A Single-blind, Randomized, Two-way, Cross-over Study to Examine the Safety of Overestimation of a Meal Insulin Bolus in the Context of Dual-hormone Closed-loop Operation Combined With a Simplified Qualitative Meal-size Estimation in Adults With Type 1 Diabetes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Percentage of time below 4.0 mmol/L
研究概览
简要总结
In previous studies, investigators have studied if a pre-meal insulin bolus based on estimated carbohydrate meal size would alleviate the burden of carbohydrate counting without a significant degradation in postprandial glucose control. With this strategy, the patient would only have to evaluate the size of the meal in terms of carbohydrate (snack, regular, large or very large) It is however important to establish safety of this simplified meal bolus approach. The safety of overestimating a meal insulin bolus in the context of single and dual-hormone CLS with the simplified meal strategy needs to be determined. Computer simulation will be used to get a reasonable estimate of risks related to over-estimation with single-hormone closed-loop while over-estimation with dual-hormone closed-loop will be tested in adults with type 1 diabètes
Investigators hypothesize that dual-hormone closed-loop with overestimated meal size bolus will not increase time below 4.0 mmol/L compared to dual-hormone closed-loop with an adequately estimated meal size bolus
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
- Single (Participant)
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
- •Males and females ≥ 18 years old.
- •Clinical diagnosis of type 1 diabetes for at least one year.
- •The subject will have been on insulin pump therapy for at least 3 months and currently using a fast actin insulin analog (Lispro, Aspart or Guilisine).
- •Last (less than 3 months) HbA1c ≤ 10%.
- •Currently using carbohydrate counting as the meal insulin dose strategy.
排除标准
- •Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy (especially diagnosed gastroparesis) or severe proliferative retinopathy as judged by the investigator.
- •Recent (< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
- •Severe hypoglycemic episode within 1 month of screening.
- •Agents affecting gastric emptying (Motilium®, Prandase®, Victoza®, Byetta® and Symlin®) as well as oral anti-diabetic agents (Metformin, SGLT-2 inhibitors and DPP-4 inhibitors) if not at a stable dose for 3 months. Otherwise, these medications are acceptable and will be kept stable during the entire protocol.
- •Oral steroids unless patients present a low stable dose (e.g. 10 mg or less of prednisone per day or physiological doses, less than 35 mg/day, of hydrocortisone Cortef®). Inhale steroids at stable dose in the last month are acceptable.
- •Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator (e.g. unstable psychiatric condition).
- •Failure to comply with team's recommendations (e.g. not willing to change pump parameters, follow algorithm's suggestions, etc).
研究组 & 干预措施
Dual-hormone CL with overestimation of meal size category
A large size standardized meal of 75g of carbohydrates will be provided to the patient and the meal size will be overestimated by one category, which will result in a meal insulin bolus for a meal of 95g of carbohydrates.
干预措施: Dual-hormone closed-loop (Other)
Dual-hormone CL with overestimation of meal size category
A large size standardized meal of 75g of carbohydrates will be provided to the patient and the meal size will be overestimated by one category, which will result in a meal insulin bolus for a meal of 95g of carbohydrates.
干预措施: Insulin (Drug)
Dual-hormone CL with overestimation of meal size category
A large size standardized meal of 75g of carbohydrates will be provided to the patient and the meal size will be overestimated by one category, which will result in a meal insulin bolus for a meal of 95g of carbohydrates.
干预措施: Glucagon (Drug)
Dual-hormone CL with overestimation of meal size category
A large size standardized meal of 75g of carbohydrates will be provided to the patient and the meal size will be overestimated by one category, which will result in a meal insulin bolus for a meal of 95g of carbohydrates.
干预措施: Dexcom G4 Platinum glucose sensor (Device)
Dual-hormone CL with overestimation of meal size category
A large size standardized meal of 75g of carbohydrates will be provided to the patient and the meal size will be overestimated by one category, which will result in a meal insulin bolus for a meal of 95g of carbohydrates.
干预措施: Accu Chek Combo insulin pump (Device)
Dual-hormone CL with adequate estimation of meal size category
A large size standardized meal of 75g of carbohydrates will be provided to the patient and the meal size will be adequately estimated, which will result in a meal insulin bolus for a meal of 65g of carbohydrates.
