The Dietary Education Trial in Carbohydrate Counting (DIET-CARB Study): A Randomized, Parallel, Open-label, Intervention Study Comparing Different Approaches to Dietary Self-management in Patients With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Change in HbA1c
研究概览
简要总结
The study is designed to evaluate two different dietitian-led self-management approaches in carbohydrate counting compared to routine dietary care (control) on glycaemic control in adult patients with type 1 diabetes:
- The basic carbohydrate counting concept aims at improving carbohydrate counting accuracy and day-to-day consistency of carbohydrate intake (the BCC intervention)
- The advanced carbohydrate counting concept aims at improving prandial insulin dose accuracy using an automated bolus calculator (the ABC-ACC intervention)
The main hypothesis is that structured training and education in either the BCC concept or the ABC-ACC concept will reduce HbA1c or the average glucose variability more than routine dietary education.
详细描述
The current study is a randomized controlled trial with a parallel-group design. A total of 231 patients will be enrolled in the trial. Participants will be randomized to one of three arms: 1) Basic carbohydrate counting (BCC), 2) Advanced carbohydrate counting with an automated bolus calculator (ABC-ACC), or 3) Standard dietary care.
The primary objective is to evaluate the six months effects of education in the BCC concept and the ABC-ACC concept compared to standard dietary care on glycaemic control as assessed by HbA1c or MAGE (mean amplitude of glycaemic excursions).
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes
- •Diabetes duration; >12 months
- •HbA1c of 53-97 mmol/mol
- •Multiple daily insulin injection therapy
- •Provided voluntary written informed consent
排除标准
- •Practicing carbohydrate counting, as judged by the investigator
- •Participated in a BCC group program within the last two years
- •Use of insulin pump, or plans of having an insulin pump within the study period
- •Fixed dose of rapid acting insulin therapy for meals
- •Split-mixed insulin therapy
- •Use of open CGM
- •Use of Freestyle Libre
- •Use of an automated bolus calculator
- •Gastroparesis
- •Pregnancy or breastfeeding, or plans of pregnancy within the study period
- •Low daily intake of carbohydrates (defined as below 25 E% or 100 g/day), as judged by the investigator
- •Uncontrolled medical issues, as judged by the investigator or a medical expert
- •Concomitant participation in other clinical studies
- •Unable to understand the informed consent and the study procedures
结局指标
主要结局
Change in HbA1c
时间窗: Baseline, 6 months
mmol/mol
Change in mean amplitude of glycaemic excursions (MAGE)
时间窗: Baseline, 6 months
mmol/l
次要结局
- Change in carbohydrate estimation accuracy(Baseline, 6 months, 12 months)
- Change in diet-related quality of life(Baseline, 6 months, 12 months)
- Change in perceived competences in diabetes(Baseline, 6 months, 12 months)
- Change in degree of autonomy-supportive dietitian(Baseline, 6 months, 12 months)
- Change in total energy intake(Baseline, 6 months)
- Change in dietary intake of carbohydrates(Baseline, 6 months)
- Change in body weight(Baseline, 6 months, 12 months)
- Change in free fatty acids (FFA)(Baseline, 6 months, 12 months)
- Change in triglycerides (TG)(Baseline, 6 months, 12 months)
- Change in systolic blood pressure(Baseline, 6 months, 12 months)
- Change in diastolic blood pressure(Baseline, 6 months, 12 months)
- Change in waist circumference(Baseline, 6 months, 12 months)
- Change in hip circumference(Baseline, 6 months, 12 months)
- Change in time in range (3.9-10.0 mmol/l)(Baseline, 6 months)
- Changes in % time spent in hypoglycaemia (<3.9 mmol/l)(Baseline, 6 months)
- Change % time spent in hyperglycaemia (e.g. >11.1 mmol/l)(Baseline, 6 months)
- Change in standard deviation of mean plasma glucose(Baseline, 6 months)
- Change in mathematical literacy(Baseline, 6 months, 12 months)
- Change in HbA1c(12 months)
- Change in high-density cholesterol (HDL-C)(Baseline, 6 months, 12 months)
- Change in total cholesterol (TC)(Baseline, 6 months, 12 months)
- Change in low-density lipoprotein cholesterol (LDL-C)(Baseline, 6 months, 12 months)
- Change in total fat free mass(Baseline, 6 months)
- Change in total fat mass(Baseline, 6 months)
- Change in dietary intake of total fat(Baseline, 6 months)
- Change in dietary intake of polyunsaturated fatty acids (PUFA)(Baseline, 6 months)
- Change in dietary intake of saturated fatty acids (SFA)(Baseline, 6 months)
- Change in dietary intake of monounsaturated fatty acids (MUFA)(Baseline, 6 months)
- Change in dietary intake of protein(Baseline, 6 months)
- Change in dietary intake of added sugar(Baseline, 6 months)
- Change in intake of dietary fibre(Baseline, 6 months)
研究者
Bettina Ewers
Head of Nutrition
Steno Diabetes Center Copenhagen