NCT Number: NCT06883344
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.
Interested in participating?
Request Info18 year–55 year
Female
Interventional
Not applicable
University of California, Los Angeles, Los Angeles, California, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
An 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.
Variable 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.
Time frame: Within 2 hours of birth
A primary clinical goal of intrapartum glycemic management is to minimize the likelihood of low neonatal glucose values (hypoglycemia).
Time frame: Within 2 weeks of delivery
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: From admission to labor/delivery unit to birth of infant
Glycemic parameters like time in range (TIR), time below range (TBR), and time above range (TAR) will be examined as markers of intrapartum glycemia
Contact information is provided by the study sponsor or research team.
University of California, San Francisco
Other
Automated Insulin for Management of Intrapartum Glycemia (AIMING): a Multicenter Randomized Controlled Trial
Acronym: AIMING
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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