NCT04782934已完成不适用
Early Feasibility and First in Human Study of the YANG System for Continuous Monitoring of Glucose, Ketones and Lactate - The GLOW Study
Indigo Diabetes NV2 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2021年2月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Incidence of device-related or sensor insertion/removal procedure-related adverse events
研究概览
简要总结
This is an open label, interventional, monocentric, prospective early feasibility study, designed to evaluate the safety of implant and short-term integration into the tissue of the YANG sensor. In addition, the set up will enable data collection which will be used to develop the software algorithm to allow real-time, continuous measurement of glucose, ketone and lactate levels in the interstitial fluid in adults with diabetes mellitus, in a future version of the device.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •T1DM patients
- •Subjects willing to sign an informed consent form (ICF),
- •Adult subjects, age ≥ 18, ≤ 50 years old
- •Body Mass Index (BMI) 20≥, ≤ 27.5 [kg/m2]
- •Subjects willing to comply to study protocol requirements (exercises, ketone ester drinks, alcohol, study visits, blood sampling etc)
- •Patients with type 1 diabetes mellitus (T1DM) according to WHO criteria, diagnosed for at least 12 months prior to screening
- •Subjects being on insulin pump for at least 12 months
- •Healthy Volunteers
- •Subjects willing to sign an informed consent form (ICF),
- •Adult subjects, age ≥ 18, ≤ 50 years old
- •BMI 20≥, ≤ 27.5
- •Subjects willing to comply to study protocol requirements (exercises, ketone ester drinks, alcohol, study visits, blood sampling etc)
- •Healthy subjects, as self-declared and confirmed by screening assessments and Principal Investigator's judgment
排除标准
- •Subjects with a contraindication to undergo challenging tests (i.e., ischemic heart disease, epilepsy, panhypopituitarism, hypoadrenalism, hypothyroidism, known allergic reaction to ibuprofen/paracetamol/acetylsalicylic acid)
- •For people with diabetes: History of severe hypoglycaemia in the previous 6 months. Severe hypoglycaemia is defined as hypoglycaemia resulting in loss of consciousness or seizure
- •For people with diabetes: History of diabetic ketoacidosis requiring emergency room visit or hospitalization in the previous 6 months
- •Any blood disorder identified by haematocrit <30% or >55%
- •History of hepatitis B, hepatitis C, or HIV
- •A condition requiring or likely to require magnetic resonance imaging (MRI) during the study duration
- •Female subjects who are pregnant, planning on becoming pregnant or nursing
- •Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.
- •Coagulation disorder, wound healing and bleeding disorder or taking anticoagulant medication
- •Any long-term drug treatments other than insulin, such as statins, low-dose aspirin, fibrates etc.
- •The presence of any other active implanted device except for insulin pumps (as defined further in protocol)
- •The presence of any other CGM sensor or transmitter located in abdomen (other location is acceptable)
- •Impaired fasting glucose or impaired glucose tolerance (for healthy volunteers)
- •Any contraindication to the use of the Yang system as listed in the device IFU (i.e. any known allergy to PDMS)
结局指标
主要结局
Incidence of device-related or sensor insertion/removal procedure-related adverse events
时间窗: 57 days
Assessment of foreign body reaction due subcutaneous implantation with biopsy
时间窗: 27 days
Assessment of i.e. inflammation, infection, tissue vascularization, formation of fibrotic scar tissue
Incidence of sensor failure
时间窗: 27 days
次要结局
- Collection of users feedback in the form of clinical questionnaire to assess the 'easiness' of surgical procedure with questionnaire(1 day)
- Requirements of duration of implantation and explantation procedure(27 days)
- Post explantation follow-up(30 days)
研究者
研究点 (2)
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