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:
NCT03827434
Eligibility Criteria:
Inclusion Criteria:
* History of Diabetes Mellitus type 2 (DM2) on insulin
* Uncontrolled glycemic control \[hyperglycemia defined as Hba1c≥9% in the last 3 months or clinically important hypoglycemia (any reported glucose values less than 54 mg/dl) or severe hypoglycemia (low glucose value that led to a severe event characterized by altered mental status and or physical status requiring assistance)\]
Exclusion Criteria:
* Subjects that have a history of type 1 DM
* History of type 2 DM, not treated or required to be treated with basal/bolus insulin (i.e diet only, any combination of non insulin antidiabetic drugs only, basal only insulin or bolus/short acting only insulin, or pre-mixed insulins) as these patients are less likely to benefit from CGM use.
* Pregnant patients
* Use of Clarity/ Share or follow applications as telehealth/telemedicine to improve DM management during the last 3 months prior to study entry.
* Extensive skin changes/disease or allergies that preclude wearing the CGM sensor
* Significant psychiatric illness or any mental condition rendering the subject incapable of understanding the objectives and potential consequences of the study.
* Subjects without personal computer and internet network access.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT03827434
Study Brief:
Protocol Section:
NCT03827434