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 @ 4:52 AM
Ignite Modification Date:
2025-12-25 @ 4:52 AM
NCT ID:
NCT04084418
Eligibility Criteria:
Inclusion Criteria:
* Duration of Type 1 Diabetes \> 12 months
* On intensive insulin therapy for \> 6 months
* Own a smartphone or tablet to use two mobile applications : Keenoa and Piezo: Achieve the Guidelines!
Exclusion Criteria:
* Known gastroparesis (clinical diagnosis)
* Advanced kidney disease (eGFR \< 50 mL/min)
* Known significant liver disease (e.g., cirrhosis, active hepatitis, liver transplantation)
* Recent (\< 6 months) major cardiovascular even (e.g. myocardial infarction, cerebrovascular accident, major revascularization, etc.)
* Pregnancy (ongoing or planned in the next 6 months)
* Breastfeeding
* Severe hypoglycemia episodes or ketoacidosis in the 4 weeks prior to recruitment
* Claustrophobia or presence of metal devices/implants in the body
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04084418
Study Brief:
Protocol Section:
NCT04084418