Study Encounter Name | Screening/ Enrollment Visit(s) | 7-day Contacta | 14-day Contacta | 21-day Contact a | 28, 35, 42-day Contact a | Prenatal Study Visits b | Delivery Visit | 30-day Postnatal Contact |
---|---|---|---|---|---|---|---|---|
Screening, informed consent, inclusion, exclusion, medical history, randomize | X | |||||||
Dispense study agent | X | XXX | ||||||
Dose escalation from 500 mg BID to 1000 mg BID | Xa | Xa | ||||||
Collect study bottle, pill count of returned bottle | XXX | X or plan to obtain | ||||||
Record total daily insulin dosing (from enrollment through delivery) | X | X | X | X | X | XXX | X | |
Maternal side effects, symptoms, episodes of hypoglycemia, adverse events | X | X | X | X | XXX | X | ||
Maternal serious adverse events | X | X | X | X | XXX | X | X | |
Copy of glucose log | XXX | X or plan to obtain | ||||||
Maternal weight and blood pressure | X | XXX | ||||||
Blood draw | 24–30 weeks’ gestation | |||||||
Maternal breastfeeding intention questionnaire | 24–30 weeks’ gestation | |||||||
Measure infant anthropometrics | Within 72 h of delivery | |||||||
Collection of delivery and neonatal outcomes | X | X | ||||||
Neonatal adverse events and serious adverse events | X | X | ||||||
Maternal breastfeeding questionnaire postpartum | X |