Intensive Glycemic Control for Gestational Diabetes in Overweight/Obese Women
(iGDM Trial)
Recruiting in Palo Alto (17 mi)
+4 other locations
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.
12345Is 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.
14678How 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.
2391011Eligibility 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.
+3 more
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
Participant Groups
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.
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.
Intensive glycemic targets is already approved in Australia, United States, Canada for the following indications:
🇦🇺 Approved in Australia as Tighter glycemic targets for:
- Gestational diabetes mellitus
🇺🇸 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Alabama at BirminghamBirmingham, AL
University of OklahomaNorman, OK
University of PittsburghPittsburgh, PA
Women and Infants Hospital of Rhode IslandProvidence, RI
More Trial Locations
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Who Is Running the Clinical Trial?
Indiana UniversityLead Sponsor
Women and Infants Hospital of Rhode IslandCollaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Collaborator
University of OklahomaCollaborator
University of PittsburghCollaborator
University of Alabama at BirminghamCollaborator
References
Different intensities of glycaemic control for pregnant women with pre-existing diabetes. [2023]The optimal glycaemic control target in pregnant women with pre-existing diabetes is unclear, although there is a clear link between high glucose concentrations and adverse birth outcomes.
Intensified versus conventional management of gestational diabetes. [2022]We tested the hypothesis that intensified management of gestational diabetes mellitus on the basis of stringent glycemic control, verified glucose data, and adherence to an established criterion for insulin initiation results in near normoglycemia control and reduction of adverse outcomes.
Tight glucose control results in normal perinatal outcome in 150 patients with gestational diabetes. [2011]To determine whether tight control of blood glucose is associated with normal outcomes in gestational diabetes.
Different intensities of glycaemic control for pregnant women with pre-existing diabetes. [2022]The optimal glycaemic control target in pregnant women with pre-existing diabetes is unclear, although there is a clear link between high glucose concentrations and adverse birth outcomes.
Different intensities of glycaemic control for pregnant women with pre-existing diabetes. [2022]The optimal glycaemic control target in pregnant women with pre-existing diabetes is unclear, although there is a clear link between high glucose concentrations and adverse birth outcomes.
A randomized controlled trial using glycemic plus fetal ultrasound parameters versus glycemic parameters to determine insulin therapy in gestational diabetes with fasting hyperglycemia. [2019]To compare management based on maternal glycemic criteria with management based on relaxed glycemic criteria and fetal abdominal circumference (AC) measurements in order to select patients for insulin treatment of gestational diabetes mellitus (GDM) with fasting hyperglycemia.
Management of diabetes and pregnancy--when to start and what pharmacological agent to choose? [2015]Gestational diabetes mellitus (GDM) complicates 3-15% of pregnancies depending upon the geographic location and ethnic groups, and its incidence is estimated to increase even further due to the increasing rates of obesity in the general population and the trend towards advanced maternal age in pregnancy. GDM is associated with adverse pregnancy outcome such as an increased rate of fetal macrosomia, neonatal metabolic disturbances, and maternal injuries. It has been shown that there is an inverse relation between maternal glycemic control and the risk of complications. When diet and exercise therapy fail in achieving good glycemic control, pharmacological intervention is warranted. This chapter deals with the evidence regarding the various pharmacological interventions for glycemic control in women with GDM, when to start, and what pharmacological agent to use.
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]The purpose of this study was to determine whether strict maternal glycemic control for the treatment of gestational diabetes lessened the risk of fetal macrosomia, birth trauma, neonatal hypoglycemia, and operative delivery. The aim of the pilot study was to prepare for a multicenter trial by assessing patient acceptance of the study, by determining realistic accrual rates, and by detecting any major adverse outcomes in the control group that received routine obstetric care.
Intensive glycemic control in gestational diabetes mellitus: a randomized controlled clinical feasibility trial. [2021]Overweight and obese women with gestational diabetes mellitus are at increased risk for adverse perinatal outcomes, and they are also more likely to have suboptimal glycemic control. However, there is a paucity of data evaluating whether lower glycemic targets could improve outcomes.
Impact Of Prepregnancy Overweight And Obesity On Treatment Modality And Pregnancy Outcome In Women With Gestational Diabetes Mellitus. [2022]We aim to evaluate the impact of prepregnancy overweight on treatment modalities of Gestational Diabetes Mellitus (GDM). We assessed the association of increased pregravid Body Mass Index (BMI) with dosing of basal and rapid acting insulin as well as pregnancy outcome.
Rationale for insulin management in gestational diabetes mellitus. [2019]A prospective study was undertaken to test the hypothesis that insulin treatment in patients with gestational diabetes mellitus (GDM) with fasting plasma glucose (FPG) greater than 5.3 mM significantly reduces adverse perinatal outcome. Assigned to insulin or diet treatment based on FPG were 471 GDM women. Four factors believed to be associated with infants large for gestational age (LGA) were evaluated: FPG, overall glycemic control, maternal weight, and treatment regimen. We found that when glycemic control was optimized, the key factors related to large infants were FPG and treatment modality. In the low-FPG group (less than 5.3 mM), diet therapy achieved an incidence of 5.3% LGA. When insulin therapy was used to optimize control, an incidence of 3.5% LGA was found. Patients in the mid-FPG group (5.3-5.8 mM) had a higher increased rate of LGA (28.6%) for diet-treated versus insulin-treated women (10.3%). In addition, a fourfold increased risk for LGA was found in the diet-treated obese subjects in the mid-FPG group compared with insulin-treated obese women. Finally, treatment with insulin resulted in similar incidence of LGA within all FPG groups. We concluded that FPG greater than 5.3 mM can be the basis for initiation of insulin treatment in GDM subjects with optimization of glycemic control as the goal. This approach may contribute significantly to reduced neonatal risk and may foster a standardized method for rapid and effective assignment to treatment.