The BRIGHT Study, an Open Label, Single-arm, Interventional, Multicenter, Prospective Study of the Diagnostic Feasibility of the HALO System, Designed to Evaluate the Safety and Performance of the HALO SYSTEM in Subjects With Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 12
- 主要终点
- Primary performance objective: Demonstration of Sensor accuracy
研究概览
简要总结
The purpose of the BRIGHT study is to evaluate safety and performance of the HALO SYSTEM in subjects with diabetes mellitus. The primary objectives of this clinical investigation are 1) the evaluation of sensor's performance by demonstrating sensor's accuracy and stability and 2) to confirm safe implantation of the Sensor and safety of the device during implantation.
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, ketone and lactate levels in the interstitial fluid in persons living with diabetes mellitus. The device will be intended for non-adjunctive use and allow integration into hybrid closed loop systems.
In this context, Indigo has developed a first and second prototype, which were used in early feasibility studies in humans (GLOW and SHINE study, respectively). Based on the outcome of these investigations, Indigo developed a third prototype: the HALO SYSTEM, which will be used during the current clinical investigation (BRIGHT study). The system is not substantially similar to any other device currently available on the EU or US markets, since it combines continuous measurement of glucose with continuous ketone (more specifically; β-hydroxybutyrate) and lactate measurement.
After demonstrating safety in previous studies (GLOW and SHINE), the primary intend of the BRIGHT study is demonstrate sensor accuracy and stability througout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Willing to sign an informed consent form
- •Age ≥ 18 years
- •Willing to comply to study protocol requirements (study visits with frequent venous blood sampling and deliberate insulin, glucose, ketone and lactate challenges)
- •Willing to charge the SENSOR on daily basis
- •Willing not to insert their standard CGM and/or insulin pump in and around the SENSOR implant site (± radius 5 cm)[TS| XR1.1] Diagnosed with type 1 diabetes mellitus according to the World Health Organization criteria, for at least 12 months prior to screening, on CSII therapy
排除标准
- •Known allergy to polydimethylsiloxane (PDMS)
- •A contraindication to undergo challenging tests (i.e., ischemic heart disease, epilepsy, panhypopituitarism, hypoadrenalism, untreated hypothyroidism)
- •History of hepatitis C or HIV or other disease transmissible by blood
- •A condition requiring or likely to require magnetic resonance imaging during the study duration
- •Female participants 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/pump located in the lower abdomen (other location is acceptable)
- •Waist circumference of >120 cm
- •Any disorder, which in the investigator's opinion might jeopardise participants' safety or compliance with the protocol.
结局指标
主要结局
Primary performance objective: Demonstration of Sensor accuracy
时间窗: 3 months
Evaluate the accuracy of the Algorithm with an in-factory-calibrated on-sensor model used by the Sensor to generate blood glucose, ketone and lactate concentration values by comparing these values to those of a venous blood reference method and develop an upgraded Algorithm to increase the accuracy of the HALO System by off-sensor model optimisations, using real-time insights and historical experimental data.
Primary performance objective: Demonstration of Sensor stability
时间窗: 3 months
confirm the accuracy of the Algorithm for glucose, ketones and lactate throughout 3 months of implantation, compared to blood reference measurements using an in-factory-calibrated on-sensor model AND using an optimised off-sensor model.
Primary safety objective: Confirm safe implantation of the Sensor in human subcutaneous tissue (insertion procedural safety)
时间窗: 30 days
Incidence of Sensor insertion procedure-related SAEs within 30 days from implantation.
Primary safety objective: Confirm the safety of the device during the implantation period
时间窗: 3 months
Assessment of device-related AEs during 3 months of implant use and all SAEs collected throughout the study.
次要结局
- Secondary performance objective: Assessment of procedural success for the implantation and explantation procedure(30 days)
- Secondary performance objective: Confirm safe explantation of the Sensor from human subcutaneous tissue (removal procedural safety)(14 days)