.forename: A
authors.initials: A
authors.lastname: Rothenbuhler
authors.affiliation: AP-HP, Department of Pediatric Endocrinology, Bicêtre Hospital, Paris Sud University, Pôle I3E, 94275, Le Kremlin Bicetre, France.
authors.forename: P
authors.initials: P
authors.lastname: Lucchini
authors.affiliation: AP-HP, Department of Pediatric Endocrinology, Bicêtre Hospital, Paris Sud University, Pôle I3E, 94275, Le Kremlin Bicetre, France.
authors.forename: B
authors.initials: B
authors.lastname: Aboumrad
authors.affiliation: AP-HP, Department of Pediatric Endocrinology, Bicêtre Hospital, Paris Sud University, Pôle I3E, 94275, Le Kremlin Bicetre, France.
authors.forename: A L
authors.initials: AL
authors.lastname: Castell
authors.affiliation: AP-HP, Department of Pediatric Endocrinology, Bicêtre Hospital, Paris Sud University, Pôle I3E, 94275, Le Kremlin Bicetre, France.
authors.forename: S
authors.initials: S
authors.lastname: Le Fur
authors.affiliation: AP-HP, Department of Pediatric Endocrinology, Bicêtre Hospital, Paris Sud University, Pôle I3E, 94275, Le Kremlin Bicetre, France.
authors.forename: P
authors.initials: P
authors.lastname: Bougnères
mesh_terms: D000293:Adolescent; D001786:Blood Glucose / Q000378:metabolism; D002648:Child; D002675:Child, Preschool; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000150:complications / Q000188:drug therapy* / Q000453:epidemiology*; D004338:Drug Combinations; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced / Q000453:epidemiology*; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D007328:Insulin / Q000008:administration & dosage / Q000009:adverse effects; D061267:Insulin Aspart / Q000008:administration & dosage* / Q000009:adverse effects; D000069057:Insulin Detemir / Q000008:administration & dosage* / Q000009:adverse effects; D007336:Insulin, Isophane / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male
chemical_list: D001786:Blood Glucose; D004338:Drug Combinations; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; D061267:Insulin Aspart; D000069057:Insulin Detemir; D007336:Insulin, Isophane
keywords: aspart-detemir mixture; diabetes children; hypoglycemia; type 1 diabetes