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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
12
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
Primary performance objective: Demonstration of Sensor accuracy
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.
Time frame: 3 months
Primary performance objective: Demonstration of Sensor stability
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.
Time frame: 3 months
Primary safety objective: Confirm safe implantation of the Sensor in human subcutaneous tissue (insertion procedural safety)
Incidence of Sensor insertion procedure-related SAEs within 30 days from implantation.
Time frame: 30 days
Primary safety objective: Confirm the safety of the device during the implantation period
Assessment of device-related AEs during 3 months of implant use and all SAEs collected throughout the study.
Time frame: 3 months
Secondary performance objective: Assessment of procedural success for the implantation and explantation procedure
* Successful Sensor implantation (first implant in case of re-implant) procedure on average performed within 20 minutes (from incision to closure) without occurrence of procedure-related SAEs. * Successful Sensor explantation procedure on average performed within 20 minutes (from incision to closure) without occurrence of procedure-related SAEs. * Procedural success defined as implantation of the Sensor within an average of 20 minutes (from start incision to closing of skin) without the occurrence of procedure-related AEs up to 30 days after implantation. * Wound status at each visit. * Final result on healing at explantation.
Time frame: 30 days
Secondary performance objective: Confirm safe explantation of the Sensor from human subcutaneous tissue (removal procedural safety)
Incidence of Sensor removal-related SAEs within 14 days from explantation
Time frame: 14 days
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