Clinical Trial Protocol for Continuous Glucose Monitoring in Critical Care

NCT07687368 | Completed

• 4 other identifiers: HCB/2023/0377PR678/2024HOS-2023-021IRB00003099/CER052429
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

High blood glucose levels (hyperglycaemia) are very common in patients admitted to intensive care units (ICUs) and are associated with worse health outcomes. Traditionally, glucose levels in critically ill patients are monitored using point-of-care blood glucose (POC-G) testing (fingerstick, arterial, or venous blood samples), which may require multiple measurements each day. Continuous glucose monitoring (CGM) is a technology that measures glucose levels continuously throughout the day and night, providing real-time information and alerts when glucose levels are too high or too low. Previous studies have shown that CGM can be used safely in critically ill patients and may reduce the number of blood glucose tests required. However, more evidence is needed to determine whether CGM improves glucose control and patient outcomes in the ICU. The purpose of this study is to compare CGM-based glucose management with standard point-of-care glucose testing in critically ill patients with hyperglycaemia admitted to the Hospital Clínic of Barcelona. Participants will be randomly assigned to one of two groups. In the experimental group, healthcare professionals will use real-time CGM data to make glucose management decisions. In the control group, glucose management will be based on standard point-of-care testing, while CGM data will be collected in the background for later analysis. The study will evaluate whether CGM improves the amount of time that glucose levels remain within the target range, reduces episodes of high and low glucose, decreases the number of blood glucose tests required, and influences patient outcomes such as complications, hospital readmissions, and mortality up to 90 days after ICU discharge. Researchers hope that the results of this study will help determine whether CGM should become part of routine ICU care, improving patient safety, reducing the burden of glucose monitoring, and supporting more efficient clinical decision-making.

Conditions

Critical Care Nursing; Critical Care, Intensive Care; Glucose Control; Critical Illness; Hyperglycaemia; Continuous Glucose Monitoring

Outcome Measures

Primary Outcomes (1)

• Time in Range

  Percentage of time that glucose values remain within the target range of 70-180 mg/dL (3.9-10.0 mmol/L), measured by continuous glucose monitoring.

  During ICU stay (up to 10 days or until ICU discharge, death, or sensor removal).

Secondary Outcomes (7)

• Time Above Range (TAR)

  During ICU stay (up to 10 days or until ICU discharge, death, or sensor removal).

• Time Below Range (TBR)

  During ICU stay (up to 10 days or until ICU discharge, death, or sensor removal).

• Number of Point-of-Care Glucose Measurements

  During ICU stay (up ICU discharge or death)

• Hospital Readmissions

  Up to 90 days after ICU discharge.

• Morbidity at 90 Days

  Up to 90 days after ICU discharge.

Study Arms (2)

Conventional Glucose Measurement

SHAM COMPARATOR

Participants receive standard glycemic management according to ICU standard practice. Capillary blood glucose is the primary method used for insulin dose adjustment and is complemented, when clinically indicated, by arterial or venous blood glucose measurements. On average, approximately six blood glucose measurements are performed per day; however, the frequency may be increased or decreased according to the prescribed treatment regimen, insulin requirements, and the patient's clinical condition during ICU admission. CGM is used throughout the study period to collect glucose data. In this control arm, CGM data are blinded to healthcare professionals and are not used for clinical decision-making, serving as a sham intervention for study comparison purposes. All therapeutic decisions, including insulin dose adjustments, are based exclusively on conventional blood glucose measurements according to standard ICU practice.

Device: Conventional Glucose Measurement

Continuous Glucose Monitoring Group

EXPERIMENTAL

Participants randomized to the experimental group will receive glucose management guided by a CGM system. A CGM sensor will be inserted on the upper arm or abdomen and will provide real-time glucose measurements every 5 minutes. Glucose values, trends, and alerts for hyperglycaemia and hypoglycaemia will be available to the clinical team and used to support glycaemic management decisions during the ICU stay. The CGM system will be configured with predefined glucose alerts and predictive hypoglycaemia alarms. Healthcare professionals may perform additional point-of-care glucose measurements when clinically indicated, including confirmation of hypoglycaemia, extreme glucose values, or during intravenous insulin therapy according to safety criteria.

Device: Continuous Glucose Monitoring

Interventions

Continuous Glucose Monitoring DEVICE

CGM uses a subcutaneous sensor inserted into the upper arm or abdomen to measure interstitial glucose every 5 minutes. The system provides real-time glucose values, trends, and configurable alerts for hyperglycaemia and hypoglycaemia to support glycaemic management. Point-of-care blood glucose measurements may be performed when clinically indicated for confirmation of hypoglycaemia, extreme glucose values, or according to institutional safety protocols during intravenous insulin therapy.

Also known as: CGM, CGM Guided

Continuous Glucose Monitoring Group

Conventional Glucose Measurement DEVICE

Conventional glucose monitoring consists of capillary blood glucose measurements as the primary method for insulin dose adjustment according to standard ICU practice, complemented by arterial or venous blood glucose measurements when clinically indicated, all know as POC-G measurements. Glucose is typically measured approximately six times daily, with frequency adjusted according to clinical condition and insulin requirements. During the study, a CGM device is worn only for glucose data collection; CGM values remain blinded to healthcare professionals and are not used for clinical decision-making. All therapeutic decisions are based exclusively on conventional blood glucose measurements.

