Glucose Management in Pregnancy for Type 1 Diabetes
Permissive Versus Strict Intrapartum Glucose Management in Type 1 Diabetes (PRISM-T1D)
Recruiting
Phase 4
Interventional Study
Pregnancy, High Risk
Type 1 Diabetes
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 44 (estimated)
- Sponsor
- Ohio State University · Other
Who this trial is looking for
This trial is looking for pregnant individuals with type 1 diabetes who are about to give birth. Participants will be randomly assigned to receive either a more relaxed or strict approach to blood sugar control during labor.
Are You a Good Fit for This Trial?
You may be able to join if
- I am pregnant
- I am at least 18 years old
- I have type 1 diabetes
- I plan to have a vaginal delivery
- I am admitted to Labor and Delivery
- I have a single, healthy baby
- I am at least 35 weeks pregnant
- My cervical dilation is less than 6 cm
You may not be able to join if
- I have a scheduled cesarean delivery
- My cervical dilation is 6 cm or more when I arrive
- I have received antenatal corticosteroids in the last 7 days
- My baby has died
- My baby has a major health issue
- I am having twins or more
- I do not speak English
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Check Your Eligibility
About This Trial
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 intrapar…
Trial Locations
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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…
Contacts