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 @ 4:37 AM
Ignite Modification Date:
2025-12-25 @ 4:37 AM
NCT ID:
NCT04807218
Eligibility Criteria:
Inclusion Criteria:
1. Able to provide electronic informed consent
2. Age 18 - 79 years old
3. Type 2 diabetes mellitus diagnosis by self-report and/or medical history
4. Taking 1 or more antihyperglycemic medications
5. Current HbA1c \> 7.5%
6. Body mass index (BMI) 25 kg/m2 or greater
7. Capable of engaging in virtual care
Exclusion Criteria:
1. Type 1 diabetes
2. Pregnant or planning pregnancy within the next 9 months
3. Lactating
4. Admission for diabetic ketoacidosis (DKA) or hyperglycemic hyperosmolar syndrome (HHS) within the last 12 months
5. Life expectancy \<1 year
6. Postural orthostatic tachycardia syndrome (POTS) and/or recurrent syncope
7. Active severe psychiatric or medical condition(s) such as advanced renal (end-stage renal disease or CKD stage 4 or 5; eGFR \<30 mL/min), cardiac (NYHA Class 4 heart failure), or hepatic dysfunction (Child-Pugh Class C)
8. Any condition which in the opinion of the investigator would make the study unsuitable for the subject including investigator opinion regarding inability to comply with Virta instructions
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
79 Years
Study:
NCT04807218
Study Brief:
Protocol Section:
NCT04807218