Acute Ischemic Stroke, Diabetes (DM), Diabetes Type 2, Hyperglycemia, Stroke
Conditions
Brief 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. 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
DEVICEContinuous 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_TESTPoint-of-Care Testing
Intermittent glucose monitoring using point-of-care finger-prick capillary blood glucose measurements according to the hospital glucose management protocol.
Sponsors
Isala
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time spent in hyperglycemia (>10 mmol/L) | 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
| Measure | Time frame | Description |
|---|---|---|
| Duration of hyperlgycemic episodes (>10 mmol/L) | During the first 72 hours of hospitalization | Duration of hyperglycemic episodes (\>10 mmol/L) measured using continuous glucose monitoring. |
| Duration of hypoglycemic episodes (<3.9 mmol/L) | During the first 72 hours of hospitalization | Duration of hypoglycemic episodes (\<3.9 mmol/L) measured using continuous glucose monitoring. |
| Time in normoglycemia (3.9-10.0 mmol/L) | 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. |
| Time in hypoglycemia (<3.9 mmol/L) | During the first 72 hours of hospitalization | Percentage of time with glucose levels \<3.9 mmol/L measured using continuous glucose monitoring |
| In-hospital complications | During the first 72 hours of hospitalization | Occurrence of in-hospital complications, including infection, symptomatic intracranial hemorrhage, and delirium during hospitalization. |
| Neurological recovery | 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. |
| Good functional outcome | 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). |
| Health-related quality of life | 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). |
| All-cause mortality | 3 months post stroke | — |
Contacts
CONTACTPeter R van Dijk, MD PhD
Outcome results
None listed