SepsisNCT07686939
Clinical Validation of Continuous Glucose Monitoring in Glycemic Management of Critically Ill Sepsis Patients
An observational study of Sepsis and Hyperglycemia, run by Taizhou Hospital at 1 site in China.
Trial summary
Poor glycemic control is common in critically ill patients with sepsis and is associated with increased morbidity and mortality; however, achieving safe and effective glucose management in the ICU remains challenging with conventional intermittent monitoring. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Hyperglycemia, Glycemic Control
- What is being tested?
- Continuous Glucose Monitoring (CGM) with FreeStyle Libre II System
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 31 Dec 2025
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Critically ill adult patients (≥18 years) with sepsis (infection + SOFA increase ≥2) admitted to the ICU. Total 60 patients (mean age 75.6 years; 42 male/18 female), with or without diabetes. Excludes those with sensor contraindications, non-cooperation, or anticipated incomplete follow-up.
Who may be able to join
- Age ≥ 18 years.
- Confirmed infection accompanied by an increase in Sequential Organ Failure Assessment (SOFA) score of ≥ 2 points.
- Written informed consent provided by the patient or legally authorized representative.
Who cannot join
- Discharge against medical advice or transfer to another facility before study completion, leading to incomplete data.
- Non-cooperation with study procedures.
- Contraindications to the application of the flash glucose monitoring sensor (e.g., severe skin disease at insertion site, known allergy to sensor components).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Validation of Continuous Glucose Monitoring in Glycemic Management of Critically Ill Sepsis Patients: A Prospective Randomized Clinical Study
Poor glycemic control is common in critically ill patients with sepsis and is associated with increased morbidity and mortality; however, achieving safe and effective glucose management in the ICU remains challenging with conventional intermittent monitoring. Continuous glucose monitoring (CGM) offers real-time interstitial glucose readings and has the potential to improve detection of dysglycemic events, enhance adherence to glycemic protocols, and reduce nursing workload. This prospective, randomized controlled trial was designed to evaluate the accuracy, clinical effectiveness, and operational utility of a factory-calibrated CGM system (FreeStyle Libre II) compared with standard blood glucose monitoring (fingerstick, arterial, and venous measurements) in septic ICU patients. The primary outcomes include CGM accuracy against reference methods, protocol adherence rates, time efficiency, and the incidence of hypoglycemic and hyperglycemic events. The findings of this trial will help determine whether CGM can provide a reliable, clinically feasible, and time-saving alternative for glycemic management in this high-risk population, thereby supporting its integration into routine ICU practice and informing future larger-scale studies on long-term outcomes and cost-effectiveness.
- Conditions
- Sepsis, Hyperglycemia, Glycemic Control
- Being tested
- Continuous Glucose Monitoring (CGM) with FreeStyle Libre II System
- Medical subject headings
- Sepsis, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Glucose Monitoring (CGM) with FreeStyle Libre II SystemDevice
Intervention Group (CGM Group):
Patients receive continuous glucose monitoring using the factory-calibrated FreeStyle Libre II system (Abbott Diabetes Care Ltd, UK). A sensor is inserted subcutaneously on the posterior aspect of the upper arm and measures interstitial glucose levels in real time. Glucose values and trend data are displayed on a reader device and are accessible to the clinical team remotely. In addition to CGM, all patients in this group also undergo standard conventional monitoring (fingertip capillary glucose, arterial blood gas, and venous blood glucose measurements) per routine ICU practice. Insulin therapy is initiated when blood glucose reaches ≥10 mmol/L.
| Study group | Role | What they receive |
|---|---|---|
| CGM Group (Intervention) | Not described Receives: Device: Continuous Glucose Monitoring (CGM) with FreeStyle Libre II System | |
| Control Group (Active Comparator) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of CGM (MARD < 15%, ISO compliance, and DTS error grid Zones A+B)
Measured: Throughout the 1-2 week ICU stay
Secondary outcomes (5)
Protocol Adherence Rate
Percentage of completed glucose measurements relative to the total prescribed tests per protocol.Unit of Measure: % (percentage)
Measured: Throughout the 1-2 week ICU stay
Target Glucose Achievement Rate
Proportion of glucose readings falling within the target range of 7.8-10.0 mmol/L.Unit of Measure: % (percentage)
Measured: Throughout the 1- to 2-week ICU stay.
Hypoglycemia Detection Rate
Incidence of hypoglycemic events (glucose ≤ 3.9 mmol/L) detected, calculated as number of events divided by total number of measurements × 100%.Unit of Measure: % (percentage)
Measured: Throughout the 1- to 2-week ICU stay.
