CGM in Acute Ischemic Stroke
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Continuous Glucose Monitoring, Point-of-Care Testing.
- Who it may be relevant to
- Registry conditions: Acute Ischemic Stroke, Diabetes (DM), Diabetes Type 2, Hyperglycemia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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.
Overview
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
Interventions
- 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. - 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.
Primary outcome measures
- Time spent in hyperglycemia (>10 mmol/L) [Time frame: During the first 72 hours of hospitalization]
Secondary outcome measures (9)
- Duration of hyperlgycemic episodes (>10 mmol/L) [Time frame: During the first 72 hours of hospitalization]
- Duration of hypoglycemic episodes (<3.9 mmol/L) [Time frame: During the first 72 hours of hospitalization]
- Time in normoglycemia (3.9-10.0 mmol/L) [Time frame: During the first 72 hours of hospitalization]
- Time in hypoglycemia (<3.9 mmol/L) [Time frame: During the first 72 hours of hospitalization]
- In-hospital complications [Time frame: During the first 72 hours of hospitalization]
- Neurological recovery [Time frame: Baseline to 24 hours post-EVT]
- Good functional outcome [Time frame: 3 months post stroke]
- Health-related quality of life [Time frame: 3 months post stroke]
- All-cause mortality [Time frame: 3 months post stroke]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07510919 · NL009652