The Influence of Technology, Education and Psychological Support on Metabolic Control in Children With T1D

Study Overview
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Brief Summary
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The first purpose of this study is to is to compare metabolic control of type 1 diabetes among children under the age of 7 years who use an insulin pump and a real-time (RT) glucose sensor, and children who use only insulin pump; the investigators will also determine dietary habits, their knowledge of type 1 diabetes management and emotional aspects of experiencing illness in the family, in both groups of children.

Official Title
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The Influence of Diabetes Related Technology, Education and Psychological Support on Metabolic Control in Young Children With Type 1 Diabetes

Conditions
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Type 1 Diabetes

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age up to 7 years insulin pump for at least 6 months more than 6 months of duration of type 1 diabetes complete remission normal blood pressure for age, only therapy insulin. Exclusion Criteria: age over 8 years type 1 diabetes less than 6 months insulin pump less than 6 months still in remission associated diseases on drug therapy, high blood pressure

Ages Eligible for Study
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Maximum Age: 7 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 |
| --- | --- |
| insulin pump group<br>20 children below the age of 7 years who use an insulin pump for at least 6 months, more than 6 months of duration of type 1 diabetes, complete remission, no associated disease (normal blood pressure for age, only therapy insulin). | |
| RT (real time) -CGMS group<br>20 children below the age of 7 years who use an insulin pump and RT-CGMS on regular basis for at least 6 months, more than 6 months of duration of type 1 diabetes, complete remission, no associated disease (normal blood pressure for age, only therapy insulin). pump for at least 6 months, and children below the age of 7 years who use RT-CGMS on regular | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycaemic control | We will determine HbA1c, average blood glucose, number of blood glucose readings/use of sensors, average AUC for sensor users, readings above and under target for both groups at the beginning and afer 3 months. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| knowledge on diet and diabetes management | Questionnaire on diet, questionnaire on diabetes management; we will assess the knowledge on diet in T1D and diabetes management in both groups at the beginning, we will give support wherever needed and check after 3 months if it had an influence on metabolic control. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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type 1 diabetes among young children, sensor, insulin pump, education, psychological support