Recruiting

CGM

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT07671599

Conditions

Dysglycemia

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

Continuous Glucose Monitor

Study Details

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

Study ID

NCT07671599

Start date

Nov 6, 2026

Status verified date

Nov, 2026

Completion date

May, 2028

Anticipated

Primary completion date

May, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

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 Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Continuous Glucose Monitor

Continuous glucose monitor during perioperative Cesarean delivery

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 and Locations

Central contacts

Nicola F Tavella, MPH

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

Kavya Shivashankar, MD

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

Locations

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Nicola F Tavella, MPH

2122413888nicola.tavella@mssm.edu

Principal Investigator:

Angela Bianco

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Nov 12, 2026

Last verified

Nov, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-13. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-11-12. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.