Simple skin test could spot diabetes in pregnancy earlier

NCT ID NCT06048510

Diagnosis Sponsor: University Hospital, Bordeaux Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing two new ways to predict gestational diabetes and large babies (macrosomia) in pregnant women. Researchers will measure skin autofluorescence and glycated albumin in 800 pregnant women and compare them to the standard HbA1c test. The goal is to see if these markers can catch problems earlier, before current screening at 24-28 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to: If successful, this could lead to earlier and simpler screening for gestational diabetes, helping prevent complications like large babies.
What could go wrong: This is an observational study, not a treatment trial. The new markers may not prove more accurate than current tests, and results may not change clinical practice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 800 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2023

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: 1. Age ≥ 18 years 2. Singleton pregnancy (or twin pregnancy reduced spontaneously or medically before 14 weeks of amenorrhea) 3. Gestational age at inclusion \<28 weeks of amenorrhea 4. Participant affiliated with or beneficiary of a social security scheme 5. Collection of patient consent. Exclusion criteria: 1. Gestational age at inclusion ≥ 28 weeks of amenorrhea 2. Multiple pregnancy 3. Known diabetes prior to pregnancy 4. History of bariatric surgery 5. Expected delivery in another maternity unit not participating in the study 6. Person deprived of liberty by judicial or administrative decision 7. Guardianship or curatorship 8. Participant not affiliated or not benefiting from a social security scheme.

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Conditions

The condition(s) this trial relates to.

Fetal Macrosomia gestational diabetes

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gestational diabetes mellitus in pregnancy Macrosomia, fetal

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Simple skin test could spot diabetes in pregnancy earlier

What the study statuses mean