CGM for the Early Detection and Management of Hyperglycemia in Pregnancy

Description

Data from continuous glucose monitoring (CGM) in the Glucose Lowering group tracked over time, will be compared to data from blinded sensors in the Usual Care group approximately every 4 weeks.

* Pregnant women who do not have diabetes and have a single, uncomplicated pregnancy will be enrolled by 14 weeks and 6 days. They will start by wearing a hidden CGM sensor to check for high blood sugar.
* The blinded CGM sensor data will be evaluated to determine if the following criterion is met: 5% to 140 mg/dL

• An initial assessment will be made after 5 days and for those not meeting the criterion, again after 10 days
* Participants meeting the CGM hyperglycemia criteria and the other study eligibility criteria will proceed to randomization, which must be performed by 16 weeks 6 days of gestation.
* Participants who do not meet the CGM hyperglycemia criteria will form an observational cohort, provided that HbA1c is <6.5% (48 mmol/mol)