Sigi Insulin Management System - First-in-Human Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 主要终点
- Serious Adverse Events
研究概览
简要总结
This early feasibility first-in-human study is a prospective single-arm single-center study of Sigi insulin patch pump. After a 1st day and night under medical surveillance during a hotel stay, Sigi system will be evaluated during 15 days at home in adults with type 1 diabetes.
详细描述
Sigi Insulin Management System (Sigi) is a novel insulin patch pump intended for subcutaneous delivery if insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin. Sigi is offering superior delivery accuracy and precision, accelerated occlusion detection, wearable patch pump, pre-filled insulin cartridges and smartphone control.
Glycemia is CGM controlled and for safety purposes, CGM data are shared with study medical team during the whole study.
Sigi FIH Study is conducted in a single clinical site in Lausanne University Hospital (CHUV) in Switzerland.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •Informed consent signed
- •Patients with T1D since more than 1 year
- •Adults 18+years
- •Patients under sensor augmented pump for at least 6 months
- •Hybrid closed-loop users willing to switch to manual mode 15 days before study
- •Patients with calculated insulin-to-carb ratio and correction factor
- •Patients with total daily insulin above 30 insulin units
- •Patients with correction factor below 3.5 mmol/L
- •No severe hypoglycemic or ketoacidosis episode requiring third-party intervention within the past 12 months
- •Active users of Teflon infusion sets
- •Patients willing to use a smartphone interface to use their pump and to answer study questionnaires
排除标准
- •Patients with T2D
- •Patients with T1D under multiple daily injections
- •Patients using Apidra and not willing to switch to NovoRapid / Fiasp / Humalog
- •Patients with history of skin diseases (e.g. generalized eczema, plan lichen, psoriasis)
- •Patients with known allergy to some insulins
- •Clarke's score ≥ 4 (hypoglycemia unawareness)
- •Severe late complications of diabetes, like severe neuropathy, non-stabilized proliferative retinopathy, EGF < 30 mL/min, myocardial infarction or stroke within the last 3 months
- •Glycated hemoglobin HbA1c > 8.5 % at screening visit
- •Medications interacting with glucose homeostasis (e.g. steroids)
- •Pregnant of breastfeeding women
- •Planned operation / MRI / CT requiring removal of infusion pad over the 15 days of the study
- •Planned travel over the 15 days of the study
- •Persons under guardianship or incapable of judgement
结局指标
主要结局
Serious Adverse Events
时间窗: 15 days
Number of serious adverse events
Adverse Device Effects
时间窗: 15 days
Number of adverse device effects (ADE)
Serious adverse device effects (SADE)
时间窗: 15 days
Number of serious adverse device effects (ADE)
Adverse Events
时间窗: 15 days
Number of adverse events
次要结局
- Severe hypoglycemia events, as a indicator of successful CSII self-management with Sigi(15 days)
- Evaluation of overall device tolerance(15 days)
- System Usability Scale (SUS) at baseline and 15 days for the Pump Assembly(15 days)
- Diabetic ketoacidosis events, as a indicator of successful CSII self-management with Sigi(15 days)
- Acceptance and confidence of participant to proceed to outpatient use(1 day)
- Acceptance and confidence of PI to proceed to outpatient use(1 day)
- Device deficiencies(15 days)
- Occlusion detection rate(15 days)
- Evaluation of pad duration (days)(15 days)
- Evaluation of skin tolerance(15 days)
- System Usability Scale (SUS) at baseline and 15 days for the PAD(15 days)