The BRIGHT Study (Device Name: HALO System)

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство The HALO System
  The FUSHO3 sensor, which is part of the HALO System, is a continuous multi-metabolite monitoring (CMM) sensor which is a miniaturized near-infrared spectrometer that measures the absorption of light in the interstitial fluid to quantify the concentration of multiple metabolites

Первичные конечные точки

• Primary performance objective: Demonstration of Sensor accuracy [Срок оценки: 3 months]
• Primary performance objective: Demonstration of Sensor stability [Срок оценки: 3 months]
• Primary safety objective: Confirm safe implantation of the Sensor in human subcutaneous tissue (insertion procedural safety) [Срок оценки: 30 days]
• Primary safety objective: Confirm the safety of the device during the implantation period [Срок оценки: 3 months]

Вторичные конечные точки (2)

• Secondary performance objective: Assessment of procedural success for the implantation and explantation procedure [Срок оценки: 30 days]
• Secondary performance objective: Confirm safe explantation of the Sensor from human subcutaneous tissue (removal procedural safety) [Срок оценки: 14 days]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07745998 · IND009

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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