Critical IllnessNCT07385391
Development of a Novel Algorithm for Real-Time Bedside Assessment of Insulin Resistance in Critically Ill Patients Based on Continuous Glucose Monitoring Data
An observational study of Critical Illness and Metabolism Disorders, run by Chinese Medical Association at 1 site in China.
Trial summary
This study aims to develop and validate a novel algorithm for the real-time assessment of insulin resistance in critically ill patients using Continuous Glucose Monitoring (CGM). Current methods for assessing insulin resistance are often invasive or unfeasible in the intensive care setting. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Critical Illness, Metabolism Disorders, Insulin Resistance
- How many people
- 179 participants
- Where
- 1 siteChina
- Study dates
- 13 Jul 2023to 1 Oct 2025
- How long will I take part?
- 6 Months
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: critically ill patient
Who may be able to join
- Age≥ 18 years and < 80 years
- ICU stay ≤48 hours
- Expected ICU stay > 24 hours
- APACHE II score≥ 8
Who cannot join
- local infection within the sensor placement area
- Laparotomy within lower abdomen
- Participated in this study before
- In other clinical trails
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of a Novel Algorithm for Real-Time Bedside Assessment of Insulin Resistance in Critically Ill Patients Based on Continuous Glucose Monitoring Data: A Multicenter, Observational, Prospective Study
This study aims to develop and validate a novel algorithm for the real-time assessment of insulin resistance in critically ill patients using Continuous Glucose Monitoring (CGM). Current methods for assessing insulin resistance are often invasive or unfeasible in the intensive care setting. By analyzing the dynamic correlation between CGM readings and reference blood glucose fluctuations, the investigators seek to construct a new algorithmic metric. The study will further evaluate the association of this new metric with established insulin resistance indices, organ function, and patient clinical outcomes.
Read the detailed description
Insulin resistance (IR) is prevalent among critically ill patients, particularly those with sepsis, and is significantly associated with increased mortality, prolonged length of stay, and infectious complications. Consequently, real-time and accurate bedside monitoring of the degree of insulin resistance in this population is of paramount importance.
Current clinical modalities for assessing insulin resistance (IR) in critical illness remain insufficient. The "gold standard" hyperinsulinemic-euglycemic clamp (HEC) is restricted by invasiveness, complexity, and cost, while its artificial steady-state fails to reflect glucose dynamics under acute stress. Alternatively, HOMA-IR is a static, hepatic-focused measure; its reliance on fasting baselines is often unfeasible due to continuous nutrition, precluding accurate assessment of peripheral glucose disposal. Similarly, the Oral Glucose Tolerance Test (OGTT) is limited by gastrointestinal dysmotility and confounded by stress-induced insulin dysregulation. Consequently, a novel strategy for real-time, dynamic, and bedside IR assessment is urgently required to overcome these limitations.
This study aims to develop a novel algorithm for the real-time, bedside assessment of insulin resistance utilizing continuous glucose monitoring (CGM) data. A primary focus is the evaluation of the capability of CGM to capture dynamic glycemic fluctuations; specifically, the correlation between the magnitude of change in reference blood glucose between time points and the concurrent change in CGM readings will be analyzed. Based on the concordance of these dynamic variations, a new algorithmic metric is to be constructed. Subsequently, the association of this metric with established insulin resistance indices, organ function, and patient prognosis will be investigated to validate its clinical utility as a minimally invasive tool for monitoring metabolic status in critically ill patients.
- Conditions
- Critical Illness, Metabolism Disorders, Insulin Resistance
- Keywords
- Metabolic Monitoring, Insulin Resistance, Prognosis
- Medical subject headings
- Critical Illness, Metabolic Diseases, Insulin Resistance
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU Mortality
The incidence of all-cause death during the patient's stay in the Intensive Care Unit
Measured: From date of study enrollment until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 60 days
Secondary outcomes (5)
Incidence of Hyperglycemia
The proportion of participants who experience at least one episode of hyperglycemia during the observation period. Hyperglycemia is defined as a blood glucose level greater than 180 mg/dL (10 mmol/L).
Measured: From date of study enrollment until ICU discharge, assessed up to 30 days.
Incidence of Hypoglycemia
The proportion of participants who experience at least one episode of hypoglycemia during the observation period. Hypoglycemia is defined as a blood glucose level less than 70 mg/dL (3.9 mmol/L). Severe hypoglycemia is defined as less than 40 mg/dL (2.2 mmol/L).
Measured: From date of study enrollment until ICU discharge, assessed up to 30 days.
Duration of Vasopressor Dependency
The total length of time a patient requires continuous intravenous vasoactive drugs to maintain adequate blood pressure.
Measured: From date of study enrollment until the date of vasopressor cessation for at least 24 hours, assessed up to 30 days.
Duration of Invasive Mechanical Ventilation
The total length of time a patient requires endotracheal intubation and support from a mechanical ventilator.
