Glucose Control for Gestational Diabetes

Overseen By Maisa Feghali, M.D.

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Major fetal anomalies, Planned Cesarean

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: During labor (up to 200 hours)

218 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a more flexible target for blood sugar levels during labor can reduce low blood sugar in newborns. It compares two approaches: the Standard Intrapartum Glucose Target Range and the Liberalized Intrapartum Glucose Target Range for managing blood sugar in pregnant individuals with diabetes. Those pregnant with a single baby, who have diabetes, are at least 35 weeks along, and plan to give birth vaginally at a specific hospital might be suitable for this trial.

As an unphased trial, participation offers a chance to contribute to important research that could improve outcomes for mothers and newborns.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that allowing a wider range of blood sugar levels during labor does not increase the risk of low blood sugar in newborns. Studies have found this approach to be safe for both mothers and babies, without leading to more complications compared to the usual method.

Previous studies have not shown an increase in negative outcomes with this broader range of blood sugar levels. This suggests that using a wider target range during labor is well-tolerated by both mothers with gestational diabetes and their newborns.

Overall, current research suggests that both the usual and more flexible approaches are safe for managing blood sugar levels during labor. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores different glucose management strategies for gestational diabetes during labor. The standard approach typically aims to keep glucose levels between 70-110 mg/dL, starting insulin when levels exceed 110 mg/dL. This trial introduces a more flexible approach, allowing glucose levels up to 160 mg/dL before initiating insulin. The hope is that this liberalized range might offer a safer, more comfortable experience for mothers without compromising health outcomes. By comparing these two target ranges, researchers aim to find the best balance between effective glucose control and maternal comfort during childbirth.

What evidence suggests that this trial's treatments could be effective for gestational diabetes?

This trial will compare two approaches to managing blood sugar levels during labor for women with gestational diabetes. Participants in one arm will follow the Standard Intrapartum Glucose Target Range, maintaining blood sugar levels between 70-110 mg/dL. In the other arm, participants will follow the Liberalized Intrapartum Glucose Target Range, with a target range of 70-160 mg/dL. Research has shown that managing blood sugar levels with a more flexible target during labor might benefit women with gestational diabetes. One study found that a more relaxed approach to blood sugar control did not increase the risk of low blood sugar in newborns. Another study found that changing insulin routines during labor led to better outcomes for mothers with diabetes. These findings suggest that a more relaxed blood sugar target could be safe and beneficial during labor for women with gestational diabetes. ^{2 3 5 6 7}

Who Is on the Research Team?

Praveen Ramesh, M.D.

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for pregnant individuals in labor who have diabetes, aiming to reduce the risk of their newborns having low blood sugar. Participants should meet specific health criteria and not be part of any other similar studies.

Inclusion Criteria

Singleton Gestations

I am pregnant and have diabetes (Type 1, Type 2, or gestational).

Greater than or equal to 35 weeks gestation

Exclusion Criteria

Major fetal anomalies anticipated to require NICU admission

Planned Cesarean delivery

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants are randomized to either a liberal or standard intrapartum glucose target range and receive insulin treatment as needed during labor

During labor (up to 200 hours)

Continuous monitoring during labor

Immediate Postnatal Monitoring

Newborns are monitored for neonatal hypoglycemia within the first 24 hours after delivery

24 hours

Continuous monitoring

Follow-up

Participants and newborns are monitored for safety and effectiveness, including neonatal hypoglycemia and NICU admissions, prior to discharge

Up to 42 days after delivery

Regular check-ups until discharge

What Are the Treatments Tested in This Trial?

Interventions

• Liberalized Intrapartum Glucose Target Range
• Standard Intrapartum Glucose Target Range

Trial Overview The study compares two glucose control strategies during labor: a 'standard' range versus a more 'liberalized' range, to see which is better at preventing low blood sugar in newborns.

How Is the Trial Designed?

Group I: Liberalized Intrapartum Glucose Target Range Experimental Treatment 1 Intervention

The goal intrapartum glucose target range will be 70-160mg/dl. Insulin infusion will be initiated when maternal capillary glucose exceeds 160 mg/dL.

