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

Klick Inc.

Status: Completed

Conditions: Healthy; Type 2 Diabetes Mellitus

Treatments: Device: Abbott Freestyle Libre Pro

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT04529239

036033

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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)

Trial design

150 participants in 3 patient groups

Low to Moderate Risk

Description:

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.

Treatment:

Device: Abbott Freestyle Libre Pro

High Risk

Description:

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.

Treatment:

Device: Abbott Freestyle Libre Pro

Very High Risk

Description:

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.

Treatment:

Device: Abbott Freestyle Libre Pro