Permissive Versus Strict Intrapartum Glucose Management in Type 1 Diabetes (PRISM-T1D)

What Was Tested

This registered phase 4 trial tested Insulin (regular human).

It had two arms (groups): Intervention group (experimental) and Standard of care (other).

The registry classes the interventions as device and drug.

More on the Plan

However, such data about permissive versus strict intrapartum glucose management has primarily been from pregnant individuals with type 2 diabetes or gestational diabetes who did not use HCL based insulin therapy.

Pregnant individuals with diabetes who use HCL with continuous glucose monitoring and closed loop insulin delivery represent a unique population, and data from this population are needed to inform intrapartum obstetric management.

The investigators will secondarily examine the association between permissive versus strict intrapartum glucose with adverse neonatal outcomes, including neonatal hypoglycemia, neonatal hyperbilirubinemia, and NICU admission, patient satisfaction, and continuous glucose monitor (CGM) metrics.

Who Took Part

44 planned participants were the target.

It was open to women only aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: ≥ 18 years old. Type 1 diabetes. Intention for vaginal delivery and admitted to Labor and Delivery. Singleton, non-anomalous fetus. Gestational age greater than or equal to 35 weeks gestation.

The full record lists 8 inclusion and 7 exclusion criteria; among the exclusions: scheduled cesarean delivery; cervical dilation ≥ 6 cm on presentation to l\&d; receipt of antenatal corticosteroids within 7 days of randomization.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when Insulin (regular human) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2026-02-25 with completion listed for 2027-06.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Mean of first neonatal blood glucose (continuous, mean with standard deviation) (time frame: From birth to 2 hours after birth).

It also tracked 7 secondary outcomes, for example Neonatal C-peptide (continuous, mean with standard deviation), Neonatal hypoglycemia, Neonatal hyperbilirubinemia, NICU admission, Birth experience satisfaction per Birth Satisfaction Survey-Revised (BSS-R) (continuous, mean with standard deviation) and Maternal Hypoglycemia.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin (regular human) in 44 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page, all human trials.