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

Diabetes type1 Clinical Trial

— DIAB-HELP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03565770
• Other study ID #: 2016_65
• Secondary ID: 2017-A03021-52
• Status: Recruiting
• Phase: N/A
• Start date: September 29, 2018
• Est. completion date: September 2021

Study information

• Verified date: August 2020
• Source: University Hospital, Lille
• Contact: Christine Lefevre, MD
• Phone: 03.20.44.50.70
• Email: christine.lefevre[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 318
• Est. completion date: September 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes type1

Intervention

Other:
• 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.
• Standard care
completion of the self-assessment test at inclusion, at M6 and M12 for all study participants

Locations

Country	Name	City	State
France	Hôpital Jeanne de Flandres	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Difference between the rate of glycosylated hemoglobin (HbA1c) before randomization (baseline) and the follow-up.		at baseline, at 3 months, at 12 months
Secondary	Rate of patients presenting at least one bad accident (ketoacidosis and/or severe hypoglycemia)		at 6 months
Secondary	Patient self-assessment score		at baseline, at 6 months, at 12 months
Secondary	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
Secondary	Binary variable attendance = 80% honored appointments		at 6 months