Digital Tracking With Auto Data Reporting

Persei Vivarium

Status: Completed

Conditions: Type 1 Diabetes Mellitus (T1DM)

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06707155

SUG_ART

Details and patient eligibility

About

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.

Full 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

Enrollment: 25 patients

Sex: All

Ages: 3+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with type 1 diabetes mellitus
• Patients treated with subcutaneous insulin in multiple daily doses or patients treated with subcutaneous insulin in continuous subcutaneous infusion systems
• Patients using a glucose monitoring system
• Patients who are able to complete the study questionnaires
• Patients who are able to handle the application on a smart mobile phone.
• Informed consent is obtained from the patient.

Exclusion criteria

• Patients who, in the opinion of the investigator will not be able to commit to carrying out the follow-ups or do not have adequate technological skills