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Assessment of Individual Follow-up by Coaching Program for Type 1 Diabetes Children

NCT ID: NCT03565770

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-29

Study Completion Date

2021-06-25

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes type1

Keywords

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child coaching telemedicine nurses individual follow-up

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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standard care + coaching

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

Group Type EXPERIMENTAL

individual coaching

Intervention Type OTHER

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.

Standard care

Intervention Type OTHER

completion of the self-assessment test at inclusion, at M6 and M12 for all study participants

Standard care

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

Group Type SHAM_COMPARATOR

Standard care

Intervention Type OTHER

completion of the self-assessment test at inclusion, at M6 and M12 for all study participants

Interventions

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individual 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.

Intervention Type OTHER

Standard care

completion of the self-assessment test at inclusion, at M6 and M12 for all study participants

Intervention Type OTHER

Eligibility Criteria

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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
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christine Lefe, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Hôpital Jeanne de Flandres

Lille, , France

Site Status

Countries

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France

Other Identifiers

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2017-A03021-52

Identifier Type: OTHER

Identifier Source: secondary_id

2016_65

Identifier Type: -

Identifier Source: org_study_id