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OpenTrials
Completed

NCT Number: NCT04529239

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Klick Inc.

Toronto, Ontario, M4W 3R8, Canada

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Abbott Freestyle Libre Pro

Device

Continuous glucose monitoring device to analyze diabetes biomarkers.

Primary outcomes

  1. 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).

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Klick Inc.

Industry

Collaborators

  • Mittal Global Clinical Trial Services

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 27, 2020
Registry last updated
Mar 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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