Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:52 PM
Ignite Modification Date:
2025-12-24 @ 5:52 PM
NCT ID:
NCT07290868
Eligibility Criteria:
Inclusion Criteria:
* Diagnosed with Type 1 Diabetes Mellitus (T1DM) for 6 months or longer (requiring \>0.5 U/kg/day of insulin and having HbA1c \>6%, i.e., not in the "honeymoon phase").
* Receiving multiple daily injection (MDI) therapy or insulin pump therapy (CSII).
* Signed informed consent authorizing legal participation in the research project (child/adolescent and parent(s)/legal guardian).
* Availability to participate in the study using an m-Health application (Diactive-1) designed for the programming of muscle-bone strengthening physical exercise.
* Understanding of Spanish.
Exclusion Criteria:
* Comorbidities that limit the ability to engage in physical activity.
* Lack of internet access when using the application, whether due to Wi-Fi, mobile data, or international roaming issues.
* Absence of a mobile phone or tablet with an Android or iOS (Apple) operating system, or no family member willing to lend a device for each session using the application for study-related purposes.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
18 Years
Study:
NCT07290868
Study Brief:
Protocol Section:
NCT07290868