An Open-label, Randomized, Two-way, Cross-over Study to Assess the Efficacy of Single-hormone Closed-loop Strategy and Sensor-augmented Pump Therapy in Regulating Glucose Levels for 12 Days in Free-living Outpatient Conditions in Patients With Type 1 Diabetes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Percentage of time of glucose levels spent between 3.9 and 10 mmol/L.
研究概览
简要总结
Closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings.
The objective of this study is to compare the effectiveness of single-hormone closed-loop and sensor-augmented pump therapy in regulating day-and-night glucose levels in adults with T1D for 12 days in outpatient settings.
The investigators hypothesize that dual-hormone closed-loop will increase the percentage of time of glucose levels spent in the target range in adults compared to single-hormone closed-loop, which in turn will be more effective than sensor-augmented pump therapy.
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 of 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.
- •HbA1c ≤ 12%.
排除标准
- •Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator
- •Recent (< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery
- •Warfarin chronic treatment if INR monitoring cannot be evaluated (can increase the risk of bleeding)
- •Chronic use of acetaminophen. Acetaminophen may interfere with glucose sensor readings
- •Pregnancy (ongoing or current attempt to become pregnant)
- •Breastfeeding
- •No nearby party for assistance if needed
- •Plans to go abroad or travel at more than 2 hours distance from Montreal during the trial period
- •Severe hypoglycemic episode within two weeks of screening or during the run-in period
- •Severe hyperglycemic episode requiring hospitalization in the last 3 months
- •Current use of glucocorticoid medication (except low stable dose and inhaled steroids)
- •Known or suspected allergy to the trial products
- •Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator
- •Anticipation of a significant change in exercise regimen between admission and end of the trial (i.e. starting or stopping an organized sport)
研究组 & 干预措施
Sensor-augmented pump therapy
Participants will use sensor-augmented pump therapy with low-glucose suspend to regulate glucose levels. The low-glucose suspend feature available in the MiniMed® Paradigm® Veo™, Medtronic combined with the Enlite sensor® will be used. This feature allows for suspension of insulin delivery at a pre-set sensor glucose value for up to 2 hours.
干预措施: 12-day intervention with sensor-augmented pump therapy (Other)
Sensor-augmented pump therapy
Participants will use sensor-augmented pump therapy with low-glucose suspend to regulate glucose levels. The low-glucose suspend feature available in the MiniMed® Paradigm® Veo™, Medtronic combined with the Enlite sensor® will be used. This feature allows for suspension of insulin delivery at a pre-set sensor glucose value for up to 2 hours.
干预措施: Insulin pump (Device)
Sensor-augmented pump therapy
Participants will use sensor-augmented pump therapy with low-glucose suspend to regulate glucose levels. The low-glucose suspend feature available in the MiniMed® Paradigm® Veo™, Medtronic combined with the Enlite sensor® will be used. This feature allows for suspension of insulin delivery at a pre-set sensor glucose value for up to 2 hours.
干预措施: Continuous glucose monitoring system (Device)
Sensor-augmented pump therapy
Participants will use sensor-augmented pump therapy with low-glucose suspend to regulate glucose levels. The low-glucose suspend feature available in the MiniMed® Paradigm® Veo™, Medtronic combined with the Enlite sensor® will be used. This feature allows for suspension of insulin delivery at a pre-set sensor glucose value for up to 2 hours.
干预措施: Insulin (Drug)
Single-hormone closed-loop strategy
Variable subcutaneous insulin infusion will be used to regulate glucose levels. Participant's usual fast-acting insulin analog will be infused using a subcutaneous infusion pump (MiniMed® Paradigm® Veo™, Medtronic). Every 10 minutes, the glucose levels as measured by the sensor (Enlite sensor®, Medtronic) will be transferred automatically to a smartphone, that harbors the algorithm, that will calculate the recommended doses and will send it wirelessly to the infusion pump.
干预措施: 12-day intervention with single-hormone closed-loop strategy (Other)
Single-hormone closed-loop strategy
Variable subcutaneous insulin infusion will be used to regulate glucose levels. Participant's usual fast-acting insulin analog will be infused using a subcutaneous infusion pump (MiniMed® Paradigm® Veo™, Medtronic). Every 10 minutes, the glucose levels as measured by the sensor (Enlite sensor®, Medtronic) will be transferred automatically to a smartphone, that harbors the algorithm, that will calculate the recommended doses and will send it wirelessly to the infusion pump.
