Effects of Nurse-counselling in the Improvement of the type1 Diabetes Control in Adolescents

Study Overview
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Brief Summary
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The incidence of type 1 diabetes is increasing in France. A recent cross sectional study has shown that in France, only 15% of children and 26% of adults had HbA1c<7%. Adolescents seem to need particularly a better metabolic control. Working Hypothesis: We hypothesized that a stricter control of glycaemia by nurse-counselling could probably improve metabolic control in adolescents with type 1 diabetes. Objectives: To show that nurse-counselling may improve levels of patient satisfaction. Methodology: The main criterion is the patient acceptance of diabetes measured by an analogical visual scale rated from 0 (I cope very well with my diabetes, I cope very badly with my diabetes) to 10 cm. The scale will be measured every quarter within 12 months follow-up. We wish to improve patient's appreciation by 10 mm, near to I cope very well with my diabetes. This is a randomised parallel group study with 36 subjects in each group. During the follow-up, the routine follow-up group will continue its routine care. The complementary follow-up group will be called by nurses every 15 days and consult monthly. HbA1c is the secondary criterion and will be measured every 3 months. The total study duration is 18 months including 6 months for the recruitment and 12 months for the patients follow-up

Official Title
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Effects of Nurse-counselling in the Improvement of the type1 Diabetes Control in Adolescents: a Randomized Controlled Trial

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Behavioral: nurse-counselling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 13 to 18 years with a type1 diabetes diagnosed at least one year earlier, HbA1c rate > 8 %. Exclusion Criteria: HbA1c < 8 %; patients participating in another study

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 18 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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nurse counseling<br>Phone calls performed by nurse 15 days after each monthly visit | Behavioral: nurse-counselling<br>* Phone calls performed by nurse 15 days after each monthly visit<br>|
| No Intervention: Control<br>Normal monthly follow-up without phone calls | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's acceptance of the disease evaluated by an analogical visual scale rating |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycaemic equilibrium by measuring the rate of glycosylated haemoglobin |  | 12 months | 
| Number of diabetic acidosis having required hospitalization, |  | 12 months | 
| Episodes number of severe hypoglycaemia having required an intervention of a third party or a hospitalization. |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type1 diabetes;, nurse-counselling;, adolescent