Hyperglycemia in Critically Ill PatientsNCT07201155
The Accuracy of Continuous Glucose Monitoring Systems in Critically Ill Patients
An observational study of Hyperglycemia in Critically Ill Patients, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
Abstract: Hyperglycemia, hypoglycemia, and glucose variability in ICU patients are associated with adverse outcomes. Continuous Glucose Monitoring Systems (CGMS) offer dynamic glucose monitoring and early warnings to improve glucose management. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hyperglycemia in Critically Ill Patients
- What is being tested?
- Continuous Glucose Monitoring Systems, Continuous Glucose Monitoring and CGMS
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 55 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to 10 Oct 2024
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: blood glucose (BG>180 mg/dL) undergoing intravenous insulin therapy
Who may be able to join
- Age ≥18 years and ≤75 years;
- Expected ICU stay of at least 3 days;
- Elevated blood glucose (BG >180 mg/dL) requiring intravenous insulin therapy;
- Informed consent obtained from the patient or their legally authorized representative.
Who cannot join
- Severe hepatic failure (Child-Pugh class C) or marked liver dysfunction (total bilirubin ≥50 μmol/L and alanine aminotransferase ≥3 times the upper limit of normal);
- Uncorrected diabetic ketoacidosis; ability to self-feed; planned magnetic resonance imaging (MRI) examination;
- Pregnancy or breastfeeding;
- Extensive skin burns, dermatitis, or severe infections precluding the use of a continuous glucose monitoring system;
- Severe brain injury, brain death, or moribund state;
- Deemed unsuitable for study participation by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510000
About this study
Abstract: Hyperglycemia, hypoglycemia, and glucose variability in ICU patients are associated with adverse outcomes. Continuous Glucose Monitoring Systems (CGMS) offer dynamic glucose monitoring and early warnings to improve glucose management. This study aims to evaluate the accuracy and reliability of the CGMS (Microtech AiDEX®) in critically ill patients and its performance under acidosis conditions, providing evidence for its application in the ICU.
Methods: This prospective observational study included patients with BG>180 mg/dL on intravenous insulin therapy. Blood glucose was monitored using point-of-care (POC), arterial blood gas analysis (aBG), and CGMS. CGMS values were paired 1:1 with POC and aBG values. CGMS accuracy was evaluated using MARD, ISO 15197-2013, CLSI POCT12-A3, and Clarke Error Grid Analysis.
- Conditions
- Hyperglycemia in Critically Ill Patients
- Being tested
- Continuous Glucose Monitoring Systems, Continuous Glucose Monitoring, CGMS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Glucose Monitoring SystemsDevice
A trained research member placed the AiDEX® Dynamic Continuous Glucose Monitoring System (Microtech Medical Devices (Hangzhou) Co., Ltd.) on the patient's abdomen, about 3-10 cm to the left or right of the navel, or on the back of the upper arm, according to the instructions. The sensor began to collect data 1-4 hours after successful activation, recording blood glucose values every 5 minutes for 7 consecutive days. For patients who stayed in the ICU for less than 7 days, the continuous glucose monitoring (CGM) was terminated on the day of ICU discharge, and the CGM device was removed.
Patients monitored their blood glucose using fingerstick point-of-care (POC) measurements every 1-6 hours as needed and had routine arterial blood gas analysis 4-6 times a day. After 24 hours of patient wear, the arterial blood gas glucose (aBG) was used to calibrate the CGMS device at least twice a day. Nurses recorded CGMS data paired with POC values and aBG values in a 1:1 format.
Continuous Glucose MonitoringDevice
This study is a single-center, prospective, observational study conducted in the Intensive Care Unit (ICU) of Nanfang Hospital, Southern Medical University, from May 2024 to August 2024. Patients with elevated blood glucose levels (BG>180 mg/dL) undergoing intravenous insulin therapy were included. Simultaneous blood glucose monitoring was performed using fingerstick blood samples and arterial blood gas analysis, along with the installation of CGMS for concurrent monitoring. CGMS data (CGM values) were recorded in a 1:1 paired format with fingerstick point-of-care (POC) values and arterial blood gas (aBG) values. The correlation of paired blood glucose data was examined using Pearson's correlation coefficient. The accuracy of CGMS was assessed using metrics such as Mean Absolute Relative Difference (MARD), ISO 15197-2013, CLSI POCT12-A3, and Clarke Error Grid Analysis, analyzed with R v.4.4.1 software.
