NCT06707155

Digital Tracking With Auto Data Reporting

Study on the Use of Digital Platforms for the Control of Insulin Treatment in Patients With Type 1 Diabetes Mellitus

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 25 (actual)
• Sponsor: Persei Vivarium · Academic / Other
• Sex: All
• Age: 3 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Type 1 Diabetes Mellitus (T1DM)

Timeline

• Start date: 2024-07-22
• Primary completion: 2025-01-04
• Completion: 2025-01-04
• First posted: 2024-11-27
• Last updated: 2025-06-05

Locations

1 site across 1 country: Spain