Glucose and Blood Pressure During Pregnancy

NCT04979312 | Suspended FDA Device

• 1 other identifier: 21-000284
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gestational Diabetes; Pre-Eclampsia; Blood Pressure

Outcome Measures

Primary Outcomes (3)

• Blood Glucose

  Blood Glucose will be measured in Mmol/L

  Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 30

• Systolic Blood Pressure

  Systolic Blood Pressure will be measured in mmHg

  Baseline

• Diastolic Blood Pressure

  Diastolic Blood Pressure will be measured in mmHg

  Baseline

Secondary Outcomes (1)

• Pittsburgh sleep study quality index

  Baseline

Study Arms (2)

LabClasp+Standard of care

EXPERIMENTAL

Device: LabClasp

Standard of care

NO INTERVENTION

Interventions

LabClasp DEVICE

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

LabClasp+Standard of care

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Only pregnant females will be recruited into this study
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55901, United States

Location

MeSH Terms

Conditions

Diabetes, Gestational; Pre-Eclampsia

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hypertension, Pregnancy-Induced

Study Officials

• Virend Somers, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: July 28, 2021
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)