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NCT05348551 Clinical Trial

Overview of Telemedicine in Children With Type 1 Diabetes

Diabetes Mellitus, Type 1 Clinical Trial

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Official title:
State of Play of Telemedicine in the Follow-up of Children With Type 1 Diabetes

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05348551
Other study ID # 2021-A02641-40
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 20, 2022
Est. completion date July 20, 2022

Study information
Verified date April 2022
Source University Hospital, Grenoble
Contact Clémentine DUPUIS
Phone 0476760924
Email cdupuis2@chu-grenoble.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Assessment of the proportion of pediatric patients with type 1 diabetes with access to remote monitoring

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 4800
Est. completion date July 20, 2022
Est. primary completion date July 20, 2022
Accepts healthy volunteers No
Gender All
Age group N/A to 17 Years
Eligibility Inclusion Criteria: - Children with type 1 diabetes Exclusion Criteria: - No consent

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Grenoble

Outcome
Type Measure Description Time frame Safety issue
Primary Assessment of the proportion of pediatric patients with access to remote monitoring Proportion of pediatric patients with access to remote monitoring 1 day
Secondary Description of the different means and modalities of remote monitoring for patients Proportion of patients in the different modalities of remote monitoring 1 day
Secondary Description of the different means and modalities of remote monitoring for patients Proportion of patients in the different objectives of remote monitoring 1 day
Secondary 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) 1 day
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