Critical Illness, Hyperglycaemia, Hypoglycaemia
Conditions
Keywords
continuous glucose monitoring, icu
Brief summary
Glucose control is an important part of supportive care for critically ill patients. Achieving optimal glucose control in such situations is challenging due to frequent fluctuations in blood glucose levels. These changes are often difficult to detect because the monitoring procedures are complex and require significant staff involvement, frequent blood draws, and consequent blood loss. Continuous glucose monitoring (CGM) is a simple and minimally invasive technique that has been approved and increasingly used by people with diabetes mellitus. However, its effectiveness in terms of glucose control management and accuracy in conditions with severe organ dysfunction has not been established. The goal of this study is to assess the performance of CGM-guided glucose control in comparison to the standard glucose monitoring procedure. Additionally, the accuracy of CGM measurements under critical conditions will be evaluated against the standard of care.
Detailed description
This study will be an investigator-initiated, non-commercial, prospective, single-center, parallel-group, randomized controlled trial. Critically ill patients with hyperglycemia requiring intravenous insulin therapy will be randomly assigned to two groups: an intervention group that will receive intravenous insulin therapy aided by continuous glucose monitoring (CGM) measurements and a control group that will receive intravenous insulin therapy guided by arterial blood glucose measurements (RadiometerABL800). Patients will be enrolled within 48 hours after ICU admission. Intravenous insulin dosing will be adjusted according to the in-house glycaemic management protocol. After enrollment, patients will be monitored for maximal 10 days (duration of the sensor) or until stopping intravenous insulin therapy, ICU discharge or death, whichever occurs first, if these events happen before the sensor duration ends. The primary outcome of the study will be the proportion of time spent within the target range of 7.8-10.0 mmol/L. Secondary outcomes will include mean glucose levels and other CGM metrics, daily vasoactive-inotropic score calculation, hospital length of stay, hospital-acquired infections, and acute renal failure. Additionally, an accuracy analysis in extreme clinical conditions (pH \< 7.20, post-resuscitation, ECMO support, severe haemodynamic instability, hypoxia) will be performed by comparing CGM measurements measured by DexcomG7 with arterial blood glucose measurements (RadiometerABL800) from the electronic health record. Satisfaction of health-care personnel will be evaluated. Sensor-related complications will be monitored.
Interventions
DEVICEContinuous glucose monitoring
Intravenous insulin therapy will be guided by interstitial glucose measurements using DexcomG7 continuous glucose monitor. Confirmatory blood glucose tests will be performed daily. In extreme clinical conditions (post-resuscitation, pH \< 7.20, severe hypoxia, severe haemodynamic compromise), confirmatory blood tests will be performed in 2 hour intervals until clinical improvement.
DIAGNOSTIC_TESTControl Arm - standard of care
Intravenous insulin dosing will be guided according to blood glucose measurements using RadiometerABL800 (standard of care). DexcomG7 continuous glucose monitor will be applied in blinded mode for interstitial glucose monitoring for later CGM metrics and comparison analysis.
Sponsors
University Medical Centre Ljubljana
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age ≥ 18 years * admission to the level 3 ICU * two consecutive blood glucose measurements \> 10.0 mmol/L * intravenous insulin therapy
Exclusion criteria
* expected ICU stay \< 48 hours * pregnancy * type 1 diabetes * diabetic emergencies (DKA, DAHS) * severe skin disease * severe neutropenia (\< 0.5 × 10\^9/L) * severe coagulopathy (thrombocytes \< 20 × 10\^9/L) * manufacturer-defined conditions (hydroxyurea use, acetaminophen more than 4 g daily)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time in range 7,8 - 10,0 mmol/l | from the enrollment until completion of the continuous glucose monitoring (up to 10 days) | Percentage of time within recommended glucose range |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic variability | from the enrollment until completion of the continuous glucose monitoring (up to 10 days) | assessed by the coefficient of variation (CV) and standard glucose variation |
| Vasopressor inotropic score | from the enrollment until completion of the continuous glucose monitoring (up to 10 days) | estimated amount of vasopressor support, daily calculated with the Vasoactive Inotropic Score (VIS): minimum 0 - 5 points (low doses), maximum \> 45 points (highest doses) |
| Hospital acquired infections | from the enrollment until hospital discharge, approximately 30 days | pneumonia, bloodstream infections, urinary infections |
| Acute renal failure | from the enrollment until hospital discharge, approximately 30 days | defined by AKIN (acute kidney injury) classification |
| Mean glucose levels | from the enrollment until completion of the continuous glucose monitoring (up to 10 days) | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time below range (level 1 and 2) | from the enrollment until completion of the continuous glucose monitoring (up to 10 days) | percentage of time below 3,0 - 3,8 mmol/l (level 1) and below 3,0 mmol/l (level 2) |
| Time above range (level 1 and 2) | from the enrollment until completion of the continuous glucose monitoring (up to 10 days) | percentage of time above 10,1 - 13,9 mmol/l (level 1) and above 13,9 mmol/l (level 2) |
| Hospital mortality | from the enrollment and before hospital discharge, approximately 30 days | death during hospitalization |
Countries
Slovenia
Contacts
Primary ContactMilica Lukic, MD
Backup ContactAlenka Golicnik, MD PhD
Outcome results
None listed