Glucose Management for Pregnant Individuals with Type 1 Diabetes
(PRISM-T1D Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores two methods for managing blood sugar during labor in pregnant individuals with type 1 diabetes. It compares a more relaxed blood sugar control range (70-140 mg/dL) with a stricter range (70-110 mg/dL) to determine if the relaxed method is equally safe for newborns. The trial targets those with type 1 diabetes using a hybrid closed-loop insulin system and planning a vaginal delivery. Participants should be near the end of their pregnancy and admitted for delivery at the study location. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, aiming to understand its benefits for more patients.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What is the safety track record for insulin in this trial?
Research has shown that using insulin to manage type 1 diabetes during pregnancy is generally safe, though some risks exist. Studies have found that continuous insulin infusions can increase the likelihood of larger babies and early births. Additionally, there is a higher risk of low blood sugar, particularly early in pregnancy.
Automated insulin delivery systems have also undergone study. While promising, their effectiveness is still under evaluation. Some reported issues include early pregnancy loss and other complications. However, insulin remains widely used and FDA-approved for managing diabetes, indicating its general safety.
In this study, both groups will use insulin but aim for different blood sugar levels. The main goal is to determine if a more relaxed blood sugar target is as safe as a stricter one.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about this trial because it explores different blood sugar management strategies for pregnant individuals with Type 1 Diabetes. Unlike the standard approach, which emphasizes strict blood sugar control (70-110 mg/dL), the experimental method allows for more permissive control (70-140 mg/dL). This approach could offer pregnant individuals more flexibility in managing their diabetes, potentially reducing stress and improving quality of life without compromising health outcomes. The trial aims to find out if this more relaxed target range is just as effective, which would be a significant shift in how diabetes is managed during pregnancy.
What evidence suggests that this trial's treatments could be effective for glucose management in pregnant individuals with type 1 diabetes?
Research shows that insulin therapy helps manage blood sugar levels in pregnant individuals with type 1 diabetes. In this trial, participants will join one of two groups: an intervention group with permissive blood sugar control (70-140 mg/dL) or a standard of care group with strict blood sugar control (70-110 mg/dL). Studies indicate that automated insulin delivery systems help pregnant women maintain their blood sugar within the target range more consistently, improving overall control. This is particularly beneficial at night, when managing blood sugar can be more challenging. Importantly, research has found no major differences in pregnancy outcomes between different types of insulin therapy. This suggests that insulin therapy, regardless of the method, effectively supports healthy pregnancies in those with type 1 diabetes.678910
Who Is on the Research Team?
Anna Brewton, MD
Principal Investigator
Ohio State University
Kartik K Venkatesh, MD, PhD
Principal Investigator
Ohio State University
Are You a Good Fit for This Trial?
This trial is for pregnant individuals with Type 1 Diabetes using hybrid closed loop therapy. They are admitted for labor management and will be randomly assigned to one of two blood sugar control methods during childbirth.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intrapartum Management
Participants are randomized to permissive or strict intrapartum glucose management during labor
Immediate Postpartum Monitoring
Monitoring of neonatal blood glucose and other outcomes within the first 48 hours after birth
Follow-up
Participants are monitored for maternal and neonatal outcomes, including satisfaction and hypoglycemia
What Are the Treatments Tested in This Trial?
Interventions
- Insulin
Trial Overview
The PRISM-T1D study tests permissive glucose management (blood sugar levels between 70-140 mg/dL) against strict glucose management (70-110 mg/dL) in the delivery room, using insulin and continuous monitoring to see if there's a difference in newborns' blood sugar levels.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
strict blood sugar control (70-110 mg/dL)
permissive blood sugar control (70-140 mg/dL)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ohio State University
Lead Sponsor
Citations
Insulin therapy for the treatment of type 1 diabetes during ...
Severe hypoglycemia, a major challenge in the management of T1D, has been reported in 19–44% of pregnant diabetes patients treated with intensive insulin ...
2.
diabetes.org
diabetes.org/newsroom/press-releases/smart-insulin-tech-helps-pregnant-women-type-1-diabetes-maintain-targetSmart Insulin Tech Helps Pregnant Women with Type 1 ...
A new study shows pregnant women with type 1 diabetes stayed in the target blood glucose (blood sugar) range for pregnancy more often with an automated insulin ...
Treatment of Type 1 Diabetes Mellitus During Pregnancy ...
The study concluded that AHCL insulin delivery is safe and enhances glycaemic control during pregnancy, particularly in the overnight period, underscoring its ...
Diabetes control and pregnancy outcomes in women with ...
Conclusions: No apparent relationships between mode of insulin therapy and pregnancy outcome were found in type 1 diabetes patients.
5.
diabetesjournals.org
diabetesjournals.org/care/article/45/12/3058/147674/Automated-Insulin-Delivery-Benefits-Challenges-andAutomated Insulin Delivery: Benefits, Challenges, and ...
A technological solution for the management of diabetes in people who require intensive insulin therapy has been sought for decades.
Pregnancy outcomes among women with type 1 diabetes ...
Continuous subcutaneous insulin infusion was associated with increased risk of large-for-gestational age (aOR 2.00, 95% CI 1.20–3.34) and preterm neonates (aOR ...
7.
diabetesjournals.org
diabetesjournals.org/care/article/48/Supplement_1/S306/157565/15-Management-of-Diabetes-in-Pregnancy-Standards15. Management of Diabetes in Pregnancy: Standards of Care ...
In early pregnancy, many people with type 1 diabetes will have lower insulin requirements and an increased risk for hypoglycemia (33). At around ...
Automated Insulin Delivery in Women with Pregnancy ...
Hybrid closed-loop insulin therapy has shown promise for management of type 1 diabetes during pregnancy; however, its efficacy is unclear.
have pregnancy outcomes in women with type 1 diabetes ...
The aim of this study was to compare metabolic control and neonatal outcomes in pregnant women with T1DM among different basal insulins (NPH vs. analogue)
Safety and efficacy of automated insulin delivery systems ...
Adverse fetal and neonatal outcomes have included early pregnancy loss, stillbirth, congenital anomalies, fetal growth and fluid abnormalities, ...
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