Glucose Profiles in Ramadan-fasting Diabetes Patients: Ramadan Flash Glucose Monitoring (RFGM) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 321
- 试验地点
- 1
- 主要终点
- Change in mean glucose level; (mmol/L)
研究概览
简要总结
Many Muslim patients with diabetes observe dawn to sunset fasting during the month of Ramadan. Hyperglycaemia and hypoglycaemia are possible problems amongst these patients. The aim of this study is to investigate glucose profiles in diabetes and non-diabetes patients that decided to fast or not to fast during Ramadan.
详细描述
A good knowledge of the profiles of blood glucose with different treatments can help in making Ramadan fasting free of unwanted effects for such patients. Previous studies, including the EPIDIAR have shown an increased risk of hypo- and hyperglycaemia in patients with diabetes who fast during the Holy month of Ramadan.Although self-monitoring of blood glucose (SMBG) is useful in fasting diabetes patients when used within a structured testing regimen, it requires a lot of effort and compliance from the patient and doesn't provide continuous blood glucose data. The amount of data provided using SMBG depends on the frequency of finger pricks measurements. Flash Glucose Monitoring (FGM) sensors provide a record of the individual's glucose levels, trends and patterns for up to 14 days. This sensor doesn't require calibration using finger pricks. FGM data show how day-to-day decisions and behaviours impact the control of blood sugar levels. Availability of FGM makes it possible to explore glucose profiles in a continuous fashion during Ramadan period and make comparisons with non-fasting times outside Ramadan. The aim of this study is to investigate glucose profiles in diabetes and non-diabetes patients that decided to fast or not to fast during Ramadan. The study will compare several parameters extracted from the FGM trace such us the incident of hypoglycaemia and hyperglycaemia, standard deviation, coefficient of variance and time in/above/below range. For this purpose the FreeStyle Libre sensor will be used. Patients will be asked to use the FreeStyle Libre sensor for a period of 3 months: 1 month before Ramadan, during Ramadan and one month after Ramadan.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diabetes, age>=18
排除标准
- •pregnancy, renal failure
结局指标
主要结局
Change in mean glucose level; (mmol/L)
时间窗: Pre-Ramadan (30 days), Ramadan (29 days), Post-Ramadan (30 days)
This primary outcome is aimed at measurement of change in mean glucose, in patients with diabetes, at the time points/frames indicated (Pre-Ramadan, Ramadan and Post-Ramadan).
Change in percentage of time in target blood glucose range (3.9 - 10.0 mmol/L); (%)
时间窗: Pre-Ramadan (30 days), Ramadan (29 days), Post-Ramadan (30 days)
This primary outcome is aimed at measurement of change in percentage of time in target blood glucose range,in patients with diabetes, at the time points/frames indicated (Pre-Ramadan, Ramadan and Post-Ramadan).
Coefficient of variance (CV); (coefficient; no units)
时间窗: Pre-Ramadan (30 days), Ramadan (29 days), Post-Ramadan (30 days)
This primary outcome is aimed at measurement of coefficient of variance of blood glucose, in patients with diabetes, at the time points/frames indicated (Pre-Ramadan, Ramadan and Post-Ramadan).
Area under the curve (AUC); ((mmol/L)*h)
时间窗: Pre-Ramadan (30 days), Ramadan (29 days), Post-Ramadan (30 days)
This primary outcome is aimed at measurement of area under the curve for blood glucose, in patients with diabetes, at the time points/frames indicated (Pre-Ramadan, Ramadan and Post-Ramadan).
次要结局
- Change in percentage of time in level 1 (>10.0 mmol/L); (%)(Pre-Ramadan (30 days), Ramadan (29 days), Post-Ramadan (30 days))
- Change in glucose management indicator (GMI) ; (index; no units)(Pre-Ramadan (30 days), Ramadan (29 days), Post-Ramadan (30 days))
- High blood glucose index (HBGI)(Pre-Ramadan (30 days), Ramadan (29 days), Post-Ramadan (30 days))
- Change in percentage of time in level 1 (<3.9 - 10.0 mmol/L) hypoglycaemic range (mmol/L); (%)(Pre-Ramadan (30 days), Ramadan (29 days), Post-Ramadan (30 days))
- Change in percentage of time in level 2 (<3.0 mmol/l) hypoglycaemic range (mmol/L); (%)(Pre-Ramadan (30 days), Ramadan (29 days), Post-Ramadan (30 days))
- Standard deviation (SD); (SD (no units) of glucose mmol/L)(Pre-Ramadan (30 days), Ramadan (29 days), Post-Ramadan (30 days))
- Low blood glucose index (LBGI)(Pre-Ramadan (30 days), Ramadan (29 days), Post-Ramadan (30 days))
- Change in percentage of time in level 2 (>13.9 mmol/L); (%)(Pre-Ramadan (30 days), Ramadan (29 days), Post-Ramadan (30 days))