GLUCUBE Australian Clinical Trial & Stakeholder Information
This medical device is not yet included in the Australian Register of Therapeutic Goods (ARTG) and is not approved for general supply in Australia. Access is currently only available through approved clinical trials.
About this page
Purpose:
This page is for expression of interest in an Australian clinical trial and for healthcare professionals and health service decisionmakers to register their interest in receiving further information about GLUCUBE when it becomes available via TGAcompliant access pathways.
Who should use this page:
- Patients considering trial participation
- Health Care Professionals
- Health service decision makers
About GLUCUBE
GLUCUBE is a noninvasive blood glucose monitoring system designed for adults with type 2 diabetes who are not insulindependent and are under active medical supervision. It is intended for complementary monitoring of glucose levels and is not a replacement for standard capillary glucometers or clinical decision making.
The system comprises three components:
GLUCUBE device
A portable, handheld unit that uses nearinfrared spectroscopy (NIRS) to measure glucose without a finger prick. The user inserts a fingertip into the device, which emits infrared light (approximately 700–2500 nm); the light passes through the tissue and blood, and the device captures how different blood components absorb that light. These optical signals are transmitted via Bluetooth Low Energy (BLE 4.2) to the GLUCUBE app on the user’s smartphone.
GLUCUBE app
A mobile application (iOS and Android) that receives the raw signal from the device and sends it to a cloud-based algorithm for processing. The algorithm accounts for the variation in light intensity across different wavelengths and incorporates user inputs such as age, sex, height and weight to estimate blood glucose concentration. The resulting glucose value is returned to the app and displayed to the user within seconds, along with trends, patterns and time-in-range summaries.
GLUCUBE Panel
A web based dashboard for healthcare professionals that allows remote, realtime access to a patient’s glucose history, trends and alerts, supporting clinical follow-up and care planning.
Key characteristics of the GLUCUBE system include:
- Noninvasive, painfree measurements with no need for lancets, test strips or other consumables.
- Realtime glucose readings and longitudinal tracking (daily, weekly, monthly) to help users identify patterns related to diet, medication, insulin and physical activity.
- Secure cloud storage of measurement history and the ability to share data with healthcare professionals in real time.
- Personalised alerts and notifications for outofrange values and scheduled measurements.
GLUCUBE is designed to complement, not replace, standard capillary glucose monitoring and clinical judgement. In Australia, the device is considered an unapproved therapeutic good until it is included in the Australian Register of Therapeutic Goods (ARTG) or accessed via an appropriate TGA pathway (e.g. clinical trial, Special Access Scheme)
Contraindications
GLUCUBE is contraindicated (must not be used) in the following situations:
- Uncontrolled insulin-dependent type 1 diabetes mellitus.
- People with serious illness, in a state of shock, or in a critical condition.
- People with calluses, deformities, or open wounds on their fingers, whether exposed to the air or covered with dressings or bandages.
- People unable to keep their hand steady during measurement, or with a progressive nervous system disorder that may cause involuntary hand movements affecting the measurement (e.g. Parkinson’s disease, moderate–severe essential tremor).
- People with visual impairments that prevent them from using the device safely and correctly.
- Pregnant or breastfeeding women.
- Paediatric patients (individuals under 18 years of age).
- Conditions affecting blood circulation in the fingers, such as Raynaud’s phenomenon.
- People with polished nails or any type of artificial nails.
- Autonomous use by people with dementia or significant memory loss (in such cases, measurements must be performed by a support person).
- Users with functional, physical or cognitive diversity that makes correct execution of the measurement difficult, unless assisted by a support person.
In addition, GLUCUBE is not intended for:
- Diagnosis of diabetes or evaluation in individuals under 18 years of age or pregnant women.
- Making treatment or insulin dose adjustment decisions based solely on GLUCUBE results; users should not ignore symptoms of hypo or hyperglycaemia and should confirm with a fingerstick glucometer and consult their healthcare professional.
GLUCUBE Australia
Expression of Interest
For diabetes patients, healthcare professionals, researchers and health service decision-makers interested in possible Australian clinical trials or future information about GLUCUBE.
Important: GLUCUBE is not yet approved for general supply in Australia. Completing this form does not guarantee trial participation or future access.
Thank you for your interest in GLUCUBE.
You can withdraw your consent or update your contact preferences at any time by emailing info@luminamedtech.com.