Effectiveness of Carbohydrate Counting on Glycaemic Control in T1DM Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- glycemic control
研究概览
简要总结
Carbohydrate counting is the most effective meal-planning strategy in type 1 diabetes (T1DM) to optimize insulin therapy. However, it may lead to weight gain and unhealthy eating habits. This study aims to compare glycemic control parameters, anthropometric measurements and dietary lifestyle in T1DM patients who practice CHO-counting, after attending a structured course to learn how to manage this tecnique, vs a control Group, in a follow up period of 2 years.
详细描述
patients with type 1 DM will be enrolled in the study. patients in the intervention group will attend a 5-lessons training to learn how to manage insulin therapy depending on the amount of carbohydrates in their meals, patients in the control group will be follow according to the the standard care. after the follow up period glycometabolic, anthropometric parameters and dietary lifestyle changes will be compared between the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 1 diabetes mellitus
- •insulin therapy
- •HbA1c from 5.5 to 10%
排除标准
- •pregnancy
- •celiac disease
- •hepatic impairment
- •chronic renal failure
研究组 & 干预措施
carbo-counters
carbohydrate counting: patients attending a structured carbohydrate-counting training and practicing this tecnique to manage insulin therapy
干预措施: carbohydrate counting (Behavioral)
control group
insulin therapy according to standard care. patients who don't practice carbohydrate-counting to manage insulin therapy
干预措施: insulin therapy according to standard care (Behavioral)
结局指标
主要结局
glycemic control
时间窗: 2 years
HbA1c
次要结局
- dietary lifestyle(2 years)
- glucose variability: mean and standard deviation of self monitoring blood glucose (SMBG)(2 YEARS)
- glucose variability: incidence of hypoglycaemia(2 YEARS)
- anthropometric parameters: BMI(2 years)
- anthropometric parameters: WAIST AND HIP CIRCUMFERENCE(2 years)
- anthropometric parameters: BIOIMPEDENTIOMETRIC PARAMETERS(2 years)
研究者
Emanuela Orsi
Head of DIabetology
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico