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

Trial Summary

What is the purpose of this trial?

The purpose of this study is to assess whether a liberal intrapartum glycemic target range compared to usual care standard control ranges will lead to a decrease in the rate of neonatal hypoglycemia among pregnant patients in labor with diabetes.

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 data supports the effectiveness of the treatment for Glucose Control for Gestational Diabetes?

Research shows that tight control of blood sugar levels in gestational diabetes is linked to normal outcomes, and using continuous glucose monitoring helps keep blood sugar within a healthy range. Additionally, intensified management of gestational diabetes with strict blood sugar control can reduce negative outcomes, suggesting that careful glucose management during labor is beneficial. ^{1 2 3 4 5}

Is glucose control during labor and delivery safe for women with gestational diabetes?

Research shows that using a controlled approach to manage blood sugar levels during labor and delivery is generally safe for women with diabetes. Some studies have used automated systems or simple infusion regimens to maintain blood sugar within a target range, and these methods have been well-tolerated without major safety concerns. ^{2 3 6 7 8}

How does the Liberalized Intrapartum Glucose Target Range treatment differ from other treatments for gestational diabetes?

The Liberalized Intrapartum Glucose Target Range treatment is unique because it allows for less strict blood sugar control during labor, which may reduce the risk of maternal hypoglycemia (low blood sugar) compared to tight glucose control. This approach suggests that a more relaxed glucose target can still achieve satisfactory outcomes for both mother and baby. ^{3 4 7 9 10}

Research Team

Praveen Ramesh, M.D.

Principal Investigator

University of Pittsburgh

Eligibility Criteria

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

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

Singleton Gestations

Greater than or equal to 35 weeks gestation

Exclusion Criteria

Major fetal anomalies anticipated to require NICU admission

Planned Cesarean delivery

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Intensified versus conventional management of gestational diabetes. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Management of Diabetes in the Intrapartum and Postpartum Patient. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Five year audit of peripartum blood glucose control in type 1 diabetic patients. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Tight glucose control results in normal perinatal outcome in 150 patients with gestational diabetes. [2011]

5. Czech Republic pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring - a new and expanding element in the care of patients with diabetes mellitus during pregnancy. [2022]

6. United States 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. [2019]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Glucose control during labour in diabetic women. [2017]

8. United States 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. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

A simple score to predict fetal outcomes in gestational diabetes mellitus. [2016]

10. England pubmed.ncbi.nlm.nih.gov

The Utility of Lower Glycemic Targets for Treating Gestational Diabetes: A Retrospective Study. [2022]