Insulin resistance and continuous glucose patterns in gestational diabetes
Official title: Insulin Resistance in Gestational Diabetes Mellitus
Run by University of Aarhus · NCT07231341 · Data updated 2026-11-12
This project will use 14 days of continuous glucose monitoring to see if glucose swings in pregnant women with gestational diabetes relate to fetal growth and short-term maternal and newborn outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 100 (estimated) |
| Sponsor | University of Aarhus Academic / other |
| Locations | 2 sites (Aarhus and 1 other locations) |
| Status | Recruiting |
| Started | September 22, 2022 |
| Main results expected | December 2025 |
| Study ends | April 2026 |
| Registry record updated | November 17, 2025 |
| Trial ID | NCT07231341 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are singleton pregnant women aged 18 or older diagnosed with GDM at 28+0 to 34+6 weeks who can attend visits at the Aarhus University Hospital or Gødstrup Hospital, are non-smokers, have no pre-existing diabetes or uncontrolled chronic disease, and can understand study information.
✕Probably not a fit
People with pre-gestational diabetes, multiple pregnancies, ongoing smoking, uncontrolled chronic inflammatory diseases, systemic corticosteroid treatment, age under 18, or who cannot attend the Danish study sites or understand the consent information are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective cohort will enroll singleton pregnant women diagnosed with GDM between 28+0 and 34+6 weeks and have them wear a continuous glucose monitor for 14 consecutive days to characterise glycaemic variability. Clinical and paraclinical data including fasting plasma glucose, HbA1c, lipid profile, organ function markers, maternal weight gain, blood pressure, and OGTT 2-hour values will be collected at two visits. Participants will receive standard GDM clinical care and routine obstetric follow-up while birth outcomes such as birth weight, birthweight z-scores, and neonatal complications will be extracted from electronic medical records after delivery. Statistical analyses will explore associations between CGM-derived glycaemic patterns and maternal and neonatal outcomes using standard statistical software.
Why it matters
Potential benefit: If successful, findings could help tailor glucose monitoring or treatment timing in GDM to improve fetal growth and short-term neonatal outcomes.
How similar studies have gone: Continuous glucose monitoring has been used in other GDM research and shown to reveal greater glycaemic variability and influence management decisions, but its direct link to fetal growth and neonatal outcomes remains incompletely established.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * All singleton pregnant women with gestational diabetes mellitus (GDM) between gestational age (GA) 28+0 and 34+6 attending the obstetric outpatient clinic at Aarhus University Hospital, Aarhus, Denmark or Gødstrup Hospital, Herning, Denmark will be offered participation. Exclusion Criteria: * Pre-gestational diabetes * Age \< 18 years * Multiple pregnancies * Chronic disease that is not well-controlled and is expected to influence study outcomes (including inflammatory diseases such as rheumatologic, gastroenterological, etc.) * Treatment with systemic corticosteroids * Smoking * Women who are unable to understand the oral and written patient information
Where it's running
-
Aarhus University Hospital
Aarhus, Denmark Recruiting -
Gødstrup Hospital
Herning, Denmark Recruiting
Study contacts
- Principal investigator: Ninna L Larsen, MD — University of Aarhus
- Study coordinator: Ninna L Larsen, MD
- Email: nll@clin.au.dk
- Phone: 0045 26533336
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.