Clinical trial NCT05421715: Remote Digital Care Effects in Adolescents With Type 1 Diabetes
Official title: Preliminary Study for the Evaluation of Teleduc-diab Additional Remote Digitalcare Effects in Adolescents With Poorly Controled Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: type1diabetes
Keywords: glucose control
patient therapeutic education
mobile application
remote digital care
adolescents
teenagers
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2022-06-16
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Monocentric longitudinal prospective cohort study
Primary purpose: SUPPORTIVE_CARE

Brief summary: Pilot study to evaluate effects of an experimental additional remote digital care (TELEDUC-DIAB) to adolescents with poorly controlled type 1 diabetes using digital monitoring platform and educative app

Detailed description: The use of digital technologies for the support and monitoring of diabetes have gradually become essential in recent years. The scientific literature reveals contrasting effects of digital and mobile technologies, both on adolescents with T1D (type 1 diabetes) and on their relatives. While the majority of studies have focused on connected devices for continuous blood glucose measurement, the specific effects of other tools, such as those of mobile patient therapeutic education applications or medical telemonitoring, are to this day still poorly documented or even unknown.

The study aim to describe the evolution of the glycemic control of adolescents with poorly controled type 1 diabetes during6 months individual TELEDUC-DIAB remote digital care in addition to their conventional follow-up.

The Medical-educational care (TELEDUC-DIAB) consist of:

* a personalized intensified remote care with a healthcare professional
* myDiabby platform: remote monitoring device integrating a data collection platform and systematized monitoring by alarms
* the Kidia application = a patient therapeutic education mobile application: developed by the Enfance, Adolescence et Diabète association, is a mobile application that patients can personalize (avatar,...) and help them understand and empower to deal with their diabetes.

This project offers original and innovative complementary monitoring: remotely, adapted to the specific needs of adolescents and aimed at improving glycemic control by developing self-efficacy and autonomy in adolescents in the management of diabetes.

Eligibility criteria: Inclusion Criteria:

* Adolescent aged ≥12 and \<18, with primary type 1 diabetes detected for at least 12 months, treated with multi-injection insulin or insulin pump
* Glycated hemoglobin greater than or equal to 8% for more than 3 months
* Use a continuous interstitial glucose recording system (CGM)
* Have at least one parent/guardian with a significant caregiver role in the management of the adolescent's diabetes (as determined by the investigator) participating in the study
* Have digital media compatible with the digital applications of the TELEDUC- DIAB (Mobile phone and computer)

Exclusion Criteria:

• Other pathologies associated with diabetes which, according to the investigator, could interfere with glycemic control or the management of adolescent diabetes (examples: secondary diabetes, cystic fibrosis, Down syndrome; transplants, corticosteroid therapy, etc.)

Primary outcomes:
measure: Evolution of glycemic control hemoglobin (HbA1c) between inclusion and 6 months
timeFrame: 6 months after inclusion
Secondary outcomes:
measure: Evolution of adherence to TELEDUC-DIAB management between inclusion and 6 months
timeFrame: 6 months after inclusion
measure: Evolution of knowledge about diabetes and glycemic targets between inclusion and T6 months
timeFrame: 6 months after inclusion
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital TOULOUSE
Study officials:
affiliation: University Hospital, Toulouse
name: Maeva TALVARD, MD
role: PRINCIPAL_INVESTIGATOR
References: