NCT04529239

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 150 (actual)
• Sponsor: Klick Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: —

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

Interventions

Type	Name	Description
DEVICE	Abbott Freestyle Libre Pro	Continuous glucose monitoring device to analyze diabetes biomarkers.

Timeline

• Start date: 2020-08-31
• Primary completion: 2022-02-01
• Completion: 2022-03-01
• First posted: 2020-08-27
• Last updated: 2022-03-29

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated device study