A research project to study the performance of CGM-Watchâ?¢ (a device which is worn around the wrist or forearm) in measuring the glucose level in patients with Diabetes Mellitus (a disease where blood glucose level are on higher side)

Not Applicable

Conditions: Health Condition 1: E08-E13- Diabetes mellitus

Registration Number: CTRI/2014/11/005157

Lead Sponsor: emaura Pharma Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 140

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures