Type 1 diabetes mellitus is a chronic pathology and represents a constant challenge for children and adolescents with diabetes and their families. The objective of the treatment of DM1 in pediatric age is to achieve and maintain an optimal glycemic control in order to avoid or delay chronic micro- and macrovascular complications related to the disease. However, currently, despite technological advances and the development of new insulin formulations, the majority of patients are unable to achieve glycemic goals. In this context, the use of digital tools/platforms that allow remote monitoring of patients and that facilitate telemedicine have shown potential to improve treatment adherence and facilitate continued therapeutic education, improving clinical results with savings in time and associated costs.
Patients are enrolled to a prospective, observational Post-Market clinical Follow-up study. This is a pilot study. The protocol and informed consent documents have been reviewed and approved by the hospital human subjects reviewboard and the study will be performed in accordance with the Declaration of Helsinki
Study Type
OBSERVATIONAL
Enrollment
25
Hospital Infantil Universitario Niño Jesús
Madrid, Madrid, Spain
Potential for improvement of type 1 diabetes through the use of a digital platform
Percentage of events related to diabetes reported through the use of a digital platform of the total events related to diabetes that occurred between medical visits.
Time frame: 12 weeks
Degree of completion of data related to treatments between medical visits
The Degree of completion of data related to treatments between medical is defined as the ratio between the questionnaires requested and completed.
Time frame: Day 0 up to Week 12
Degree of completion of data related to intercurrent processes between visits
The Degree of completion by patients of data related to intercurrent processes between is defined as the ratio between the questionnaires requested and completed
Time frame: Day 0 up to Week 12
Degree of completion of therapeutic adherence between visits
The Degree of completion of therapeutic adherence by patients between visits is defined as the ratio between the questionnaires requested and completed.
Time frame: Weekly up to 12 weeks
Change in the patient's quality of life scale
Change in the patient's quality of life scale the study compared to baseline. Health-Related Quality of Life in children and adolescents: Values (0-100), a higher score reflects a higher health-related quality of life (HRQoL).
Time frame: Day 0 and week 12
Degree of completion of the questionnaires
Degree of completion of the questionnaires depending on age and gender, type of treatment and degree of glycemic control
Time frame: Week 12
Variation in clinical parameters of glycemic control, HbA1c and CGM data: TIR
Variation in clinical parameters of glycemic control, HbA1c and CGM data: TIR (time in range)
Time frame: Day 0 and Biweekly up to 12 weeks
Percentage of patients who complete the study correctly
Percentage of patients who complete the study correctly by completing all questionnaires
Time frame: Week 12
Variation in clinical parameters of glycemic control, HbA1c and CGM data: TBR
Variation in clinical parameters of glycemic control, HbA1c and CGM data: TBR (time below range)
Time frame: Day 0 and Biweekly up to 12 weeks
Variation in clinical parameters of glycemic control, HbA1c and CGM data: CV
Variation in clinical parameters of glycemic control, HbA1c and CGM data: CV (Coefficient of Variation)
Time frame: Day 0 and Biweekly up to 12 weeks
Variation in clinical parameters of glycemic control, HbA1c and CGM data: GRI
Variation in clinical parameters of glycemic control, HbA1c and CGM data: GRI (Glycemic Risk Index).
Time frame: Day 0 and Biweekly up to 12 weeks
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