Background: Several drugs and pharmaceutical formulations not sold in our country for different reasons: economic, market requirements or the prevalence of the disease. Like occur in so-called orphan treatments, diabetes mellitus (DM) children may be deprived of pharmaceutical presentations for its lower numerical prevalence vs the number of adult patients affections DMtipo2 One of the problems that young children face DM1 is its high sensitivity to insulin. Since May 2014 marketing begins in Spain vials for JUNIORSTAR system that allows the administration of glargine and glisulide in pens 0.5 UI.
Objective and hypotheses: To evaluate the impact of using vials for device JUNIORSTAR 0.5/0.5 UI in young children with DM1 and compare it with our previous experience and published Rev Esp Pediatr Endocrinol 2013; 4(Suppl) device imported from abroad.
Method: DM1 children over 2 years with at least 6 months duration from debut. Age>2a. Sensitivity index >100 mGrs/dl/IU. Desire of parents to not use syringes. Rejection Insuflow® type devices. No possibility ISCI. Using glisulide insulin and/or insulin glargine and comparison with the data (Farmaco Foreign Ministry authorization code 011813) RAPID NOVO PenFill CARTUCHOS®. Study comparativo. IBM Stastistics SPSS 19.0, Nonparametric paired samples n<30. Health Survey Questionnaire SF-36 (Spanish and summarised).
Results: Ten children (5♂), mean age 5.8 to (58.5). Prior è HbA1c (DCA): 8.1% (6.48.8) needs: 0.72 IU/kg per day (0.450.88), sensitivity 168 mg/dl/UI (135280) and Survey 7.2 points (68). After 6 months of use è HbA1c (DCA): 7.5% (6.87.9) P: 0.38, needs 0.88 IU/kg per day (0.771.05) p differences: 0.01 95% CI (0.120.34), sensitivity 145 mg/dl/UI (125205) P: 0.001, and Enc 8.5 points (79). Improvement score similar to previous study.
Conclusion: Improving quality of life perceived by parents with the low cost of operation defines the potential of this dosage form as a transition to adult-type devices.
01 - 03 Oct 2015
European Society for Paediatric Endocrinology