Health Condition 1: E08-E13- Diabetes mellitus
Conditions
Interventions
Intervention1: Device- CGM-Watchâ?¢: The CGM Watchâ?¢ device is a non-invasive medical device for continuous glucose monitoring. The technology used is reverse iontophoresis, which applies a current t
Sponsors
Nemaura Pharma Ltd
Max Neeman Medical International Limited
Eligibility
Inclusion criteria
Inclusion criteria: a) Male or female between 18-72 years of age at screening visit b) Diagnosed with Type 1 or Type 2 diabetes mellitus and on stable antidiabetic treatment for at least 3 months prior to screening visit c) No clinically significant derangement in liver and kidney functions per investigator discretion as assessed by standard laboratory parameters d) No clinical significant abnormality in haematocrit (Packed Cell volume) level per investigator discretion as assessed by standard laboratory parameters e) Willing to provide written informed consent
Exclusion criteria
Exclusion criteria: a) Has skin changes or disease that preclude wearing of the device on normal skin at the application site, e.g. psoriasis, recent burns/scalds, recent sunburn, eczema, extensive scarring, extensive tattoos, dermatitis etc. b) Has a known allergy to medical grade adhesives c) Is pregnant (confirmed by positive pregnancy test) or suspected to be pregnant or are not willing to use appropriate contraception during the clinical investigation d) Has participated in another investigational study within 30 days of screening e) Any other clinically significant condition e.g. ischaemic heart disease, peripheral vascular disease, cardiomyopathy, cerebrovascular disease, congenital heart disease, or significant arrhythmia, epilepsy, significant hypoglycaemia unawareness, chronic infectious disease or any other inter-current illness which in the judgement of the investigator will interfere with the subjectâ??s ability to participate in this Clinical Investigational Plan f) History of severe hypoglycemia within 6 months of screening visit g) History of HIV, Hepatitis B or Hepatitis C h) Active psychotic illness or severe cognitive impairment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Correlation between the raw data obtained by CGM-Watchâ?¢ and readings from standard blood glucose monitoring equipment (HemoCue)Timepoint: Throughout the study period (for details, please refer to the study design mentioned in brief summary) | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate safety of CGM Watchâ?¢Timepoint: Throughout the study period. | — |
Countries
India
Contacts
Public ContactDr Shariq Anwar
Max Neeman Medical International Limited
Outcome results
None listed