Diabetes type1 Clinical Trial
— DIAB-HELPOfficial title:
Assessment of Individual Follow-up by Reference Nurses (Telemedicine Coaching Program) for Type 1 Diabetes Children With Therapy Adjustment Difficulties
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.
Status | Recruiting |
Enrollment | 318 |
Est. completion date | September 2021 |
Est. primary completion date | September 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 18 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Jeanne de Flandres | Lille |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Lille |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Difference between the rate of glycosylated hemoglobin (HbA1c) before randomization (baseline) and the follow-up. | at baseline, at 3 months, at 12 months | ||
Secondary | Rate of patients presenting at least one bad accident (ketoacidosis and/or severe hypoglycemia) | at 6 months | ||
Secondary | Patient self-assessment score | at baseline, at 6 months, at 12 months | ||
Secondary | 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 | ||
Secondary | Binary variable attendance = 80% honored appointments | at 6 months |
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