Glucose and Blood Pressure During Pregnancy

Study Overview
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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.

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.

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

Conditions
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Gestational Diabetes, Pre-Eclampsia, Blood Pressure

Intervention / Treatment
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* Device: LabClasp


Participation Criteria
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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 Target disease or condition: pregnancy Individuals with treated hypertension, prehypertension, and dyslipidemia will be allowed to participate in the 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: LabClasp|participants will be randomized to LabClasp + standard care or just standard care|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention of gestational diabetes mellitus and preeclampsia | measuring glucose non-invasively will prevent gestational diabetes mellitus and preeclampsia during pregnancy | 24-39 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Examine role of sleep as a potential mechanism in changing blood glucose in pregnancy | measuring glucose non-invasively may aid in sleep, thereby improving blood glucose | 24-39 weeks | 
| Examine role of sleep as a potential mechanism in changing blood pressure in pregnancy | measuring glucose non-invasively may aid in sleep, thereby improving blood pressure | 24-39 weeks |