Assessment of Individual Follow-up by Coaching Program for Type 1 Diabetes Children

Study Overview
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Brief Summary
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The purpose of this project is to assess the introduction of an individual follow-up distance coaching (phone and messages on a secure line platform) in order to optimize the health care of type 1 diabetes children with therapy adjustment difficulties. It is a personalized, multi-disciplinary, medical et paramedical. It will consist of an individual coaching for the children and families with therapy adjustment difficulties. The hypothesis is that the proposed coaching would allow to improve the patient glycemic control not only during this coaching, but also, to bring long lasting improvement following the coaching.

Official Title
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Assessment of Individual Follow-up by Reference Nurses (Telemedicine Coaching Program) for Type 1 Diabetes Children With Therapy Adjustment Difficulties

Conditions
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Diabetes type1

Intervention / Treatment
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* Other: individual coaching
* Other: Standard care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Less than 18 years old when coaching starts. Any diabetic patient (girl or boy) who doesn't master the adjustments of the treatment according to the investigator's judgment (non-adaptations of the treatment between 2 consultations or mistakes in adapting the insulin doses, not taking properly into account previous days tendencies, food, or activities) and/or average HbA1c of more than 8% during the last year. The patient, his 2 parents or legal representatives all agree to participate in the research Absence of justice protection measures Good predictable observance of the protocol Family can be reached by phone during the coaching timetables working hours or must be listed on the platform line  MyDiabby . Exclusion Criteria: Non auto-immun diabetes Major understanding difficulties from the relatives (difficulties in understanding French or what anticipatory adaptation means) The child or parents or legal representatives refuse to participate and to sign a consent Contact on the phone or on the platform impossible according to the protocol procedures Patient non-registered under Social Security Patient under justice protection measures

Ages Eligible for Study
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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

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: standard care + coaching<br>minor patients with a type 1 diabetes, having therapy adjustment difficulties, receiving individual coaching and usual standard care | Other: individual coaching<br>* coaching on the phone or with messages on line twice a month in order to help patients to adjust their insulin doses and fill in their self-assessment test.<br>Other: Standard care<br>* completion of the self-assessment test at inclusion, at M6 and M12 for all study participants<br>|
| Sham Comparator: Standard care<br>minor patients with a type 1 diabetes, having therapy adjustment difficulties, receiving usual standard care only. | Other: Standard care<br>* completion of the self-assessment test at inclusion, at M6 and M12 for all study participants<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between the rate of glycosylated hemoglobin (HbA1c) before randomization (baseline) and the rate of glycosylated hemoglobin after 6 months coaching (measure M6). |  | at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between the rate of glycosylated hemoglobin (HbA1c) before randomization (baseline) and the follow-up. |  | at baseline, at 3 months, at 12 months | 
| Rate of patients presenting at least one bad accident (ketoacidosis and/or severe hypoglycemia) |  | at 6 months | 
| Patient self-assessment score |  | at baseline, at 6 months, at 12 months | 
| Capacity of proper adjustment of the treatment: binary variable  yes/no  evaluated to the judgment of the investigator |  | at baseline, at 6 months, at 12 months | 
| Binary variable attendance = 80% honored appointments |  | at 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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child, coaching, telemedicine, nurses, individual follow-up