Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CGM-guided glucose management | Experimental | 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. |
|
| POCT-guided glucose management | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peter R van Dijk, MD PhD | Contact | +316 88 624 50 00 | p.r.van.dijk@isala.nl |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| D006943 | Hyperglycemia |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000095583 | Continuous Glucose Monitoring |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
|
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 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |