Continuous Glucose MonitoringNCT06755788
Effects of Intraoperative Glycemic Management Strategies Assisted With RT-CGM on TIR and Postoperative Recovery
A study testing RT-CGM in people with Continuous Glucose Monitoring, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The purpose of this study is to investigate the effect of intraoperative blood glucose management based on real-time continuous glucose monitoring ( RT-CGM) on time in range (TIR) and postoperative recovery during pancreaticoduodenectomy. The primary outcome is intraoperative TIR. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Continuous Glucose Monitoring
- What is being tested?
- RT-CGM
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 9 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18
- Scheduled for pancreaticoduodenectomy
- ASA classification I-III
Who cannot join
- Emergency surgery
- scheduled for MRI the day before surgery
- Allergy to CGM sensor
- Communication barriers or refusal to participate
- BMI < 18.5 kg/m²
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Intraoperative Glycemic Management Strategies Assisted With RT-CGM on TIR and Postoperative Recovery During Pancreaticoduodenectomy: A Randomized Controlled Trial
The purpose of this study is to investigate the effect of intraoperative blood glucose management based on real-time continuous glucose monitoring ( RT-CGM) on time in range (TIR) and postoperative recovery during pancreaticoduodenectomy. The primary outcome is intraoperative TIR. Additionally, it aims to compare the differences in other glucose metrics, quality of postoperative recovery, and 30-day postoperative complications and mortality between the two glycemic management methods .
Read the detailed description
Pancreaticoduodenectomy (PD) is the standard surgical procedure for treating malignancies of the pancreatic head, distal bile duct, and periampullary region. Due to its extensive scope, high demands for anastomosis, and prolonged operative time, PD is considered one of the most complex surgeries in general surgery. Perioperative management of PD presents unique challenges, particularly in glycemic control. In addition to stress-induced hyperglycemia caused by surgery, Patients with PD are more prone to perioperative glycemic disturbances compared to other surgeries. The main reasons include insulin resistance, resection of pancreatic tissue during surgery, and early postoperative nutritional support. However, perioperative glycemic management guidelines often receive limited attention. Several studies have reported low adherence to recommendations for glycemic monitoring and insulin administration among healthcare professionals. This issue is also evident during the perioperative period of PD, where demanding workloads may lead to neglect of glycemic management, and insulin therapy poses risks of hypoglycemia.
Continuous glucose monitoring (CGM) technology uses subcutaneous electrodes to monitor interstitial glucose levels electronically. RT-CGM provides continuous, comprehensive, and reliable glycemic data, capturing trends and fluctuations in glucose levels, and identifying hidden hyperglycemia and hypoglycemia. It overcomes the limitations of traditional glucose monitoring, such as pain from finger pricks, delayed assessments, and an inability to reflect glucose variability. The latest diabetes guidelines in China and the United States incorporate Time in Range (TIR), derived from CGM, as a new metric for glycemic control. CGM is gradually being used in glycemic management for diabetic patients, and its efficacy and safety have been consistently demonstrated in randomized controlled trials and real-world studies. A randomized controlled trial involving 299 patients with type 2 diabetes showed that CGM improved TIR by 7.9% over 12 months compared to fingerstick glucose monitoring.
Pancreaticoduodenectomy (PD) is the standard surgical procedure for treating malignancies of the pancreatic head, distal bile duct, and periampullary region. Due to its extensive scope, the high demands for anastomosis, and prolonged operative time, PD is considered one of the most complex surgeries in general surgery. Perioperative management of PD presents unique challenges, particularly in glycemic control. In addition to stress-induced hyperglycemia caused by surgery, patients undergoing PD are more susceptible to perioperative glycemic disturbances than those undergoing other types of surgery. The primary factors contributing to this include insulin resistance, the resection of pancreatic tissue during surgery, and early postoperative nutritional support. However, perioperative glycemic management guidelines often receive limited attention, with several studies reporting poor adherence to recommendations for glycemic monitoring and insulin administration among healthcare professionals. This issue is particularly evident during the perioperative period of PD, where heavy workloads may lead to neglect of glycemic management, and insulin therapy may increase the risk of hypoglycemia.
