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

Perioperative Use of Continuous Glucose Monitoring for Scheduled Cesarean Deliveries (PERUSE): A Pilot Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dysglycemia
• Intervention / Treatment: Device: Continuous Glucose Monitor

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Nicola F Tavella, MPH; Phone Number: (212) 241-3888; Email: nicola.tavella@mssm.edu
• Study Contact Backup: Name: Kavya Shivashankar, MD; Phone Number: (212) 241-5681; Email: kavya.shivashankar@mssm.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai
      • Contact: Nicola F Tavella, MPH; Phone Number: 2122413888; Email: nicola.tavella@mssm.edu
      • Principal Investigator: Angela Bianco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Continuous glucose monitor during perioperative Cesarean delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of surgical site infection	Diagnosis of surgical site infection as a measure of post-operative complications	Post-op through end of postpartum hospital say, up to ten days.

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Angela Bianco, MD, Faculty

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: June 22, 2026
• First Submitted That Met QC Criteria: June 22, 2026
• First Posted (Actual): June 26, 2026

Study Record Updates

• Last Update Posted (Actual): June 26, 2026
• Last Update Submitted That Met QC Criteria: June 22, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: STUDY-26-00229

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the individual participant data collected during the trial, after deidentification.
• IPD Sharing Time Frame: Immediately following publication. No end date.
• IPD Sharing 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).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes