Digital Tracking With Auto Data Reporting

NCT06707155 | Completed

• 1 other identifier: SUG_ART
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 1 Diabetes Mellitus (T1DM)

Keywords

T1DM; digital platforms; Remote patient monitoring; glycemic control; Caaring

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (10)

• Degree of completion of data related to treatments between medical visits

  Day 0 up to Week 12

• Degree of completion of data related to intercurrent processes between visits

  Day 0 up to Week 12

• Degree of completion of therapeutic adherence between visits

  Weekly up to 12 weeks

• Change in the patient's quality of life scale

  Day 0 and week 12

• Degree of completion of the questionnaires

  Week 12

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients from the Hospital Infantil Universitario Niño Jesús diagnosed with type 1 diabetes mellitus who meet the selection criteria and sign the informed consent will be included.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Persei Vivarium: lead
• Effice Servicios Para la Investigacion S.L.: collaborator

Study Sites (1)

Hospital Infantil Universitario Niño Jesús

Madrid, Madrid, 28009, Spain

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: November 27, 2024
• Study Start: July 22, 2024
• Primary Completion: January 4, 2025
• Study Completion: January 4, 2025
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)