Continuous glucose monitoring (CGM) technology uses subcutaneous electrodes to electronically monitor interstitial glucose levels. Real-time CGM (RT-CGM) provides continuous, comprehensive, and reliable glycemic data, capturing glucose trends and fluctuations while identifying hidden hyperglycemia and hypoglycemia. It overcomes the limitations of traditional glucose monitoring, such as pain from finger pricks, delayed assessments, and an inability to reflect glucose variability. Both China and the United States have incorporated Time in Range (TIR) from CGM data as a key metric for glycemic control in their latest diabetes guidelines. CGM is increasingly used for managing glycemia in diabetic patients, with its efficacy and safety consistently demonstrated in randomized controlled trials and real-world studies. For instance, a randomized controlled trial with 299 patients with type 2 diabetes found that CGM improved TIR by 7.9% over 12 months compared to fingerstick glucose monitoring.
In recent years, the use of CGM has expanded to hospitalized patients, and its adoption is growing in clinical settings. However, compared to medical inpatients and ICU patients, surgical patients rarely use CGM, and studies on its use during surgery are limited. CGM systems measure interstitial glucose every minute and provide real-time alerts for values outside the target range. These alerts help clinicians intervene promptly to manage perioperative hyperglycemia or hypoglycemia, minimizing risks and reducing the burden of traditional blood glucose testing on both patients and medical staff. This study explores the benefits of CGM-assisted glycemic management during PD, promoting dynamic and precise glycemic control during PD.
- Conditions
- Continuous Glucose Monitoring
- Being tested
- RT-CGM, Control
- Keywords
- glycemic management, pancreaticoduodenectomy, time in range
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RT-CGMDevice
In the RT-CGM group, patients will wear a CGM sensor the day before surgery. Before entering the operating room, capillary blood glucose will be measured and compared with CGM interstitial glucose values for calibration. The target range for intraoperative blood glucose management is 3.9-10.0 mmol/L, with arterial blood gas measurements required at least every 2 hours. Following the administration of insulin or glucose, arterial blood gases should be retested at least every hour. RT-CGM monitoring will also be employed during surgery. A tablet in the operating room will be configured with low and high glucose alerts set at 3.9 mmol/L and 10.0 mmol/L, respectively. When an alarm is triggered, arterial blood gases will be rechecked, and glucose levels will be adjusted based on the arterial blood glucose results. If interstitial glucose values do not reach the intervention threshold, arterial blood gas measurements are recommended every 30 minutes.
ControlDevice
In the control group, patients will wear a CGM sensor the day before surgery. Before entering the operating room, capillary blood glucose will be measured and compared with CGM interstitial glucose values for calibration. The target range for intraoperative blood glucose management is 3.9-10.0 mmol/L, with arterial blood gas measurements required at least every 2 hours. Following the administration of insulin or glucose, arterial blood gases should be retested at least every hour. CGM monitoring will also be employed during surgery, but the CGM interstitial glucose readings and alerts will be masked during the operation. The final intraoperative glucose management approach will be determined by the anesthesiologist, considering the patient's condition and surgical circumstances. The anesthesiologist can choose the intravenous insulin adjustment protocol we recommend.
| Study group | Role | What they receive |
|---|---|---|
| RT-CGM | Experimental | Intraoperative blood glucose monitoring and management based on a real-time RT-CGM system. Receives: Device: RT-CGM |
| Control | Other | Patients enrolled in the control group will have the CGM sensor attached the day before surgery but the CGM , interstitial glucose readings, and alerts will be masked during the operation. Receives: Device: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative time in range (TIR)
Time in range (TIR) from CGM generally refers to the percentage of time that glucose levels stay within a target range (3.9-10 mmol/L)
Measured: during surgery
Secondary outcomes (13)
Intraoperative insulin dosage
unit
Measured: during surgery
Intraoperative time above range (TAR)
Time above range (TAR) from CGM generally refers to the percentage of time glucose levels exceed the upper limit of the target range (>180 mg/dL).
