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

NCT03565770 | Completed

• 2 other identifiers: 2016_652017-A03021-52
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes type1

Keywords

child; coaching; telemedicine; nurses; individual follow-up

Outcome Measures

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).

  at 6 months

Secondary Outcomes (5)

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

  at baseline, at 3 months, at 12 months

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

  at 6 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

Study Arms (2)

standard care + coaching

EXPERIMENTAL

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

Other: individual coaching; Other: Standard care

Standard care

SHAM COMPARATOR

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

Other: Standard care

Interventions

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 + coaching

Standard care OTHER

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

Standard care; standard care + coaching

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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 ".

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hôpital Jeanne de Flandres

Lille, France

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Christine Lefe, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2018
• First Posted: June 21, 2018
• Study Start: September 29, 2018
• Primary Completion: June 25, 2021
• Study Completion: June 25, 2021
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

FR (1)