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
- Are there results?
- Not yet: the study is under way
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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Use of Continuous Glucose Monitoring for Scheduled Cesarean Deliveries (PERUSE): A Pilot Study
- ClinicalTrials.gov ID
- NCT07671599
- Acronym / sponsor ID
- PERUSE / STUDY-26-00229
- Conditions
- Dysglycemia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 26 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| scheduled term c-section | – | Device: Continuous Glucose MonitorPatients 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- continuous glucose monitor (CGM) use for perioperative glucose surveillance during scheduled Cesarean delivery for nondiabetic patients
Key inclusion criteria (4 listed)
- singleton pregnancy
- no prior diagnosis of diabetes (gestational included)
- scheduled term cesarean delivery in Mount Sinai Health System
- aged 18-50 years
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Glucose MonitorContinuous glucose monitor during perioperative Cesarean delivery | Device | scheduled term c-section |
Primary outcome
interstitial glucose from CGM device
Time frame: from pre-operative appointment through end of postpartum hospital stay, up to ten days
glucose of interstitial fluid as measured by CGM device on participant's arm
1 secondary outcome
Number of surgical site infection
Time frame: Post-op through end of postpartum hospital say, up to ten days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
Related trials for Dysglycemia
Active, not recruiting
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Enrolling by invitation
Pilot Study of Continuous Glucose Monitoring for Postpartum Glucose Screening
Gestational Diabetes
Not yet recruitingPhase 2
Verapamil Effect in Cystic Fibrosis-related Dysglycemia
Cystic Fibrosis Related Diabetes, Cystic Fibrosis (CF)
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Platform Trial in Stage 1 Diabetes: Comparing Golimumab vs Placebo
Type 1 Diabetes (T1D)
Not yet recruiting
Continuous Glucose Monitoring to Detect Postpartum Dysglycemia in Patients With Gestational Diabetes
Gestational Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Angela Bianco, MD principal investigator
Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dysglycemia, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicola F Tavella, MPH ((212) 241-3888, nicola.tavella@mssm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
interstitial glucose from CGM device (time frame: from pre-operative appointment through end of postpartum hospital stay, up to ten days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.