CGM in Acute Ischemic Stroke (SENSTROKE)

Continuous Glucose Monitoring for Enhanced Management of Hyperglycemia in Persons With Type 2 Diabetes Undergoing Endovascular Therapy for Acute Ischemic Stroke: a Randomized Controlled Trial.

The goal of this randomized clinical trial is to evaluate whether continuous glucose monitoring (CGM) can be used to guide glucose management in patients with type 2 diabetes who are admitted with an acute ischemic stroke and undergo endovascular therapy. Hyperglycemia frequently occurs during hospitalization in stroke and is associated with worse neurological and clinical outcomes. In current clinical practice, glucose levels are monitored using intermittent point-of-care testing (POCT) with finger-prick measurements, which may miss clinically relevant glucose fluctuations. CGM provides continuous glucose measurements and may allow earlier detection of hyperglycemia and more timely glucose management.

This study is designed as a non-inferiority randomized controlled trial comparing CGM-guided glucose management with standard POCT-guided glucose management. The primary objective is to determine whether CGM-guided glucose management is non-inferior to POCT-guided management in terms of percentage time spent in hyperglycemia (glucose >10 mmol/L) during the first 72 hours of hospitalization.

Researchers will compare CGM-guided glucose management to POCT-guided glucose management to evaluate whether CGM can be used as an alternative strategy to guide glucose control in hospitalized stroke patients.

Participants will:

• Be randomly assigned to either CGM-guided glucose management or standard POCT-guided glucose management
• Have their glucose levels continuously monitored (blinded in the POCT-guided group) during hospitalization
• Receive glucose management according to the assigned monitoring strategy, based on the hospital insulin protocol

Study Overview

• Status: Not yet recruiting
• Conditions: Hyperglycemia; Stroke; Acute Ischemic Stroke; Diabetes Type 2; Diabetes (DM)
• Intervention / Treatment: Device: Continuous Glucose Monitoring; Diagnostic test: Point-of-Care Testing

• Study Type: Interventional
• Enrollment (Estimated): 82
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Peter R van Dijk, MD PhD; Phone Number: +316 88 624 50 00; Email: p.r.van.dijk@isala.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥18 years
• Acute ischemic stroke treated with endovascular therapy (EVT)
• Type 2 diabetes mellitus, defined as one of the following:
• documented diagnosis of type 2 diabetes mellitus
• use of glucose-lowering medication
• admission plasma glucose ≥11.1 mmol/L
• HbA1c ≥48 mmol/mol (≥6.5%)

Exclusion Criteria:

• Current pregnancy
• Extensive skin infections or dermatological conditions at the intended sensor site
• Medical situations known to interfere with CGM accuracy, including:
• Hypotension defined as a systolic blood pressure <100 mmHg at 30 and 60 minutes after admission
• Dialysis treatment
• Estimated glomerular filtration rate (eGFR) <15 mL/min/1.73 m²
• Use of medications known to interfere with CGM accuracy, including:
• Acetaminophen >4 g/day
• Dopamine
• High-dose vitamin C (ascorbic acid)
• Hydroxyurea / hydroxycarbamide
• Clinically relevant pancreatic disease
• Systemic glucocorticoid therapy with a prednisone-equivalent dose >5 mg/day
• Expected admission to an intensive care unit (ICU)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CGM-guided glucose management; Participants receive glucose monitoring using a continuous glucose monitoring (CGM) system (FreeStyle Libre 2). Glucose management during hospitalization is guided by CGM measurements and used for treatment decisions according to the hospital glucose management protocol.	Device: Continuous Glucose Monitoring; Continuous glucose monitoring using the FreeStyle Libre systems (Abbott Diabetes Care) to measure interstitial glucose levels through a subcutaneous sensor that continuously records glucose concentrations during hospitalization.; Other Names: CGM; FreeStyle Libre 2
Active Comparator: POCT-guided glucose management; Participants receive standard glucose monitoring using intermittent point-of-care testing (POCT) with capillary finger-prick measurements. Glucose management during hospitalization follows the hospital glucose management protocol based on POCT values. A blinded continuous glucose monitoring sensor (FreeStyle Libre Pro iQ) is placed for data collection purposes only. CGM data are not available to the clinical team and are not used for treatment decisions.	Diagnostic test: Point-of-Care Testing; Intermittent glucose monitoring using point-of-care finger-prick capillary blood glucose measurements according to the hospital glucose management protocol.; Other Names: POCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time spent in hyperglycemia (>10 mmol/L)	Percentage of time during hospitalization with glucose levels above 10 mmol/L measured using continuous glucose monitoring.	During the first 72 hours of hospitalization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of hyperlgycemic episodes (>10 mmol/L)	Duration of hyperglycemic episodes (>10 mmol/L) measured using continuous glucose monitoring.	During the first 72 hours of hospitalization
Duration of hypoglycemic episodes (<3.9 mmol/L)	Duration of hypoglycemic episodes (<3.9 mmol/L) measured using continuous glucose monitoring.	During the first 72 hours of hospitalization
Time in normoglycemia (3.9-10.0 mmol/L)	Percentage of time with glucose levels between 3.9-10.0 mmol/L measured using continuous glucose monitoring.	During the first 72 hours of hospitalization
Time in hypoglycemia (<3.9 mmol/L)	Percentage of time with glucose levels <3.9 mmol/L measured using continuous glucose monitoring	During the first 72 hours of hospitalization
In-hospital complications	Occurrence of in-hospital complications, including infection, symptomatic intracranial hemorrhage, and delirium during hospitalization.	During the first 72 hours of hospitalization
Neurological recovery	Neurological recovery assessed by change in National Institutes of Health Stroke Scale (NIHSS) score (range 0-42, higher scores indicate more severe neurological deficit) from baseline to 24 hours post-EVT. Early neurological improvement is defined as a ≥4-point decrease in NIHSS score, and major neurological improvement as a ≥8-point decrease or NIHSS ≤1.	Baseline to 24 hours post-EVT
Good functional outcome	Good functional outcome defined as a modified Rankin Scale (mRS) score ≤2 (range 0-6, lower scores indicate better functional outcome).	3 months post stroke
Health-related quality of life	Health-related quality of life measured using the PROMIS-10 Global Health questionnaire (range 10-50, higher scores indicate better health-related quality of life).	3 months post stroke
All-cause mortality		3 months post stroke

Collaborators and Investigators

• Sponsor: Isala

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: March 24, 2026
• First Submitted That Met QC Criteria: March 31, 2026
• First Posted (Actual): April 6, 2026

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Ischemic Stroke; Stroke; Diabetes Mellitus, Type 2; Diabetes Mellitus; Hyperglycemia; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Blood Chemical Analysis; Clinical Chemistry Tests; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Continuous Glucose Monitoring
• Other Study ID Numbers: NL009652

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No