Measured: during surgery
Intraoperative time below range (TBR)
Time below range (TBR) from CGM generally refers to the percentage of time glucose levels fall below the lower limit of the target range (<70 mg/dL).
Measured: during surgery
Intraoperative mean glucose
The average glucose level recorded by the CGM over a specified period
Measured: during surgery
Intraoperative coefficient of variation (CV)
Coefficient of variation (CV) from CGM generally refers to the degree of fluctuation in glucose levels, typically expressed as a percentage of the coefficient of variation.
Measured: during surgery
Postoperative time in range (TIR)
Time in range (TIR) from CGM generally refers to the percentage of time that glucose levels stay within a target range (3.9-10 mmol/L)
Measured: Throughout the 72 hours after surgery
Postraoperative time above range (TAR)
Time above range (TAR) from CGM generally refers to the percentage of time glucose levels exceed the upper limit of the target range (>180 mg/dL).
Measured: Throughout the 72 hours after surgery
Postoperative time below range (TBR)
Time below range (TBR) from CGM generally refers to the percentage of time glucose levels fall below the lower limit of the target range (<70 mg/dL).
Measured: Throughout the 72 hours after surgery
Postoperative mean glucose
The average glucose level recorded by the CGM over a specified period
Measured: Throughout the 72 hours after surgery
Postoperative coefficient of variation (CV)
Coefficient of variation (CV) from CGM generally refers to the degree of fluctuation in glucose levels, typically expressed as a percentage of the coefficient of variation.
Measured: Throughout the 72 hours after surgery
Quality of Recovery-15 score on the third day after surgery
Using Quality of Recovery-15 questionnaire to evaluate the quality of perioperative recovery. Quality of Recovery-15 consists of 15 comprehensive questions, including physical comfort (5 items), psychological support (2 items), physical independence (2 items), emotional state (4 items), and pain (2 items), each item is scored with 0-10 points, 0 represents poor state, 10 represents good state, and the total score ranging from 0 to 150 is the Quality of Recovery-15 score of the patient. A higher score indicates a better quality of recovery.
Measured: on the third day after surgery
The rate of surgery-related complications
surgery-related complications including clinically relevent postoperative pancreatic fistula,bile leakage,chyle leak,postpancreatectomy hemorrhage,abdominal infection,delayed gastric emptying.
Measured: 30 days after surgery
Quality of Recovery-15 score on the 30th day after surgery
Using Quality of Recovery-15 questionnaire to evaluate the quality of perioperative recovery. Quality of Recovery-15 consists of 15 comprehensive questions, including physical comfort (5 items), psychological support (2 items), physical independence (2 items), emotional state (4 items), and pain (2 items), each item is scored with 0-10 points, 0 represents poor state, 10 represents good state, and the total score ranging from 0 to 150 is the Quality of Recovery-15 score of the patient. A higher score indicates a better quality of recovery.
Measured: on the 30th day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start1 Jan 2025
- Primary completion9 Jan 2026
- Study completion9 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Continuous Glucose MonitoringStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Le Shen, PhD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06755788
- Sponsor's protocol ID
- 2023-I2M-CT-B-028
- Status last verified
- Dec 2024
- First submitted
- 17 Dec 2024
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intraoperative Glycemic Management Strategies Assisted With RT-CGM on TIR and Postoperative Recovery During Pancreaticoduodenectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06755788
- Acronym / sponsor ID
- 2023-I2M-CT-B-028
- Conditions
- Continuous Glucose Monitoring
- Keywords
- glycemic management, pancreaticoduodenectomy, time in range
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 9 Jan 2026 (actual)
- Study completion
- 9 Feb 2026 (actual)
- First posted
- 1 Jan 2025 (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.
The purpose of this study is to investigate the effect of intraoperative blood glucose management based on real-time continuous glucose monitoring ( RT-CGM) on time in range (TIR) and postoperative recovery during pancreaticoduodenectomy. The primary outcome is intraoperative TIR. Additionally, it aims to compare the differences in other glucose metrics, quality of postoperative recovery, and 30-day postoperative complications and mortality between the two glycemic management methods .
