Assessment of Individual Follow-up by Coaching Program for Type 1 Diabetes Children (DIAB-HELP)
Primary Purpose
Diabetes type1
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
individual coaching
Standard care
Sponsored by
About this trial
This is an interventional supportive care trial for Diabetes type1 focused on measuring child, coaching, telemedicine, nurses, individual follow-up
Eligibility Criteria
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
Sites / Locations
- Hôpital Jeanne de FlandresRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
standard care + coaching
Standard care
Arm Description
minor patients with a type 1 diabetes, having therapy adjustment difficulties, receiving individual coaching and usual standard care
minor patients with a type 1 diabetes, having therapy adjustment difficulties, receiving usual standard care only.
Outcomes
Primary Outcome Measures
Difference between the rate of glycosylated hemoglobin (HbA1c) before randomization (baseline) and the rate of glycosylated hemoglobin after 6 months coaching (measure M6).
Secondary Outcome Measures
Difference between the rate of glycosylated hemoglobin (HbA1c) before randomization (baseline) and the follow-up.
Rate of patients presenting at least one bad accident (ketoacidosis and/or severe hypoglycemia)
Patient self-assessment score
Capacity of proper adjustment of the treatment: binary variable " yes/no " evaluated to the judgment of the investigator
Binary variable attendance = 80% honored appointments
Full Information
NCT ID
NCT03565770
First Posted
June 11, 2018
Last Updated
August 24, 2020
Sponsor
University Hospital, Lille
1. Study Identification
Unique Protocol Identification Number
NCT03565770
Brief Title
Assessment of Individual Follow-up by Coaching Program for Type 1 Diabetes Children
Acronym
DIAB-HELP
Official Title
Assessment of Individual Follow-up by Reference Nurses (Telemedicine Coaching Program) for Type 1 Diabetes Children With Therapy Adjustment Difficulties
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 29, 2018 (Actual)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
September 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes type1
Keywords
child, coaching, telemedicine, nurses, individual follow-up
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
318 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
standard care + coaching
Arm Type
Experimental
Arm Description
minor patients with a type 1 diabetes, having therapy adjustment difficulties, receiving individual coaching and usual standard care
Arm Title
Standard care
Arm Type
Sham Comparator
Arm Description
minor patients with a type 1 diabetes, having therapy adjustment difficulties, receiving usual standard care only.
Intervention Type
Other
Intervention Name(s)
individual coaching
Intervention Description
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
Intervention Name(s)
Standard care
Intervention Description
completion of the self-assessment test at inclusion, at M6 and M12 for all study participants
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
Title
Rate of patients presenting at least one bad accident (ketoacidosis and/or severe hypoglycemia)
Time Frame
at 6 months
Title
Patient self-assessment score
Time Frame
at baseline, at 6 months, at 12 months
Title
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
Title
Binary variable attendance = 80% honored appointments
Time Frame
at 6 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christine Lefevre, MD
Phone
03.20.44.50.70
Ext
+33
Email
christine.lefevre@chru-lille.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine Lefe, MD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Jeanne de Flandres
City
Lille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Lefevre, MD
12. IPD Sharing Statement
Learn more about this trial
Assessment of Individual Follow-up by Coaching Program for Type 1 Diabetes Children
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