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NCT Number: NCT07510919

CGM in Acute Ischemic Stroke

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

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Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Diabetes (DM) Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetes Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperglycemia Ischemic Stroke Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Continuous glucose monitoring

Device

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: FreeStyle Libre 2, CGM

Point-of-Care Testing

Diagnostic Test

Intermittent glucose monitoring using point-of-care finger-prick capillary blood glucose measurements according to the hospital glucose management protocol.

Other names: POCT

Primary outcomes

  1. Time spent in hyperglycemia (>10 mmol/L)

    Time frame: During the first 72 hours of hospitalization

    Percentage of time during hospitalization with glucose levels above 10 mmol/L measured using continuous glucose monitoring.

Secondary outcomes

  1. Duration of hyperlgycemic episodes (>10 mmol/L)

    Time frame: During the first 72 hours of hospitalization

    Duration of hyperglycemic episodes (>10 mmol/L) measured using continuous glucose monitoring.

  2. Duration of hypoglycemic episodes (<3.9 mmol/L)

    Time frame: During the first 72 hours of hospitalization

    Duration of hypoglycemic episodes (<3.9 mmol/L) measured using continuous glucose monitoring.

  3. Time in normoglycemia (3.9-10.0 mmol/L)

    Time frame: During the first 72 hours of hospitalization

    Percentage of time with glucose levels between 3.9-10.0 mmol/L measured using continuous glucose monitoring.

  4. Time in hypoglycemia (<3.9 mmol/L)

    Time frame: During the first 72 hours of hospitalization

    Percentage of time with glucose levels <3.9 mmol/L measured using continuous glucose monitoring

  5. In-hospital complications

    Time frame: During the first 72 hours of hospitalization

    Occurrence of in-hospital complications, including infection, symptomatic intracranial hemorrhage, and delirium during hospitalization.

  6. Neurological recovery

    Time frame: Baseline to 24 hours post-EVT

    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.

  7. Good functional outcome

    Time frame: 3 months post stroke

    Good functional outcome defined as a modified Rankin Scale (mRS) score ≤2 (range 0-6, lower scores indicate better functional outcome).

  8. Health-related quality of life

    Time frame: 3 months post stroke

    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).

  9. All-cause mortality

    Time frame: 3 months post stroke

Study contacts

Contact information is provided by the study sponsor or research team.

Peter R van Dijk, MD PhD

CONTACT

[email protected]

+316 88 624 50 00

Sponsors and collaborators

Lead sponsor

Isala

Other

Registry information

Official study title

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.

Acronym: SENSTROKE

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 6, 2026
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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