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

Healthy Clinical Trial

Official title:

A Triple Cohort, Prospective Observational Study to Analyze Type 2 Diabetes Glucose Biomarkers With a Continuous Glucose Monitoring System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04529239
• Other study ID #: 036033
• Status: Completed
• Start date: August 31, 2020
• Est. completion date: March 1, 2022

Study information

• Verified date: August 2020
• Source: Klick Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 1, 2022
• Est. primary completion date: February 1, 2022
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Healthy
• Type 2 Diabetes Mellitus

Intervention

Device:
• Abbott Freestyle Libre Pro
Continuous glucose monitoring device to analyze diabetes biomarkers.

Locations

Country	Name	City	State
Canada	Klick Inc.	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Klick Inc.	Mittal Global Clinical Trial Services

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose biomarker data from the continuous glucose monitoring device, which will be analyzed as a function of different homeostasis responses from the 3 different cohorts of individuals (i.e., i) low to moderate risk; ii) high risk, iii) very high risk).	Continuous glucose data from the FreeStyle Libre device will be collected from each individual and analyzed for differences in glucose responses (i.e., "ups" and "downs") across the different study groups.	The device is worn for 14 days on each participant