Perioperative Use of Continuous Glucose Monitoring for Scheduled Cesarean Deliveries (PERUSE)

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT07671599
Status
Not Yet Recruiting

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Conditions

  • Dysglycemia

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Continuous Glucose Monitor — DEVICE
    Continuous glucose monitor during perioperative Cesarean delivery

Study Details

This prospective pilot study is exploratory in nature and is designed to evaluate the validity of continuous glucose monitor (CGM) use for perioperative glucose surveillance during scheduled Cesarean delivery for nondiabetic patients. Primary objective is characterization of perioperative glucose trends during elective Cesarean delivery in patients without diabetes and exploratory analyses will describe perioperative glucose patterns captured by CGM. Secondary objective is to examine rates of and associations with post-operative complications, including surgical site infections.

Key Dates

Start date
Sep 30, 2026
Status verified
Jun 2026
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
150 participants (estimated)

Arms

  • Arm: scheduled term c-section
    Patients scheduled for term cesarean deliveries and who are screened eligible and consented will be administered a continuous glucose monitor prior to their c-section, and they will wear the device through their stay in the hospital.

Primary Outcome Measure

interstitial glucose from CGM device [ Time Frame: from pre-operative appointment through end of postpartum hospital stay, up to ten days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Nicola F Tavella, MPH
2122413888
Angela Bianco (PRINCIPAL_INVESTIGATOR)

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