Overview of Telemedicine in Children With Type 1 Diabetes

• Conditions: Diabetes Mellitus, Type 1; Telemedicine; Children, Only

• Registration Number: NCT05348551
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

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 Timeline

• Study First Submitted: 2022-03-30
• Status Verified: 2022-04
• Study First Submitted QC: 2022-04-20
• Last Update Submitted: 2022-04-20
• Study First Posted: 2022-04-27
• Last Update Posted: 2022-04-27
• Study Start: 2022-05-20
• Primary Completion: 2022-07-20
• Study Completion: 2022-07-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 4800

Inclusion Criteria

• Children with type 1 diabetes

Exclusion Criteria

• No consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of the proportion of pediatric patients with access to remote monitoring	1 day	Proportion of pediatric patients with access to remote monitoring

Secondary Outcome Measures

Name	Time	Method
Description of the different means and modalities of remote monitoring for patients	1 day	Proportion of patients in the different objectives of remote monitoring
Evaluation of patients' (and parents') perception of telemonitoring using a scale	1 day	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)