Measured: From date of study enrollment until the date of successful extubation, tracheostomy, or death from any cause, whichever came first, assessed up to 30 days
Duration of Continuous Renal Replacement Therapy (CRRT)
The total length of time a patient requires continuous renal replacement therapy for acute kidney injury.
Measured: From date of study enrollment until the date of CRRT discontinuation for at least 24 hours or death from any cause, whichever came first, assessed up to 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start13 Jul 2023
- Primary completion13 Mar 2024
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 179 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Chinese Medical Association
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Wenkui Yu, PhD, Professor, Principal investigator, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07385391
- Sponsor's protocol ID
- Insulin0114
- Status last verified
- Jan 2026
- First submitted
- 27 Jan 2026
- Last updated
- 4 Feb 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 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Novel Algorithm for Real-Time Bedside Assessment of Insulin Resistance in Critically Ill Patients Based on Continuous Glucose Monitoring Data: A Multicenter, Observational, Prospective Study
- ClinicalTrials.gov ID
- NCT07385391
- Acronym / sponsor ID
- Insulin0114
- Conditions
- Critical Illness, Metabolism Disorders, Insulin Resistance
- Keywords
- Metabolic Monitoring, Insulin Resistance, Prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Chinese Medical AssociationResearch network
- Study start
- 13 Jul 2023 (actual)
- Primary completion
- 13 Mar 2024 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 4 Feb 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 study aims to develop and validate a novel algorithm for the real-time assessment of insulin resistance in critically ill patients using Continuous Glucose Monitoring (CGM). Current methods for assessing insulin resistance are often invasive or unfeasible in the intensive care setting. By analyzing the dynamic correlation between CGM readings and reference blood glucose fluctuations, the investigators seek to construct a new algorithmic metric. The study will further evaluate the association of this new metric with established insulin resistance indices, organ function, and patient clinical outcomes.
Detailed description
Insulin resistance (IR) is prevalent among critically ill patients, particularly those with sepsis, and is significantly associated with increased mortality, prolonged length of stay, and infectious complications. Consequently, real-time and accurate bedside monitoring of the degree of insulin resistance in this population is of paramount importance.
Current clinical modalities for assessing insulin resistance (IR) in critical illness remain insufficient. The "gold standard" hyperinsulinemic-euglycemic clamp (HEC) is restricted by invasiveness, complexity, and cost, while its artificial steady-state fails to reflect glucose dynamics under acute stress. Alternatively, HOMA-IR is a static, hepatic-focused measure; its reliance on fasting baselines is often unfeasible due to continuous nutrition, precluding accurate assessment of peripheral glucose disposal. Similarly, the Oral Glucose Tolerance Test (OGTT) is limited by gastrointestinal dysmotility and confounded by stress-induced insulin dysregulation. Consequently, a novel strategy for real-time, dynamic, and bedside IR assessment is urgently required to overcome these limitations.
This study aims to develop a novel algorithm for the real-time, bedside assessment of insulin resistance utilizing continuous glucose monitoring (CGM) data. A primary focus is the evaluation of the capability of CGM to capture dynamic glycemic fluctuations; specifically, the correlation between the magnitude of change in reference blood glucose between time points and the concurrent change in CGM readings will be analyzed. Based on the concordance of these dynamic variations, a new algorithmic metric is to be constructed. Subsequently, the association of this metric with established insulin resistance indices, organ function, and patient prognosis will be investigated to validate its clinical utility as a minimally invasive tool for monitoring metabolic status in critically ill patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- critically ill patient
Key inclusion criteria (4 listed)
- Age≥ 18 years and < 80 years
- ICU stay ≤48 hours
- Expected ICU stay > 24 hours
- APACHE II score≥ 8
Key exclusion criteria (4 listed)
- local infection within the sensor placement area
- Laparotomy within lower abdomen
- Participated in this study before
- In other clinical trails
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ICU Mortality
Time frame: From date of study enrollment until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 60 days
The incidence of all-cause death during the patient's stay in the Intensive Care Unit
5 secondary outcomes
Incidence of Hyperglycemia
Time frame: From date of study enrollment until ICU discharge, assessed up to 30 days.
Incidence of Hypoglycemia
Time frame: From date of study enrollment until ICU discharge, assessed up to 30 days.
Duration of Vasopressor Dependency
Time frame: From date of study enrollment until the date of vasopressor cessation for at least 24 hours, assessed up to 30 days.
Duration of Invasive Mechanical Ventilation
Time frame: From date of study enrollment until the date of successful extubation, tracheostomy, or death from any cause, whichever came first, assessed up to 30 days
Duration of Continuous Renal Replacement Therapy (CRRT)
Time frame: From date of study enrollment until the date of CRRT discontinuation for at least 24 hours or death from any cause, whichever came first, assessed up to 30 days.
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 4 Feb 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.
Wenkui Yu, PhD, Professor principal investigator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
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 Critical Illness and Metabolism Disorders, run by Chinese Medical Association 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 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: finished, as of the sponsor's last update on 4 Feb 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?
ICU Mortality (time frame: From date of study enrollment until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 60 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 4 Feb 2026.