Glucose and Blood Pressure During Pregnancy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-08-31

Study Completion Date

2027-01-31

Brief Summary

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The purpose of this research is to examine the beneficial effects of regular, non-invasive, glucose (sugar) assessment on glucose (sugar) and blood pressure regulation during pregnancy to help in predicting gestational diabetes and preeclampsia.

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Detailed Description

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This is an open-label pilot trial for the LabClasp combined with standard clinical care compared to standard clinical on \[glucose\] and blood pressure during pregnancy. Potential study participants will be pre-screened using questionnaires and review of their clinical records. Once the consent has been obtained, participants will undergo screening to confirm eligibility. Subjects who meet all criteria will be randomized to either LC+SC or SC cohorts for 24-39wks depending upon their gestational duration at enrollment. Study measures including anthropometrics, surveys/questionnaires, 24hr ABPM, accelerometry, and an oral glucose tolerance test (OGTT). Furthermore, the investigators will obtain repeated (annual) subject information including vitals, labs, medications, and development of cardiometabolic disorders for up to 10yrs in follow-up by reviewing Mayo Clinic medical records.

Conditions

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Gestational Diabetes Pre-Eclampsia Blood Pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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LabClasp+Standard of care

Group Type EXPERIMENTAL

LabClasp

Intervention Type DEVICE

Subjects will complete up to 10 measurements per day with potentially more before and during their OGTT using the LabClasp

Standard of care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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LabClasp

Subjects will complete up to 10 measurements per day with potentially more before and during their OGTT using the LabClasp

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No