Automated Insulin for Management of Intrapartum Glycemia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-55
SponsorUniversity of California, San Francisco
About this trial
The goal of this clinical trial is learn if automated insulin delivery (AID) systems can be used for glucose management during labor/delivery for pregnant people with type 1 diabetes (T1D). The main questions this study aims to answer are
* What are the neonatal glycemic outcomes with use of AID systems during labor/delivery? * Do patients report higher birth satisfaction with use of AID systems during labor/delivery? * Are glycemic parameters like time-in-range (TIR) better with use of AID systems during labor/delivery?
Researchers will compare AID systems to intravenous (IV) insulin (the current standard of care for glucose management during labor/delivery) by randomly assigning participants to one or the other.
Eligibility criteria
Qualifiers
Currently pregnant at ≥ 34 weeks
Known diagnosis of type 1 diabetes ≥ 1 year
Use of commercially available AID system since at least 28 weeks gestation
Singleton pregnancy
Disqualifiers
Multifetal gestation
Planned cesarean delivery
Use of medications known to interfere with glucose metabolism
Intrauterine fetal demise
Trial design
Treatments tested in this trial
- Automated insulin delivery (AID) system
- Intravenous (IV) insulin
Treatment groups
150 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov