NCT04835350Unknown不适用
Feasibility Study of the Pancreas4ALL Closed-loop Automated Glycemic Control System in Patients With Type 1 Diabetes Mellitus: Pancreas4ALL Project - Good News Study - Phase I
Lenka Petruzelkova2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2021年2月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- The feasibility of the prototype device Pancreas4ALL
研究概览
简要总结
Pilot prospective controlled monocentric open-label, randomized study evaluating the feasibility and safety of the Pancreas4All automated "closed loop" glycemic control system.
详细描述
- Screening - day 0
- Hospitalization (Day 1-10) Day 1 - Deployment of study equipment, patient education Day 2 - Start of study, activation of Pancreas4ALL closed loop in mode - hybrid closed loop (2.7.1) Day 4 - Randomization of patients to Group A and to Group B Group A - Activation of Pancreas4ALL closed loop in closed loop mode - "food announcement" (2.7.2) Group B - Activation of Pancreas4ALL closed loop in mode - full closed loop mode (2.7.3) Day 7 - Crossover - Group exchange Day 10 - Return to the initial treatment modality.
- Termination of the study
Detailed description of the clinical trial - study control plan:
Outpatient check:
- Signing of informed consents to the study and GDPR consent to the processing of personal data by the legal representative and the entity that will be included in the study
- Urine pregnancy test for women and girls after menarche
- Blood collection for the determination of HbA1c, TSH and creatinine
- Evaluation of entry criteria (inclusion criteria); if all criteria are met, the subject will be included in the study.
Day 1:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects will be included in the study if they meet the following entry criteria:
- •The subject was diagnosed with type 1 DM ≥ 1 year
- •The subject is aged 15-25
- •The subject has an HbA1C value between 43 mmol / mol and 75 mmol / mol at the time of the screening visit
- •The subject must have experience with insulin pump therapy and CGM ≥ 3 months
- •The subject is willing to use the system Pancreas4ALL continuously throughout the study
排除标准
- •The subject does not tolerate the adhesive patch at the sensor site for CGM
- •Women of productive age who have a positive pregnance test at the time of screening or are planning to become pregnant at the time of the study
- •The subject underwent the following diagnoses in the year preceding screening: myocardial infarction, unstable angina pectoris, coronary artery bypass passage, stent insertion into the coronary artery, transient ischemic attack, cerebrovascular accident, angina pectoris, congestive heart failure, ventricular arrhythmia or thromboembolism
- •The subject has an abnormal (> 1.5x times the upper reference limit, as assessed by the laboratory) creatinine at the time of screening
- •The subject has clinically significant abnormalities (outside the reference range as assessed by the laboratory) of thyroid stimulating hormone (TSH) at the time of screening
- •The subject has taken any oral or injectable corticosteroids in the last 8 weeks prior to the screening visit, or plans to take any oral or injectable corticosteroids during the study
- •The subject is actively involved in any research study (drug or instrumental) in which he or she has undergone treatment with a research drug or research facility in the previous 2 weeks prior to the screening visit.
- •The subject is currently using illicit drugs
- •The subject is currently abusing prescription drugs
- •The subject is currently addicted to alcohol
- •The subject is taking pramlintide (Symlin) or an SGLT2 inhibitor at the time of the screening visit
- •The subject suffers from a visual impairment that does not allow him to participate in the study and to safely perform all tasks within the study, as determined by the investigator
- •The subject has planned elective surgery requiring general anesthesia for the duration of the study
- •The subject has currently been diagnosed with an eating disorder such as anorexia or bulimia
- •The subject has been diagnosed with chronic renal failure leading to chronic anemia
- •The subject is dialyzed
结局指标
主要结局
The feasibility of the prototype device Pancreas4ALL
时间窗: ten days
Percentage of time of automatic control of glucose by Pancreas4ALL would be \> 90%
The safety of the prototype device Pancreas4ALL
时间窗: ten days
Percentage of time spent in hypoglycemia 2.degrees (\<3 mmol / L) would be \< 1% during sutomatic glucose control by Pancreas4ALL
次要结局
- GCM parametrs of glycemic control(ten days)
- Quality of life of patient living on closed loop system Pancreas4ALL(seven days)
研究者
Lenka Petruzelkova
MD, PhD
University Hospital, Motol
研究点 (2)
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