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

NCT04529239 | Completed DMC FDA Device

• 1 other identifier: 036033
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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

Outcome Measures

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).

  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

Study Arms (3)

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.

Device: Abbott Freestyle Libre Pro

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.

Device: Abbott Freestyle Libre Pro

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.

Device: Abbott Freestyle Libre Pro

Interventions

Abbott Freestyle Libre Pro DEVICE

Continuous glucose monitoring device to analyze diabetes biomarkers.

High Risk; Low to Moderate Risk; Very High Risk

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Healthy adults and those at risk of developing prediabetes or type 2 diabetes.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Klick Inc.: lead
• Mittal Global Clinical Trial Services: collaborator

Study Sites (1)

Klick Inc.

Toronto, Ontario, M4W 3R8, Canada

Location

Related Publications (1)

• 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.

  PMID: 40206722 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples to collect glycated hemoglobin (HbA1c) measurements, fasting plasma glucose (FPG), and plasma glucose during an oral glucose tolerance test (OGTT).

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2020
• First Posted: August 27, 2020
• Study Start: August 31, 2020
• Primary Completion: February 1, 2022
• Study Completion: March 1, 2022
• Last Updated: March 29, 2022

Record last verified: 2020-08

Locations

CA (1)