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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
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TELEDUC-DIAB | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of adherence to TELEDUC-DIAB management between inclusion and 6 months | Non-adherence to the program will be determined if:
|
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Inclusion Criteria:
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.)
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| Name | Affiliation | Role |
|---|---|---|
| Maeva TALVARD, MD | University Hospital, Toulouse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital TOULOUSE | Toulouse | 31000 | France |
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Monocentric longitudinal prospective cohort study
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| 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). | 6 months after inclusion |