type1diabetesTELEDUC-DIAB1NCT05421715
Remote Digital Care Effects in Adolescents With Type 1 Diabetes
A study testing TELEDUC-DIAB in people with type1diabetes, run by University Hospital, Toulouse at 1 site in France.
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 Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- type1diabetes
- What is being tested?
- TELEDUC-DIAB
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 11 Apr 2023to 11 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preliminary Study for the Evaluation of Teleduc-diab Additional Remote Digitalcare Effects in Adolescents With Poorly Controled Type 1 Diabetes
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
Read the 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
- Being tested
- TELEDUC-DIAB
- Keywords
- glucose control, patient therapeutic education, mobile application, remote digital care, adolescents, teenagers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TELEDUC-DIABOther
- 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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: TELEDUC-DIAB |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after inclusion
Secondary outcomes (2)
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
Measured: 6 months after inclusion
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).
Measured: 6 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start11 Apr 2023
- Primary completion11 Oct 2024
- Study completion11 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for type1diabetesStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Monocentric longitudinal prospective cohort study
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maeva TALVARD, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05421715
- Sponsor's protocol ID
- RC31/21/0617
- Acronym
- TELEDUC-DIAB1
- Status last verified
- May 2026
- First submitted
- 13 Jun 2022
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Study for the Evaluation of Teleduc-diab Additional Remote Digitalcare Effects in Adolescents With Poorly Controled Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT05421715
- Acronym / sponsor ID
- TELEDUC-DIAB1 / RC31/21/0617
- Conditions
- type1diabetes
- Keywords
- glucose control, patient therapeutic education, mobile application, remote digital care, adolescents, teenagers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 11 Apr 2023 (actual)
- Primary completion
- 11 Oct 2024 (actual)
- Study completion
- 11 Oct 2024 (actual)
- First posted
- 16 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Monocentric longitudinal prospective cohort study
| Arm | Type | Receives |
|---|---|---|
| ALL ADOLESCENTS | Experimental | Other: TELEDUC-DIABFor 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). |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (1 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | ALL ADOLESCENTS |
Primary outcome
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.
2 secondary outcomes
Evolution of adherence to TELEDUC-DIAB management between inclusion and 6 months
Time frame: 6 months after inclusion
Evolution of knowledge about diabetes and glycemic targets between inclusion and T6 months
Time frame: 6 months after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maeva TALVARD, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TELEDUC-DIAB in people with type1diabetes, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of glycemic control hemoglobin (HbA1c) between inclusion and 6 months (time frame: 6 months after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.