Intensive Glycemic Control for Gestational Diabetes in Overweight/Obese Women

(iGDM Trial)

Recruiting at4 trial locations

Overseen by Christina Scifres, MD

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Indiana University

Must not be taking: Steroids

Disqualifiers: Renal disease, Fetal anomalies, others

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing if stricter blood sugar targets can help overweight and obese pregnant women with gestational diabetes have healthier pregnancies. By aiming for lower blood sugar levels, the study hopes to reduce complications for both mothers and babies. The trial will also check if this approach is safe and cost-effective.

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.

What data supports the effectiveness of the treatment Intensive Glycemic Control for Gestational Diabetes in Overweight/Obese Women?

Research shows that tight control of blood sugar levels in gestational diabetes can lead to normal outcomes and reduce negative effects for both mother and baby. ^{1 2 3 4 5}

Is intensive glycemic control safe for overweight/obese women with gestational diabetes?

Research suggests that strict glycemic control in gestational diabetes can reduce risks like large babies and birth complications, but the studies focus more on effectiveness rather than detailed safety outcomes. Generally, maintaining good blood sugar levels is linked to fewer complications, but specific safety data for intensive control in overweight/obese women is limited. ^{1 4 6 7 8}

How does the treatment of intensive glycemic control differ for gestational diabetes in overweight/obese women?

Intensive glycemic control for gestational diabetes involves setting stricter blood sugar targets to improve outcomes, especially in overweight or obese women, compared to conventional management which may use less stringent targets. This approach aims to achieve near-normal blood sugar levels and reduce the risk of complications during pregnancy. ^{2 3 9 10 11}

Research Team

Christina Scifres, MD

Principal Investigator

Indiana University

Eligibility Criteria

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.

I am pregnant, aged 18-45, and expecting one baby.

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.

Trial Timeline

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

Treatment Details

Interventions

• Intensive glycemic targets (Other)
• Standard glycemic targets (Other)

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.

Participant Groups

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 Canada for the following indications:

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+

Alan Palkowitz

Indiana University

Chief Executive Officer since 2020

PhD in Chemistry from Indiana University

David Ingram

Indiana University

Chief Medical Officer since 2020

MD from Indiana University School of Medicine

Women and Infants Hospital of Rhode Island

Collaborator

Trials

119

Recruited

59,200+

Shannon Sullivan

Women and Infants Hospital of Rhode Island

Chief Executive Officer since 2020

Executive Master’s degree in Healthcare Leadership from Brown University, Master’s degree in Social Work from Boston College

Dr. Lisa Rameaka

Women and Infants Hospital of Rhode Island

Chief Medical Officer

MD from Robert Larner, M.D. College of Medicine at the University of Vermont, MBA from the University of Massachusetts

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

Collaborator

Trials

2,103

Recruited

2,760,000+

Dr. Diana W. Bianchi

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

Chief Executive Officer since 2016

MD from Stanford University

Dr. Alison Cernich

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

Chief Medical Officer since 2020

PhD in Clinical Psychology from University of Maryland

University of Oklahoma

Collaborator

Trials

484

Recruited

95,900+

Dr. Scott Rollins

University of Oklahoma

Chief Executive Officer since 2016

PhD in Immunology from the University of Oklahoma

Dr. Ondria Gleason

University of Oklahoma

Chief Medical Officer

MD from the University of Oklahoma College of Medicine

University of Pittsburgh

Collaborator

Trials

1,820

Recruited

16,360,000+

David Apelian

University of Pittsburgh

Chief Executive Officer since 2019

PhD in Molecular Biology from Rutgers University, MD from the University of Medicine and Dentistry of New Jersey, MBA from Quinnipiac University

Pamela D. Garzone

University of Pittsburgh

Chief Medical Officer

PhD in Clinical Science from the University of Pittsburgh

University of Alabama at Birmingham

Collaborator

Trials

1,677

Recruited

2,458,000+

Kierstin Kennedy

University of Alabama at Birmingham

Chief Medical Officer since 2022

MD

S. Dawn Bulgarella

University of Alabama at Birmingham

Chief Executive Officer since 2023

BSc in Commerce and Business Administration from the University of Alabama, MS in Health Administration from the University of Alabama at Birmingham

Findings from Research

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]

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 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, 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]

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 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]

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 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 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 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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Different intensities of glycaemic control for pregnant women with pre-existing diabetes. [2023]

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

Intensified versus conventional management of gestational diabetes. [2022]

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

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

4. England pubmed.ncbi.nlm.nih.gov

Different intensities of glycaemic control for pregnant women with pre-existing diabetes. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Different intensities of glycaemic control for pregnant women with pre-existing diabetes. [2022]

6. United States 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. [2019]

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

Management of diabetes and pregnancy--when to start and what pharmacological agent to choose? [2015]

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

Intensive glycemic control in gestational diabetes mellitus: a randomized controlled clinical feasibility trial. [2021]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Impact Of Prepregnancy Overweight And Obesity On Treatment Modality And Pregnancy Outcome In Women With Gestational Diabetes Mellitus. [2022]

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

Rationale for insulin management in gestational diabetes mellitus. [2019]