Artificial Intelligence to Improve Cardiometabolic Risk Evaluation Using CT Scans (ACRE-CT)

Caristo Diagnostics

Status: Not yet enrolling

Conditions: Diabetes Mellitus; Pre-diabetes

Treatments: Diagnostic Test: Oral Glucose Tolerance Test

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05058690

ACRE-CT

Details and patient eligibility

About

To validate the ability of the FatHealth algorithm to identify individuals with pre-diabetes and with type 2 diabetes mellitus

Full description

This multicentre prospective study will evaluate the ability of the FatHealth technology to correctly identify individuals with pre-diabetes and diabetes, validating the technology against the current gold-standard diagnostic method, oral glucose tolerance testing.

Participants will be individuals who have undergone a CT scan of the chest (coronary CT angiogram [CCTA] or CT chest) as part of observational cohort studies.

Participants will be invited for an oral glucose tolerance test (OGTT), which is the current gold-standard method for detecting pre-diabetes and diabetes mellitus. All patients must have an evaluable OGTT. The study population will include:

1. Approximately 90 individuals who had a CCTA as part of their clinical care (45 identified as having an abnormal FatHealth algorithm calculation and 45 with a normal FatHealth algorithm calculation) will undergo OGTT which is evaluable; and
2. Approximately 90 individuals who had a chest CT as part of their clinical care (45 identified as having an abnormal FatHealth algorithm calculation and 45 with a normal FatHealth algorithm calculation) will undergo OGTT which is evaluable.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participant is willing and able to give informed consent for participation in the study. Male or Female, aged 18 to 80 years.

• Body mass index (BMI) ≥ 25kg/m2

• FatHealth status assessed as the following:

  • Elevated FatHealth status (50% of participants)
  • Non-elevated FatHealth status (50% of participants)

Exclusion criteria

• Participant is unable or unwilling to give informed consent
• Participant is unable to understand English language
• Confirmed diagnosis of diabetes mellitus treated with oral medication or Insulin

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 2 patient groups

Individuals who had a CCTA as part of their clinical care

Experimental group

Description:

Approximately 90 individuals who had a CCTA as part of their clinical care (45 identified as having an abnormal FatHealth algorithm calculation and 45 with a normal FatHealth algorithm calculation) will undergo OGTT which is evaluable;

Treatment:

Diagnostic Test: Oral Glucose Tolerance Test

Individuals who had a chest CT as part of their clinical care

Experimental group

Description:

Approximately 90 individuals who had a chest CT as part of their clinical care (45 identified as having an abnormal FatHealth algorithm calculation and 45 with a normal FatHealth algorithm calculation) will undergo OGTT which is evaluable.

Treatment:

Diagnostic Test: Oral Glucose Tolerance Test