干预措施: Insulin pump (Device)
Single-hormone closed-loop strategy
Variable subcutaneous insulin infusion will be used to regulate glucose levels. Participant's usual fast-acting insulin analog will be infused using a subcutaneous infusion pump (MiniMed® Paradigm® Veo™, Medtronic). Every 10 minutes, the glucose levels as measured by the sensor (Enlite sensor®, Medtronic) will be transferred automatically to a smartphone, that harbors the algorithm, that will calculate the recommended doses and will send it wirelessly to the infusion pump.
干预措施: Continuous glucose monitoring system (Device)
Single-hormone closed-loop strategy
Variable subcutaneous insulin infusion will be used to regulate glucose levels. Participant's usual fast-acting insulin analog will be infused using a subcutaneous infusion pump (MiniMed® Paradigm® Veo™, Medtronic). Every 10 minutes, the glucose levels as measured by the sensor (Enlite sensor®, Medtronic) will be transferred automatically to a smartphone, that harbors the algorithm, that will calculate the recommended doses and will send it wirelessly to the infusion pump.
干预措施: Insulin (Drug)
结局指标
主要结局
Percentage of time of glucose levels spent between 3.9 and 10 mmol/L.
时间窗: 288 hours
次要结局
- Percentage of time of glucose sensor availability(288 hours)
- Time between failures due to pump connectivity(288 hours)
- Percentage of time of overnight glucose levels spent below 2.8 mmol/L(72 hours)
- Percentage of time of glucose levels spent between 3.9 and 7.8 mmol/L(288 hours)
- Percentage of time of glucose levels spent below 3.9 mmol/L(288 hours)
- Percentage of time of glucose levels spent below 3.3 mmol/L(288 hours)
- Percentage of time of glucose levels spent above 13.9 mmol/L(288 hours)
- Percentage of time of glucose levels spent below 2.8 mmol/L(288 hours)
- Percentage of time of glucose levels spent above 10.0 mmol/L(288 hours)
- Percentage of time of glucose levels spent above 16.7 mmol/L(288 hours)
- Percentage of time of overnight glucose levels spent between 3.9 and 7.8 mmol/L(72 hours)
- Percentage of time of overnight glucose levels spent between 3.9 and 10.0 mmol/L(72 hours)
- Percentage of time of overnight glucose levels spent below 3.9 mmol/L(72 hours)
- Percentage of time of overnight glucose levels spent below 3.3 mmol/L(72 hours)
- Total number of hypoglycemic events below 3.1 mmol/L(288 hours)
- Number of nights with hypoglycemic events below 3.1 mmol/L(72 hours)
- Percentage of time of overnight glucose levels spent above 10.0 mmol/L(72 hours)
- Percentage of time of overnight glucose levels spent above 13.9 mmol/L(72 hours)
- Percentage of time of overnight glucose levels spent above 16.7 mmol/L(72 hours)
- Number of days with hypoglycemic events below 3.1 mmol/L(126 hours)
- Mean glucose levels(288 hours)
- Standard deviation of glucose levels(288 hours)
- Time between failures due to glucose sensor unavailability(288 hours)
- Coefficient of variation of glucose levels(288 hours)
- Between-day variability in glucose levels(288 hours)
- Total daily insulin dose(24 hours)
- Standard deviation of insulin delivery(288 hours)
- Coefficient of variation of insulin delivery(288 hours)
- Between-day variability in insulin delivery(288 hours)
- Total number of hours of glucose sensor availability(288 hours)
- Percentage of time when patients switched back to insulin pump therapy(288 hours)
- Number of hours when patients switched back to insulin pump therapy(288 hours)
- Percentage of time when the closed-loop was automatically switched to insulin pump therapy(288 hours)
- Number of hours when the closed-loop was automatically switched to insulin pump therapy(288 hours)
- Number of days with at least one technical problem(288 hours)
- Number of calls for technical issues related to the closed-loop system(288 hours)
- Number of patients calling for technical issues related to the closed-loop system(288 hours)
研究者
Rémi Rabasa-Lhoret
Professor of Medicine
Institut de Recherches Cliniques de Montreal