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

作者：Petit Bibal C; Rothenbuhler A; Lucchini P; Aboumrad B; Castell A L; Le Fur S; Bougneres P^*

来源：Pediatric Diabetes, 2015, 16(5): 345-353.

DOI：10.1111/pedi.12156

• aspart-detemir mixture
• diabetes children
• hypoglycemia
• type 1 diabetes

ObjectiveTo 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 methodsThis 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.
OutcomesFrequency of severe or symptomatic episodes, glycated hemoglobin A1c (HbA1c), and blood glucose (BG) values.
ResultsCompared 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).
ConclusionsUsing a free-mixing preparation of aspart and detemir insulin decreases hypoglycemia in young children with type 1 diabetes.

• 出版日期2015-8