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Acute Ischemic StrokeSENSTROKENCT07510919

CGM in Acute Ischemic Stroke

A study testing Continuous Glucose Monitoring and Point-of-Care Testing in people with Acute Ischemic Stroke and Diabetes (DM), run by Isala.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Continuous Glucose Monitoring and Point-of-Care Testing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
No sites listed yet
Study dates
Apr 2026to Aug 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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%)

Who cannot join

  • 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
Show all 14Show fewer
  • 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)

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Peter R van Dijk, MD PhD contact

+316 88 624 50 00

p.r.van.dijk@isala.nl

About this study

Official 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.

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.

Read more

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
Being tested
Continuous Glucose Monitoring, Point-of-Care Testing
Medical subject headings
Ischemic Stroke, Diabetes Mellitus, Diabetes Mellitus, Type 2, Hyperglycemia, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Continuous Glucose MonitoringDevice

    Also called FreeStyle Libre 2, CGM

    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.

  • Point-of-Care TestingDiagnostic test

    Also called POCT

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

Study groups in NCT07510919
Study groupRoleWhat they receive
CGM-guided glucose managementExperimentalParticipants 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.
Receives: Device: Continuous Glucose Monitoring
POCT-guided glucose managementActive comparatorParticipants 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.
Receives: Diagnostic Test: Point-of-Care Testing

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: During the first 72 hours of hospitalization

Secondary outcomes (9)

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

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

    Measured: During the first 72 hours of hospitalization

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

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

    Measured: During the first 72 hours of hospitalization

  3. 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.

    Measured: During the first 72 hours of hospitalization

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

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

    Measured: During the first 72 hours of hospitalization

  5. In-hospital complications

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

    Measured: During the first 72 hours of hospitalization

  6. 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.

    Measured: Baseline to 24 hours post-EVT

  7. Good functional outcome

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

    Measured: 3 months post stroke

  8. 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).

    Measured: 3 months post stroke

  9. All-cause mortality

    Measured: 3 months post stroke

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2026
  2. Study startApr 2026 (estimated)
  3. Primary completionMay 2028 (estimated)
  4. Study completionAug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a prospective, single-center, open-label, randomized controlled trial with a parallel assignment design comparing CGM-guided versus POCT-guided glucose management in patients with type 2 diabetes mellitus and acute ischemic stroke undergoing endovascular therapy. Participants are randomized 1:1 to either CGM-guided or POCT-guided management. In the intervention group, CGM is used to guide treatment decisions, while in the control group glucose management is based on intermittent POCT, with blinded CGM for data collection. The study is designed as a non-inferiority trial to evaluate whether CGM-guided glucose management is non-inferior to POCT-guided management in terms of percentage time spent in hyperglycemia (\>10 mmol/L) during the first 72 hours of hospitalization.
Masking
None (open label)
Enrolment
82 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07510919
Sponsor's protocol ID
NL009652
Acronym
SENSTROKE
Status last verified
Mar 2026
First submitted
24 Mar 2026
Last updated
6 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Continuous Glucose Monitoring and Point-of-Care Testing in people with Acute Ischemic Stroke and Diabetes (DM), run by Isala.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Peter R van Dijk, MD PhD (+316 88 624 50 00, p.r.van.dijk@isala.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time spent in hyperglycemia (>10 mmol/L) (time frame: During the first 72 hours of hospitalization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07510919.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.

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