Treatment Satisfaction of Insulin Glargine Plus Insulin Apidra Compared With NPH Insulin Plus Insulin Apidra in Recently Diagnosed Type 1 Diabetes Children and Adolescents
Treatment Satisfaction of Insulin Glargine Plus Insulin Apidra Compared With NPH Insulin Plus Insulin Apidra in Recently Diagnosed Type 1 Diabetes Children and Adolescents
A randomized, crossover, open study in order to compare treatment satisfaction with insulin
 Glargine plus insulin Apidra Vs NPH insulin plus insulin Apidra in newly diagnosed children
 and adolescents with type 1 diabetes.

 The study will include two consecutive periods: 2 weeks run in period and 24 weeks
 intervention period, divided into two separate treatment periods of 12 weeks. According to
 randomization, each patient will be treated consecutively with both treatment arms: 12 weeks
 with insulin Glargine and than 12 weeks with NPH insulin or 12 weeks with insulin NPH ad than
 12 weeks with insulin Glargine. Patients will complete DTSQ (Diabetes Treatment Satisfaction
 Questionnaire) at months 0, 12 and 24 weeks, before and at the end of each study arm.
A randomized, crossover, open study in order to compare treatment satisfaction with insulin
 Glargine plus insulin Apidra Vs NPH insulin plus insulin Apidra in newly diagnosed children
 and adolescents with type 1 diabetes.

 134 Patients with new onset Diabetes type 1, diagnosed 12 months previously at maximum will
 be enrolled.

 The study will include two consecutive periods: 2 weeks run in period and 24 weeks
 intervention period, divided into two separate treatment periods of 12 weeks. According to
 randomization, each patient will be treated consecutively with both treatment arms: 12 weeks
 with insulin Glargine and than 12 weeks with NPH insulin or 12 weeks with NPH insulin and
 than 12 weeks with insulin Glargine.

 The study will consist of 4 clinical visits, taking place at -2, 0, 12 and 24 weeks.
 Height,weight,vital signs, HbA1c and insulin doses will be determined during the clinical
 visits.

 Patients will complete DTSQ (Diabetes Treatment Satisfaction Questionnaire) at months 0, 12
 and 24 weeks, before and at the end of each study arm.

 The DTSQ questionnaires consists of DTSQ parents- for patients below the age of 13, and DTSQ
 teen for those above age 13.
Inclusion Criteria:

 1. Type 1 diabetes diagnosed less than 12 months prior to study entry

 2. Age: 7-20 years old.

 3. HbA1c>/=8.0

 4. Signing inform consent form

 Exclusion Criteria:

 1. Any significant disease or conditions, including psychiatric disorders that in the
 opinion of the investigator are likely to effect his compliance or ability to complete
 the study.

 2. Patients participating in other device or drug studies.

 3. Any contraindication to insulin glargine and or insulin Apidra and or Insulin NPH
 according to SmPC.

 4. Inability, of adolescent or parent, to understand/complete the Treatment satisfaction
 questionnaire.