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 @ 2:34 AM
Ignite Modification Date:
2025-12-25 @ 2:34 AM
NCT ID:
NCT05487534
Eligibility Criteria:
Inclusion Criteria:
* Type 1 diabetes (\> 12 months)
* Age between 18 and 65 years old
* 6.5 % \< A1C \< 9% (to avoid potential severe eating disorder)
Exclusion Criteria:
* Type 2 diabetes or other form of diabetes; gastroparesis (clinical diagnosis);
* Recent (\< 6 months) major cardiovascular event (e.g. myocardial infarction, cerebrovascular accident, major revascularization)
* Recent (\< 12 weeks) severe hypoglycemia episodes (\<2.8 mmol/L or assistance from a third party)
* Recent (\< 12 weeks) changes in insulin type or delivery method
* Automated Insulin Delivery
* History of severe brain trauma, epilepsy, schizophrenia or bipolar disorders
* Inability to use a computer
* Incorrect vision or auditory problems
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05487534
Study Brief:
Protocol Section:
NCT05487534