Type 2 Diabetes Glucose Biomarker Study- A data analysis project

Not Applicable

• Conditions: Health Condition 1: E11- Type 2 diabetes mellitus

• Registration Number: CTRI/2021/08/035957
• Lead Sponsor: Klick Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

• Healthy participants and those with prediabetes or at risk of developing T2D will be screened and classified according to scores from the CANRISK Canadian Diabetes Risk Questionnaire (https://www.healthycanadians.gc.ca/en/canrisk)

• Participants who are diagnosed with T2D must have a confirmation according to their latest medical records from a certified physician

• Participants who are treated for T2D must only be taking Metformin, and not insulin or other medications, which may strongly control glucose levels

• No restrictions on gender or ethnicity will be implemented

• Participants must speak English fluently (no restrictions on language accent)

• Subjects willing to give written informed consent

• Subjects able to comply with the study protocol

• Women of child bearing potential must have a negative urine pregnancy test prior to study entry

Exclusion Criteria

• Any person below the age of 18 years or above the age of 60 years

• Suspected or confirmed pregnancy

• Currently breastfeeding

• Diagnosis of any known chronic or acute medical disease other than T2D (e.g., cardiovascular disease, respiratory disease, influenza, pneumonia, etc.)

• Diagnosis of any known neurological disease or psychological disorder of any kind (e.g., brain lesion, epilepsy, anxiety, eating disorder, mood disorder, sleep disorder, etc.)

• Any implanted electrical medical device (e.g., pacemaker, insulin pump, deep brain stimulator, etc.)

• Use of antibiotics in the three months prior to enrollment

• Any person planning to undergo a Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment during the duration of the study (as per restrictions of the FreeStyle Libre device)

Study & Design

• Study Type: Observational
• Study Design: Not specified