search
Back to results

Remote Digital Care Effects in Adolescents With Type 1 Diabetes (TELEDUC-DIAB1)

Primary Purpose

type1diabetes

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
TELEDUC-DIAB
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for type1diabetes focused on measuring glucose control, patient therapeutic education, mobile application, remote digital care, adolescents, teenagers

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • Uh ToulouseRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ALL ADOLESCENTS

Arm Description

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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).

Full Information

First Posted
June 13, 2022
Last Updated
April 14, 2023
Sponsor
University Hospital, Toulouse
search

1. Study Identification

Unique Protocol Identification Number
NCT05421715
Brief Title
Remote Digital Care Effects in Adolescents With Type 1 Diabetes
Acronym
TELEDUC-DIAB1
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 11, 2023 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
type1diabetes
Keywords
glucose control, patient therapeutic education, mobile application, remote digital care, adolescents, teenagers

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Monocentric longitudinal prospective cohort study
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ALL ADOLESCENTS
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
TELEDUC-DIAB
Intervention Description
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
Primary Outcome Measure Information:
Title
Evolution of glycemic control hemoglobin (HbA1c) between inclusion and 6 months
Description
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.
Time Frame
6 months after inclusion
Secondary Outcome Measure Information:
Title
Evolution of adherence to TELEDUC-DIAB management between inclusion and 6 months
Description
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
Time Frame
6 months after inclusion
Title
Evolution of knowledge about diabetes and glycemic targets between inclusion and T6 months
Description
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).
Time Frame
6 months after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julie PELICAN, MD PhD
Phone
05 67 77 13 39
Email
juliepelicand@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maeva TALVARD, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uh Toulouse
City
Toulouse
ZIP/Postal Code
31000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
UH TOULOUSE
Email
juliepelicand@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Remote Digital Care Effects in Adolescents With Type 1 Diabetes

We'll reach out to this number within 24 hrs