Detailed description
Pancreaticoduodenectomy (PD) is the standard surgical procedure for treating malignancies of the pancreatic head, distal bile duct, and periampullary region. Due to its extensive scope, high demands for anastomosis, and prolonged operative time, PD is considered one of the most complex surgeries in general surgery. Perioperative management of PD presents unique challenges, particularly in glycemic control. In addition to stress-induced hyperglycemia caused by surgery, Patients with PD are more prone to perioperative glycemic disturbances compared to other surgeries. The main reasons include insulin resistance, resection of pancreatic tissue during surgery, and early postoperative nutritional support. However, perioperative glycemic management guidelines often receive limited attention. Several studies have reported low adherence to recommendations for glycemic monitoring and insulin administration among healthcare professionals. This issue is also evident during the perioperative period of PD, where demanding workloads may lead to neglect of glycemic management, and insulin therapy poses risks of hypoglycemia.
Continuous glucose monitoring (CGM) technology uses subcutaneous electrodes to monitor interstitial glucose levels electronically. RT-CGM provides continuous, comprehensive, and reliable glycemic data, capturing trends and fluctuations in glucose levels, and identifying hidden hyperglycemia and hypoglycemia. It overcomes the limitations of traditional glucose monitoring, such as pain from finger pricks, delayed assessments, and an inability to reflect glucose variability. The latest diabetes guidelines in China and the United States incorporate Time in Range (TIR), derived from CGM, as a new metric for glycemic control. CGM is gradually being used in glycemic management for diabetic patients, and its efficacy and safety have been consistently demonstrated in randomized controlled trials and real-world studies. A randomized controlled trial involving 299 patients with type 2 diabetes showed that CGM improved TIR by 7.9% over 12 months compared to fingerstick glucose monitoring.
Pancreaticoduodenectomy (PD) is the standard surgical procedure for treating malignancies of the pancreatic head, distal bile duct, and periampullary region. Due to its extensive scope, the high demands for anastomosis, and prolonged operative time, PD is considered one of the most complex surgeries in general surgery. Perioperative management of PD presents unique challenges, particularly in glycemic control. In addition to stress-induced hyperglycemia caused by surgery, patients undergoing PD are more susceptible to perioperative glycemic disturbances than those undergoing other types of surgery. The primary factors contributing to this include insulin resistance, the resection of pancreatic tissue during surgery, and early postoperative nutritional support. However, perioperative glycemic management guidelines often receive limited attention, with several studies reporting poor adherence to recommendations for glycemic monitoring and insulin administration among healthcare professionals. This issue is particularly evident during the perioperative period of PD, where heavy workloads may lead to neglect of glycemic management, and insulin therapy may increase the risk of hypoglycemia.
Continuous glucose monitoring (CGM) technology uses subcutaneous electrodes to electronically monitor interstitial glucose levels. Real-time CGM (RT-CGM) provides continuous, comprehensive, and reliable glycemic data, capturing glucose trends and fluctuations while identifying hidden hyperglycemia and hypoglycemia. It overcomes the limitations of traditional glucose monitoring, such as pain from finger pricks, delayed assessments, and an inability to reflect glucose variability. Both China and the United States have incorporated Time in Range (TIR) from CGM data as a key metric for glycemic control in their latest diabetes guidelines. CGM is increasingly used for managing glycemia in diabetic patients, with its efficacy and safety consistently demonstrated in randomized controlled trials and real-world studies. For instance, a randomized controlled trial with 299 patients with type 2 diabetes found that CGM improved TIR by 7.9% over 12 months compared to fingerstick glucose monitoring.
