Actively Recruiting

Phase Not Applicable
Age: 18Years - 55Years
FEMALE
ID06883344

Automated Insulin for Management of Intrapartum Glycemia (AIMING): a Multicenter Randomized Controlled Trial

Led by University of California, San Francisco · Updated on 2026-05-18

150

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating how automated insulin delivery (AID) systems can manage blood sugar levels during labor and delivery for pregnant people with type 1 diabetes (T1D). This study compares AID systems to the current standard, intravenous (IV) insulin, to see if AID improves newborn blood sugar levels, patient birth satisfaction, and time spent in the ideal glucose range during labor. The trial is sponsored by the University of California, San Francisco and includes pregnant people with pre-gestational diabetes. Participants are randomly assigned to use either the automated insulin delivery system or intravenous insulin during labor and delivery. The AID system uses continuous glucose monitoring to automatically adjust insulin delivery based on predicted glucose levels and other factors, while IV insulin is given at a continuous rate with manual adjustments according to hospital protocols. This study focuses on glucose management specifically during the labor and delivery period. Throughout the study, researchers will measure the newborn's first blood glucose within two hours of birth, assess birth satisfaction within two weeks after delivery, and monitor continuous glucose monitoring data from admission to birth. The trial will involve single pregnancies at 34 or more weeks gestation among women who have used an AID system since at least 28 weeks. Safety and glucose control will be closely tracked during labor and delivery, with participation lasting through the delivery and immediate postpartum period.

CONDITIONS

Brief Title

Automated Insulin for Management of Intrapartum Glycemia

Who Can Participate

Age: 18Years - 55Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Currently pregnant at 64 34 weeks
  • Known diagnosis of type 1 diabetes for at least 1 year
  • Use of a commercially available automated insulin delivery system since at least 28 weeks gestation
  • Singleton pregnancy
  • English- or Spanish-speaking
Not Eligible

You will not qualify if you...

  • 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 study conduct or ability to participate in own healthcare

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - From admission to labor/delivery unit until birth of infant

Participants use either an automated insulin delivery system or intravenous insulin during labor to manage blood glucose levels.

1 continuous hospital stay during labor and delivery

Follow-up

Duration - Up to 2 weeks after delivery

Participants complete assessments including satisfaction and neonatal glucose measurements after delivery.

1 to 2 visits post-delivery

Trial Site Locations

Total: 2 locations

1

University of California, San Diego

San Diego, California, United States, 92121

Actively Recruiting

2

University of California, San Francisco

San Francisco, California, United States, 94143

Actively Recruiting

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Research Team

P

Principal Investigator

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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