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No-Needle glucose monitor could spot pregnancy risks early

NCT ID NCT04979312

Knowledge-focused Sponsor: Mayo Clinic Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Sep 16, 2026 · Updated 2 times

Summary

This pilot study is testing a device called LabClasp that measures blood sugar without needles. Researchers want to see if regular, non-invasive glucose checks can help predict gestational diabetes and preeclampsia in pregnant women. The study plans to enroll 100 women with at least one risk factor for gestational diabetes, but it is currently suspended.

What this could mean

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

Active substance
LabClasp (non-invasive glucose monitoring device)
What this could lead to
If successful, this could lead to a simple, needle-free way to predict gestational diabetes and preeclampsia early in pregnancy.
What could go wrong
This is a small pilot study (100 participants) that is currently suspended, so results are uncertain. The device's accuracy and real-world usefulness are not yet proven.

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.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Jan 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.

Ages

18 to 45 years

Sex

Female participants only

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: * Age range: 18-45 years (inclusive) * Body mass index (BMI) ≤40kg/m2 * \>1 risk factor for GDM * \<16wks gestation * Gender: only females will be recruited into this study * Ability to provide written informed consent Exclusion Criteria: * Presence of chronic kidney disease (creatinine \>2.5mg/dL) and/or active cancer * Smoking * Multiple pregnancies * Congenital abnormalities * Use of chronic medications which influence blood \[glucose\] or \[insulin\] * Subsequent diagnosis of GDM or preeclampsia

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Conditions

The condition(s) this trial relates to.

gestational diabetes hypertensive disorder preeclampsia

As listed by the trial registrant

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

Blood pressure Gestational diabetes Pre-eclampsia

Contacts and locations

Locations

  • Mayo Clinic

    Rochester, Minnesota, 55901, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.