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

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ClinicalTrials.gov Identifier: NCT03565770
Recruitment Status : Not yet recruiting
First Posted : June 21, 2018
Last Update Posted : September 12, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

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.


Condition or disease Intervention/treatment Phase
Diabetes type1 Other: individual coaching Other: Standard care Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 318 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Assessment of Individual Follow-up by Reference Nurses (Telemedicine Coaching Program) for Type 1 Diabetes Children With Therapy Adjustment Difficulties
Estimated Study Start Date : November 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03565770


Contacts
Contact: Christine Lefevre, MD 03.20.44.50.70 ext +33 christine.lefevre@chru-lille.fr

Sponsors and Collaborators
University Hospital, Lille
Investigators
Principal Investigator: Christine Lefe, MD University Hospital, Lille

Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03565770     History of Changes
Other Study ID Numbers: 2016_65
2017-A03021-52 ( Other Identifier: ID-RCB number, ANSM )
First Posted: June 21, 2018    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Lille:
child
coaching
telemedicine
nurses
individual follow-up

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases