NCT03832907已完成不适用
Inpatient and Post-hospital Discharge Assessment of Glycemic Control by Capillary Point-of-care Glucose Testing and by Continuous Glucose Monitoring in Insulin-treated Patients With Type 1 and Type 2 Diabetes: Dexcom G6 Observational Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 2
- 主要终点
- Number of Clinical Significant Hypoglycemia (<54 mg/dl) Events by POC Reading Compared to CGM Reading
研究概览
简要总结
This is an exploratory prospective study primary aiming to evaluate differences between Point-of-care (POC) testing (standard of care) and Dexcom G6 CGM (Continues Glucose Monitoring sensor system) in 1) glycemic control measured by mean daily blood glucose and 2) identifying hypoglycemic and hyperglycemic events - in patients with type 1 and type 2 diabetes treated with basal bolus insulin regimen.
详细描述
Several studies have shown that the use of a device that can measure blood glucose levels every 5 minutes is more effective in identifying low blood glucose (hypoglycemia) and high blood glucose (hyperglycemia) when compared to regular measurements with fingersticks [point of care (POC)].
This is an exploratory prospective study primary aiming to evaluate differences between Point-of-care (POC) testing (standard of care) and Dexcom G6 CGM (Continues Glucose Monitoring sensor system) in 1) glycemic control measured by mean daily blood glucose and 2) identifying hypoglycemic and hyperglycemic events - in patients with type 1 and type 2 diabetes treated with basal bolus insulin regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •> 18 years admitted to a general medicine or surgical service.
- •Known history of T1D or T2D receiving insulin therapy
- •Subjects must have a randomization BG between 140 mg and 400 mg/dL without laboratory evidence of diabetic ketoacidosis (bicarbonate < 18 mEq/L, pH < 7.30, or positive serum or urinary ketones).
- •Patients with expected hospital length-of-stay of 3 or more days
排除标准
- •Patients with acute illness admitted to the ICU or expected to require admission to the ICU.
- •Patients expected to require MRI procedures during hospitalization.
- •Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
- •Female subjects who are pregnant or breast-feeding at time of enrollment into the study.
结局指标
主要结局
Number of Clinical Significant Hypoglycemia (<54 mg/dl) Events by POC Reading Compared to CGM Reading
时间窗: During hospital stay (3 days - up to 30 days)
Number of clinical significant hypoglycemia (\<54 mg/dl) events will be calculated
Mean Daily Blood Glucose by POC Reading сompared to CGM Reading
时间窗: During hospital stay (3 days - up to 30 days)
Mean daily blood glucose will be calculated
Number of Severe Hyperglycemia (>240 mg/dl) Events by POC Reading Compared to CGM Reading
时间窗: During hospital stay (3 days - up to 30 days)
Number of severe hyperglycemia (\>240 mg/dl) events will be recorded
次要结局
- Percentage of Patients With Greater Than 5%-Time Below Glucose Target <70 mg/dl by CGM Reading(10 days post discharge)
- Percentage of Patients With Greater Than 5%-Time Above Glucose Target >180 mg/dl by CGM Reading(10 days post discharge)
- Number of Hypoglycemic Events < 54mg/dl by POC Reading Compared to CGM Reading(10 days post discharge)
- Percentage of Patients With Greater Than 5%-Time Below Glucose Target <54mg/dl by CGM Reading(During hospital stay (3 days - up to 30 days))
- Percentage of Dexcom G6 CGM Sensor Values Within 15/15% for Values 140-180 mg/dl , Compared to the Standard-of-care POC BG(During hospital stay (3 days - up to 30 days))
- Time in Hypoglycemia (Minutes) During the Day and Night by CGM Reading(10 days post discharge)
- Number of Hyperglycemic Events > 240 mg/dl by POC Reading Compared to CGM Reading(10 days post discharge)
- Percentage of Values Within Zone A, B, C of the Clarke Error Grid Measured in Arm(During hospital stay (3 days - up to 30 days) measured in arm)
- Percentage of Patients With Greater Than 5%-Time Below Glucose Target <54 mg/dl by CGM Reading(10 days post discharge)
- Number of Clinical Significant Hypoglycemia (<54 mg/dl) Events by POC Reading Compared to CGM Reading(10 days post discharge)
- Number of Nocturnal Hypoglycemic Events < 70 mg/dl (Between 22:00 and 06:00) by POC Reading Compared to CGM Reading(10 days post discharge)
- Number of Hypoglycemic Events < 70mg/dl by POC Reading Compared to CGM Reading(10 days post discharge)
- Percentage of Patients With Greater Than 5%-Time Below Glucose Target <70mg/dl by CGM Reading(During hospital stay (3 days - up to 30 days))
- Percentage of Patients With Greater Than 5%-Time Above Glucose Target >180mg/dl by CGM Reading(During hospital stay (3 days - up to 30 days))
- Mean Absolute Relative Difference (MARD) of CGM Compared to POC(During hospital stay (3 days - up to 30 days))
- Percentage of Dexcom G6 CGM Sensor Values Within 30/30% for Values < 70 mg/d Compared to the Standard-of-care POC BG(During hospital stay (3 days - up to 30 days))
- Mean Daily Blood Glucose by POC Reading Compared to CGM Reading(10 days post discharge)
- Time in Hyperglycemia (Minutes) During the Day and Night> 240 mg/dl by CGM Reading(10 days post discharge)
- Percentage of BG Readings Within Target BG of 70 and 180 mg/dl by POC Reading Compared to CGM Reading(10 days post discharge)
- Number of Nocturnal Hypoglycemic Events < 54 mg/dl (Between 22:00 and 06:00) by POC Reading Compared to CGM Reading(10 days post discharge)
- Number of Clinical Significant Severe Hyperglycemia (>240 mg/dl) Events by POC Reading Compared to CGM Reading(10 days post discharge)
- Number of of Hypoglycemic Events < 70mg/dl in POC Group by POC Reading Compared to CGM Reading(During hospital stay (3 days - up to 30 days))
- Glycemic Variability Calculated by Standard Deviation by CGM Reading(10 days post discharge)
- Glycemic Variability Calculated by MAGE by CGM Reading(During hospital stay (3 days - up to 30 days))
- Number of Sensor Removal/Failures/Dislodgments(During hospital stay (3 days - up to 30 days))
- Percentage of Values Within Zone A, B, C, D of the Clarke Error Grid Measured in Abdomen(During hospital stay (3 days - up to 30 days))
- Number of of Hypoglycemic Events < 54 in POC Group by POC Reading Compared to CGM Reading(During hospital stay (3 days - up to 30 days))
- Percentage of Patients With Greater Than 5%-Time Above Glucose Target >240 mg/dl by CGM Reading(During hospital stay (3 days - up to 30 days))
- Percentage of Dexcom G6 CGM Sensor Values Within 20/20% for Values < 70 mg/dl Compared to the Standard-of-care POC BG(During hospital stay (3 days - up to 30 days))
- Percentage of Dexcom G6 CGM Sensor Values Within 20/20%for Values > 180 mg/dl, Compared to the Standard-of-care POC BG(During hospital stay (3 days - up to 30 days))
- Percentage of Dexcom G6 CGM Sensor Values Within 30/30% for Values 70-140 mg/dl Compared to the Standard-of-care POC BG(During hospital stay (3 days - up to 30 days))
- Percentage of Dexcom G6 CGM Sensor Values Within 30/30% for Values 140-180 mg/dl , Compared to the Standard-of-care POC BG(During hospital stay (3 days - up to 30 days))
- Percentage of Dexcom G6 CGM Sensor Values Within 30/30%for Values > 180 mg/dl, Compared to the Standard-of-care POC BG(During hospital stay (3 days - up to 30 days))
- Percentage of Dexcom G6 CGM Sensor Values Within 20/20% for Values 140-180 mg/dl , Compared to the Standard-of-care POC BG(During hospital stay (3 days - up to 30 days))
- Percentage of Dexcom G6 CGM Sensor Values Within 15/15%for Values > 180 mg/dl, Compared to the Standard-of-care POC BG(During hospital stay (3 days - up to 30 days))
- Percentage of Dexcom G6 CGM Sensor Values Within 20/20% for Values 70-140 mg/dl Compared to the Standard-of-care POC BG(During hospital stay (3 days - up to 30 days))
- Percentage of Dexcom G6 CGM Sensor Values Within 15/15% for Values < 70 mg/dl Compared to the Standard-of-care POC BG(During hospital stay (3 days - up to 30 days))
- Percentage of Dexcom G6 CGM Sensor Values Within 15/15% for Values 70-140 mg/dl Compared to the Standard-of-care POC BG(During hospital stay (3 days - up to 30 days))
研究者
Guillermo Umpierrez, MD
Professor
Emory University
研究点 (2)
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