Type 2 Diabetes Glucose Biomarker Study With a Continuous Glucose Monitoring System

NCT ID: NCT04529239

Last Updated: 2022-03-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-08-31
• Study Completion Date: 2022-03-01

Brief Summary

Current gold standard methodologies for diagnosing type 2 diabetes (T2D) or prediabetes can be unreliable and inaccurate, and require the need for multiple different tests for comparison. It is possible that a simpler and more refined method of diagnosing T2D or prediabetes involves examining the proportional-integral (PI) control system of the body's glycemic function (i.e., a model of the glucose curve). The purpose of this research is to examine how well a PI model can diagnose nondiabetic, prediabetic, or diabetic patients based on glucose data gathered from a wearable glucose monitoring device.

Conditions

Healthy; Type 2 Diabetes Mellitus

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Low to Moderate Risk

The CANRISK Canadian Diabetes Risk Questionnaire will be used for study group categorization to assess who is at risk of having prediabetes or type 2 diabetes. Participants will be categorized into one the following groups: i) low to moderate risk; ii) high risk, iii) very high risk.

Abbott Freestyle Libre Pro

Intervention Type: DEVICE

Continuous glucose monitoring device to analyze diabetes biomarkers.

High Risk

The CANRISK Canadian Diabetes Risk Questionnaire will be used for study group categorization to assess who is at risk of having prediabetes or type 2 diabetes. Participants will be categorized into one the following groups: i) low to moderate risk; ii) high risk, iii) very high risk.

Abbott Freestyle Libre Pro

Intervention Type: DEVICE

Continuous glucose monitoring device to analyze diabetes biomarkers.

Very High Risk

The CANRISK Canadian Diabetes Risk Questionnaire will be used for study group categorization to assess who is at risk of having prediabetes or type 2 diabetes. Participants will be categorized into one the following groups: i) low to moderate risk; ii) high risk, iii) very high risk.

Abbott Freestyle Libre Pro

Intervention Type: DEVICE

Continuous glucose monitoring device to analyze diabetes biomarkers.

Interventions

Abbott Freestyle Libre Pro

Continuous glucose monitoring device to analyze diabetes biomarkers.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Either male or non-pregnant, non-lactating female aged > 18-60 <years (both inclusive)
• Subjects willing to give written informed consent
• Healthy Volunteers
• Subjects able to comply with the study protocol
• Women of child bearing potential must have a negative urine pregnancy test prior to study entry
• Minimum 4 subjects in each interval of approx 7 years (18-25/26-32/32-38/39-45/46-52/53-59)
• Minimum 40% subjects of one gender to mark relative distribution

Exclusion Criteria

• Any person below the age of 18 years
• Suspected or confirmed pregnancy
• Currently breastfeeding
• Diagnosis of any known chronic or acute medical disease of any kind (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.)
• Any form of prescription medication
• 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 pro device)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mittal Global Clinical Trial Services

UNKNOWN

Sponsor Role: collaborator

Klick Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Klick Inc.

Toronto, Ontario, Canada

Countries

Canada

References

Kaufman JM, van Veen L, Fossat Y. Screening for Impaired Glucose Homeostasis: A Novel Metric of Glycemic Control. Mayo Clin Proc Digit Health. 2023 May 24;1(2):189-200. doi: 10.1016/j.mcpdig.2023.02.008. eCollection 2023 Jun.

Reference Type: DERIVED

PMID: 40206722 (View on PubMed)

Other Identifiers

036033

Identifier Type: -

Identifier Source: org_study_id