Treatment Satisfaction of Insulin Glargine Plus Insulin Apidra Compared With NPH Insulin Plus Insulin Apidra in Recently Diagnosed Type 1 Diabetes Children and Adolescents

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Treatment Satisfaction of Insulin Glargine Plus Insulin Apidra Compared With NPH Insulin Plus Insulin Apidra in Recently Diagnosed Type 1 Diabetes Children and Adolescents

Conditions
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Diabetes Type 1

Intervention / Treatment
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* Drug: insulin Glargine + Insulin Apidra
* Drug: Insulin NPH + Insulin Apidra: Active Comparator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 1 diabetes diagnosed less than 12 months prior to study entry Age: 7-20 years old. HbA1c>/=8.0 Signing inform consent form Exclusion Criteria: 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. Patients participating in other device or drug studies. Any contraindication to insulin glargine and or insulin Apidra and or Insulin NPH according to SmPC. Inability, of adolescent or parent, to understand/complete the Treatment satisfaction questionnaire.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: insulin Glargine + insulin Apidra<br>insulin Glargine + insulin Apidra | Drug: insulin Glargine + Insulin Apidra<br>* 12 wees treatment with Insulin Glargine + Insulin Apidra<br>|
| Active Comparator: Insulin NPH + Insulin Apidra<br>12 weeks treatment with Insulin NPH + Insulin Apidra | Drug: Insulin NPH + Insulin Apidra: Active Comparator<br>* Insulin NPH + Insulin Apidra: Active Comparator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment satisfaction |  | patients will complete DTSQ at months 0,12 and 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | value of Hba1C will be measured at screening visit and at the end of each study arm | 
| 4 and 7 points glucose profile |  | patients will complete a diary before all clinical visits | 
| Insulin doses |  | Insulin doses will be determined at baseline visit and every visit after | 
| Hypoglycemic events |  | patients will report in their diary every episode of hypoglycemia | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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treatment satisfaction, insulin Glargine, insulin Apidra, NPH insulin