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RecruitingNCT07671599PERUSEUpdated Nov 12, 2026

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

An observational study in Dysglycemia, sponsored by Icahn School of Medicine at Mount Sinai. Recruiting at 1 site in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-11-12.

Sponsored by Icahn School of Medicine at Mount Sinai · Observational

Updated Nov 12, 2026Now RecruitingSite recruiting status changedGo to Updates ↓

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Dysglycemia
03

In context

Lead sponsor

Icahn School of Medicine at Mount Sinai is the lead sponsor of 776 studies on the registry; 176 are open to participants now.

Of its 125 completed or terminated interventional studies of FDA-regulated products, 83 (66%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 within the two weeks prior to delivery
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • DeviceContinuous Glucose Monitor

    Continuous glucose monitor during perioperative Cesarean delivery

06

What researchers measure

Primary outcomes

  1. interstitial glucose from CGM device

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

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

Secondary outcomes

  1. Number of surgical site infection

    Diagnosis of surgical site infection as a measure of post-operative complications

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — All of the individual participant data collected during the trial, after deidentification.

Supporting information: Study protocol, Informed consent form

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).

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Nov 2026 (actual). Primary completion is estimated for May 2028, 18 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 22, 2026
First posted
Jun 26, 2026
StartActual
Nov 6, 2026
Primary completionEst.
May 2028
CompletionEst.
May 2028
Last update
Nov 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Nov 12, 2026
Sites
Icahn School of Medicine at Mount Sinai is now Recruiting
Nov 12, 2026
Show all 1 update
  1. Nov 12, 2026
    Not yet recruiting→Recruiting
    Icahn School of Medicine at Mount Sinai is now Recruiting
    + 2 other changes: verification date and date precision

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07671599
Responsible party
Angela Bianco (Director, Division of Maternal-Fetal Medicine, Icahn School of Medicine at Mount Sinai) — Principal investigator
First posted
Jun 26, 2026
Start date
Nov 6, 2026
Primary completion
May 2028 (estimated)
Completion
May 2028 (estimated)
Last update
Nov 12, 2026

Study contacts

Nicola F Tavella, MPH
Contact
nicola.tavella@mssm.edu
(212) 241-3888
Kavya Shivashankar, MD
Contact
kavya.shivashankar@mssm.edu
(212) 241-5681
Angela Bianco, MD
principal investigator · Faculty

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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