Preliminary Study for the Evaluation of Teleduc-diab Additional Remote Digitalcare Effects in Adolescents With Poorly Controled Type 1 Diabetes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- Evolution of glycemic control hemoglobin (HbA1c) between inclusion and 6 months
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 12 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.)
Arms & Interventions
ALL ADOLESCENTS
For all adolescents, the proposed treatment consists, in addition to conventional care,an individual digital care and education(TELEDUC-DIAB)for 6 months using digital devices (myDiabby + Kidia).
Intervention: TELEDUC-DIAB (Other)
Outcomes
Primary Outcomes
Evolution of glycemic control hemoglobin (HbA1c) between inclusion and 6 months
Time Frame: 6 months after inclusion
Glycated hemoglobin (HbA1c) is currently the universally recognized biological marker for monitoring diabetes. Glycated hemoglobin levels will be measured at inclusion, then 6 months after inclusion : a ratio will be deduced 6 months after inclusion with those two measures.
Secondary Outcomes
- Evolution of knowledge about diabetes and glycemic targets between inclusion and T6 months(6 months after inclusion)
- Evolution of adherence to TELEDUC-DIAB management between inclusion and 6 months(6 months after inclusion)