Group II: Standard Intrapartum Glucose Target Range Active Control 1 Intervention

The goal intrapartum glucose target range will be 70-110mg/dl. Insulin infusion will be initiated when maternal capillary glucose exceeds 110 mg/dL.

Liberalized Intrapartum Glucose Target Range is already approved in United States, European Union for the following indications:

Approved in United States as Liberalized Intrapartum Glycemic Target Range for:

• Management of diabetes in pregnancy to reduce neonatal hypoglycemia

Approved in European Union as Liberalized Intrapartum Glycemic Target Range for:

• Management of diabetes in pregnancy to reduce neonatal hypoglycemia

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

Published Research Related to This Trial

A standardized protocol for managing maternal blood glucose levels during labor was developed at Northwestern Memorial Hospital to improve consistency and individualization in care for women with pregestational and gestational diabetes.

This protocol aims to achieve better maternal euglycemia, which is crucial for reducing the risk of neonatal hypoglycemia, by using algorithms based on maternal insulin needs for real-time glucose control during labor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of Diabetes in the Intrapartum and Postpartum Patient. Dude, A., Niznik, CM., Szmuilowicz, ED., et al.[2020]

In a study of 604 gestational diabetes patients, using lower glycemic targets (fasting 85 mg/dL and 2-hour postprandial 110 mg/dL) did not significantly reduce the incidence of large for gestational age (LGA) infants compared to higher targets, with LGA rates at 24.0% for low targets versus 31.8% for high targets.

However, the lower targets were associated with a higher rate of inductions (39.4% vs. 20.5%), suggesting that while lower glycemic targets may not improve fetal growth outcomes, they could lead to more medical interventions during delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Utility of Lower Glycemic Targets for Treating Gestational Diabetes: A Retrospective Study. Hagen, G., Brown, C., Dietrich, J., et al.[2022]

In a study involving 32 pregnant women with type 1 diabetes, 27 chose to use an automated closed-loop insulin delivery system during labor and postpartum, achieving 82% time-in-target glucose range during labor and 83.3% postpartum.

The closed-loop system maintained effective glucose control with mean glucose levels of 6.9 mmol/L during labor and 7.2 mmol/L postpartum, showing no significant difference in maternal glucose levels between mothers of infants with and without neonatal hypoglycemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptability of Closed Loop During Labor, Delivery, and Postpartum: A Secondary Analysis of Data from Two Randomized Crossover Trials in Type 1 Diabetes Pregnancy. Stewart, ZA., Yamamoto, JM., Wilinska, ME., et al.[2019]

A simple glucose/insulin infusion regimen effectively maintained blood glucose levels in insulin-dependent diabetic women during labor, with mean levels of 5.2 mmol/L before delivery and 4.7 mmol/L one hour before delivery, indicating good control.

Despite some instances of mild hypoglycemia in mothers and neonatal hypoglycemia in seven infants, there was no direct link between maternal blood glucose levels and neonatal outcomes, suggesting that less stringent blood glucose control may be sufficient during labor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Five year audit of peripartum blood glucose control in type 1 diabetic patients. Njenga, E., Lind, T., Taylor, R.[2019]

A standardized intravenous insulin-glucose infusion protocol during labor effectively maintained stable maternal blood glucose levels in diabetic women, resulting in low rates of maternal hypoglycemia (6.6% with blood glucose ≤ 3.5 mmol/L).

The protocol also contributed to a relatively low neonatal hypoglycemia rate of 7.3%, particularly beneficial for women with pre-existing diabetes, although the reduction in blood glucose levels outside the target range was not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glucose control during labour in diabetic women. Ryan, EA., Sia, WW., Khurana, R., et al.[2017]

In a study of 300 women with gestational diabetes, strict maternal glycemic control did not significantly reduce birth weight or the rates of fetal macrosomia, birth trauma, or neonatal hypoglycemia compared to routine care.

