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OpenTrials
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NCT Number: NCT04979312

Glucose and Blood Pressure During Pregnancy

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.

Why the study stopped: Device Unavailable
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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LabClasp

Device

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

Primary outcomes

  1. Blood Glucose

    Time frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 30

    Blood Glucose will be measured in Mmol/L

  2. Systolic Blood Pressure

    Time frame: Baseline

    Systolic Blood Pressure will be measured in mmHg

  3. Diastolic Blood Pressure

    Time frame: Baseline

    Diastolic Blood Pressure will be measured in mmHg

Secondary outcomes

  1. Pittsburgh sleep study quality index

    Time frame: Baseline

    The Pittsburgh Sleep Quality Index measures the severity of sleep disturbances. Possible scores range from 0 to 21 with higher scores indicating a worse outcome/more severe symptoms of sleep disturbance.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Predictive Role of Non-Invasive Glucose Assessment During Pregnancy: A Pilot Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 28, 2021
Registry last updated
Sep 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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