our clinical studies
Cilcare has launched in 2023 a series of prospective observational studies aiming to collect auditory data from different subpopulations of patients with defined pathologies in view of better characterizing their hearing impairments using subjective and objective biomarkers.
Indeed, due to a number of physiopathological mechanisms leading to cochlear damage, one approach to solve the issue of patient selection in clinical trials is to define subpopulations of patients at risk for hearing loss and suffering from underlying pathologies that are well characterized.
DIAMANT: an observational study aiming at characterizing the auditory profile of diabetic patients
November 2024 update
Investigation centers
If you are interested in learning more, please email us for more information at info@cilcare.com
The first study, DIAMANT, is being carried out in diabetic patients to deepen our knowledge of the link between diabetes and auditory pathologies, which are highly prevalent in this population. The trial will enroll over 300 patients with type 2 Diabetes Mellitus (T2D), aged between 25 & 70 years old.
The objective of the study is to define cochlear synaptopathy which corresponds to difficulty in understanding in a noisy environment and is the first sign of hearing loss. Endpoints will include speech recognition, auditory neuropathy, otoacoustic emissions, and acoustic reflex thresholds. Correlations will be examined between auditory read-outs and biochemical parameters such as glycemia (HbA1c), dyslipidemia, kidney functions, and inflammation.
The results of DIAMANT study will be used to refine the phase Ib/IIa clinical study protocols planned with CIL001, Cilcare’s lead candidate for the treatment of cochlear synaptopathy, clinically characterized by speech-in-noise intelligibility deficit with normal audiometric thresholds.
