Development of a Novel Algorithm for Real-Time Bedside Assessment of Insulin Resistance in Critically Ill Patients Based on Continuous Glucose Monitoring Data

NCT07385391 | Completed DMC

• 1 other identifier: Insulin0114
• Study Type: observational
• Target: 179
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Critical Illness; Metabolism Disorders; Insulin Resistance

Keywords

Metabolic Monitoring; Insulin Resistance; Prognosis

Outcome Measures

Primary Outcomes (1)

• ICU Mortality

  The incidence of all-cause death during the patient's stay in the Intensive Care Unit

  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

  From date of study enrollment until ICU discharge, assessed up to 30 days.

• Incidence of Hypoglycemia

  From date of study enrollment until ICU discharge, assessed up to 30 days.

• Duration of Vasopressor Dependency

  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

  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)

  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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

critically ill patient

You may qualify if:

• Age≥ 18 years and \< 80 years
• ICU stay ≤48 hours
• Expected ICU stay \> 24 hours
• APACHE II score≥ 8

You may not qualify if:

• local infection within the sensor placement area
• Laparotomy within lower abdomen
• Participated in this study before
• In other clinical trails

Sponsors & Collaborators

• Chinese Medical Association: lead

Study Sites (1)

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210000, China

Location

MeSH Terms

Conditions

Critical Illness; Metabolic Diseases; Insulin Resistance

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Hyperinsulinism; Glucose Metabolism Disorders

Study Officials

• Wenkui Yu, PhD, Professor

  The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 4, 2026
• Study Start: July 13, 2023
• Primary Completion: March 13, 2024
• Study Completion: October 1, 2025
• Last Updated: February 4, 2026

Record last verified: 2026-01

Locations

CN (1)