Intensive glycaemic targets in overweight and obese individuals with gestational diabetes mellitus: clinical trial protocol for the iGDM study.
Christina M Scifres, Ashley N Battarbee, Maisa N Feghali...
https://pubmed.ncbi.nlm.nih.gov/38423770/Actively Recruiting
Led by Indiana University · Updated on 2026-06-24
828
Participants Needed
5
Research Sites
13 weeks
Total Duration
Researchers are studying overweight and obese pregnant women diagnosed with gestational diabetes to compare two different blood sugar control targets. This trial aims to see if tighter blood sugar control improves outcomes for mothers and their babies without increasing risks. The study is a large, randomized clinical trial conducted at multiple centers across the U.S. involving 828 women. Participants are randomly assigned to one of two groups one group will aim for intensive blood sugar targets with fasting levels below 90 mgdL and one-hour post-meal levels below 120 mgdL, while the other group will follow standard targets with fasting levels below 95 mgdL and one-hour post-meal levels below 140 mgdL. The study team will monitor blood sugar control and pregnancy outcomes throughout the pregnancy period. Women in the study will have their blood sugar levels regularly checked and monitored from the time of enrollment until delivery. Researchers will assess key outcomes including newborn health issues within a week of delivery, birth weight, maternal blood sugar control, hypoglycemia episodes, and pregnancy complications. The total participation lasts from gestational weeks 12 to 33, with follow-up through delivery and shortly after to evaluate both mother and infant health.
CONDITIONS
Intensive Glycemic Targets in Overweight and Obese Women With Gestational Diabetes
S
Sarah Oswalt
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Indiana University
Lead Sponsor
University of Pittsburgh
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Intensive glycemic targets (fasting glucose <90 mg/dL, 1h after meal <120 mg/dL) | Standard glycemic targets (fasting glucose <95 mg/dL, 1h after meal <140 mg/dL) |
|---|---|---|
| What it is | Intensive glycemic targets require participants to keep fasting glucose below 90 mg/dL and 1-hour post-meal glucose below 120 mg/dL. These targets are achieved through diet, monitoring, and, if needed, medication adjustments. | Standard glycemic targets require fasting glucose to remain below 95 mg/dL and 1-hour post-meal glucose below 140 mg/dL. This regimen is also managed through diet, blood sugar checks, and medication if indicated. |
| Role in trial | Experimental arm testing whether stricter glycemic goals reduce complications compared to standard care. | Active comparator arm reflecting current standard glycemic targets for gestational diabetes management. |
| Primary use | Evaluating if lower glycemic thresholds can reduce risks for newborns and mothers with gestational diabetes beyond standard targets. | Providing glycemic control using widely adopted thresholds to reduce common complications of gestational diabetes. |
| How is it given or performed | Participants monitor blood glucose levels with home checks, adjust diet, and follow up with the care team. Medications are used if targets are not met with lifestyle measures alone. | Blood glucose is monitored at home, with adjustments in diet and medications as needed. Regular contact with the clinical team ensures standard glycemic targets are maintained. |
| Evidence status | The effectiveness of intensive glycemic targets in overweight and obese pregnant women with gestational diabetes is still being tested. No published results are available yet. | Standard glycemic targets are widely used and recommended, but optimal thresholds for overweight and obese women are still under investigation in this population. |
| Important limitations | Potential for increased risk of maternal hypoglycemia and burdens from strict monitoring. Results not yet available for this specific group. | Standard targets are well accepted, but their effectiveness for reducing adverse outcomes in overweight and obese women with gestational diabetes is not fully established. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From enrollment through delivery (up to approximately 20 weeks)
Participants follow assigned blood sugar targets, either intensive or standard, throughout the remainder of their pregnancy. Blood sugar levels are regularly monitored and managed.
Regular prenatal visits and blood glucose monitoring
Duration - Up to 7 days after delivery
After delivery, participants and their newborns are monitored for health outcomes including neonatal complications and maternal postpartum health.
Post-delivery assessments during hospital stay and shortly after
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Have more questions? Get in touch with our team for quick support
Christina M Scifres, Ashley N Battarbee, Maisa N Feghali...
https://pubmed.ncbi.nlm.nih.gov/38423770/Indiana University
Lead Sponsor
University of Pittsburgh
Collaborating Sponsor