NCT02774876已完成2 期
An Open-label, Randomized, Four-way, Cross-over Study to Examine the Efficacy of Single-hormone Closed-loop System in Regulating Glucose Levels in Adults With Type 1 Diabetes Following Meals of Various Macronutrient Contents: a Pilot Study
Institut de Recherches Cliniques de Montreal1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2016年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Area under the curve of sensor glucose levels
研究概览
简要总结
Carbohydrates are the main determinant of post-meal glucose excursion. However, fat and protein have been shown to also impact the postprandial glucose control, adding to the complexity of meal insulin calculation. Few studies have looked at the effect of macronutrients other than carbohydrates on postprandial glucose excursions with the closed-loop strategy. The objective of this study is to test whether the single-hormone closed-loop strategy can achieve similar post-meal glucose control with meals with a fixed carbohydrate content, but high in protein and/or fat when compared to a meal with a fixed carbohydrate content only.
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
- •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 fast-acting insulin analog (Lispro, Aspart or Guilisine).
- •Last (less than 3 months) HbA1c ≤ 10%.
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.
- •Ongoing pregnancy.
- •Severe hypoglycemic episode within 1 month of screening.
- •Agents affecting gastric emptying (Motilium®, Prandase®, all GLP-1 analogs) 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®). Inhaled 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
Carbohydrate + protein meal
Active Comparator
干预措施: Patient's insulin pump (Device)
Carbohydrate + fat meal
Active Comparator
干预措施: Patient's insulin pump (Device)
Carbohydrate meal
Active Comparator
干预措施: Patient's insulin pump (Device)
Carbohydrate meal
Active Comparator
干预措施: Insulin (Drug)
Carbohydrate meal
Active Comparator
干预措施: Dexcom G4 Platinum glucose sensor (Device)
Carbohydrate meal
Active Comparator
干预措施: Single-hormone closed-loop (Other)
Carbohydrate + fat meal
Active Comparator
干预措施: Insulin (Drug)
Carbohydrate + fat meal
Active Comparator
干预措施: Dexcom G4 Platinum glucose sensor (Device)
Carbohydrate + fat meal
Active Comparator
干预措施: Single-hormone closed-loop (Other)
Carbohydrate + protein meal
Active Comparator
干预措施: Insulin (Drug)
Carbohydrate + protein meal
Active Comparator
干预措施: Dexcom G4 Platinum glucose sensor (Device)
Carbohydrate + protein meal
Active Comparator
干预措施: Single-hormone closed-loop (Other)
Carbohydrate + fat + protein meal
Active Comparator
干预措施: Patient's insulin pump (Device)
Carbohydrate + fat + protein meal
Active Comparator
干预措施: Insulin (Drug)
Carbohydrate + fat + protein meal
Active Comparator
干预措施: Dexcom G4 Platinum glucose sensor (Device)
Carbohydrate + fat + protein meal
Active Comparator
干预措施: Single-hormone closed-loop (Other)
结局指标
主要结局
Area under the curve of sensor glucose levels
时间窗: The outcome measure will be calculated over the 5 hours following the breakfast meal given on the single-hormone closed-loop intervention. The 5-hour period is from 8:00 to 13:00.
次要结局
- Time to peak glucose(The outcome measure will be calculated over the 5 hours following the breakfast meal given on the single-hormone closed-loop intervention. The 5-hour period is from 8:00 to 13:00.)
- Percentage of time of sensor glucose concentrations between 3.9 and 7.8 mmol/L(The outcome measure will be calculated over the 5 hours following the breakfast meal given on the single-hormone closed-loop intervention. The 5-hour period is from 8:00 to 13:00.)
- Percentage of time of sensor glucose concentrations between 3.9 and 10 mmol/L(The outcome measure will be calculated over the 5 hours following the breakfast meal given on the single-hormone closed-loop intervention. The 5-hour period is from 8:00 to 13:00.)
- Mean sensor glucose levels(The outcome measure will be calculated over the 5 hours following the breakfast meal given on the single-hormone closed-loop intervention. The 5-hour period is from 8:00 to 13:00.)
- Peak glucose excursion(The outcome measure will be calculated over the 5 hours following the breakfast meal given on the single-hormone closed-loop intervention. The 5-hour period is from 8:00 to 13:00.)
- Percentage of time of sensor glucose concentrations above 10 mmol/L(The outcome measure will be calculated over the 5 hours following the breakfast meal given on the single-hormone closed-loop intervention. The 5-hour period is from 8:00 to 13:00.)
- Percentage of time of sensor glucose concentrations above 13.9 mmol/L(The outcome measure will be calculated over the 5 hours following the breakfast meal given on the single-hormone closed-loop intervention. The 5-hour period is from 8:00 to 13:00.)
- Total insulin delivery(The outcome measure will be calculated over the 5 hours following the breakfast meal given on the single-hormone closed-loop intervention. The 5-hour period is from 8:00 to 13:00.)
- Standard deviation of glucose levels(The outcome measure will be calculated over the 5 hours following the breakfast meal given on the single-hormone closed-loop intervention. The 5-hour period is from 8:00 to 13:00.)
- Coefficient of variation of glucose levels(The outcome measure will be calculated over the 5 hours following the breakfast meal given on the single-hormone closed-loop intervention. The 5-hour period is from 8:00 to 13:00.)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Additional Insulin for High Fat/Protein in Type 1 DiabetesAdolescentType 1 DiabetesNCT05152121Ege University20
已完成
4 期
Lifestyle Modification for Obesity-Related Type 2 DiabetesOverweightType 2 Diabetes MellitusObesityNCT00415688Robert C. Atkins Foundation90
Unknown
不适用
Best Timing of Insulin Bolus Before Meals of Different ContentsType 1 Diabetes MellitusNCT01406496Kaplan Medical Center24
已完成
不适用
Postprandial Metabolic and Appetite Responses to Different Food Intake Sequences in AthletesHealthyNutrition, HealthyPostprandial HyperglycemiaHungerCravingNCT06365385Universidade do Porto14
已完成
不适用
Ordered Eating and Acute ExerciseGlucose Metabolism DisordersHungerNCT06242015Old Dominion University23