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Randomized Controlled Trial
. 2015 Aug;16(5):345-53.
doi: 10.1111/pedi.12156. Epub 2014 May 29.

Decrease in clinical hypoglycemia in young children with type 1 diabetes treated with free-mixed aspart and detemir insulin: an open labeled randomized trial

C Petit-Bibal  1 , A Rothenbuhler  1 , P Lucchini  1 , B Aboumrad  1 , A L Castell  1 , S Le Fur  1 , P Bougnères  1
Affiliations
Randomized Controlled Trial

Decrease in clinical hypoglycemia in young children with type 1 diabetes treated with free-mixed aspart and detemir insulin: an open labeled randomized trial

C Petit-Bibal et al. Pediatr Diabetes. 2015 Aug.

Erratum in

  • Corrigendum.
    [No authors listed] [No authors listed] Pediatr Diabetes. 2016 Mar;17(2):164. doi: 10.1111/pedi.12365. Pediatr Diabetes. 2016. PMID: 26833723 No abstract available.
  • Corrigendum.
    [No authors listed] [No authors listed] Pediatr Diabetes. 2017 Mar;18(2):163. doi: 10.1111/pedi.12511. Pediatr Diabetes. 2017. PMID: 28145635 No abstract available.

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.

Research design and 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.

Outcomes: 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.

Keywords: aspart-detemir mixture; diabetes children; hypoglycemia; type 1 diabetes.

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