Comparison of Two Closed-Loop Strategies for Glucose Control in Type 1 Diabetes The DREMED Trail- 2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Percentage of glucose sensor readings within 70 to 180 mg/dl
研究概览
简要总结
The purpose of the study is to compare two closed-loop strategies in terms of glycemic control in Type 1 Diabetes during a camp setting.
The proposed study is a four-segment feasibility study. One segment is a proof of concept study (with two parts) conducted as in-patient clinic study ,the second segment is two-arms, cross-over, randomized and single-center and the third segment is four-arms, parallel, randomized and single-center, in diabetes camp study in subjects with type 1 diabetes on insulin pump therapy and the forth segment is a single arm feasibility in a diabetes camp setting followed by a 3 weeks period at home.
Segment 1 will be divided into two parts: part 1 is a single arm pilot study aim to asses logistical and safety issues in 12 patients and part 2 is a randomized cross over study aim to evaluate glucose performance using closed-loop control. Part 2-is a randomized cross-over (two arms) in-patient study: A total of 12 patients will participate in this part of the study. Following the run-in period subjects will be randomized to participate in two periods of closed-loop treatment, each period will last 36 hours in hospital setting. During the first period, glycemic control will be controlled by the Hybrid closed-loop system and during the second period by Hybrid Logic closed-loop system. The sequence of treatment first period HCL therapy than AHCL or vice versa will be randomly assigned.
Segment 2 is a randomized cross-over (two arms) Camp Study including up to 30 patients. Following the run-in period subjects will be randomized to participate in two periods of closed-loop treatment, each period will last 2days in a camp setting, the total duration of the camp will be up to 6 days. In one period, glycemic control will be controlled by the Hybrid closed-loop system and another period by Hybrid Logic closed-loop system. The sequence of treatment first period HCL therapy than AHCL or vice versa will be randomly assigned.
Segment 3 is a randomized, parallel (four arm) Camp Study including up to 80 patients. Following the run-in period subjects will be randomized to participate in one of 4 intervention arms of closed-loop treatment in camp settings. The duration of the camp will be 12 days in which glycemic control will be controlled by one of 4 versions of closed-loop system: Hybrid Closed Loop (HCL) or one of 3 versions of Advanced Hybrid Closed Loop (AHCL).
Segment 4 is a single arm, feasibility study in a diabetes camp setting followed by a three week period at home. After the completion of segments 1-3, the AHCL system will be optimized and a new version of the system will be created for use in segment 4. Up to 20 subjects will participate in this part of the study. Following a minimum of 5 days run-in period, subjects will be placed in a camp setting and closed loop will be initiated. Subjects will remain in closed loop for 5 days and will have 3 days of challenges, including missed meal bolus, late meal bolus and moderate-intensity exercise. At the conclusion of the camp, subjects will continue to use the system at home in Auto Mode for a period of 21 days.
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
- 10 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes duration > 1 year since diagnosis
- •Pump therapy for at least 6 months and experience with sensor use
- •Age10-40 years: Age 10-30 for segments 1-3, Age 14-40 for segment
- •7>HbA1c <10.0 at time of screening visit for segments 1 and 2, <10.0 at segments 3 and
- •Willing to follow study instructions
- •Willing to perform ≥ 3 finger stick blood glucose measurements daily
- •Willing to perform required sensor calibrations
- •Patient capable of reading and understand instructions in English
- •Willing to have an adult experienced in the management of diabetes to live with during the outpatient phase of the protocol.
排除标准
- •Subject is unable to tolerate tape adhesive in the area of sensor placement
- •Subject has any unresolved adverse skin condition in the area of sensor or device placement
- •Subject is actively participating in an investigational study (drug or device) wherein they have received treatment from an investigational study (drug or device) in the last 2 weeks
- •Subject has a positive pregnancy screening test
- •Subject is female, sexually active without the use of contraception, and plans/able to become pregnant during the course of the study and is not using an acceptable method of contraception
- •Subject has had a hypoglycemic seizure within the past 6 months prior to screening visit
- •Subject has had hypoglycemia resulting in loss of consciousness within the past 6 months prior to screening visit
- •Subject has had an episode of diabetic ketoacidosis (DKA) within the past 6 months prior to screening visit
- •Subject has a history of a seizure disorder
- •Subject has central nervous system or cardiac disorder resulting in syncope
- •Subject has a history of myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack (TIA), cerebrovascular accident (CVA), angina, congestive heart failure, ventricular rhythm disturbances or thromboembolic disease
- •Subjects with hematocrit lower than the normal reference range per local lab testing
- •Subjects with a history or findings on screening electrocardiogram of any cardiac arrhythmia
- •Subjects with a history of adrenal insufficiency
- •Subjects with history of migraines that have occurred at least 2 times in the last 3 months prior to enrollment
- •Any disease or condition that may influence the HbA1c testing
- •Subject needs to travel by air during the study duration.
结局指标
主要结局
Percentage of glucose sensor readings within 70 to 180 mg/dl
时间窗: Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion
次要结局
- Area Under the Curve of glucose sensor readings below 70 mg/dl(Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion)
- Percentage of glucose sensor readings below 70 mg/dl(Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion)
- Area Under the Curve of glucose sensor readings above 180 mg/dl(Day 21 for segments 1-3 and day 31 for segment 4)
- Percentage of glucose sensor readings above 180 mg/dl(Day 20)
- Average of glucose sensor readings(Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion)
- Standard Deviation of glucose sensor readings(Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion)
- Time in glucose range of 70-180 mg/dl during day time (6am-12am)(Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion)
- Time in glucose range of 70-180 mg/dl during night time (12am-6am)(Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion)
- Area Under the Curve of glucose sensor readings above 250 mg/dL(Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion)
- Area Under the Curve of glucose sensor readings above 300 mg/dL(Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion)
- Percentage of glucose sensor readings above 250 mg/dL(Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion)
- Percentage of glucose sensor readings above 300 mg/dL(Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion)
- Area Under the Curve of glucose sensor readings below 50 mg/dL(Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion)
- Percentage of glucose sensor readings below 50 mg/dL(Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion)
- Percentage of glucose sensor readings below 60 mg/dL(Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion)
- Percentage of time in Closed Loop(Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion)
- Sensor mean absolute relative difference (MARD)(Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion)
- Total insulin dose(Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion)
- Serious Adverse Events (SAE)(Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion)
- Serious Adverse Device Events (SADE)(Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion)
- Unanticipated Adverse Device Effects (UADE)(Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion)
- Incidence of Severe Hypoglycemia(Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion)
- Incidence of Diabetic Ketoacidosis (DKA)(Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion)
- Closed-loop acceptance questionnaire(Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion)
- Area Under the Curve of glucose sensor readings below 60 mg/dL(Day 21 for segments 1-3 , day 5 for segment 4 camp portion and day 31 for segment 4 home portion)