Clinical trial NCT06707155: Digital Tracking With Auto Data Reporting
Official title: Study on the Use of Digital Platforms for the Control of Insulin Treatment in Patients With Type 1 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes Mellitus (T1DM)
Keywords: T1DM
digital platforms
Remote patient monitoring
glycemic control
Caaring
Lead sponsor: Persei Vivarium
Sponsor class: OTHER
Collaborators: name: Effice Servicios Para la Investigacion S.L.
First posted: 2024-11-27
Enrollment: 25
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Potential for improvement of type 1 diabetes through the use of a digital platform
timeFrame: 12 weeks
Secondary outcomes:
measure: Degree of completion of data related to treatments between medical visits
timeFrame: Day 0 up to Week 12
measure: Degree of completion of data related to intercurrent processes between visits
timeFrame: Day 0 up to Week 12
measure: Degree of completion of therapeutic adherence between visits
timeFrame: Weekly up to 12 weeks
measure: Change in the patient's quality of life scale
timeFrame: Day 0 and week 12
measure: Degree of completion of the questionnaires
timeFrame: Week 12
measure: Variation in clinical parameters of glycemic control, HbA1c and CGM data: TIR
timeFrame: Day 0 and Biweekly up to 12 weeks
measure: Percentage of patients who complete the study correctly
timeFrame: Week 12
measure: Variation in clinical parameters of glycemic control, HbA1c and CGM data: TBR
timeFrame: Day 0 and Biweekly up to 12 weeks
measure: Variation in clinical parameters of glycemic control, HbA1c and CGM data: CV
timeFrame: Day 0 and Biweekly up to 12 weeks
measure: Variation in clinical parameters of glycemic control, HbA1c and CGM data: GRI
timeFrame: Day 0 and Biweekly up to 12 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Infantil Universitario Niño Jesús
Study officials:
References: