Assessment of Individual Follow-up by Coaching Program for Type 1 Diabetes Children (DIAB-HELP)

University Hospital, Lille

Status: Completed

Conditions: Diabetes type1

Treatments: Other: individual coaching; Other: Standard care

Study type: Interventional

Funder types: Other

Identifiers

NCT03565770

2017-A03021-52 (Other Identifier)

2016_65

Details and patient eligibility

About

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.

Enrollment: 106 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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106 participants in 2 patient groups

standard care + coaching

Experimental group

Description:

minor patients with a type 1 diabetes, having therapy adjustment difficulties, receiving individual coaching and usual standard care

Treatment:

Other: Standard care

Other: individual coaching

Standard care

Sham Comparator group

Description:

minor patients with a type 1 diabetes, having therapy adjustment difficulties, receiving usual standard care only.

Treatment:

Other: Standard care