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Completed

NCT Number: NCT03565770

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

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.

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Key information

Conditions

Diabetes type1

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Jeanne de Flandres

Lille, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

individual coaching

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

Other

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

Primary outcomes

  1. 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

  1. Difference between the rate of glycosylated hemoglobin (HbA1c) before randomization (baseline) and the follow-up.

    Time frame: at baseline, at 3 months, at 12 months

  2. Rate of patients presenting at least one bad accident (ketoacidosis and/or severe hypoglycemia)

    Time frame: at 6 months

  3. Patient self-assessment score

    Time frame: at baseline, at 6 months, at 12 months

  4. Capacity of proper adjustment of the treatment: binary variable " yes/no " evaluated to the judgment of the investigator

    Time frame: at baseline, at 6 months, at 12 months

  5. Binary variable attendance = 80% honored appointments

    Time frame: at 6 months

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

Assessment of Individual Follow-up by Reference Nurses (Telemedicine Coaching Program) for Type 1 Diabetes Children With Therapy Adjustment Difficulties

Acronym: DIAB-HELP

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jun 21, 2018
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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