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.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 82
- 主要终点
- Time spent in hyperglycemia (>10 mmol/L)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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%)
排除标准
- •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
- •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)
研究组 & 干预措施
CGM-guided glucose management
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.
干预措施: Continuous Glucose Monitoring (Device)
POCT-guided glucose management
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.
干预措施: Point-of-Care Testing (Diagnostic Test)
结局指标
主要结局
Time spent in hyperglycemia (>10 mmol/L)
时间窗: During the first 72 hours of hospitalization
Percentage of time during hospitalization with glucose levels above 10 mmol/L measured using continuous glucose monitoring.
次要结局
- Duration of hypoglycemic episodes (<3.9 mmol/L)(During the first 72 hours of hospitalization)
- Duration of hyperlgycemic episodes (>10 mmol/L)(During the first 72 hours of hospitalization)
- Time in normoglycemia (3.9-10.0 mmol/L)(During the first 72 hours of hospitalization)
- Time in hypoglycemia (<3.9 mmol/L)(During the first 72 hours of hospitalization)
- In-hospital complications(During the first 72 hours of hospitalization)
- Neurological recovery(Baseline to 24 hours post-EVT)
- Good functional outcome(3 months post stroke)
- Health-related quality of life(3 months post stroke)
- All-cause mortality(3 months post stroke)
研究者
Peter van Dijk
Principal Investigator, Internist-Endocrinologist
Isala