Digital Tracking With Auto Data Reporting

June 2, 2025 updated by: Persei Vivarium

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28009
        • Hospital Infantil Universitario Niño Jesús

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Potential for improvement of type 1 diabetes through the use of a digital platform
Time Frame: 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.
12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Persei Vivarium

Collaborators

Effice Servicios Para la Investigacion S.L.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 22, 2024

Primary Completion (Actual)

January 4, 2025

Study Completion (Actual)

January 4, 2025

Study Registration Dates

First Submitted

November 19, 2024

First Submitted That Met QC Criteria

November 26, 2024

First Posted (Actual)

November 27, 2024

Study Record Updates

Last Update Posted (Estimated)

June 5, 2025

Last Update Submitted That Met QC Criteria

June 2, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SUG_ART

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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