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:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-25 @ 4:59 AM
NCT ID:
NCT05944718
Eligibility Criteria:
Inclusion Criteria:
* Recipient of care participants are eligible to be included in the Study only if all the following inclusion criteria apply:
People living with T1 diabetes with HbA1c current levels ≥10% within the last 3 months (and at least 2 HbA1c ≥10% within the last 18 months prior to study enrolment) who are attending for diabetes care at the 3 study clinics.
* Care givers to children/adolescents living with T1 diabetes are eligible to be included in the study only if all the following inclusion criteria apply:
• The child/adolescent that the person is a care giver to is enrolled in the study.
* Healthcare providers are eligible to be included in the study only if all the following inclusion criteria apply:
* Healthcare provider at the study sties engaged in diabetes care provision related to the study.
Exclusion Criteria:
* Participants are excluded from the Study if any of the following exclusion criteria apply:
* People living with T1 diabetes under 4 years old as this the minimum age for use of CGM as per the CGMs used in this study manufacturer instructions.
* People diagnosed with T1 diabetes within the last 2 years.
* People who have used a CGM in the last 6 months prior to enrollment.
* People who anticipate that they would have access to a CGM through means outside this study during the duration of the study (15 months).
* People living with Type 2 diabetes.
* Known pregnancy at the time of study enrolment.
* People who are not willing to agree to Freestyle Libre T\&Cs
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
4 Years
Study:
NCT05944718
Study Brief:
Protocol Section:
NCT05944718