Special management of insulin lispro in continuous subcutaneous insulin infusion in young diabetic children: a randomized cross-over study.
OBJECTIVE
To compare the safety, efficacy and management of insulin lispro (LP) with regular human insulin (RH) in young diabetic children treated with continuous subcutaneous insulin infusion (CSII).


METHODS
27 very young diabetic children (age 4.6 +/- 2.2 years) treated with CSII participated in an open-label, randomized cross-over multicenter study comparing 2 periods of 16 weeks of CSII with LP or RH.


RESULTS
Mean daily basal rate was significantly higher during the LP period (p = 0.04). No differences were seen in changes in HbA1c levels, number of hypoglycemic events, cutaneous infections and catheter occlusions. There was no significant difference between the two treatments for preprandial and postprandial glucose values, although prandial glucose excursions tended to be lower with LP (significant at dinner, p = 0.01). Mean blood glucose levels were significantly higher at 0.00 and 3.00 a.m. during LP therapy (p < 0.05). No episode of ketoacidosis occurred during LP treatment. More parents indicated that LP made their own and the child's daily life easier (p = 0.02) and preferred LP (p = 0.01).


CONCLUSIONS
LP in CSII therapy in children is safe, as effective as RH, improved postprandial excursions, met the needs of young children in their daily life well, and gained their parents' satisfaction and preference. However, a shorter duration of LP resulted in hyperglycemia during the first part of the night, which must be compensated for by increasing nocturnal basal rates during this time.
Tubiana-Rufi
Nadia
N
Department of Pediatric Endocrinology and Diabetology, Hôpital Robert-Debré, Assistance Publique-Hôpitaux de Paris, France. n.tubiana@free.fr
Coutant
Regis
R
Bloch
Juliette
J
Munz-Licha
Geraldine
G
Delcroix
Christine
C
Montaud-Raguideau
Nathalie
N
Ducrocq
Rolande
R
Limal
Jean-Marie
JM
Czernichow
Paul
P
D001786:Blood Glucose / Q000378:metabolism; D015992:Body Mass Index; D002648:Child; D002675:Child, Preschool; D018592:Cross-Over Studies; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy*; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D015918:Infusion Pumps, Implantable; D007279:Injections, Subcutaneous; D007328:Insulin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D061268:Insulin Lispro; D008297:Male; D010290:Parents; D019518:Postprandial Period / Q000502:physiology; D011446:Prospective Studies; D012874:Skin Diseases, Infectious / Q000453:epidemiology; D011795:Surveys and Questionnaires
D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; D061268:Insulin Lispro