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RecruitingPhase 4

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares two blood sugar target ranges during labor: 70–140 mg/dL and 70–110 mg/dL. It is for pregnant adults with type 1 diabetes who use a hybrid closed-loop system, which helps manage insulin delivery. The study checks whether the wider range is as safe as the stricter range for the baby's blood sugar.

PRISM-TID is a single center non-inferiority randomized controlled trial of permissive intrapartum glucose management (intervention) versus strict intrapartum glucose management (standard of care) among pregnant individuals with type 1 diabetes (T1D) using hybrid closed loop therapy (HCL) who are admitted for labor management. Participants will be randomized in a 1:1 fashion to one of two intrapartum glycemic control options: permissive (70-140 mg/dL) or strict (70-110 mg/dL). The primary aim of this trial it to demonstrate that permissive intrapartum glucose management is not associated with an increased risk of neonatal dysglycemia compared with strict intrapartum glucose management.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are pregnant and at least 18 years old.
  • You have type 1 diabetes.
  • You plan to give birth through the vagina and are admitted to Labor and Delivery.
  • You are pregnant with one baby who has no birth defects.
  • You are at least 35 weeks pregnant.
  • Your cervix, the opening to the womb, is open less than 6 cm.
  • You will give birth at the study hospital.

Who can't join

  • You have a planned cesarean birth (C-section).
  • Your cervix is open 6 cm or more when you arrive at Labor and Delivery.
  • You received steroid medicines during pregnancy within 7 days before being assigned to a study group.
  • Your baby has died in the womb.
  • Your baby has a major birth defect.
  • You are pregnant with more than one baby.
  • You do not speak English.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria * Pregnant individuals * ≥ 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. * Cervical dilation is less than 6 cm. * Delivering at the study institution Exclusion criteria: * Scheduled cesarean delivery * Cervical dilation ≥ 6 cm on presentation to L\&D * Receipt of antenatal corticosteroids within 7 days of randomization * Fetal demise * Major fetal anomaly (attached) * Multiple gestation * Non-English speaking

Study sites (1)

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