What side effects are associated with this type of intervention?

The most common treatments for Gestational Diabetes Mellitus (GDM) include metformin, glyburide, and insulin. Metformin is generally considered safe with short-term use, but it can cause gastrointestinal side effects such as nausea and diarrhea. Glyburide, while effective in improving glycemic control, has raised safety concerns due to its association with a higher risk of hypoglycemia and potential adverse effects on pregnancy outcomes, thus it should be used only when benefits outweigh the risks. Insulin therapy, which is often necessary for more intensive glycemic control, can lead to hypoglycemia and weight gain. Each treatment option should be carefully considered in consultation with a healthcare provider to balance efficacy and safety.

What prior FDA approvals exist?

The FDA has approved several treatments for managing blood glucose levels in type 2 diabetes, which can be relevant for gestational diabetes. These include GLP-1 receptor agonists like liraglutide and exenatide, which help improve glycemic control. While specific FDA approvals for gestational diabetes are not detailed, these medications are indicative of the types of treatments that may be considered for managing blood glucose levels in gestational diabetes.

What other types of research exist?

Promising novel alternatives for glycemic control in gestational diabetes patients include the use of continuous glucose monitoring (CGM) systems to provide real-time glucose data and improve glycemic control. Additionally, the use of newer insulin analogs such as insulin degludec, which has shown reduced hypoglycemia risk, and the potential application of SGLT2 inhibitors, which have shown benefits in other diabetic populations, may be considered under careful medical supervision. Lifestyle interventions, including personalized medical nutrition therapy and structured exercise programs, remain foundational and are increasingly supported by digital health tools for better adherence and outcomes.

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Intensive Glycemic Control for Gestational Diabetes in Overweight/Obese Women (iGDM Trial)

Q: What is the mechanism of action of this treatment?

Common treatments for Gestational Diabetes (GDM) include insulin and metformin. Insulin therapy lowers blood glucose levels by enhancing cellular glucose uptake, directly addressing hyperglycemia. Metformin reduces hepatic glucose production and increases insulin sensitivity, thereby lowering blood glucose levels. These treatments are crucial for preventing complications like macrosomia, preeclampsia, and neonatal hypoglycemia, ensuring better outcomes for both mother and baby.

N/A

Recruiting

Led By Christina Scifres, MD

Research Sponsored by Indiana University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Overweight or obese BMI at the first prenatal visit (BMI ≥25 kg/m2 or ≥23 kg/m2 in Asian Americans)

Pregnant women between the ages of 18-45 with singleton gestation

Must not have

Known renal disease with a baseline creatinine >1.5 mg/dL

Inability to communicate with members of the study team, despite the presence of an interpreter

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 24 hours of delivery

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include low blood sugar episodes more frequently in the intensive treatment group due to tighter glucose control. Other risks could relate to the methods used for maintaining these targets but are not specified here.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

I can communicate with the study team, even with an interpreter if needed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization to delivery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization to delivery

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to delivery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants with composite neonatal morbidity

Secondary study objectives

Early maternal glycemic levels

Episodes of maternal hypoglycemia

Glycemic levels during study enrollment

+14 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intensive glycemic targetsExperimental Treatment1 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 targetsActive Control1 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.

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Gestational Diabetes (GDM) include insulin and metformin. Insulin therapy lowers blood glucose levels by enhancing cellular glucose uptake, directly addressing hyperglycemia. Metformin reduces hepatic glucose production and increases insulin sensitivity, thereby lowering blood glucose levels. These treatments are crucial for preventing complications like macrosomia, preeclampsia, and neonatal hypoglycemia, ensuring better outcomes for both mother and baby.

Oral anti-diabetic pharmacological therapies for the treatment of women with gestational diabetes.Metformin vs insulin in the management of gestational diabetes: a systematic review and meta-analysis.