Diabetes Mellitus, Diabetes Mellitus - Type 1, Diabetes Mellitus - Type 2, Hyperglycaemia (Diabetic), Hypoglycemia (Diabetic), Ketoacidosis, Diabetic
Conditions
Keywords
CMM, CGM, Diabetes mellitus - type 1, Diabetes mellitus - type 2, ketoacidosis, diabetic, continuous multi-metabolite monitoring, hyperglycaemia (diabetic), hypoglycaemia (diabetic)
Brief summary
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.
Detailed description
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.
Interventions
DEVICEThe 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
Sponsors
Indigo Diabetes NV
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary performance objective: Demonstration of Sensor accuracy | 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 | 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) | 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 | 3 months | Assessment of device-related AEs during 3 months of implant use and all SAEs collected throughout the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary performance objective: Assessment of procedural success for the implantation and explantation procedure | 30 days | * 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) | 14 days | Incidence of Sensor removal-related SAEs within 14 days from explantation |
Contacts
CONTACTGijs Klarenbeek, Dr.
PRINCIPAL_INVESTIGATORChristophe De Block, Prof. dr.
University Hospital, Antwerp
Outcome results
None listed