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 @ 4:28 PM
Ignite Modification Date:
2025-12-24 @ 4:28 PM
NCT ID:
NCT05670366
Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent
* 18-80 years old
* Type 1 diabetes ≥1 year
* Using a CGM for more than 6 months
* Using insulin (insulin pens, insulin pumps or hybrid closed-loop systems) to manage glycaemia for more than 6 months
* No use of adjunctive therapies, such as SGLT2-inhibitors or GLP-1 analogues
* No known diabetic gastroparesis
* HbA1c of the last two diabetes consultations are both \<10%
* Being physically active at least twice a week on two separate days for 30 consecutive minutes
Exclusion Criteria:
* Age \<18 years or \>80 years
* People with type 2 diabetes, people with secondary diabetes
* Begin treatment with insulin (insulin pens, insulin pumps or hybrid closed-loop systems) less than 6 months before inclusion
* Not using CGM prior to inclusion
* Known diabetic gastroparesis
* HbA1c \> 10% during one of the last two diabetes consultations
* Not willing to use an activity tracker, the diary app or the food app
* Not being physically active on a regular basis
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05670366
Study Brief:
Protocol Section:
NCT05670366