Clinical Assessment of Carbohydrate Counting in Adult Patients With Type 1 Diabetes Treated With Continuous Subcutaneous Insulin Infusion: a Randomized Controlled Study (GIOCAR)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Glycated haemoglobin (HbA1c)
研究概览
简要总结
The investigators postulate that carbohydrate (CHO) counting in adult patients with type 1 diabetes mellitus (T1DM) treated with continuous subcutaneous insulin infusion (CSII) may improve glycemic control, glycemic variability and quality of life.
详细描述
This study was designed as a randomized, controlled (versus standard education), open, one-center trial. Patients in group 1 were taught carbohydrate counting to estimate insulin preprandial bolus, while the patients in group 2 followed standard education. Primary outcome (glycosylated hemoglobin, HbA1c) and secondary outcomes (fasting glucose, glycemic variability, insulin requirement, body mass index (BMI), waist circumference, quality of life) were measured at baseline, 3, and 6 months.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 1 diabetes mellitus
- •age 18-65
- •continuous subcutaneous insulin infusion for at least 3 months
排除标准
- •patients who have already been trained in carbohydrate counting
- •known hypothyroidism not on replacement therapy
- •renal disease (serum creatinine >1.4 mg/dl in females and >1.7 mg/dl in males)
- •patients with celiac disease
- •pregnancy
- •serious diseases or disabilities which may interfere with study assessments
结局指标
主要结局
Glycated haemoglobin (HbA1c)
时间窗: 6 months
次要结局
- Fasting glucose(6 months)
- Glycemic variability (mean, sd, min, max, variability range, BG in target range, LBGI, HBGI) based on capillary glucose data(6 months)
- Daily insulin requirement (basal daily requirement, bolus daily requirement, total daily requirement)(6 months)
- Body Mass Index (BMI)(6 months)
- Waist circumference(6 months)
- Quality of life by Diabetes Specific Quality of Life Scale (DSQOLS) questionnaire(6 months)
- Hypoglycemia (capillary glucose<50 mg/dl)(6 months)