Glucose and Blood Pressure During Pregnancy

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

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.

Study Overview

• Status: Suspended
• Conditions: Blood Pressure; Pre-Eclampsia; Gestational Diabetes
• Intervention / Treatment: Device: LabClasp

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55901
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Study Population

pregnant women between the ages of 18-45 with risk factors for gestational diabetes and preeclampsia

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of care
Experimental: LabClasp+Standard of care	Device: LabClasp; Subjects will complete up to 10 measurements per day with potentially more before and during their OGTT using the LabClasp

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pittsburgh sleep study quality index	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.	Baseline

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Virend Somers, MD, PhD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: July 14, 2021
• First Submitted That Met QC Criteria: July 26, 2021
• First Posted (Actual): July 28, 2021

Study Record Updates

• Last Update Posted (Estimated): September 10, 2025
• Last Update Submitted That Met QC Criteria: September 4, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Female Urogenital Diseases and Pregnancy Complications; Metabolic Diseases; Pregnancy Complications; Glucose Metabolism Disorders; Diabetes Mellitus; Hypertension, Pregnancy-Induced; Nutritional and Metabolic Diseases; Diabetes, Gestational; Pre-Eclampsia
• Other Study ID Numbers: 21-000284

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No