Remote Digital Care Effects in Adolescents With Type 1 Diabetes

NCT ID: NCT05421715

Last Updated: 2024-06-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-11
• Study Completion Date: 2024-12-01

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.

Conditions

type1diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

TELEDUC-DIAB

Intervention Type: OTHER

• Systematic monthly remote monitoring between traditional face-to-face consultations by a medical researcher using Kidia and My Diabby digital devices:

• With downloading by the adolescent of all data on My Diabby platform (clinical data from diabetes monitoring)
• Evaluation of adverse events related to the treatment of diabetes (hospitalizations and concomitant treatment)
• Analysis of data collected via My Diabby and Kidia: glycemic balance, captured data, connection frequency, alerts and alarms, diabetes knowledge)
• The proposal of a therapeutic education session according to the needs of the adolescent via the Kidia application
• Treatment adaptation
• A follow-up in case there is an alert identified by the teenager, the relative or My Diabby/caregiver

• The medical orientation of the patient according to the needs identified
• A proposal for a therapeutic education session according to the needs of the adolescent via the Kidia application

Interventions

TELEDUC-DIAB

• Systematic monthly remote monitoring between traditional face-to-face consultations by a medical researcher using Kidia and My Diabby digital devices:

• With downloading by the adolescent of all data on My Diabby platform (clinical data from diabetes monitoring)
• Evaluation of adverse events related to the treatment of diabetes (hospitalizations and concomitant treatment)
• Analysis of data collected via My Diabby and Kidia: glycemic balance, captured data, connection frequency, alerts and alarms, diabetes knowledge)
• The proposal of a therapeutic education session according to the needs of the adolescent via the Kidia application
• Treatment adaptation
• A follow-up in case there is an alert identified by the teenager, the relative or My Diabby/caregiver

• The medical orientation of the patient according to the needs identified
• A proposal for a therapeutic education session according to the needs of the adolescent via the Kidia application

Intervention Type: OTHER

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.)

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maeva TALVARD, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

University Hospital TOULOUSE

Toulouse, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Julie PELICAN, MD PhD

Role: CONTACT

juliepelicand@gmail.com

05 67 77 13 39

Facility Contacts

Julie PELICAN, MD

Role: primary

Other Identifiers

RC31/21/0617

Identifier Type: -

Identifier Source: org_study_id