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 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 1:18 AM
NCT ID:
NCT05597293
Eligibility Criteria:
Inclusion Criteria:
* Males and females living with type 2 diabetes mellitus (T2DM) who are aged ≥ 18 and ≤ 75 years
* On one or more non-insulin glucose lowering agent(s)
* HbA1c ≥ 69 mmol/mol
* Able to provide written informed consent
Exclusion Criteria:
* Participants with a life expectancy of less than 1 year
* Participants with cognitive dysfunction or neurological disorder, which will interfere with regular, flash glucose monitoring
* Participants with chronic kidney disease (CKD) with eGFR \< 45ml/min/1.73m2 or decompensated liver disease or decompensated congestive cardiac failure
* Myocardial infarction in the preceding 3 months or if percutaneous coronary intervention planned in the next 6 months
* Participants on supra-physiological doses of steroids, for example, Prednisolone for the treatment of Rheumatoid arthritis
* Participants on active dialysis or planned for dialysis treatment during the study
* Currently participating in another device or drug study that could affect glucose measurements or management
* Women who are pregnant, breastfeeding or planning to become pregnant. Women should use a reliable form of contraception throughout the study
* Participants who are already using continuous glucose monitoring (CGM)
* Participants who have pacemakers, implanted cardioverter defibrillator devices or neurostimulators
* Participants with an allergy to medical grade adhesive
* A blood transfusion in the preceding 3 months or a planned blood transfusion during the course of the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05597293
Study Brief:
Protocol Section:
NCT05597293