Remote Digital Care Effects in Adolescents With Type 1 Diabetes

NCT05421715 | Completed

• 1 other identifier: RC31/21/0617
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

type1diabetes

Keywords

glucose control; patient therapeutic education; mobile application; remote digital care; adolescents; teenagers

Outcome Measures

Primary Outcomes (1)

• Evolution of glycemic control hemoglobin (HbA1c) between inclusion and 6 months

  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.

  6 months after inclusion

Secondary Outcomes (2)

• Evolution of adherence to TELEDUC-DIAB management between inclusion and 6 months

  6 months after inclusion

• Evolution of knowledge about diabetes and glycemic targets between inclusion and T6 months

  6 months after inclusion

Study Arms (1)

ALL ADOLESCENTS

EXPERIMENTAL

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).

Other: TELEDUC-DIAB

Interventions

TELEDUC-DIAB 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

ALL ADOLESCENTS

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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.)

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital TOULOUSE

Toulouse, 31000, France

Location

Study Officials

• Maeva TALVARD, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Monocentric longitudinal prospective cohort study

Study Record Dates

• First Submitted: June 13, 2022
• First Posted: June 16, 2022
• Study Start: April 11, 2023
• Primary Completion: October 11, 2024
• Study Completion: October 11, 2024
• Last Updated: May 8, 2026

Record last verified: 2026-05

Locations

FR (1)