Continuous Glucose MonitoringDevice
Patients who met the inclusion and exclusion criteria were enrolled in the study after obtaining informed consent from the patient or their legal representative. A trained research member placed the AiDEX® Dynamic Continuous Glucose Monitoring System (Microtech Medical Devices (Hangzhou) Co., Ltd.) on the patient's abdomen, about 3-10 cm to the left or right of the navel, or on the back of the upper arm, according to the instructions. The sensor began to collect data 1-4 hours after successful activation, recording blood glucose values every 5 minutes for 7 consecutive days. For patients who stayed in the ICU for less than 7 days, the continuous glucose monitoring (CGM) was terminated on the day of ICU discharge, and the CGM device was removed.
CGMSDevice
Patients who met the inclusion and exclusion criteria were enrolled in the study after obtaining informed consent from the patient or their legal representative. A trained research member placed the AiDEX® Dynamic Continuous Glucose Monitoring System (Microtech Medical Devices (Hangzhou) Co., Ltd.) on the patient's abdomen, about 3-10 cm to the left or right of the navel, or on the back of the upper arm, according to the instructions. The sensor began to collect data 1-4 hours after successful activation, recording blood glucose values every 5 minutes for 7 consecutive days. For patients who stayed in the ICU for less than 7 days, the continuous glucose monitoring (CGM) was terminated on the day of ICU discharge, and the CGM device was removed.
What is being measured
The primary outcome is the main question the study is designed to answer.
MARD
MARD was calculated as the average of absolute percentage differences between paired glucose measurements: MARD = (1/n) × Σ(|CGMS-Reference|/Reference) × 100%.
Measured: From enrollment to discharge/completion of 14-day CGMS wear.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start1 May 2024
- Primary completion15 Aug 2024
- Study completion10 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperglycemia in Critically Ill PatientsStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07201155
- Sponsor's protocol ID
- NFEC-2025-052
- Status last verified
- Sep 2025
- First submitted
- 24 Jun 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Accuracy of Continuous Glucose Monitoring Systems in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT07201155
- Acronym / sponsor ID
- NFEC-2025-052
- Conditions
- Hyperglycemia in Critically Ill Patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 15 Aug 2024 (actual)
- Study completion
- 10 Oct 2024 (actual)
- First posted
- 1 Oct 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.
Abstract: Hyperglycemia, hypoglycemia, and glucose variability in ICU patients are associated with adverse outcomes. Continuous Glucose Monitoring Systems (CGMS) offer dynamic glucose monitoring and early warnings to improve glucose management. This study aims to evaluate the accuracy and reliability of the CGMS (Microtech AiDEX®) in critically ill patients and its performance under acidosis conditions, providing evidence for its application in the ICU.
Methods: This prospective observational study included patients with BG>180 mg/dL on intravenous insulin therapy. Blood glucose was monitored using point-of-care (POC), arterial blood gas analysis (aBG), and CGMS. CGMS values were paired 1:1 with POC and aBG values. CGMS accuracy was evaluated using MARD, ISO 15197-2013, CLSI POCT12-A3, and Clarke Error Grid Analysis.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- blood glucose (BG>180 mg/dL) undergoing intravenous insulin therapy
Key inclusion criteria (4 listed)
- Age ≥18 years and ≤75 years;
- Expected ICU stay of at least 3 days;
- Elevated blood glucose (BG >180 mg/dL) requiring intravenous insulin therapy;
- Informed consent obtained from the patient or their legally authorized representative.
