Assessment of Individual Follow-up by Reference Nurses (Telemedicine Coaching Program) for Type 1 Diabetes Children With Therapy Adjustment Difficulties
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 106
- Locations
- 1
- Primary Endpoint
- Difference between the rate of glycosylated hemoglobin (HbA1c) before randomization (baseline) and the rate of glycosylated hemoglobin after 6 months coaching (measure M6).
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- — to 18 Years (Child, Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
standard care + coaching
minor patients with a type 1 diabetes, having therapy adjustment difficulties, receiving individual coaching and usual standard care
Intervention: individual coaching (Other)
standard care + coaching
minor patients with a type 1 diabetes, having therapy adjustment difficulties, receiving individual coaching and usual standard care
Intervention: Standard care (Other)
Standard care
minor patients with a type 1 diabetes, having therapy adjustment difficulties, receiving usual standard care only.
Intervention: Standard care (Other)
Outcomes
Primary Outcomes
Difference between the rate of glycosylated hemoglobin (HbA1c) before randomization (baseline) and the rate of glycosylated hemoglobin after 6 months coaching (measure M6).
Time Frame: at 6 months
Secondary Outcomes
- Rate of patients presenting at least one bad accident (ketoacidosis and/or severe hypoglycemia)(at 6 months)
- Difference between the rate of glycosylated hemoglobin (HbA1c) before randomization (baseline) and the follow-up.(at baseline, at 3 months, at 12 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)