Remote Digital Care Effects in Adolescents With Type 1 Diabetes

type1diabetes Clinical Trial

— TELEDUC-DIAB1  

Official title:

Preliminary Study for the Evaluation of Teleduc-diab Additional Remote Digitalcare Effects in Adolescents With Poorly Controled Type 1 Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05421715
• Other study ID #: RC31/21/0617
• Status: Recruiting
• Phase: N/A
• Start date: April 11, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: June 2024
• Source: University Hospital, Toulouse
• Contact: Julie PELICAN, MD PhD
• Phone: 05 67 77 13 39
• Email: juliepelicand[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• type1diabetes

Intervention

Other:
• 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

Locations

Country	Name	City	State
France	University Hospital TOULOUSE	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evolution of adherence to TELEDUC-DIAB management between inclusion and 6 months	Non-adherence to the program will be determined if: <80% of interstitial blood glucose is entered by the adolescent on the app over the last 14 days; For adolescents with an insulin pump: average duration between 2 catheter changes greater than 3 days; Monthly frequency of use of the TELEDUC-DIAB device : < 4 monthly connections to the download platform; <1 monthly connection to the KIDIA application; <1 monthly telemonitoring connection with the professional	6 months after inclusion
Secondary	Evolution of knowledge about diabetes and glycemic targets between inclusion and T6 months	an open question is asked to the participant each months of the study: "describe what glycated hemoglobin (hb1AC) is and the ideal ranges in which capillary blood glucose and hemoglobin measurements glycated must be located" Correctly answering these 3 key questions is associated with better glycemic control.; Each question will be scored by 0 (wrong answer or no answer), 0.5 (incomplete answer) and 1 (correct and complete answer).	6 months after inclusion