type1diabetes Clinical Trial
— TELEDUC-DIAB1Official 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
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.) |
Country | Name | City | State |
---|---|---|---|
France | University Hospital TOULOUSE | Toulouse |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Toulouse |
France,
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 |
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