Also known as: POC-G Group, Conventional Group, Sham Group

Conventional Glucose Measurement

Eligibility Criteria

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

You may qualify if:

• Aged 18 years or over
• Stay in ICU and/or intermediate care
• Blood glucose levels \>180 mg/dL (10 mmol/L).

You may not qualify if:

• Pregnancy
• Contraindications for the use of CGM (such as skin issues or allergies to adhesives)
• End-of-life process

Sponsors & Collaborators

• Institut d'Investigacions Biomèdiques August Pi i Sunyer: lead

Study Sites (1)

Carrer de Villarroel, 170

Barcelona, Catalonia, 08036, Spain

Location

Related Publications (8)

• Panero-Moreno M, Muxella-Roson M, Dube-Llobet G, Cabrerizo-Jimenez M, Guix-Comellas EM, Villamor-Ordozgoiti A, Marsa-Perez N. The use of continuous glucose monitoring: A scoping review of accuracy, feasibility and nursing workload reduction in intensive care setting. Enferm Intensiva (Engl Ed). 2025 Jul-Sep;36(3):500534. doi: 10.1016/j.enfie.2025.500534.

  PMID: 40883056 BACKGROUND

• Faulds ER, Boutsicaris A, Sumner L, Jones L, McNett M, Smetana KS, May CC, Buschur E, Exline MC, Ringel MD, Dungan K. Use of Continuous Glucose Monitor in Critically Ill COVID-19 Patients Requiring Insulin Infusion: An Observational Study. J Clin Endocrinol Metab. 2021 Sep 27;106(10):e4007-e4016. doi: 10.1210/clinem/dgab409.

  PMID: 34100545 BACKGROUND

• Agarwal S, Mathew J, Davis GM, Shephardson A, Levine A, Louard R, Urrutia A, Perez-Guzman C, Umpierrez GE, Peng L, Pasquel FJ. Continuous Glucose Monitoring in the Intensive Care Unit During the COVID-19 Pandemic. Diabetes Care. 2021 Mar;44(3):847-849. doi: 10.2337/dc20-2219. Epub 2020 Dec 23.

  PMID: 33361145 BACKGROUND

• Rijkenberg S, van Steen SC, DeVries JH, van der Voort PHJ. Accuracy and reliability of a subcutaneous continuous glucose monitoring device in critically ill patients. J Clin Monit Comput. 2018 Oct;32(5):953-964. doi: 10.1007/s10877-017-0086-z. Epub 2017 Dec 7.

  PMID: 29218549 BACKGROUND

• Ammar MA, Ammar AA, Wee T, Deshpande R, Band M, Akhtar S. Relationship Between Glucose Time in Range in Diabetic and Non-Diabetic Patients and Mortality in Critically Ill Patients. J Intensive Care Med. 2022 Dec;37(12):1625-1633. doi: 10.1177/08850666221098383. Epub 2022 May 2.

  PMID: 35491687 BACKGROUND

• American Diabetes Association Professional Practice Committee for Diabetes*. 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes-2026. Diabetes Care. 2026 Jan 1;49(Suppl 1):S183-S215. doi: 10.2337/dc26-S009.

  PMID: 41358900 BACKGROUND

• Panero-Moreno M, Carbonell-Sabate C, Conesa-Gonzalez R, Risco-Patino L, Guix-Comellas EM, Villamor-Ordozgoiti A, Cordon-Arnau T. Continuous glucose monitoring in a critically ill patient with extracorporeal membrane oxygenation (ECMO), intra-aortic balloon pump, and continuous renal replacement therapy: Case report. Enferm Intensiva (Engl Ed). 2026 Apr-Jun;37(2):500589. doi: 10.1016/j.enfie.2026.500589. Epub 2026 Apr 11.

  PMID: 41967195 RESULT

• Panero-Moreno M, Guix-Comellas EM, Villamor-Ordozgoiti A. Clinical trial protocol for continuous glucose monitoring in critical care at Hospital Clinic of Barcelona (CGM-UCI23). Nurs Crit Care. 2025 May;30(3):e13198. doi: 10.1111/nicc.13198. Epub 2024 Oct 28.

  PMID: 39467825 RESULT

MeSH Terms

Conditions

Critical Illness; Hyperglycemia

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• Eva M Guix-Comellas, PhD

  University of Barcelona

  STUDY DIRECTOR

• Alberto Villamor-Ordozgoiti, PhD

  Hospital Clínic of Barcelona

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded. Both study groups will wear the same CGM sensor and receiver. In the experimental group, glucose data will be visible to the clinical team and used for glycaemic management. In the control group, continuous glucose monitoring data will be unavailable for clinical decision-making. Due to the nature of the intervention, ICU nurses and treating clinicians cannot be blinded to group assignment.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups.

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: July 7, 2026
• Study Start: June 14, 2025
• Primary Completion: June 1, 2026
• Study Completion: June 1, 2026
• Last Updated: July 7, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Beginning 12 months after publication of the study results and ending 5 years after publication.
• Access Criteria: Anonymized IPD underlying the published results to researchers upon reasonable request. Requests will be reviewed by the principal investigator and may require approval from the relevant ethics committee and the sponsoring institution. Data will be provided for scientifically sound research purposes and in accordance with applicable data protection regulations. Access will be granted through a secure data-sharing process following the execution of an appropriate data access agreement.

Locations

ES (1)