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 @ 7:12 PM
Ignite Modification Date:
2025-12-24 @ 7:12 PM
NCT ID:
NCT03704103
Eligibility Criteria:
Inclusion Criteria:
* Diagnosed Type 2 Diabetes, based on the World Health Organization (WHO) criteria, treated with basal insulin
* HbA1c 8-11% inclusive
* Glomerular filtration rate (GFR) \> 60 ml/min
* Has an Android or iOS based compatible smartphone (iOS 9.0 or above, Android 4.4 or above)
* Willing to perform at least 1 fasting finger stick glucose measurements every morning
* English speaking
Exclusion Criteria:
* Diagnosis of hypoglycemic unawareness
* Diagnosis of hyperglycemic hyperosmolar non-ketotic coma (HONK) or diabetic ketoacidosis (DKA) within 6 months of enrollment
* Recent (within the last 6 months)/current use of non-topical steroids
* Insulin requirements in excess of 1 U/kg per day
* Use of pioglitazone or another thiazolidinedione (TZD)
* In the opinion of the provider, HgbA1c goals should be adjusted above 7% due to infirmity, unstable cardiovascular disease, etc.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT03704103
Study Brief:
Protocol Section:
NCT03704103