Key exclusion criteria (6 listed)
- Severe hepatic failure (Child-Pugh class C) or marked liver dysfunction (total bilirubin ≥50 μmol/L and alanine aminotransferase ≥3 times the upper limit of normal);
- Uncorrected diabetic ketoacidosis; ability to self-feed; planned magnetic resonance imaging (MRI) examination;
- Pregnancy or breastfeeding;
- Extensive skin burns, dermatitis, or severe infections precluding the use of a continuous glucose monitoring system;
- Severe brain injury, brain death, or moribund state;
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 SystemsA trained research member placed the AiDEX® Dynamic Continuous Glucose Monitoring System (Microtech Medical Devices (Hangzhou) Co., Ltd.) on the patient's abdomen, about 3-10 cm to the left or right of the navel, or on the back of the upper arm, according to the instructions. The sensor began to collect data 1-4 hours after successful activation, recording blood glucose values every 5 minutes for 7 consecutive days. For patients who stayed in the ICU for less than 7 days, the continuous glucose monitoring (CGM) was terminated on the day of ICU discharge, and the CGM device was removed. Patients monitored their blood glucose using fingerstick point-of-care (POC) measurements every 1-6 hours as needed and had routine arterial blood gas analysis 4-6 times a day. After 24 hours of patient wear, the arterial blood gas glucose (aBG) was used to calibrate the CGMS device at least twice a day. Nurses recorded CGMS data paired with POC values and aBG values in a 1:1 format. | Device | – |
| Continuous Glucose MonitoringThis study is a single-center, prospective, observational study conducted in the Intensive Care Unit (ICU) of Nanfang Hospital, Southern Medical University, from May 2024 to August 2024. Patients with elevated blood glucose levels (BG>180 mg/dL) undergoing intravenous insulin therapy were included. Simultaneous blood glucose monitoring was performed using fingerstick blood samples and arterial blood gas analysis, along with the installation of CGMS for concurrent monitoring. CGMS data (CGM values) were recorded in a 1:1 paired format with fingerstick point-of-care (POC) values and arterial blood gas (aBG) values. The correlation of paired blood glucose data was examined using Pearson's correlation coefficient. The accuracy of CGMS was assessed using metrics such as Mean Absolute Relative Difference (MARD), ISO 15197-2013, CLSI POCT12-A3, and Clarke Error Grid Analysis, analyzed with R v.4.4.1 software. | Device | – |
| Continuous Glucose MonitoringPatients who met the inclusion and exclusion criteria were enrolled in the study after obtaining informed consent from the patient or their legal representative. A trained research member placed the AiDEX® Dynamic Continuous Glucose Monitoring System (Microtech Medical Devices (Hangzhou) Co., Ltd.) on the patient's abdomen, about 3-10 cm to the left or right of the navel, or on the back of the upper arm, according to the instructions. The sensor began to collect data 1-4 hours after successful activation, recording blood glucose values every 5 minutes for 7 consecutive days. For patients who stayed in the ICU for less than 7 days, the continuous glucose monitoring (CGM) was terminated on the day of ICU discharge, and the CGM device was removed. | Device | – |
| CGMSPatients who met the inclusion and exclusion criteria were enrolled in the study after obtaining informed consent from the patient or their legal representative. A trained research member placed the AiDEX® Dynamic Continuous Glucose Monitoring System (Microtech Medical Devices (Hangzhou) Co., Ltd.) on the patient's abdomen, about 3-10 cm to the left or right of the navel, or on the back of the upper arm, according to the instructions. The sensor began to collect data 1-4 hours after successful activation, recording blood glucose values every 5 minutes for 7 consecutive days. For patients who stayed in the ICU for less than 7 days, the continuous glucose monitoring (CGM) was terminated on the day of ICU discharge, and the CGM device was removed. | Device | – |
Primary outcome
MARD
Time frame: From enrollment to discharge/completion of 14-day CGMS wear.
MARD was calculated as the average of absolute percentage differences between paired glucose measurements: MARD = (1/n) × Σ(|CGMS-Reference|/Reference) × 100%.
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 1 Oct 2025.
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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 Hyperglycemia in Critically Ill Patients, run by Nanfang Hospital, Southern Medical University 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 4 inclusion and 6 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 1 Oct 2025. 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?
MARD (time frame: From enrollment to discharge/completion of 14-day CGMS wear.). 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 1 Oct 2025.