Digital Tracking With Auto Data Reporting

Active, not recruiting

• Conditions: Type 1 Diabetes Mellitus (T1DM)

• Registration Number: NCT06707155
• Lead Sponsor: Persei Vivarium

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.

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

Study Timeline

• Study Start: 2024-07-22
• Study First Submitted: 2024-11-19
• Study First Submitted QC: 2024-11-26
• Study First Posted: 2024-11-27
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-04-02
• Primary Completion: 2025-04-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Potential for improvement of type 1 diabetes through the use of a digital platform	12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Degree of completion of data related to treatments between medical visits	Day 0 up to Week 12	The Degree of completion of data related to treatments between medical is defined as the ratio between the questionnaires requested and completed.
Degree of completion of data related to intercurrent processes between visits	Day 0 up to Week 12	The Degree of completion by patients of data related to intercurrent processes between is defined as the ratio between the questionnaires requested and completed
Degree of completion of therapeutic adherence between visits	Weekly up to 12 weeks	The Degree of completion of therapeutic adherence by patients between visits is defined as the ratio between the questionnaires requested and completed.
Degree of completion of the questionnaires	Week 12	Degree of completion of the questionnaires depending on age and gender, type of treatment and degree of glycemic control
Change in the patient's quality of life scale	Day 0 and week 12	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).
Variation in clinical parameters of glycemic control, HbA1c and CGM data: TIR	Day 0 and Biweekly up to 12 weeks	Variation in clinical parameters of glycemic control, HbA1c and CGM data: TIR (time in range)
Percentage of patients who complete the study correctly	Week 12	Percentage of patients who complete the study correctly by completing all questionnaires
Variation in clinical parameters of glycemic control, HbA1c and CGM data: CV	Day 0 and Biweekly up to 12 weeks	Variation in clinical parameters of glycemic control, HbA1c and CGM data: CV (Coefficient of Variation)
Variation in clinical parameters of glycemic control, HbA1c and CGM data: TBR	Day 0 and Biweekly up to 12 weeks	Variation in clinical parameters of glycemic control, HbA1c and CGM data: TBR (time below range)
Variation in clinical parameters of glycemic control, HbA1c and CGM data: GRI	Day 0 and Biweekly up to 12 weeks	Variation in clinical parameters of glycemic control, HbA1c and CGM data: GRI (Glycemic Risk Index).

Trial Locations

Locations (1)

Hospital Infantil Universitario Niño Jesús; 🇪🇸 Madrid, Spain