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

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

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.

Study Overview

• Status: Unknown
• Conditions: Diabetes type1
• Intervention / Treatment: Other: individual coaching; Other: Standard care

• Study Type: Interventional
• Enrollment (Anticipated): 318
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christine Lefevre, MD; Phone Number: +33 03.20.44.50.70; Email: christine.lefevre@chru-lille.fr

Study Locations

• France
  • Lille, France
    • Recruiting
    • Hôpital Jeanne de Flandres
    • Principal Investigator: Christine Lefevre, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: standard care + coaching; minor patients with a type 1 diabetes, having therapy adjustment difficulties, receiving individual coaching and usual standard care	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.; Other: Standard care; completion of the self-assessment test at inclusion, at M6 and M12 for all study participants
Sham Comparator: Standard care; minor patients with a type 1 diabetes, having therapy adjustment difficulties, receiving usual standard care only.	Other: Standard care; completion of the self-assessment test at inclusion, at M6 and M12 for all study participants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Christine Lefe, MD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2018
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: June 11, 2018
• First Submitted That Met QC Criteria: June 11, 2018
• First Posted (Actual): June 21, 2018

Study Record Updates

• Last Update Posted (Actual): August 25, 2020
• Last Update Submitted That Met QC Criteria: August 24, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: telemedicine; child; nurses; coaching; individual follow-up
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 2016_65; 2017-A03021-52 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No