POC of CH-002 in T2DM and associated fatty liver
Research type
Research Study
Full title
Proof-of-Concept Evaluation of the Effect of an Antioxidative Electron Therapeutic Device (CH-002) on Insulin Resistance and Glycaemic Control in Overweight Patients with Type 2 Diabetes and Associated Fatty Liver
IRAS ID
222339
Contact name
Nimantha De-Alwis
Contact email
Sponsor organisation
Cambwick Healthcare K.K.
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
The purpose of the study is assess the use of the 'CH-002' medical device in overweight patients with type 2 diabetes and associated fatty liver - in particular whether the device treats their insulin resistance and helps their glycaemic control.
The study sample size will be conducted through the NHS. Patients who agree to participate in the study will be randomised to wear either the active CH002 device or a ‘placebo’ device.
‘CH002’ is an electronic device that is worn on a person’s arm and sends electrons into their body at a very small current to try and reduce oxidative stress, which we hypothesize contributes to insulin resistance and other factors including progression of diabetes to more serious diseases.
Participants will need to wear the device on a regular basis (60 minutes per treatment for 3 times a day) and undergo additional non-routine tests (e.g. undergo a fibroscan assessment and provide additional bloods).
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
19/NE/0052
Date of REC Opinion
16 Apr 2019
REC opinion
Further Information Favourable Opinion