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

NCT07671599 | Not Yet Recruiting FDA Device

• 1 other identifier: STUDY-26-00229
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dysglycemia

Outcome Measures

Primary Outcomes (1)

• interstitial glucose from CGM device

  glucose of interstitial fluid as measured by CGM device on participant's arm

  from pre-operative appointment through end of postpartum hospital stay, up to ten days

Secondary Outcomes (1)

• Number of surgical site infection

  Post-op through end of postpartum hospital say, up to ten days.

Study Arms (1)

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.

Device: Continuous Glucose Monitor

Interventions

Continuous Glucose Monitor DEVICE

Continuous glucose monitor during perioperative Cesarean delivery

scheduled term c-section

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

continuous glucose monitor (CGM) use for perioperative glucose surveillance during scheduled Cesarean delivery for nondiabetic patients

You may qualify if:

• singleton pregnancy
• no prior diagnosis of diabetes (gestational included)
• scheduled term cesarean delivery in Mount Sinai Health System
• aged 18-50 years

You may not qualify if:

• preexisting diabetes mellitus
• diagnosis of gestational diabetes mellitus (GDM) in the current pregnancy, based on standard prenatal screening
• known endocrine disorder affecting glucose metabolism (such as Cushing syndrome, poorly controlled thyroid disorder, etc.)
• use of antenatal steroids within the two weeks prior to delivery

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Study Officials

• Angela Bianco, MD

  Faculty

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicola F Tavella, MPH

CONTACT

(212) 241-3888; nicola.tavella@mssm.edu

Kavya Shivashankar, MD

CONTACT

(212) 241-5681; kavya.shivashankar@mssm.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Division of Maternal-Fetal Medicine

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: June 26, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: June 26, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Researchers who provide a methodologically sound proposal. To achieve aims in the approved proposal. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in the University's data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data may be found at (Link tbd).

Locations

US (1)