In recent years, the use of CGM has expanded to hospitalized patients, and its adoption is growing in clinical settings. However, compared to medical inpatients and ICU patients, surgical patients rarely use CGM, and studies on its use during surgery are limited. CGM systems measure interstitial glucose every minute and provide real-time alerts for values outside the target range. These alerts help clinicians intervene promptly to manage perioperative hyperglycemia or hypoglycemia, minimizing risks and reducing the burden of traditional blood glucose testing on both patients and medical staff. This study explores the benefits of CGM-assisted glycemic management during PD, promoting dynamic and precise glycemic control during PD.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RT-CGM | Experimental | Device: RT-CGMIntraoperative blood glucose monitoring and management based on a real-time RT-CGM system. |
| Control | Other | Device: ControlPatients enrolled in the control group will have the CGM sensor attached the day before surgery but the CGM , interstitial glucose readings, and alerts will be masked during the operation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18
- Scheduled for pancreaticoduodenectomy
- ASA classification I-III
Key exclusion criteria (5 listed)
- Emergency surgery
- scheduled for MRI the day before surgery
- Allergy to CGM sensor
- Communication barriers or refusal to participate
- BMI < 18.5 kg/m²
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 |
|---|---|---|
| RT-CGMIn the RT-CGM group, patients will wear a CGM sensor the day before surgery. Before entering the operating room, capillary blood glucose will be measured and compared with CGM interstitial glucose values for calibration. The target range for intraoperative blood glucose management is 3.9-10.0 mmol/L, with arterial blood gas measurements required at least every 2 hours. Following the administration of insulin or glucose, arterial blood gases should be retested at least every hour. RT-CGM monitoring will also be employed during surgery. A tablet in the operating room will be configured with low and high glucose alerts set at 3.9 mmol/L and 10.0 mmol/L, respectively. When an alarm is triggered, arterial blood gases will be rechecked, and glucose levels will be adjusted based on the arterial blood glucose results. If interstitial glucose values do not reach the intervention threshold, arterial blood gas measurements are recommended every 30 minutes. | Device | RT-CGM |
| ControlIn the control group, patients will wear a CGM sensor the day before surgery. Before entering the operating room, capillary blood glucose will be measured and compared with CGM interstitial glucose values for calibration. The target range for intraoperative blood glucose management is 3.9-10.0 mmol/L, with arterial blood gas measurements required at least every 2 hours. Following the administration of insulin or glucose, arterial blood gases should be retested at least every hour. CGM monitoring will also be employed during surgery, but the CGM interstitial glucose readings and alerts will be masked during the operation. The final intraoperative glucose management approach will be determined by the anesthesiologist, considering the patient's condition and surgical circumstances. The anesthesiologist can choose the intravenous insulin adjustment protocol we recommend. | Device | Control |
Primary outcome
Intraoperative time in range (TIR)
Time frame: during surgery
Time in range (TIR) from CGM generally refers to the percentage of time that glucose levels stay within a target range (3.9-10 mmol/L)
13 secondary outcomes
Intraoperative insulin dosage
Time frame: during surgery
Intraoperative time above range (TAR)
Time frame: during surgery
Intraoperative time below range (TBR)
Time frame: during surgery
Intraoperative mean glucose
Time frame: during surgery
Intraoperative coefficient of variation (CV)
Time frame: during surgery
Postoperative time in range (TIR)
Time frame: Throughout the 72 hours after surgery
Postraoperative time above range (TAR)
Time frame: Throughout the 72 hours after surgery
Postoperative time below range (TBR)
Time frame: Throughout the 72 hours after surgery
Postoperative mean glucose
Time frame: Throughout the 72 hours after surgery
Postoperative coefficient of variation (CV)
Time frame: Throughout the 72 hours after surgery
Quality of Recovery-15 score on the third day after surgery
Time frame: on the third day after surgery
The rate of surgery-related complications
Time frame: 30 days after surgery
Quality of Recovery-15 score on the 30th day after surgery
Time frame: on the 30th day after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
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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. This study is not recruiting at the moment.
Le Shen, PhD principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RT-CGM in people with Continuous Glucose Monitoring, run by Peking Union Medical College Hospital at 1 site in China.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 9 Jul 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative time in range (TIR) (time frame: during surgery). 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 9 Jul 2026.