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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Automated insulin delivery (AID) system
DeviceAn AID system incorporates data from a continuous glucose monitor (CGM) to automatically adjust the amount of insulin delivered by an insulin pump via an algorithm that incorporates multiple factors, including predicted glucose level in the next 30-60 minutes, target glucose level, and recent insulin delivery.
Intravenous (IV) insulin
Other interventionVariable rate IV insulin infusions are used in most labor/delivery units as the standard of care for glycemic management for pregnant people with T1D. A continuous rate of IV insulin is infused, with manual rate adjustments made based on current glucose level and hospital-specific protocols.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Intravenous (IV) insulinActive comparator 1 intervention
Group B: Automated insulin delivery (AID) systemExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
First neonatal glucose value
A primary clinical goal of intrapartum glycemic management is to minimize the likelihood of low neonatal glucose values (hypoglycemia).
Time frame
Within 2 hours of birthSecondary outcomes
1
Birth Satisfaction Scale Revised (BSS-R) score
The BSS-R is a 10-item, multi-dimensional, psychometric instrument that has been validated as a measure of birth satisfaction. This endpoint was selected to adequately assess patient perception of quality of care received and labor-related stress experienced.
Time frame
Within 2 weeks of delivery2
CGM-derived glycemic parameters
Glycemic parameters like time in range (TIR), time below range (TBR), and time above range (TAR) will be examined as markers of intrapartum glycemia
Time frame
From admission to labor/delivery unit to birth of infantSponsors and contacts
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Source ClinicalTrials.gov