Intensive Glycemic Control for Gestational Diabetes in Overweight/Obese Women

(iGDM Trial)

Recruiting at 4 trial locations

Overseen By Sarah Oswalt

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Indiana University

Must not be taking: Steroids

Disqualifiers: Renal disease, Fetal anomalies, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 29 weeks

828 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if stricter blood sugar goals help pregnant women who are overweight or obese manage gestational diabetes more effectively. It compares two groups: one with intensive glycemic targets and another with standard targets. Women diagnosed with gestational diabetes during pregnancy and who have a higher body weight might be suitable for this study. Participants will help researchers understand how varying blood sugar levels affect the health of both mother and baby during pregnancy. As an unphased trial, this study offers a unique opportunity to contribute to valuable research that could improve pregnancy outcomes for many women.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. However, if you are using oral or injected steroids, you must not have used them within 7 days before joining the study.

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

Research shows that aiming for lower blood sugar levels is generally safe for pregnant women with gestational diabetes. Studies have found that maintaining lower blood sugar levels does not cause significant health problems for the mother or baby.

For instance, a large study comparing different blood sugar goals found no major increase in side effects with stricter control. Some women might experience low blood sugar, but careful monitoring and treatment adjustments can usually manage this. Overall, aiming for lower blood sugar levels is well-tolerated and improves health outcomes for both mothers and their babies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the intensive glycemic control approach for gestational diabetes in overweight and obese women because it aims for stricter blood sugar targets than current standards. While standard treatments focus on maintaining a fasting blood glucose of less than 95 mg/dL and post-meal levels under 140 mg/dL, this approach targets levels below 90 mg/dL fasting and under 120 mg/dL after meals. This tighter control could potentially reduce complications for both mothers and babies, offering a more proactive approach to managing gestational diabetes.

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

This trial will compare intensive glycemic targets with standard glycemic targets for managing blood sugar levels in pregnant women with gestational diabetes. Research has shown that careful blood sugar management greatly benefits both mothers and their babies. Participants in the intensive glycemic targets arm will aim for fasting blood sugar below 90 mg/dL and post-meal levels below 120 mg/dL. Studies suggest that these stricter targets can help prevent issues such as high birth weight in babies and the need for a cesarean section, leading to better health outcomes for both mother and baby compared to standard targets. ^{1 2 3 4 6}

Who Is on the Research Team?

Christina Scifres, MD

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

This trial is for overweight or obese pregnant women aged 18-45 with gestational diabetes. They should have a BMI of at least 25 kg/m2 (or ≥23 kg/m2 in Asian Americans) and be between 12 to almost 33 weeks into their pregnancy. Women with significant fetal anomalies, communication barriers, non-study hospital delivery plans, inability to consent, kidney disease with high creatinine levels, or recent steroid use can't participate.

Inclusion Criteria

My BMI was 25 or higher (23 if I'm Asian American) at my first prenatal visit.

You are between 12 and 32 weeks pregnant and have been diagnosed with gestational diabetes during this time.

Exclusion Criteria

Inability or unwillingness to provide informed consent

I have not taken oral or injected steroids in the last 7 days.

My kidney function is impaired with a creatinine level over 1.5 mg/dL.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either intensive or standard glycemic targets and monitored for glycemic control from randomization through delivery

Up to 29 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of neonatal and maternal outcomes

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Intensive glycemic targets
• Standard glycemic targets

Trial Overview The study compares two approaches to managing blood sugar in participants: one group will follow intensive glycemic targets while the other follows standard ones. It's a multicenter trial where participants are randomly assigned to either group.

How Is the Trial Designed?

Group I: Intensive glycemic targets Experimental Treatment 1 Intervention

Participants in this arm will target a fasting blood glucose of \<90 mg/dL and 1 hour post-prandial blood glucose values \<120 mg/dL.

Group II: Standard glycemic targets Active Control 1 Intervention

Participants in this arm will target a fasting blood glucose of \<95 mg/dL and 1 hour post-prandial blood glucose values \<140 mg/dL.

Intensive glycemic targets is already approved in United States, Canada for the following indications:

Approved in United States as Intensive glucose control for:

• Gestational diabetes mellitus
• Type 1 diabetes in pregnancy
• Type 2 diabetes in pregnancy

Approved in Canada as Tighter glycemic targets for:

• Gestational diabetes mellitus

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Women and Infants Hospital of Rhode Island

Collaborator

Trials

119

Recruited

59,200+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

University of Oklahoma

Collaborator

Trials

484

Recruited

95,900+

University of Pittsburgh

Collaborator

Trials

1,820

Recruited

16,360,000+

University of Alabama at Birmingham

Collaborator

Trials

1,677

Recruited

2,458,000+

Published Research Related to This Trial

In a study of 60 overweight and obese women with gestational diabetes, those who followed intensive glycemic control targets had significantly lower glucose levels compared to those on standard targets, indicating better glycemic control.

The intensive glycemic control approach was associated with minimal risk of hypoglycemia, suggesting it is a safe option for managing blood sugar levels in this high-risk group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensive glycemic control in gestational diabetes mellitus: a randomized controlled clinical feasibility trial. Scifres, CM., Mead-Harvey, C., Nadeau, H., et al.[2021]

In a pilot study of 98 women with gestational diabetes mellitus (GDM) and fasting hyperglycemia, using maternal glycemic criteria led to significantly lower blood glucose levels and a reduced cesarean delivery rate compared to a more relaxed management approach that included fetal abdominal circumference measurements.

