DysglycemiaPERUSENCT07671599
Perioperative Use of Continuous Glucose Monitoring for Scheduled Cesarean Deliveries (PERUSE)
An observational study of Dysglycemia, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Dysglycemia
- What is being tested?
- Continuous Glucose Monitor
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to May 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: continuous glucose monitor (CGM) use for perioperative glucose surveillance during scheduled Cesarean delivery for nondiabetic patients
Who may be able to join
- singleton pregnancy
- no prior diagnosis of diabetes (gestational included)
- scheduled term cesarean delivery in Mount Sinai Health System
- aged 18-50 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Nicola F Tavella, MPH, 2122413888, nicola.tavella@mssm.edu
Angela Bianco
About this study
Official title: 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.
- Conditions
- Dysglycemia
- Being tested
- Continuous Glucose Monitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Glucose MonitorDevice
Continuous glucose monitor during perioperative Cesarean delivery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Continuous Glucose Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
interstitial glucose from CGM device
glucose of interstitial fluid as measured by CGM device on participant's arm
Measured: 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
Measured: Post-op through end of postpartum hospital say, up to ten days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study startNov 2026 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysglycemiaStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angela Bianco, Icahn School of Medicine at Mount Sinai
- Investigators
- Angela Bianco, MD, Principal investigator, Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07671599
- Sponsor's protocol ID
- STUDY-26-00229
- Acronym
- PERUSE
- Status last verified
- Sep 2026
- First submitted
- 22 Jun 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.