FOR IMMEDIATE RELEASE
Indigo Diabetes initiates first clinical study of its continuous glucose monitoring sensor
The breakthrough subcutaneous sensor aims to continuously monitor multiple metabolites, including ketones, in people with diabetes
BELGIUM – Ghent, March 18, 2021 – Indigo Diabetes NV (“Indigo” or the “Company”), a pioneering developer of medical solutions using nanophotonics, announces that its Continuous Multimetabolite Sensor (“CMM”) has been successfully implanted subcutaneously in the first three participants in its first clinical Study to evaluate the device. Indigo’s CMM sensor is under development to continuously measure glucose, ketone and lactate levels in people with diabetes.
Indigo is developing its CMM sensor as part of a next generation of Continuous Glucose Monitoring (CGM) systems that allow people with diabetes to have access to information about their glucose and other metabolite levels at any time without having to carry an external device on their Body.
The GLOW study (listed on clinicaltrials.gov under the identifier NCT04782934) is being carried out at the Belgian University Hospital Antwerp and has seven participants. It is a prospective, single-center, early feasibility study to assess the safety of the sensor and its short-term integration into the tissue.
Professor Christophe De Block, principal researcher on the study at Antwerp University Hospital, added: “It is important that people with diabetes are able to closely monitor their metabolite levels to avoid fluctuations that can seriously affect their health. Currently, ketones cannot be monitored, which means that people with diabetes are unaware of the levels of this important metabolite and therefore may be prone to ketoacidosis. The GLOW study will help us take a first step towards a potentially transformative new solution for these patients. “
Dr. Danaë Delbeke, CEO, inventor and co-founder of Indigo Diabetes NV commented: “The initiation of our first clinical trial is a momentous event for all Indigo Diabetes employees and we are excited to be reaching this important milestone as a company. Our CMM sensor technology could revolutionize the experience of patients with diabetes who rely on constant and strenuous monitoring to stay healthy. We look forward to sharing our progress with the diabetes community in due course. “
More details on the GLOW study
The GLOW study will recruit three healthy volunteers and four volunteers with type 1 diabetes. For participants who receive the CMM sensor, the sensor is inserted up to 10 mm deep into the subcutaneous abdominal tissue under local anesthesia. The sensor remains in situ for 30 days, after which it is removed. For each participant, 6 measurement visits are planned over the 30-day insertion period, during which data on glucose, lactate and ketone levels are collected and under controlled circumstances (hypo- / hyperglycaemia, anaerobic stress, ketogenic conditions and during the administration of the potential) with the Applicable standards are compared to interferences such as NSAIDS, vitamin C).
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About Indigo Diabetes NV
Indigo Diabetes NV (Indigo) is a pioneering developer of medical solutions using nanophotonics. Indigo was founded in 2016 by Danaë Delbeke and her team. Today Indigo is developing the world’s first invisible sensor for people with diabetes to meet their need for continuous accurate glucose and ketone monitoring with an enhanced user experience. Indigo leverages the breakthrough photonics technology that revolutionized the internet to transform diabetes management. Indigo is based in Ghent, Belgium. More information is available at www.indigomed.com.
About the Indigo Diabetes CMM sensor
The Indigo Diabetes CMM sensor is a small spectrometer on a chip for simultaneous and continuous monitoring of multiple metabolites in vivo. The inert, miniaturized integrated silicon photonics spectrometer chip measures the absorption of light in the interstitial fluid to quantify the concentration of multiple metabolites simultaneously without the use of enzymes or fluorophores. Once inserted under the skin, the CMM sensor is invisible to the naked eye and creates a secure and wireless connection to mobile devices to display and record the concentration profiles of the metabolites for the user. A rechargeable sensor battery supplies the measurements with power. The sensor is expected to have a lifespan of up to 2 years. Preclinical studies have successfully demonstrated proof of concept with promising accuracy.
contacts
Indigo Diabetes NV
Dr. Danaë Delbeke, CEO
Email: info@indigomed.com
Financial communication
Strategic plan communication
Amber Fennell, Ashley Tapp and Priit Piip
Tel .: +44 (0) 20 3709 5700
Email: indigodiabetes@consilium-comms.com
