Actively Recruiting
Insulin Resistance in Gestational Diabetes Mellitus Observational Study Using Continuous Glucose Monitoring
Led by University of Aarhus · Updated on 2025-11-17
100
Participants Needed
2
Research Sites
17 weeks
Total Duration
On this page
Sponsors
U
University of Aarhus
Lead Sponsor
A
Aarhus University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating glycaemic variability in pregnant women with gestational diabetes mellitus (GDM) using continuous glucose monitoring (CGM). The study aims to understand how blood sugar fluctuations relate to fetal growth and important outcomes for both mother and baby. This observational study collects detailed clinical and laboratory data to explore these associations comprehensively. Participants will wear a CGM device for 14 consecutive days during pregnancy, between gestational weeks 28+0 and 34+6, to record blood sugar patterns. Clinical measurements including fasting plasma glucose, HbA1c, lipid profiles, organ function markers, maternal weight gain, and blood pressure will be taken at two study visits. Standard care for GDM, including dietary counseling and routine obstetric follow-up, will continue throughout the study. After delivery, birth weight and neonatal outcomes will be recorded. During the study, participants will have two visits to collect clinical data and blood samples. Researchers will analyze CGM data alongside maternal and neonatal health indicators such as birth weight z-scores and neonatal hypoglycaemia. Statistical analyses will explore links between maternal glucose variability and pregnancy outcomes, adjusting for relevant factors. The total follow-up extends to 12 weeks after delivery, with data collection continuing through delivery and neonatal assessment.
CONDITIONS
Brief Title
Insulin Resistance in Gestational Diabetes Mellitus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant women with gestational diabetes mellitus between gestational age 28+0 and 34+6
- Singleton pregnancy
- Age 18 years or older
- Attending obstetric outpatient clinic at designated hospitals
You will not qualify if you...
- Pre-gestational diabetes
- Age under 18 years
- Multiple pregnancies
- Poorly controlled chronic diseases affecting study outcomes
- Treatment with systemic corticosteroids
- Smoking
- Inability to understand oral and written patient information
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 14 days
Participants undergo continuous glucose monitoring (CGM) for 14 consecutive days during pregnancy to characterize individual patterns of glycaemic variability. Clinical and paraclinical parameters including fasting plasma glucose, HbA1c, lipid profile, organ markers, maternal weight gain, and blood pressure are recorded at the start and end of the monitoring period.
2 visits (in-person) for measurements before and after monitoring
Duration - Up to 12 weeks after delivery
Participants are followed through delivery and up to 12 weeks postpartum to collect relevant maternal and neonatal data including birth weight and pregnancy or neonatal complications.
Routine obstetric follow-up visits as per standard care
Trial Site Locations
Total: 2 locations
1
Aarhus University Hospital
Aarhus, Denmark, 8200
Actively Recruiting
2
Gødstrup Hospital
Herning, Denmark, 7400
Actively Recruiting
Research Team
N
Ninna L Larsen, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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