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OpenTrials
Completed

NCT Number: NCT06707155

Digital Tracking With Auto Data Reporting

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.

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Key information

Conditions

Type 1 Diabetes Mellitus (T1DM) Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

3 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Infantil Universitario Niño Jesús

Madrid, 28009, Spain

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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).

  5. 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

  6. 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)

  7. Percentage of patients who complete the study correctly

    Time frame: Week 12

    Percentage of patients who complete the study correctly by completing all questionnaires

  8. 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)

  9. 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)

  10. 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).

Sponsors and collaborators

Lead sponsor

Persei Vivarium

Other

Collaborators

  • Effice Servicios Para la Investigacion S.L.

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 27, 2024
Registry last updated
Jun 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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