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Wearable sensors in early pregnancy may reveal hidden diabetes risk

NCT ID NCT07783178

Knowledge-focused Sponsor: DCB Research AG Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 24, 2026 · Last updated Aug 27, 2026 · Updated 3 times

Summary

This observational study tests whether continuous glucose monitors (CGMs) worn from about 12 weeks of pregnancy can detect subtle blood sugar changes that might indicate a higher risk of gestational diabetes, before the usual screening at 24-28 weeks. Researchers will follow 48 pregnant women—half with known risk factors for gestational diabetes and half without—tracking their glucose levels, diet, activity, sleep, and stress. The goal is to find glucose patterns that could help identify at-risk women earlier, potentially leading to sooner interventions and better outcomes for mothers and babies.

What this could mean

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

Active substance
Continuous glucose monitoring (CGM) devices (Dexcom G7 and FreeStyle Libre 3)
What this could lead to
If successful, this could lead to earlier detection of gestational diabetes risk, allowing timely interventions to prevent complications for mothers and babies.
What could go wrong
This is a small, observational pilot study, so findings may not apply broadly. It does not test a treatment, and the identified thresholds will need validation in larger trials.

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.

Participants

About 48 people

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

Started

Aug 2026

Expected to finish

Apr 2027

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.

Who is studied

The study plans to recruit 48 pregnant women who are approximately in the 12th week of gestation (GW). Potential study participants will be stratified into two mutually exclusive groups: individuals without risk factor according to the Swiss Expertenbrief No. 8118 or at least one with the exception of age \>35 years, which will not be considered for the stratification allocation. The following risks will be considered: * History of bariatric surgery * Pre-pregnancy BMI \>30 kg/m² * Non-European background (Africa, Asia, Latin America) * First-degree relative with type 2 diabetes * Previous gestational diabetes * Previous macrosomic (\>4000 g) offspring * Diagnosis of polycystic ovary syndrome (PCOS) or polyendocrine metabolic ovarian syndrome (PMOS) * Early pregnancy symptoms suggestive of diabetes (e.g. frequent urination, excessive thirst, glucosuria)

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Female sex * Aged ≥18 years at inclusion * Pregnant with singleton ≤12 GW * Willingness to wear a CGM device for 12-16 weeks * Signed informed consent Exclusion Criteria: * Pre-existing type 1 or type 2 diabetes mellitus or known prediabetes * Diagnosis of GDM during current pregnancy * Known allergy to adhesive materials or sensor components * Inability to follow procedures or insufficient knowledge of project languages (German, French or English) * Inability to give consent.

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Conditions

The condition(s) this trial relates to.

gestational diabetes

As listed by the trial registrant

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

Gestational diabetes

How to take part

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  1. The places running it

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  2. The official record

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

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • DCB Research AG

    RECRUITING

    Bern, Canton of Bern, 3010, Switzerland

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