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

Completed

• Conditions: Type 2 Diabetes Mellitus; Healthy
• Interventions: Device: Abbott Freestyle Libre Pro

• Registration Number: NCT04529239
• Lead Sponsor: Klick Inc.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-08
• Study First Submitted: 2020-08-24
• Study First Submitted QC: 2020-08-24
• Study First Posted: 2020-08-27
• Study Start: 2020-08-31
• Primary Completion: 2022-02-01
• Study Completion: 2022-03-01
• Last Update Submitted: 2022-03-28
• Last Update Posted: 2022-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Very High Risk	Abbott Freestyle Libre Pro	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.
High Risk	Abbott Freestyle Libre Pro	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.
Low to Moderate Risk	Abbott Freestyle Libre Pro	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.

Primary Outcome Measures

Name	Time	Method
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).	The device is worn for 14 days on each participant	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.

Trial Locations

Locations (1)

Klick Inc.; 🇨🇦 Toronto, Ontario, Canada