Automated Insulin for Management of Intrapartum Glycemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Automated insulin delivery (AID) system, Intravenous (IV) insulin.
- Who it may be relevant to
- Registry conditions: Type 1 Diabetes (T1D), Pregnancy, Pre-Gestational Diabetes. Basic parameters: 18 years — 55 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Automated Insulin for Management of Intrapartum Glycemia (AIMING): a Multicenter Randomized Controlled Trial
Overview
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.
Interventions
- Device 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. - Other 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.
Primary outcome measures
- First neonatal glucose value [Time frame: Within 2 hours of birth]
Secondary outcome measures (2)
- Birth Satisfaction Scale Revised (BSS-R) score [Time frame: Within 2 weeks of delivery]
- CGM-derived glycemic parameters [Time frame: From admission to labor/delivery unit to birth of infant]
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 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 3 centers
- University of California, Los Angeles — Los Angeles
- University of California, San Diego — San Diego
- University of California, San Francisco — San Francisco
Identifiers
NCT: NCT06883344 · 25-43619