Hyperglycemia Detection Rate
Incidence of hyperglycemic events (glucose ≥ 11.1 mmol/L) detected, calculated as number of events divided by total number of measurements × 100%.Unit of Measure: % (percentage)
Measured: hroughout the 1- to 2-week ICU stay.
Nursing Time per Measurement
Average time required for nursing staff to complete a single glucose measurement (from preparation to recording result).seconds (or minutes, as appropriate; your study reports seconds)
Measured: Throughout the 1- to 2-week ICU stay.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start1 Jan 2023
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Taizhou Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheng Zheng, Taizhou Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07686939
- Sponsor's protocol ID
- KTSB-WST-2022-014
- Status last verified
- Jun 2026
- First submitted
- 24 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of Continuous Glucose Monitoring in Glycemic Management of Critically Ill Sepsis Patients: A Prospective Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT07686939
- Acronym / sponsor ID
- KTSB-WST-2022-014
- Conditions
- Sepsis, Hyperglycemia, Glycemic Control
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Taizhou HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 7 Jul 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.
Poor glycemic control is common in critically ill patients with sepsis and is associated with increased morbidity and mortality; however, achieving safe and effective glucose management in the ICU remains challenging with conventional intermittent monitoring. Continuous glucose monitoring (CGM) offers real-time interstitial glucose readings and has the potential to improve detection of dysglycemic events, enhance adherence to glycemic protocols, and reduce nursing workload. This prospective, randomized controlled trial was designed to evaluate the accuracy, clinical effectiveness, and operational utility of a factory-calibrated CGM system (FreeStyle Libre II) compared with standard blood glucose monitoring (fingerstick, arterial, and venous measurements) in septic ICU patients. The primary outcomes include CGM accuracy against reference methods, protocol adherence rates, time efficiency, and the incidence of hypoglycemic and hyperglycemic events. The findings of this trial will help determine whether CGM can provide a reliable, clinically feasible, and time-saving alternative for glycemic management in this high-risk population, thereby supporting its integration into routine ICU practice and informing future larger-scale studies on long-term outcomes and cost-effectiveness.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CGM Group (Intervention) | – | Device: Continuous Glucose Monitoring (CGM) with FreeStyle Libre II System |
| Control Group (Active Comparator) | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Critically ill adult patients (≥18 years) with sepsis (infection + SOFA increase ≥2) admitted to the ICU. Total 60 patients (mean age 75.6 years; 42 male/18 female), with or without diabetes. Excludes those with sensor contraindications, non-cooperation, or anticipated incomplete follow-up.
Key inclusion criteria (3 listed)
- Age ≥ 18 years.
- Confirmed infection accompanied by an increase in Sequential Organ Failure Assessment (SOFA) score of ≥ 2 points.
- Written informed consent provided by the patient or legally authorized representative.
Key exclusion criteria (3 listed)
- Discharge against medical advice or transfer to another facility before study completion, leading to incomplete data.
- Non-cooperation with study procedures.
- Contraindications to the application of the flash glucose monitoring sensor (e.g., severe skin disease at insertion site, known allergy to sensor components).
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 Monitoring (CGM) with FreeStyle Libre II SystemIntervention Group (CGM Group): Patients receive continuous glucose monitoring using the factory-calibrated FreeStyle Libre II system (Abbott Diabetes Care Ltd, UK). A sensor is inserted subcutaneously on the posterior aspect of the upper arm and measures interstitial glucose levels in real time. Glucose values and trend data are displayed on a reader device and are accessible to the clinical team remotely. In addition to CGM, all patients in this group also undergo standard conventional monitoring (fingertip capillary glucose, arterial blood gas, and venous blood glucose measurements) per routine ICU practice. Insulin therapy is initiated when blood glucose reaches ≥10 mmol/L. | Device | CGM Group (Intervention) |
Primary outcome
Accuracy of CGM (MARD < 15%, ISO compliance, and DTS error grid Zones A+B)
Time frame: Throughout the 1-2 week ICU stay
5 secondary outcomes
Protocol Adherence Rate
Time frame: Throughout the 1-2 week ICU stay
Target Glucose Achievement Rate
Time frame: Throughout the 1- to 2-week ICU stay.
Hypoglycemia Detection Rate
Time frame: Throughout the 1- to 2-week ICU stay.
Hyperglycemia Detection Rate
Time frame: hroughout the 1- to 2-week ICU stay.
Nursing Time per Measurement
Time frame: Throughout the 1- to 2-week ICU stay.
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 7 Jul 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Sepsis and Hyperglycemia, run by Taizhou 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 3 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 7 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?
Accuracy of CGM (MARD < 15%, ISO compliance, and DTS error grid Zones A+B) (time frame: Throughout the 1-2 week ICU stay). 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 7 Jul 2026.