Automated Insulin for Management of Intrapartum Glycemia

About

Brief Summary

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.

Primary Purpose

Treatment

Study Type

Interventional

Phase

N/A

Eligibility

Gender

Female

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

55 Years

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

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