Clinical trial NCT03565770: Assessment of Individual Follow-up by Coaching Program for Type 1 Diabetes Children
Official title: Assessment of Individual Follow-up by Reference Nurses (Telemedicine Coaching Program) for Type 1 Diabetes Children With Therapy Adjustment Difficulties
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes type1
Keywords: child
coaching
telemedicine
nurses
individual follow-up
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2018-06-21
Enrollment: 318
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Difference between the rate of glycosylated hemoglobin (HbA1c) before randomization (baseline) and the rate of glycosylated hemoglobin after 6 months coaching (measure M6).
timeFrame: at 6 months
Secondary outcomes:
measure: Difference between the rate of glycosylated hemoglobin (HbA1c) before randomization (baseline) and the follow-up.
timeFrame: at baseline, at 3 months, at 12 months
measure: Rate of patients presenting at least one bad accident (ketoacidosis and/or severe hypoglycemia)
timeFrame: at 6 months
measure: Patient self-assessment score
timeFrame: at baseline, at 6 months, at 12 months
measure: Capacity of proper adjustment of the treatment: binary variable " yes/no " evaluated to the judgment of the investigator
timeFrame: at baseline, at 6 months, at 12 months
measure: Binary variable attendance = 80% honored appointments
timeFrame: at 6 months
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Jeanne de Flandres
Study officials:
affiliation: University Hospital, Lille
name: Christine Lefe, MD
role: PRINCIPAL_INVESTIGATOR
References: