Diabetes type1DIAB-HELPNCT03565770
Assessment of Individual Follow-up by Coaching Program for Type 1 Diabetes Children
A study testing individual coaching in people with Diabetes type1, run by University Hospital, Lille at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Diabetes type1
- What is being tested?
- individual coaching
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 siteFrance
- Study dates
- 29 Sep 2018to 25 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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 ".
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Diabetes type1
- Being tested
- individual coaching, Standard care
- Keywords
- child, coaching, telemedicine, nurses, individual follow-up
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
individual coachingOther
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 careOther
completion of the self-assessment test at inclusion, at M6 and M12 for all study participants
| Study group | Role | What they receive |
|---|---|---|
| standard care + coaching | Experimental | minor patients with a type 1 diabetes, having therapy adjustment difficulties, receiving individual coaching and usual standard care Receives: 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. Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between the rate of glycosylated hemoglobin (HbA1c) before randomization (baseline) and the rate of glycosylated hemoglobin after 6 months coaching (measure M6).
Measured: at 6 months
Secondary outcomes (5)
Difference between the rate of glycosylated hemoglobin (HbA1c) before randomization (baseline) and the follow-up.
Measured: at baseline, at 3 months, at 12 months
Rate of patients presenting at least one bad accident (ketoacidosis and/or severe hypoglycemia)
Measured: at 6 months
Patient self-assessment score
Measured: 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
Measured: at baseline, at 6 months, at 12 months
Binary variable attendance = 80% honored appointments
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2018
- Study start29 Sep 2018
- Primary completion25 Jun 2021
- Study completion25 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes type1Studies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine Lefe, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03565770
- Sponsor's protocol ID
- 2016_65
- Other IDs
- 2017-A03021-52
- Acronym
- DIAB-HELP
- Status last verified
- Dec 2025
- First submitted
- 11 Jun 2018
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Individual Follow-up by Reference Nurses (Telemedicine Coaching Program) for Type 1 Diabetes Children With Therapy Adjustment Difficulties
- ClinicalTrials.gov ID
- NCT03565770
- Acronym / sponsor ID
- DIAB-HELP / 2016_65
- Conditions
- Diabetes type1
- Keywords
- child, coaching, telemedicine, nurses, individual follow-up
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 29 Sep 2018 (actual)
- Primary completion
- 25 Jun 2021 (actual)
- Study completion
- 25 Jun 2021 (actual)
- First posted
- 21 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard care + coaching | Experimental | Other: individual coaching, Other: Standard careminor patients with a type 1 diabetes, having therapy adjustment difficulties, receiving individual coaching and usual standard care |
| Standard care | Sham comparator | Other: Standard careminor patients with a type 1 diabetes, having therapy adjustment difficulties, receiving usual standard care only. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| individual coachingcoaching 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 + coaching |
| Standard carecompletion of the self-assessment test at inclusion, at M6 and M12 for all study participants | Other | Standard care, standard care + coaching |
Primary outcome
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
5 secondary outcomes
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
Rate of patients presenting at least one bad accident (ketoacidosis and/or severe hypoglycemia)
Time frame: at 6 months
Patient self-assessment score
Time frame: 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
Time frame: at baseline, at 6 months, at 12 months
Binary variable attendance = 80% honored appointments
Time frame: at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Lefe, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing individual coaching in people with Diabetes type1, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.