No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 55
Sex
Female
Study type
Interventional
Purpose
Treatment
Participants needed
150 (estimated)
Sponsor
University of California, San Francisco · Other
Who this trial is looking for
This trial is looking for pregnant people with type 1 diabetes who are at least 34 weeks along. Participants will use either an automated insulin delivery system or receive insulin through an IV during labor and delivery.
Are You a Good Fit for This Trial?
You may be able to join if
I am currently pregnant at 34 weeks or more.
I have been diagnosed with type 1 diabetes for at least one year.
I have been using an automated insulin delivery system since at least 28 weeks pregnant.
I have a single baby.
You may not be able to join if
I am pregnant with more than one baby.
I have a planned cesarean delivery.
I am taking medications that can interfere with glucose metabolism.
I have had a loss of my baby's heartbeat before delivery.
I have a physical or mental health condition that may affect my ability to participate.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 …
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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
* English- or Spanish-speaking
Exclusion Criteria:
* Multifetal gestation
* Planned cesarean deli…
Inclusion Criteria:
* 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
* English- or Spanish-speaking
Exclusion Criteria:
* Multifetal gestation
* Planned cesarean delivery
* Use of medications known to interfere with glucose metabolism
* Intrauterine fetal demise
* Physical or psychological disease likely to interfere with the conduct of the study and/or the ability to participate in own healthcare
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