Automated Insulin for Management of Intrapartum Glycemia
NCT ID: NCT06883344
Last Updated: 2025-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
150 participants
INTERVENTIONAL
2025-12-05
2026-12-31
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intravenous (IV) insulin
Intravenous (IV) insulin
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.
Automated insulin delivery (AID) system
Automated insulin delivery (AID) system
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.
Interventions
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Automated insulin delivery (AID) system
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.
Intravenous (IV) insulin
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.
Eligibility Criteria
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Inclusion Criteria
* Current use of commercially available AID system ≥ 6 months
* Currently pregnant at ≥ 34 weeks
* Singleton pregnancy
* English- or Spanish-speaking
Exclusion Criteria
* 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
13 Years
55 Years
FEMALE
No
Sponsors
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University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Nasim Sobhani, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California, San Francisco
San Francisco, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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25-43619
Identifier Type: -
Identifier Source: org_study_id
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