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.
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
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
Single group
The HALO System
DeviceThe 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.
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.
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.
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.
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.
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
Exploratory study objective: Compare daily measurement performance to the participant's standard CGM system.
Reported MARD for HALO System vs. the participant's standard CGM system.
Participant and Surgeon Usability and Satisfaction Assessed via the HALO Usability Test Form
Usability and satisfaction assessed using the study-specific "HALO Usability Test Form," for participants and implanting surgeons. Participant version rates the implant procedure, device comfort, healing, and daily-life impact on a 4-point scale, plus a structured usability section covering the manual, sensor (FUSHO3), charger, and App. Items use either a comfort scale (1 = "very uncomfortable" to 4 = "very comfortable," or 1 = "big impact" to 4 = "no impact," with higher scores indicating a better outcome) or 4-point agreement scale (1 = "strongly disagree" to 4 = "strongly agree," - so higher agreement reflects a worse outcome for those specific items). The surgeon version additionally records procedure duration and rates confidence in correct implantation (1 = "extremely unconfident"to 4 = "extremely confident," higher = better), plus a 10-item section on the implantation procedure (packaging, pocket preparation, tools, training needs), with 1-4 "strongly (dis)agree and free text
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