The SHINE Study: An Open Label, Interventional, Multicentre, Prospective Feasibility Study, Designed to Evaluate the Safety of Implant and Preliminary Performance of the SHINE SYSTEM in Diabetic Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 4
- 主要终点
- Primary Initial Performance Objectives: Confirm the ability to (a) retrieve spectral and metadata from the SENSOR and upload to the CLOUD
研究概览
简要总结
The objectives of SHINE study are to confirm the safety aspects of the SHINE SYSTEM. Moreover, the goal of this clinical investigation is the initial evaluation of sensor's performance by assessing sensor's ability to qualitatively detect the appropriate analytes in subjects with diabetes of 18 years and older.
详细描述
Indigo Diabetes N.V. is currently developing an active implantable medical device, intended to be used for real time, continuous measurement of glucose and ketone levels in the interstitial fluid in adults (18 years and older) with diabetes mellitus. Based on the outcome of the GLOW Study, Indigo developed a prototype, the SHINE SYSTEM, that will be used during the planned clinical investigation (SHINE study).The objectives of SHINE study are to confirm the safety aspects of the SHINE system. Moreover, the goal of this clinical investigation is the initial evaluation of sensor's performance by assessing sensor's ability to qualitatively detect the appropriate analytes in subjects with diabetes of 18 years and older. Clinical performance of the device will not be formally evaluated during this clinical investigation. The study is designed to enable data collection (i.e., continuous collection of data by FUSHO sensor, implanted in study subject, combined with simultaneous collection of data collected by Dexcom G6), which will be used to develop the software algorithm in a future version of the device, in order to display measurements in real-time to the user.
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
- •Subjects willing to sign an informed consent form (ICF)
- •Adult subjects, age ≥ 18
- •Subjects willing to comply to study protocol requirements (study visits with frequent venous blood sampling and deliberate insulin, glucose, ketone and lactate (sub study only) challenges)
- •Subjects willing to wear a Dexcom G6 CGM during duration of the study
- •Subjects willing to charge the FUSHO SENSOR/ED and CHARGER on daily basis
- •Patients with type 1 diabetes mellitus (T1DM) according to WHO criteria, diagnosed for at least 12 months prior to screening, on Multiple Daily Injections (MDI), not on insulin pump treatment during the course of the study
- •Patients with type 2 diabetes mellitus (T2DM) on Intensive Insulin Therapy (IIT), with a minimum of four injections per day and known dosing parameters
排除标准
- •Known allergy to PDMS
- •Subjects with a contraindication to undergo challenging tests (i.e., ischemic heart disease, epilepsy, panhypopituitarism, hypoadrenalism, untreated hypothyroidism)
- •History of severe hypoglycaemia in the previous 6 months. Severe hypoglycaemia is defined as hypoglycaemia resulting in loss of consciousness or seizure
- •History of diabetic ketoacidosis requiring emergency room visit or hospitalization in the previous 6 months
- •History of, hepatitis C or HIV or other disease transmissible by blood
- •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
- •Coagulation disorder, wound healing and bleeding disorder or taking anticoagulant medication (oral anticoagulants; antiplatelets (such as aspirin, ticagrelor are allowed).
- •Anemia identified by a haemoglobin <14 g/dL for men or <12 g/dL for women
- •The presence of any other active implanted device
- •The presence of any other CGM sensor or transmitter located in lower abdomen or back (other location is acceptable)
- •Waist circumference of >120 cm
- •Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.
研究组 & 干预措施
The SHINE SYSTEM
干预措施: The SHINE SYSTEM (Device)
结局指标
主要结局
Primary Initial Performance Objectives: Confirm the ability to (a) retrieve spectral and metadata from the SENSOR and upload to the CLOUD
时间窗: 6 months
(a) Evaluation of the Bluetooth transmission: successful transmission of the spectral data from FUSHO SENSOR to the CLOUD via Bluetooth Low Energy (BLE). The proportion of data transmitted to the CLOUD versus the expected amount of data when device used as intended
Primary Initial Performance Objectives: Confirm the ability to (b) show the battery and SENSOR-ED connectivity status to subject
时间窗: 6 months
(b) Display of battery and FUSHO SENSOR-ED connectivity status to subject
Primary Initial Performance Objectives: Demonstration of SENSOR stability
时间窗: 6 months
Demonstrate that device is able to provide a stable spectral signal and whether it is feasible to use these data points to create an algorithm. SENSOR Stability is defined by maintaining its spectral characteristics (availability, intensity and range) over its implantation duration of 6 months
Primary Initial Performance Objectives: Confirm the ability to (c) recharge the SENSOR, ED and CHARGER.
时间窗: 6 months
(c) Charging (charging efficiency) of the FUSHO SENSOR, as recorded on the APP
Primary Safety Objectives: Confirm safe implantation of the SENSOR in human subcutaneous tissue (insertion procedural safety)
时间窗: 30 days
Incidence of FUSHO SENSOR insertion procedure-related serious adverse events within 30 days from implant
Primary Safety Objectives: Confirm the safety of the device during the implantation period (safety of device integration in the subcutaneous tissue)
时间窗: 6 months
Assessment of device related adverse events during 6 months of implant use
次要结局
- Secondary Performance Objective: Assessment of procedural success for the implantation and explantation procedure(30 days)
- Secondary Performance Objective: Assessment of procedural success for the explantation procedure(30 days)
- Secondary Safety Objectives: Confirm safe explantation of the SENSOR from human subcutaneous tissue (removal procedural safety)(30 days)
- Secondary Safety Objectives: Confirm general safety in the clinic and during home use (general safety)(6 months)
- Secondary Performance Objective: Assessment of procedural success for the implantation procedure(30 days)