The relaxed criteria allowed 38% of patients to avoid insulin therapy without increasing neonatal morbidity, indicating that monitoring fetal growth can help identify low-risk pregnancies and potentially reduce unnecessary treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial using glycemic plus fetal ultrasound parameters versus glycemic parameters to determine insulin therapy in gestational diabetes with fasting hyperglycemia. Kjos, SL., Schaefer-Graf, U., Sardesi, S., et al.[2019]

In a review of three trials involving 223 women with type 1 diabetes, very tight glycaemic control did not show significant advantages over tight-moderate control, with no perinatal deaths reported in the very tight group but some birth defects noted.

Loose glycaemic control (FBG above 7 mmol/L) was associated with increased risks of pre-eclampsia, cesarean sections, and higher birthweights, indicating that maintaining tighter control is safer for pregnant women with pre-existing diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Different intensities of glycaemic control for pregnant women with pre-existing diabetes. Middleton, P., Crowther, CA., Simmonds, L.[2022]

Gestational diabetes mellitus (GDM) affects 3-15% of pregnancies and is linked to serious complications for both mothers and babies, highlighting the importance of effective management.

When lifestyle changes like diet and exercise are insufficient for controlling blood sugar levels in GDM, pharmacological treatments become necessary to reduce the risk of adverse outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of diabetes and pregnancy--when to start and what pharmacological agent to choose? Hiersch, L., Yogev, Y.[2015]

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]

In a review of three trials involving 223 women with type 1 diabetes, there were no significant differences in perinatal outcomes between very tight and tight-moderate glycaemic control targets, suggesting that both approaches may be similarly effective.

Loose glycaemic control (FBG above 7 mmol/L) was associated with increased risks of pre-eclampsia, higher rates of caesarean sections, and larger birthweights, indicating that maintaining tighter control is safer for pregnant women with pre-existing diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Different intensities of glycaemic control for pregnant women with pre-existing diabetes. Middleton, P., Crowther, CA., Simmonds, L.[2023]

In a study of 471 women with gestational diabetes mellitus (GDM), insulin treatment significantly reduced the incidence of large for gestational age (LGA) infants, especially in those with fasting plasma glucose (FPG) levels above 5.3 mM, compared to diet therapy.

Optimizing glycemic control with insulin led to a lower incidence of LGA (3.5%) compared to diet therapy (5.3%) in the low-FPG group, and insulin treatment was particularly effective in reducing LGA rates in mid-FPG group women, highlighting the importance of insulin for managing GDM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale for insulin management in gestational diabetes mellitus. Langer, O., Berkus, M., Brustman, L., et al.[2019]

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]

In a review of three trials involving 223 women with type 1 diabetes, very tight glycaemic control (3.33 to 5.0 mmol/L fasting blood glucose) showed no significant advantage over tight-moderate control (4.45 to 6.38 mmol/L) in terms of perinatal outcomes, although there were fewer cases of maternal hypoglycaemia in the tight-moderate group.

Loose glycaemic control (FBG above 7 mmol/L) was associated with increased risks of adverse outcomes, including higher rates of pre-eclampsia, cesarean sections, and larger birthweights, indicating that maintaining tighter control is safer for pregnant women with pre-existing diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Different intensities of glycaemic control for pregnant women with pre-existing diabetes. Middleton, P., Crowther, CA., Simmonds, L., et al.[2022]

In a study of 509 women with gestational diabetes, higher pregravid Body Mass Index (BMI) was linked to an increased need for glucose-lowering medications, with each 1 kg/m² increase in BMI raising the odds of requiring treatment by 8%.

Obese mothers not only needed the highest doses of insulin and more frequent use of metformin, but they also faced greater risks of cesarean sections and delivering larger babies, highlighting the importance of managing maternal weight for better pregnancy outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact Of Prepregnancy Overweight And Obesity On Treatment Modality And Pregnancy Outcome In Women With Gestational Diabetes Mellitus. Linder, T., Eder, A., Monod, C., et al.[2022]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05124808

Intensive Glycemic Targets in Overweight and Obese ... This is a multicenter randomized clinical trial of 828 overweight and obese individuals with gestational diabetes designed to compare standard to intensive ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10910683/

Intensive glycaemic targets in overweight and obese ... A large, pragmatic randomised clinical trial designed to investigate the impact of intensive versus standard glycaemic targets on perinatal outcomes in women ...

3. journals.plos.org journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1004087

Tighter or less tight glycaemic targets for women with ... The TARGET Trial assessed whether tighter compared with less tight glycaemic control reduced maternal and perinatal morbidity.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7100550/

Different intensities of glycaemic control for women with ... The focus of this review is comparing different treatment targets of glycaemic control in women with GDM and the impact on maternal and fetal health. How the ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2212109925004339

Cost Comparison of 2 Different Targets for Glycemic ... This study addresses an important evidence gap by examining how different glycemic targets in gestational diabetes care influence healthcare costs, ...

6. diabetesjournals.org diabetesjournals.org/care/article/46/Supplement_1/S97/148053/6-Glycemic-Targets-Standards-of-Care-in-Diabetes

6. Glycemic Targets: Standards of Care in Diabetes—2023 ACCORD, ADVANCE, and VADT suggested no significant reduction in CVD outcomes with intensive glycemic control in participants followed for ...