Looping Whilst Restricting Carbohydrates (LINEAR) - a Randomised Two-Period Crossover Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Percentage of time in target glucose range (3.9 - 10.0 mmol/L)
研究概览
简要总结
To investigate the efficacy, safety and utility of hybrid closed-loop glucose control during a low carbohydrate vs. iso-energetic balanced diet in individuals with type 1 diabetes.
详细描述
Closed-loop systems combining an insulin pump, a glucose sensor and a dosing algorithm that adjusts insulin delivery in a glucose-responsive manner achieve significantly better glucose control than conventional therapy in type 1 diabetes. Achieving satisfactory postprandial glucose control, however, continues to be challenging. The main limitation is the delayed pharmacokinetics and -dynamics of subcutaneously administered insulin with peak actions between 1 and 2 hours. Conversely, glucose levels typically rise within 10minutes following carbohydrate intake. This mismatch largely explains the inability of current closed-loop systems to control postprandial glucose excursions and the increased risk of late postprandial hypoglycaemia in response to both user-derived meal bolus administration and reactive algorithm-driven insulin infusion.
Restricting carbohydrate may therefore significantly improve post-prandial glucose control whilst reducing hypoglycaemia. The efficacy of hybrid closed-loop operation in individuals with type 1 diabetes adhering to a low carbohydrate compared to a iso-caloric balanced diet has not been investigated to date.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- •Female and male subjects aged 18 years or older
- •Diabetes mellitus Type 1 as definded by WHO for at least 2 years or C-peptide negative (<100 pmol/L with concomitant blood glucose > 4 mmol/L)
- •hybrid-closed-loop Insulin therapy (Minimed 670G) for at least 2 months
- •HbA1c <= 9 %
- •The subject is willing and capable of adhering to the diet plan.
排除标准
- •Physical or psychological condition likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator.
- •Excess alcohol consumption (> 3 units/day for men, > 2 units/day for women)
- •Pregnancy, planned pregnancy or breast feeding
- •Current participation in another clinical trial
- •Total daily insulin dose >2 IU/kg/day
- •Nephrolithiasis
- •Hereditary dyslipidemia
- •Liver steatosis
结局指标
主要结局
Percentage of time in target glucose range (3.9 - 10.0 mmol/L)
时间窗: 2 weeks
The percentage of time in target glucose range will be assessed using continuous glucose monitoring (CGM).
次要结局
- Hypoglycemia burden quantified as the area under the curve (AUC) with glucose < 3 mmol/L(2 weeks)
- Daily manual bolus Insulin dose (U)(2 weeks)
- Percentage of time above target (>10 mmol/L)(2 weeks)
- Percentage of time in hypoglycemia (<3.0 mmol/L)(2 weeks)
- 2 hour postprandial glucose increment (mmol/)(2 weeks)
- Between days coefficient of variation of glucose (%)(2 weeks)
- Night-time mean glucose levels(Between 00:00-06:00 over 2 weeks)
- Within night-time standard deviation of glucose (mmol/l)compared to within daytime period (06: - 24:00) standard deviation of glucose (mmol/l)(Between 00:00-06:00 over 2 weeks)
- Night-time percentage of time in target glucose range (3.9 - 10.0 mmol/L)(Between 00:00-06:00 over 2 weeks)
- Percentage of time in hyperglycemia (>16.7 mmol/L)(2 weeks)
- Total daily insulin dose (U)(2 weeks)
- Within day coefficient of variation of glucose (%)(2 weeks)
- Percentage of time below target (<3.9 mmol/L)(2 weeks)
- Night-time percentage of time below target (< 3.9 mmol/L)(Between 00:00-06:00 over 2 weeks)
- Change from baseline in lipid profile(2 weeks)
- Change from baseline in fasting plasma metabolome(2 weeks)
- Night-time percentage of time in hypoglycemia (< 3.0 mmol/L)(Between 00:00-06:00 over 2 weeks)
- Mean glucose levels (mmol/l)(2 weeks)
- Within-day standard deviation of glucose (mmol/l)(2 weeks)
- Night-time percentage of time above target (> 10.0 mmol/L)(Between 00:00-06:00 over 2 weeks)
- Night-time percentage of time in hyperglycemia (> 16.7 mmol/L)(Between 00:00-06:00 over 2 weeks)
- Within nighttime coefficient of variation of glucose(%)(Between 00:00-06:00 over 2 weeks)
- Total daily calorie intake (kcal/day)(2 weeks)
- Mean beta-hydroxy butyrate level(2 weeks)
- Incidence of (serious) adverse events(12 weeks)
- Percentage of time when pump was in Auto-mode(2 weeks)
研究者
Lia Bally
Head of Metabolic Science Research Group
Insel Gruppe AG, University Hospital Bern