TelemedicineTLS-DIDNCT05348551
Overview of Telemedicine in Children With Type 1 Diabetes
An observational study of Telemedicine and Diabetes Mellitus, Type 1, run by University Hospital, Grenoble.
Trial summary
Assessment of the proportion of pediatric patients with type 1 diabetes with access to remote monitoring Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Telemedicine, Diabetes Mellitus, Type 1, Children, Only
- How many people
- 4,800 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2022to 20 Jul 2022
- Phase
- Observational
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children aged 0 to 17 years with type 1 diabetes
Who may be able to join
- Children with type 1 diabetes
Who cannot join
- No consent
Trial locations and contacts
No sites are listed yet.
About this study
Official title: State of Play of Telemedicine in the Follow-up of Children With Type 1 Diabetes
Assessment of the proportion of pediatric patients with type 1 diabetes with access to remote monitoring
Read the detailed description
In the follow-up of type 1 diabetes in children, contact with families besides the appointements with medical et paramedic staff (paediatrician, diabetologist, nurses) is very common but not well coded, start from telehealth hubs (like myDiabby), to less unofficial contact by phone or email. This is even more so widespread since generalization of continuous glucometer (freestyle, dexcom,...), which allowed a quick data transfer to the medical staff.
Some studies had shown that telemedicine in diabetes allowed a better glycemic control and a higher implication in the desease. Indeed, in 1999 already, HbA1c significant improvement was shown when patients was regularly called by a nurse (Thompson et al.). Same finding was demonstrated in Schiaffini and al. clinical trial in 2016. This trial also shown a better adhesion to the follow up into the telemedicine group. Despite all of this studies, in France, remote monitoring isn't standardised and financed, except the national experimentation ETAPES which promotes and financially supports the deployment of remote monitoring projects around the territory.
- Conditions
- Telemedicine, Diabetes Mellitus, Type 1, Children, Only
- Keywords
- Diabetes mellitus type 1, Children, Telemedicine
- Medical subject headings
- Diabetes Mellitus, Type 1
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the proportion of pediatric patients with access to remote monitoring
Proportion of pediatric patients with access to remote monitoring
Measured: 1 day
Secondary outcomes (3)
Description of the different means and modalities of remote monitoring for patients
Proportion of patients in the different modalities of remote monitoring
Measured: 1 day
Description of the different means and modalities of remote monitoring for patients
Proportion of patients in the different objectives of remote monitoring
Measured: 1 day
Evaluation of patients' (and parents') perception of telemonitoring using a scale
Perceived importance of this remote monitoring score using a scale from 1 (mean no importance, I could do without) to 10 (mean it's very important, I think it's essential)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start20 May 2022 (estimated)
- Primary completion20 Jul 2022 (estimated)
- Study completion20 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TelemedicineStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 4,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clémentine DUPUIS, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05348551
- Sponsor's protocol ID
- 2021-A02641-40
- Acronym
- TLS-DID
- Status last verified
- Apr 2022
- First submitted
- 30 Mar 2022
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- State of Play of Telemedicine in the Follow-up of Children With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT05348551
- Acronym / sponsor ID
- TLS-DID / 2021-A02641-40
- Conditions
- Telemedicine, Diabetes Mellitus, Type 1, Children, Only
- Keywords
- Diabetes mellitus type 1, Children, Telemedicine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,800 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 20 May 2022 (estimated)
- Primary completion
- 20 Jul 2022 (estimated)
- Study completion
- 20 Jul 2022 (estimated)
- First posted
- 27 Apr 2022 (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.
Assessment of the proportion of pediatric patients with type 1 diabetes with access to remote monitoring
Detailed description
In the follow-up of type 1 diabetes in children, contact with families besides the appointements with medical et paramedic staff (paediatrician, diabetologist, nurses) is very common but not well coded, start from telehealth hubs (like myDiabby), to less unofficial contact by phone or email. This is even more so widespread since generalization of continuous glucometer (freestyle, dexcom,...), which allowed a quick data transfer to the medical staff.
Some studies had shown that telemedicine in diabetes allowed a better glycemic control and a higher implication in the desease. Indeed, in 1999 already, HbA1c significant improvement was shown when patients was regularly called by a nurse (Thompson et al.). Same finding was demonstrated in Schiaffini and al. clinical trial in 2016. This trial also shown a better adhesion to the follow up into the telemedicine group. Despite all of this studies, in France, remote monitoring isn't standardised and financed, except the national experimentation ETAPES which promotes and financially supports the deployment of remote monitoring projects around the territory.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children aged 0 to 17 years with type 1 diabetes
Key inclusion criteria (1 listed)
- Children with type 1 diabetes
Key exclusion criteria (1 listed)
- No consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of the proportion of pediatric patients with access to remote monitoring
Time frame: 1 day
Proportion of pediatric patients with access to remote monitoring
3 secondary outcomes
Description of the different means and modalities of remote monitoring for patients
Time frame: 1 day
Description of the different means and modalities of remote monitoring for patients
Time frame: 1 day
Evaluation of patients' (and parents') perception of telemonitoring using a scale
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Clémentine DUPUIS principal investigator
University Hospital, Grenoble
Questions about this trial
What is this clinical trial studying?
An observational study of Telemedicine and Diabetes Mellitus, Type 1, run by University Hospital, Grenoble.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Clémentine DUPUIS (0476760924, cdupuis2@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the proportion of pediatric patients with access to remote monitoring (time frame: 1 day). 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 27 Apr 2022.