The treatment group did show lower preprandial and postprandial glucose levels by 32 weeks' gestation, indicating effective glycemic management, but this did not translate into improved fetal outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of strict glycemic control and tertiary level obstetric care versus routine obstetric care in the management of gestational diabetes: a pilot study. Garner, P., Okun, N., Keely, E., et al.[2019]

In a study of 150 patients with gestational diabetes, maintaining tight control of blood glucose levels resulted in normal perinatal outcomes, with no cases of perinatal mortality or significant complications.

The average glucose levels were well-managed, with 31% of patients requiring insulin, and there were no increased risks of adverse outcomes such as large or small for gestational age infants or other delivery complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tight glucose control results in normal perinatal outcome in 150 patients with gestational diabetes. Thompson, DM., Dansereau, J., Creed, M., et al.[2011]

A more lenient glycemic control strategy in managing gestational diabetes mellitus (GDM) can still lead to satisfactory fetal outcomes, as indicated by a study of 94 patients where a glycemic score was developed to assess control.

The glycemic score effectively predicted adverse fetal outcomes, showing good sensitivity and specificity for conditions like macrosomia and congenital anomalies, suggesting that controlling three out of four blood glucose values may be sufficient to prevent complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A simple score to predict fetal outcomes in gestational diabetes mellitus. Naha, K., Naha, S., Pandit, VR., et al.[2016]

Intensified management of gestational diabetes mellitus, focusing on strict glycemic control, led to significantly better perinatal outcomes, including lower rates of macrosomia and cesarean sections, compared to conventional management.

The study involved 2461 participants with gestational diabetes and showed that mean blood glucose levels were strong predictors of perinatal outcomes, emphasizing the importance of effective glucose monitoring and control during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensified versus conventional management of gestational diabetes. Langer, O., Rodriguez, DA., Xenakis, EM., et al.[2022]

Time in range (TIR) is a new important measure for managing blood glucose levels in pregnant women with diabetes, aiming for values between 3.5 to 7.8 mmol/L.

For women with pre-gestational type 1 diabetes, maintaining TIR above 70% of the total measurement time is crucial, with a maximum of 4% time allowed in hypoglycemia, highlighting the need for careful glucose monitoring during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring - a new and expanding element in the care of patients with diabetes mellitus during pregnancy. Urbanová, Jana., Brunerová, Ludmila., Janíčková Žďárská, Denisa., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05647798

NCT05647798 | Intrapartum Glycemic Control in GDMA2 That study's findings suggest that an approach to a more liberalized intrapartum glycemic management was not associated with a higher rate of neonatal ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7395867/

Evaluation of an Intrapartum Insulin Regimen for Women ... To examine whether an insulin protocol for intrapartum glucose control among parturients with diabetes was associated with improved outcomes.

3. cdn-links.lww.com cdn-links.lww.com/permalink/aog/b/aog_133_6_2019_03_18_hamel_19-22_sdc1.pdf

This document contains correspondence generated during ... This seems to go along with the findings of this study being reviewed for publication now, that the range of liberalized control ( 60-120 mg/dL ) ...

4. liebertpub.com liebertpub.com/doi/pdf/10.1089/dia.2025.0148?download=true

Update on Management of Gestational Diabetes Mellitus ... Gestational diabetes mellitus (GDM) complicates 5%–25% of pregnancies worldwide and is the most prevalent metabolic complication of pregnancy.

5. wa.kaiserpermanente.org wa.kaiserpermanente.org/static/pdf/public/guidelines/diabetes-gestational.pdf

Gestational Diabetes Screening and Treatment Guideline In women with GDM, what is the comparative safety and efficacy of tight versus liberalized intrapartum glycemic control on maternal and neonatal blood glucose ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9945305/

Intrapartum and early postpartum glycemic profiles in women ... The average glucose level was 92.2 mg/dL, and the level was higher in the GDM group (95.5 ± 12.1 mg/dL vs. 89.1 ± 13.4 mg/dL, P = 0.008) during the intrapartum ...

7. mdedge.com mdedge.com/node/195938

Tight intrapartum glucose control doesn't improve neonatal ... At 36 weeks' gestation, participants were block-randomized 1:1 to receive tight or liberalized intrapartum blood glucose control, with ...