Accu-Chek Combo in Young Patients

Study Overview
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Brief Summary
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This is an open, prospective, descriptive study aiming to evaluate the change in treatment satisfaction of primary care givers of young children who use the Accu-Chek Combo System. Patients will routinely be scheduled and start their therapy with the Accu-Chek Combo System on visit 1. Twelve weeks later the final acquisition of data will occur. Diabetes Treatment Satisfaction Questionnaires (DTSQ) will be completed at baseline and after 12 weeks, a distinct acceptance questionnaires will be completed at final visit. In addition, Diabetes related therapeutic information will be collected and data about the use of the device components will be downloaded from the Accu-Chek Combo System

Official Title
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Evaluation of the Use of the Accu-Chek Combo System in Young Patients With Type 1 Diabetes

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Device: Accu-Chek Combo System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diabetes Mellitus type 1 Continuous Subcutaneous Insulin Infusion(CSII)therapy(for at least 6 months) Age below 6 years Planned and scheduled change to a Accu-Chek Combo System within the next 3 weeks at least Signing on an Inform Consent Form Exclusion Criteria: Patient has been diagnosed with progressive/serious diseases that in judgment of the physician preclude successful completion of the observational period primary care giver not skilled enough to comment in a qualitative way

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 6 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Accu-Chek Combo<br>15 type 1 young patients under 6 years old who begin to use the Accu-Chek Combo System | Device: Accu-Chek Combo System<br>* 12 weeks using the Accu Chek Combo System, which is an insulin pump system that offers a remote control integrating a bolus calculator, a blood glucose meter, data storage and analysis function.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetes Treatment Satisfaction | we will assess patient's treatment satisfaction using Treatment Satisfaction Questionnaires | after 12 weeks | 
| Study device acceptance | We will assess study device acceptance using a distinct Acceptance Questionnaire | after 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Blood Glucose level | we will compare mean blood glucose level at baseline and after 12 weeks | after 12 weeks | 
| Number of Hypoglycemia Events | we will compare the number of hypoglycemia events at baseline and after 12 weeks | after 12 weeks | 
| Number of Hyperglycemia Events | We will compare the number of hyperglycemia events at baseline and after 12 weeks | after 12 weeks | 
| HbA1c | We will compare HbA1c level at baseline and after 12 weeks | after 12 weeks | 
| postprandial SMBG (self monitoring blood glucose) | We will compare between postprandial SMBG at baseline and after 12 weeks | after 12 weeks | 
| Overall number of BG (Blood glucose) measurements | We will compare between number of BG measurements at baseline and after 12 weeks | after 12 weeks | 
| Number of ketosis events | We will compare number of ketosis events (without documented acidosis with home/hospital management)at baseline and after 12 weeks | after 12 weeks | 
| Number of Diabetic Ketoacidosis (DKA) events | We will compare number of Diabetic ketoacidosis events at baseline and after 12 weeks | after 12 weeks | 
| preprandial SMBG (self monitoring blood glucose) | We will compare between preprandial SMBG at baseline and after 12 weeks | after 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insulin Pump Therapy, Type 1 Diabetes, Treatment Satisfaction