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 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 1:22 AM
NCT ID:
NCT07224893
Eligibility Criteria:
Inclusion Criteria:
* Patients older than 18 years of age;
* The patient is fluent in English, physically and mentally able to understand the informed consent, and is willing to participate in this study;
* Type II diabetes mellitus requiring insulin;
* The patient is between 24 weeks 0 days and 28 weeks 0 days of gestation at the time of enrollment. Gestational age will be determined by last menstrual period, confirmed with a first trimester ultrasound, per the recommended guidelines by the American College of Obstetricians and Gynecologists.
* Currently using or willing to use a clinically indicated continuous glucose monitor for glycemic management
Exclusion Criteria:
* Known allergy or reaction to insulin glargine, or concurrent medical condition where the use of insulin glargine is contraindicated;
* Contraindication to CGM use, patient declines CGM use, or CGM not covered by patient's insurance;
* Concomitant use of other anti-diabetic medication (such as metformin); use of a short-acting insulin will not be considered an exclusion;
* Known or suspected fetal anomaly or aneuploidy;
* Prisoners;
* Ongoing prenatal care outside EVMS or planned delivery outside Sentara Norfolk General Hospital.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT07224893
Study Brief:
Protocol Section:
NCT07224893