Real-time CGM in Perioperative Glycemic Management

November 8, 2026 updated by: Sinocare

Real-Time Continuous Glucose Monitoring in Perioperative Glycemic Management of Patients Undergoing Non-Emergency Surgery: Clinical Benefits and Performance - A Randomized Controlled Trial

This is a single-center, prospective, open-label, 1:1 randomized parallel-controlled investigator-initiated trial. A total of 120 adult patients with abnormal glucose undergoing elective or semi-elective non-emergency general or orthopedic surgery will be enrolled. Subjects are randomized to rtCGM-guided perioperative glycemic management (experimental group) or conventional POCT-only glycemic management (control group, using blinded rtCGM sensor for post-hoc data collection). The primary endpoint is hierarchical composite of postoperative length-of-stay and CGM Time-In-Range analyzed by win-ratio. Secondary objectives include glycemic metrics, rtCGM accuracy, postoperative complications, hypoglycemia/hyperglycemia events, health-economic indexes and satisfaction assessments. Safety including adverse events and device-related reactions will be descriptively evaluated. Follow-up includes in-hospital monitoring plus telephone follow-up 30 days after surgery.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Diabetes and stress hyperglycemia are common among perioperative surgical patients and are associated with higher risks of postoperative infection, complications and prolonged hospital stay. Real-time continuous glucose monitoring (rtCGM) can capture continuous interstitial glucose data including asymptomatic hypo- and hyperglycemia, which may optimize perioperative glycemic control. This single-center, prospective, open-label, randomized parallel-controlled trial aims to compare perioperative glycemic management guided by real-time continuous glucose monitoring versus conventional point-of-care capillary glucose testing (POCT) among adults with abnormal glucose receiving non-emergency elective or semi-elective general or orthopedic surgery. One-hundred-twenty eligible subjects will be randomized 1:1 into experimental rtCGM group or POCT control group. Experimental group uses visible rtCGM (Sinocare iCan h6) as main monitoring tool, supplemented by POCT when clinically indicated. Control group wears blinded rtCGM sensor (data and alarms disabled for clinical use) and is managed exclusively by routine POCT finger-stick glucose. Both groups target perioperative glucose 5.6-10.0 mmol/L, and clinical treatment including anti-hyperglycemic drugs and surgical procedures follows standard hospital practice without protocol-mandated modifications. Primary endpoint is hierarchical composite of postoperative length of hospital stay (first priority) and CGM Time-In-Range (TIR, second priority), evaluated with win-ratio analysis. Secondary endpoints cover multiple glycemic variability indices, rtCGM accuracy metrics (MARD, Clarke error grid, Bland-Altman), postoperative complication rates, hypoglycemia and severe metabolic event rates, 30-day unplanned readmission / emergency visit rates, total hospitalization costs, patient and healthcare-worker satisfaction. Safety assessment collects all adverse events, serious adverse events and device-related adverse reactions up to 30 days post-surgery. Study includes screening/baseline period, perioperative in-hospital intervention period, discharge visit, and post-operative 30-day ±3-day telephone follow-up. Statistical analysis will adopt full analysis set (FAS) as primary population; per-protocol set (PPS) and safety set (SS) will also be analyzed.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 18-75 years inclusive at the time of signing informed consent, any gender.
  • Scheduled for elective surgery with expected perioperative glycemic monitoring.
  • Expected postoperative hospital stay ≥ 24 hours.
  • Able to understand and voluntarily sign the written informed consent form.
  • Agree to wear the CGM sensor during the perioperative in-hospital period.

Exclusion Criteria:

  • History of type 1 diabetes mellitus.
  • Severe skin disease or known allergy to CGM sensor adhesive material.
  • Planned surgery duration less than 1 hour.
  • Severe hepatic or renal dysfunction requiring dialysis.
  • Pregnant or breastfeeding women.
  • Enrolled in another interventional clinical trial that may interfere with glycemic management.
  • Conditions that preclude reliable CGM data acquisition.
  • Investigator judgment that the participant is unsuitable to enter this trial for any other reason.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Real-time CGM group

Participants use real-time continuous glucose monitoring (rtCGM) for perioperative glycemic management, with glucose alerts and real-time glucose data available to clinicians.
Device: Real-time continuous glucose monitoring（rtCGM）

Real-time continuous glucose monitoring is used during the perioperative period. Clinicians can view live glucose readings and alerts to guide glycemic adjustment.
Active Comparator: Conventional POCT group

Participants receive conventional point-of-care blood glucose testing. A blinded CGM sensor is worn for data collection only; glucose values are not accessible to clinical staff.
Device: Point-of-care blood glucose testing (POCT)

Perioperative glycemic management is performed with routine point-of-care blood glucose testing. Participants wear a blinded CGM sensor only for research data collection; real-time glucose data and alerts are not available to the clinical team for treatment decisions.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hierarchical composite endpoint of postoperative length of hospital stay and CGM-derived time in range (TIR)
Time Frame: From the day of surgery until hospital discharge, whichever comes first, assessed up to 30 days

Hierarchical rank-based composite endpoint assessed by win-ratio analysis (Finkelstein-Schoenfeld method). First priority: postoperative length of hospital stay, defined as integer days from the day of surgery to discharge (discharge day is excluded from counting). Second priority: CGM-derived percentage time in range (TIR), glucose within 5.6-10.0 mmol/L, only compared for participant pairs tied at the first-priority endpoint.
From the day of surgery until hospital discharge, whichever comes first, assessed up to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sinocare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 2, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 29, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SN-CGM-PO-003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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