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Type 2 Diabetes Glucose Biomarker Study- A data analysis project

A quadruple cohort, prospective observational study to analyze Type 2 Diabetes Glucose biomarkers and physiological variables with continuous glucose monitoring system

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/08/035957
Enrollment
600
Registered
2021-08-26
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E11- Type 2 diabetes mellitus

Interventions

Intervention1: NIL: NIL

Sponsors

Klick Inc
Lead Sponsor

Eligibility

Inclusion criteria

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

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)

Design outcomes

Primary

MeasureTime frame
Change in Voice with respect to blood glucoseTimepoint: 14 days

Secondary

MeasureTime frame
NATimepoint: NA

Countries

India

Contacts

Public ContactPuneet Mittal

Mittal Global Clinical Trial Services

puneetmittal@mgcts.org8937015757

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 11, 2026