Clinical trial NCT04529239: Type 2 Diabetes Glucose Biomarker Study With a Continuous Glucose Monitoring System
Official title: A Triple Cohort, Prospective Observational Study to Analyze Type 2 Diabetes Glucose Biomarkers With a Continuous Glucose Monitoring System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Type 2 Diabetes Mellitus
Lead sponsor: Klick Inc.
Sponsor class: INDUSTRY
Collaborators: name: Mittal Global Clinical Trial Services
First posted: 2020-08-27
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy adults and those at risk of developing prediabetes or type 2 diabetes.

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.


Eligibility criteria: 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)

Primary outcomes:
measure: 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).
timeFrame: The device is worn for 14 days on each participant
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Klick Inc.
state: Ontario
Study officials:
References: