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 @ 7:51 PM
Ignite Modification Date:
2025-12-24 @ 7:51 PM
NCT ID:
NCT07009704
Eligibility Criteria:
Inclusion Criteria:
* Pregnant (\<20w0d)
* At least 18 years to 45 years old
* BMI \>25, personal history of GDM, or first-degree family member with type II diabetes
* Comfortable conversing in English
* Own a smartphone and willing to use the CGM app and Signal
* Receiving prenatal care and planning to deliver at Tufts Medicine (Boston)
* Signed the consent form
* Currently located in the United States
Exclusion Criteria:
* Current pregnancy a multiple gestation (e.g., twins)
* Smoked during this current pregnancy
* Active hepatitis or HIV infection
* Current pregnancy have any documented fetal congenital anomalies
* Current history of heroin, cocaine, crack, LSD, or methamphetamines
* Current history of alcohol abuse
* Previous gastric bypass
* Shift work that alters the sleep/wake periods
* Have known rheumatological or chronic inflammatory state (i.e., arthritis, inflammatory bowel disease)?
* Chronic illnesses, including diabetes and dialysis, that require regular medication use
* Uncontrolled hypothyroidism
* Known culture of positive chorioamnionitis?
* An adult who is unable to consent (e.g., cognitively impaired adults)
* Ward of the state
* Unable to read or write English
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT07009704
Study Brief:
Protocol Section:
NCT07009704