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 @ 7:18 PM
Ignite Modification Date:
2025-12-24 @ 7:18 PM
NCT ID:
NCT04228003
Eligibility Criteria:
Inclusion Criteria:
* Body mass index ≤ 45 kg/m2.
* Subjects with type 2 diabetes that are on a stable dose of one or more injectable or oral antihyperglycemia agents for at least 8 weeks prior to screening.
* HbA1c ≥ 6.5 % and ≤ 9.5% obtained at the screening visit.
* Subjects with any gastrointestinal symptoms including but not limited to heartburn, indigestion, diarrhea, constipation.
* Must be willing and be able to give written informed consent.
Exclusion Criteria:
* Type 1 diabetes
* Pregnant, nursing or planning pregnancy
* Planning elective surgery in the next 8 weeks
* Current or planned use of steroids, orally or injected
* Diagnosis of irritable bowel disease , diverticulitis, other significant GI illness
* Co-existing severe health condition, such as active cancer or unstable cardiovascular disease/congestive heart failure.
* Severe allergy to tape or any component of the CGM device
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04228003
Study Brief:
Protocol Section:
NCT04228003