Parental preference of prandial insulin aspart compared with preprandial human insulin in a basal-bolus scheme with NPH insulin in a 12-wk crossover study of preschool children with type 1 diabetes.
OBJECTIVE
Preprandial insulin injection in preschool children is complicated by irregular eating habits. Postprandial injection of rapid-acting insulin analogs such as insulin aspart (IAsp) offers the convenience of adjusting insulin dose to match food consumed. This trial compared safety and efficacy - including parental treatment satisfaction - of two basal-bolus regimens [IAsp plus Neutral Protein Hagedorn (NPH) insulin vs. regular human insulin (HI) plus NPH] in preschool children with type 1 diabetes.


METHODS
This study is a randomized, 12-wk, crossover trial comparing IAsp and regular HI in 26 children (17 boys and 9 girls; age: 2.4-6.9 yr). Regular HI was injected 30 min before and IAsp after or shortly before meals. Treatment satisfaction was assessed by a modified version of the WHO Diabetes Treatment Satisfaction Questionnaire (DTSQ-M).


RESULTS
Glycemic control for IAsp treatment was not different from that for regular HI treatment as assessed by mean postprandial blood glucose increment (IAsp vs. regular HI: 2.0 vs. 1.6 mmol/L), fructosamine (300 vs. 302 micromol/L), and hemoglobin A(1c) (HbA(1c)) (7.7 vs. 7.6%). The relative risk of hypoglycemia was not significantly different [relative risk for IAsp/regular HI (95% CI): 1.06 (0.96-1.17), p = 0.225]. Mean total daily insulin dose (0.7 U/kg) remained constant throughout the trial with both treatments. The DTSQ-M score tended to be better for IAsp and reached statistical significance regarding the parental satisfaction with continuing IAsp treatment (p < 0.05).


CONCLUSIONS
In preschool children, a basal-bolus treatment scheme with postprandial IAsp as bolus insulin was equally effective and safe compared with preprandial regular HI, although the parents showed a preference for the IAsp treatment.
Danne
Thomas
T
Kinderkrankenhaus auf der Bult, Hannover, Germany. danne@hka.de
Råstam
Jacob
J
Odendahl
Rainer
R
Näke
Andrea
A
Schimmel
Ulf
U
Szczepanski
Rüdiger
R
Moeller
Johannes
J
Deiss
Dorothea
D
D001786:Blood Glucose / Q000378:metabolism; D002675:Child, Preschool; D018592:Cross-Over Studies; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy*; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D004435:Eating; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D007328:Insulin / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D061267:Insulin Aspart; D007336:Insulin, Isophane / Q000008:administration & dosage / Q000627:therapeutic use*; D017060:Patient Satisfaction; D011795:Surveys and Questionnaires
D001786:Blood Glucose; D007004:Hypoglycemic Agents; D007328:Insulin; D007336:Insulin, Isophane; D061267:Insulin Aspart