干预措施: Dual-hormone closed-loop (Other)
Dual-hormone CL with adequate estimation of meal size category
A large size standardized meal of 75g of carbohydrates will be provided to the patient and the meal size will be adequately estimated, which will result in a meal insulin bolus for a meal of 65g of carbohydrates.
干预措施: Insulin (Drug)
Dual-hormone CL with adequate estimation of meal size category
A large size standardized meal of 75g of carbohydrates will be provided to the patient and the meal size will be adequately estimated, which will result in a meal insulin bolus for a meal of 65g of carbohydrates.
干预措施: Glucagon (Drug)
Dual-hormone CL with adequate estimation of meal size category
A large size standardized meal of 75g of carbohydrates will be provided to the patient and the meal size will be adequately estimated, which will result in a meal insulin bolus for a meal of 65g of carbohydrates.
干预措施: Dexcom G4 Platinum glucose sensor (Device)
Dual-hormone CL with adequate estimation of meal size category
A large size standardized meal of 75g of carbohydrates will be provided to the patient and the meal size will be adequately estimated, which will result in a meal insulin bolus for a meal of 65g of carbohydrates.
干预措施: Accu Chek Combo insulin pump (Device)
结局指标
主要结局
Percentage of time below 4.0 mmol/L
时间窗: The outcome measure will be calculated over the 4 hours following the breakfast meal given on the dual-hormone closed-loop intervention. The 4-hour period is from 9:00 to 13:00.
次要结局
- Mean glucose(The outcome measure will be calculated over the 4 hours following the breakfast meal given on the dual-hormone closed-loop intervention. The 4-hour period is from 9:00 to 13:00.)
- Percentage of time of glucose concentrations below 3.1 mmol/L(The outcome measure will be calculated over the 4 hours following the breakfast meal given on the dual-hormone closed-loop intervention. The 4-hour period is from 9:00 to 13:00.)
- Number of patients with at least one hypoglycemic event with or without symptoms(The outcome measure will be calculated over the 4 hours following the breakfast meal given on the dual-hormone closed-loop intervention. The 4-hour period is from 9:00 to 13:00.)
- Total insulin delivery(The outcome measure will be calculated over the 4 hours following the breakfast meal given on the dual-hormone closed-loop intervention. The 4-hour period is from 9:00 to 13:00.)
- Percentage of time of glucose concentrations between 4.0 and 8.0 mmol/L(The outcome measure will be calculated over the 4 hours following the breakfast meal given on the dual-hormone closed-loop intervention. The 4-hour period is from 9:00 to 13:00.)
- Percentage of time of glucose concentrations between 4.0 and 10.0 mmol/L(The outcome measure will be calculated over the 4 hours following the breakfast meal given on the dual-hormone closed-loop intervention. The 4-hour period is from 9:00 to 13:00.)
- Total number of hypoglycemic event below 3.1 mmol/L(The outcome measure will be calculated over the 4 hours following the breakfast meal given on the dual-hormone closed-loop intervention. The 4-hour period is from 9:00 to 13:00.)
- Total carbohydrate intake for hypoglycemia correction(The outcome measure will be calculated over the 4 hours following the breakfast meal given on the dual-hormone closed-loop intervention. The 4-hour period is from 9:00 to 13:00.)
- Area under the curve of glucose values below 4.0 mmol/L(The outcome measure will be calculated over the 4 hours following the breakfast meal given on the dual-hormone closed-loop intervention. The 4-hour period is from 9:00 to 13:00.)
- Area under the curve of glucose values below 3.1 mmol/L(The outcome measure will be calculated over the 4 hours following the breakfast meal given on the dual-hormone closed-loop intervention. The 4-hour period is from 9:00 to 13:00.)
- Total glucagon delivery(The outcome measure will be calculated over the 4 hours following the breakfast meal given on the dual-hormone closed-loop intervention. The 4-hour period is from 9:00 to 13:00.)
研究者
Rémi Rabasa-Lhoret
Associate Professor of Medicine
Institut de Recherches Cliniques de Montreal