Diabetes type1
Conditions
Keywords
child, coaching, telemedicine, nurses, individual follow-up
Brief summary
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.
Interventions
OTHERindividual coaching
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.
OTHERStandard care
completion of the self-assessment test at inclusion, at M6 and M12 for all study participants
Sponsors
University Hospital, Lille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
France
Outcome results
None listed